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    Pneumococcal Vaccines

    DEA CLASS

    Rx

    DESCRIPTION

    Protects against serious pneumococcal infection
    Contain capsular polysaccharides from S. pneumoniae; 2 types available, 13-valent conjugated vaccine (Prevnar 13) and non-conjugated 23-valent vaccine (Pneumovax 23)
    Only Prevnar 13 is immunogenic in children < 2 years of age

    COMMON BRAND NAMES

    Pneumovax 23, Prevnar 13

    HOW SUPPLIED

    Pneumovax 23 Intramuscular Inj Sol
    Pneumovax 23 Subcutaneous Inj Sol
    Prevnar 13 Intramuscular Inj Susp

    DOSAGE & INDICATIONS

    For pneumococcal prophylaxis .
    For routine prophylaxis of infants and children as part of the primary childhood immunization schedule.
    Intramuscular dosage (Prevnar 13 only)

    NOTE: Infants and children who have received one or more doses of Prevnar should complete the 4-dose immunization series with Prevnar 13. Infants and children 59 months of age and younger who have not yet begun the pneumococcal vaccine series should complete the entire series using Prevnar 13.

    Infants 6 weeks to 6 months of age at first dose

    0.5 mL/dose IM for a total of 4 doses. Give the first 3 doses at intervals of 4 to 8 weeks, ideally at 2, 4, and 6 months of age; the first dose can be given as young as 6 weeks. The fourth dose is given as a booster between 12 to 15 months of age and at least 8 weeks after the third dose.

    Infants 7 to 11 months of age at first dose

    0.5 mL/dose IM for 3 doses. Give the first 2 doses 4 to 8 weeks apart. The third dose should ideally be given at 12 to 15 months; it must separated from the second dose by 2 months or more and given after the first birthday.

    Children 12 to 23 months of age at first dose or received primary vaccination with PCV7

    0.5 mL/dose IM for 2 doses administered at least 2 months apart. For children 14 to 23 months of age who have received an age appropriate series of 7-valent PCV (PCV7), give 1 dose of PCV13 at least 8 weeks after the final dose of PCV7.

    Children 24 to 71 months of age at first dose or received primary vaccination with PCV7

    0.5 mL/dose IM for 1 dose prior to the sixth birthday. For children who have received an age appropriate series of 7-valent PCV (PCV7), give 1 dose of PCV13 at least 8 weeks after the final dose of PCV7. The manufacturer recommends a single dose for patients 15 to 71 months of age whereas the ACIP recommends a single dose for all children 14 to 59 months of age and for all children 60 to 71 months of age with underlying medical conditions.

    For routine prophylaxis of healthy adults, adolescents, and children 6 years and older.
    Intramuscular or Subcutaneous dosage (Pneumovax 23 only)
    Adults 50 to 64 years

    0.5 mL IM or subcutaneously as a single dose.

    Intramuscular dosage (Prevnar 13 only)
    Adults 18 to 64 years

    0.5 mL IM as a single dose.

    Children and Adolescents 6 to 17 years

    0.5 mL IM as a single dose. If Prevnar was previously administered, wait at least 8 weeks before giving Prevnar 13.

    For prophylaxis of patients at least 2 years of age with risk factors.
    Intramuscular dosage (Prevnar 13)
    Children 24 to 71 months of age with underlying chronic disease or immunosuppression†

    If 3 doses of PCV (PCV7 or PCV13) were received previously, give 0.5 mL IM as a single dose at least 8 weeks after the last PCV dose. If less than 3 doses of PCV were received previously, give 2 doses at least 8 weeks apart. Patients who have received a dose of Pneumovax 23 should also receive the recommended Prevnar 13 doses. If not previously received, a dose of Pneumovax 23 is needed at least 8 weeks after the last Prevnar or Prevnar 13 dose.

    Children and Adolescents 6 years and older

    Give 0.5 mL IM as a single dose to patients previously unvaccinated with PCV13; if the patient has previously received PCV7, at least 8 weeks should elapse before administration of the single dose of PCV13.

    Children and Adolescents 6 years and older who are PPSV23-naive

    Give one 0.5 mL dose IM of PCV13 first, followed at least 8 weeks later by a dose of PPSV23.

    Children and Adolescents 6 years and older who received previous vaccination with PPSV23

    Give one 0.5 mL dose IM of PCV13 at least 8 weeks after last PPSV23 dose, even if the patient has previously received PCV7.

    Intramuscular or Subcutaneous dosage (Pneumovax 23 only)
    Immunocompetent Adults with risk factors

    0.5 mL IM or subcutaneously. A one-time revaccination after 5 years is recommended for persons with chronic renal failure or nephrotic syndrome; functional or anatomic asplenia; and for persons with immunocompromising conditions. Risk factors for pneumococcal disease include concurrent alcoholism, cigarette smoking, cerebrospinal fluid leaks, chronic cardiovascular disease (i.e., CHF, cardiomyopathy), diabetes mellitus, cochlear implants, chronic liver disease (i.e., cirrhosis), chronic pulmonary disease (i.e., COPD or asthma), functional or anatomic asplenia, immunocompromising conditions including chronic renal failure or nephrotic syndrome, or those living in special environments (e.g., residents of nursing homes or other long-term care facilities). Routine use of pneumococcal polysaccharide vaccination is not recommended for Alaska Natives or American Indians unless they have underlying medical conditions that are indications for Pneumovax. Public health authorities may consider recommending Pneumovax for Alaska Natives and American Indians 50 to 64 years of age who are living in areas of increased risk of invasive pneumococcal disease.

    HIV positive Adults

    0.5 mL IM or subcutaneously; revaccination is recommended 5 years or more after the original dose. If prior vaccination status is unknown, administer the vaccine. Administer at least 8 weeks after PCV13 in patients with a CD4 count 200 cells/mm3 or more. Vaccination may be offered at least 8 weeks after PCV13 to those with CD4 counts less than 200 cells/mm3 or patients can defer until after the CD4 count is 200 cells/mm3 or more. The recommendation to vaccinate is increasingly pertinent because of the rising incidence of infections with drug-resistant strains of S. pneumoniae.

    Other Immunocompromised Adults

    0.5 mL IM or subcutaneously. Revaccination is recommended 5 years or more after the original dose. If prior vaccination status is unknown, administer the vaccine. 'Immunocompromised' includes patients with neoplastic disease (e.g., Hodgkin's disease, leukemia, lymphoma, multiple myeloma or other generalized malignancy); chronic renal failure or nephrotic syndrome; patients receiving immunosuppressive drug therapy (e.g., chemotherapy or corticosteroid therapy); recipients of an organ or bone marrow transplant; or congenital immunodeficiencies.

    Children and Adolescents 2 years and older

    0.5 mL IM or subcutaneously as a single dose at least 8 weeks after the last dose of PCV (PCV7 or PCV13). In patients with anatomic or functional asplenia (including sickle cell disease) or other immunocompromising conditions, give 1 additional dose of 0.5 mL IM or subcutaneously after 5 years (Max: 2 doses of PPSV23 before age 65 years). For HIV-infected adolescents with a CD4 count less than 200 cells/mm3, the PPV23 can be offered; however, it may be beneficial to wait until the CD4 count increases to more than 200 cells/mm3.

    Children and Adolescents 6 years and older who are PCV13- and PPSV23-naive

    0.5 mL IM or subcutaneously of PPSV23 once at least 8 weeks after PCV13 administration.

    For prophylaxis in patients who will undergo elective splenectomy, cochlear implant surgery, organ transplantation, chemotherapy, or other immunosuppressive therapy.
    NOTE: If vaccination before the procedure is not feasible, give the vaccine as soon as possible after surgery.
    Intramuscular or Subcutaneous dosage (Pneumovax 23 only)
    Adults, previously unvaccinated

    0.5 mL IM or subcutaneously given at least 2 weeks before elective splenectomy, cochlear implant surgery, organ transplantation, chemotherapy, or other immunosuppressive therapy. If possible, each candidate for a cochlear implant needs to be up-to-date on age-appropriate pneumococcal vaccination at least 2 weeks before surgery.

    Children and Adolescents older than 2 years, previously unvaccinated

    0.5 mL IM or subcutaneously given at least 2 weeks before elective splenectomy, cochlear implant surgery, organ transplantation, chemotherapy, or other immunosuppressive therapy. If possible, each candidate for a cochlear implant needs to be up-to-date on age-appropriate pneumococcal vaccination at least 2 weeks before surgery.

    For routine prophylaxis of healthy geriatric patients.
    NOTE: The Advisory Committee on Immunization Practices (ACIP) recommends all patients at least 65 years of age receive routine vaccination with both Prevnar 13 and Pneumovax 23.
    Intramuscular dosage (Prevnar 13)
    Geriatric patients who are pneumococcal vaccine-naive

    0.5 mL IM; give Prevnar 13 first; then preferably 6 to 12 months later, give Pneumovax 23. Doses can be administered 8 weeks apart if necessary.

    Geriatric patients who have previously received Pneumovax 23 at age 65 years and older

    0.5 mL IM Prevnar 13 given at least 1 year after the last Pneumovax 23 dose.

    Geriatric patients who have previously received Pneumovax 23 before age 65 years

    0.5 mL IM Prevnar 13 given at least 1 year after the last Pneumovax 23 dose. Then an additional Pneumovax 23 dose given 6 to 12 months (minimum acceptable interval of 8 weeks) after the Prevnar 13 dose and at least 5 years after the most recent Pneumovax 23 dose.

    Intramuscular or Subcutaneous dosage (Pneumovax 23)
    Geriatric patients who are pneumococcal vaccine naive

    0.5 mL Pneumovax 23 given IM or subcutaneously at least 6 to 12 months after (minimum acceptable interval of 8 weeks) Prevnar 13 administration.

    Geriatric patients who have previously received Pneumovax 23 before age 65 years

    Give Prevnar 13 at least 1 year after the last Pneumovax 23 dose. Then give an additional 0.5 mL IM or subcutaneous dose of Pneumovax 23 at least 6 to 12 months (minimum acceptable interval of 8 weeks) after the Prevnar 13 dose and at least 5 years after the most recent Pneumovax 23 dose.

    For prophylaxis of adults 19 years and older with immunocompromising conditions, functional or anatomic asplenia, cerebrospinal fluid leaks, or cochlear implants.
    NOTE: The Advisory Committee on Immunization Practices (ACIP) recommends adults 19 years and older with immunocompromising conditions, functional or anatomic asplenia, cerebrospinal fluid leaks, or cochlear implants receive vaccination with both Prevnar 13 and Pneumovax 23.
    Intramuscular dosage (Prevnar 13)
    Adults 19 years and older with risk factors who are pneumococcal vaccine naive

    0.5 mL IM dose of Prevnar 13 first, followed at least 8 weeks later by Pneumovax 23. A second Pneumovax 23 vaccination is recommended 5 years after the first dose for adults aged 19 to 64 years with immunocompromising conditions or functional or anatomic asplenia. Additionally, geriatric patients who received original vaccination before age 65, should receive another Pneumovax 23 dose at or after age 65 years if at least 5 years have elapsed since the previous dose.

    Adults 19 years and older with risk factors who have previously received Pneumovax 23

    0.5 mL IM Prevnar 13 dose at least 1 year after the last Pneumovax 23 dose. For those individuals requiring additional Pneumovax 23 doses, the vaccination should occur no sooner than 8 weeks after the Prevnar 13 dose and 5 years after the most recent Pneumovax 23 dose.

    Intramuscular or Subcutaneous dosage (Pneumovax 23)
    Adults 19 years and older with risk factors who are pneumococcal vaccine naive

    0.5 mL Pneumovax 23 given IM or subcutaneously at least 8 weeks after Prevnar 13 administration. A second Pneumovax 23 vaccination is recommended 5 years after the first dose for adults aged 19 to 64 years with immunocompromising conditions or functional or anatomic asplenia. Additionally, geriatric patients who received original vaccination before age 65, should receive another Pneumovax 23 dose at or after age 65 years if at least 5 years have elapsed since the previous dose.

    For otitis media prophylaxis in infants and children younger than 6 years.
    Intramuscular dosage (Prevnar 13 only)
    Children 24 to 71 months of age at first dose or received primary vaccination with PCV7

    0.5 mL/dose IM for 1 dose prior to the sixth birthday. For children who have received an age appropriate series of 7-valent PCV (PCV7), give 1 dose of PCV13 at least 8 weeks after the final dose of PCV7. The manufacturer recommends a single dose for patients 15 to 71 months of age whereas the ACIP recommends a single dose for all children 14 to 59 months of age and for all children 60 to 71 months of age with underlying medical conditions.

    Children 12 to 23 months of age at first dose or received primary vaccination with PCV7

    0.5 mL/dose IM for 2 doses administered at least 2 months apart. For children 14 to 23 months of age who have received an age appropriate series of 7-valent PCV (PCV7), give 1 dose of PCV13 at least 8 weeks after the final dose of PCV7.

    Infants 7 to 11 months of age at first dose

    0.5 mL/dose IM for 3 doses. Give the first 2 doses 4 to 8 weeks apart. The third dose should ideally be given at 12 to 15 months; it must separated from the second dose by 2 months or more and given after the first birthday.

    Infants 6 weeks to 6 months of age at first dose

    0.5 mL/dose IM for a total of 4 doses. Give the first 3 doses at intervals of 4 to 8 weeks, ideally at 2, 4, and 6 months of age; the first dose can be given as young as 6 weeks. The fourth dose is given as a booster between 12 to 15 months of age and at least 8 weeks after the third dose.

    MAXIMUM DOSAGE

    Adults

    For Pneumovax 23, 0.5 mL/dose IM or SC; For Prevnar 13, 0.5 mL/dose IM.

    Geriatric

    For Pneumovax 23, 0.5 mL/dose IM or SC; For Prevnar 13, 0.5 mL/dose IM.

    Adolescents

    For Prevnar 13, 0.5 mL/dose IM; For Pneumovax 23, 0.5 mL/dose IM or SC.

    Children

    2 to 12 years: For Prevnar 13, 0.5 mL/dose IM; For Pneumovax 23, 0.5 mL/dose IM or SC.
    1 year: For Prevnar 13, 0.5 mL/dose IM; safety and efficacy of Pneumovax 23 not established.

    Infants

    6 weeks and older: For Prevnar 13, 0.5 mL/dose IM; safety and efficacy of Pneumovax 23 not established.
    Younger than 6 weeks: Do not use.

    DOSING CONSIDERATIONS

    Hepatic Impairment

    Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

    Renal Impairment

    Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

    ADMINISTRATION

    Health care professionals administering vaccines should take appropriate precautions to prevent allergic reactions in vaccine recipients (see Contraindications).
    Inform the patient, parent, guardian, or responsible adult of the benefits and risks of the vaccine. Provide the Vaccine Information Statements from the manufacturer to the recipient or guardian before each immunization. The action is required by the National Childhood Vaccine Injury Act of 1986.
    Per U.S. federal law, record the manufacturer and lot number of the vaccine; date of administration; and the name, address, and title of the person who administered the vaccine in the recipient's permanent medical record.

    Injectable Administration

    Visually inspect parenteral products for particulate matter and discoloration prior to administration.
    Prevnar 13: Administer by intramuscular (IM) injection only.
    Pneumovax 23: May give intramuscularly (IM) or subcutaneously (SC).
     
    Prevnar 13 preparation:
    No dilution or reconstitution is necessary. Aseptic technique must be observed. Use a separate syringe and needle for each patient.
    Shake the vial well immediately before use to re-suspend the vaccine into a homogenous suspension. Do not use the vaccine if it cannot be re-suspended.
    Do not mix with any other vaccine in the same syringe.
     
    Pneumovax 23 vaccine preparation:
    No dilution or reconstitution is necessary. Aseptic technique must be observed. Use a separate syringe and needle for each patient.
    The vaccine is a clear and colorless solution. Do not use if discolored or contains a precipitate.

    Intramuscular Administration

    Pneumovax 23 or Prevnar 13:
    Adults: Inject IM into the deltoid muscle or into the anterolateral thigh muscle. Aspirate prior to injection to avoid injection into a blood vessel. If a vessel is penetrated, withdraw the needle, and use a new syringe and needle at a different injection site.
    Toddlers and young children: Inject IM into the deltoid muscle of the upper arm. Aspirate prior to injection to avoid injection into a blood vessel. If a vessel is penetrated, withdraw the needle, and use a new syringe and needle at a different injection site. Do not inject in the gluteal area or other areas where there may be a major nerve trunk and/or blood vessel.
    Infants: Inject IM into the anterolateral thigh muscle. Aspirate prior to injection to avoid injection into a blood vessel. If a vessel is penetrated, withdraw the needle, and use a new syringe and needle at a different injection site. Do not inject in the gluteal area or other areas where there may be a major nerve trunk and/or blood vessel.

    Subcutaneous Administration

    Pneumovax 23 only:
    Inject subcutaneously into the outer aspect of the upper arm. Care should be taken to avoid intradermal injection.

    STORAGE

    Pneumovax 23:
    - Discard product if it contains particulate matter, is cloudy, or discolored
    - Store between 36 to 46 degrees F
    Prevnar:
    - Protect from freezing
    - Refrigerate (between 36 and 46 degrees F)
    Prevnar 13 :
    - Discard if product has been frozen
    - Do not freeze
    - Refrigerate (between 36 and 46 degrees F)

    CONTRAINDICATIONS / PRECAUTIONS

    General Information

    Pneumococcal vaccines are contraindicated in patients who have had a previous hypersensitivity reaction to the vaccine to be administered or to any components of the vaccine. Prevnar 13 is contraindicated in patients who have had a hypersensitivity reaction to any diphtheria toxoid-containing vaccine. Before the administration of any dose, precautions should be taken to prevent allergic and other adverse reactions. Specifically, review the patient's immunization history for previous allergic or adverse reactions. Epinephrine and other appropriate medications used to manage anaphylaxis must be readily available.

    Intravenous administration

    Do not give the pneumococcal vaccines via intravenous administration. Prior to administration, health care personnel should inform the patient, parent, guardian, or responsible adult of the vaccine's benefits and risks. This should include the provision of the vaccine information statement from the manufacturer. The responsible adult should report any adverse reaction following vaccine administration to the health care provider. The US Department of Health and Human Services has established a Vaccine Adverse Event Reporting System (VAERS) to accept all reports of suspected adverse events after the administration of any vaccine. This includes, but is not limited to, the reporting of events required by the National Childhood Vaccine Injury Act of 1986. The toll-free number for VAERS is (800) 822—7967.

    Fever

    Pneumococcal vaccine can cause fever, so it should not be given to patients with fever of unknown etiology. During the 2010-2011 influenza season, there were increased reports of febrile seizures in children 6 months to 4 years of age receiving the inactivated influenza vaccine and the conjugated pneumococcal vaccine (Prevnar 13) concomitantly. At this time the CDC is not recommending any changes to the childhood immunization schedule, and based on the benefits of timely vaccination against these diseases, they are also not recommending that the vaccines be separated into multiple healthcare visits. The CDC found that febrile seizures were rare in this group with approximately one additional seizure occurring for every 2000—3000 children vaccinated. Febrile seizures occurred most commonly in children 12—23 months of age who received both vaccines at the same healthcare visit.

    Idiopathic thrombocytopenic purpura (ITP)

    Use pneumococcal vaccine with caution in patients with idiopathic thrombocytopenic purpura (ITP) because pneumococcal vaccination has been associated with relapse of this condition in previously stabilized patients.

    Cardiac disease, pulmonary disease

    Use pneumococcal vaccine cautiously in patients with severe cardiac disease or pulmonary disease because anaphylactoid reactions may not be well tolerated in these individuals.

    Chemotherapy, Hodgkin's disease, immunosuppression, organ transplant, radiation therapy

    Pneumococcal vaccine should be given at least 2 weeks before elective splenectomy, organ transplant, immunosuppressive therapy, or chemotherapy. Patients with severe immunosuppression can have a suboptimal antibody response to vaccination. The formerly-available 12 valent pneumococcal vaccine was less immunogenic in patients with Hodgkin's disease who had received intensive chemo- or radio-therapy. Furthermore, the 12 valent vaccine has been shown to decrease preexisting antibody concentrations to other strains of pneumococcus. Because of this, the 23 valent pneumococcal vaccine is not indicated in Hodgkin's disease patients who have received intensive chemotherapy and/or radiation therapy. In patients (age 2 to 71 years) who received an allogeneic hematopoietic stem cell transplant 3 to 6 months prior to a series of PCV13 vaccines, sera was obtained approximately one month after each vaccination. Immune responses (IgG GMCs) were numerically higher after the first dose compared with baseline and were, similarly, numerically higher after each subsequent dose compared to the previous dose.

    Acquired immunodeficiency syndrome (AIDS), human immunodeficiency virus (HIV) infection

    Compared to healthy individuals, patients with human immunodeficiency virus (HIV) infection generally have lower vaccine-induced antibody concentrations, which are proportional to the severity of infection (i.e., CD4+ counts) and are lowest in those with acquired immunodeficiency syndrome (AIDS). Pneumococcal vaccination should be offered to patients with HIV infection who have not received it in the previous 5 years and have CD4+ counts >= 200 cells/mm3. It should be offered to those with CD4+ counts < 200 cells/mm3, although there may be diminished efficacy. Consider revaccination in those who had CD4+ counts < 200 cells/mm3 at the time of immunization, and currently have > 200 cells/mm3 on HAART. Vaccination is increasingly pertinent with the rising incidence of drug-resistant S. pneumoniae infections. Pneumococcal vaccine can be administered during pregnancy. In studies evaluating antibody response to the pneumococcal conjugate vaccine (PCV13) in children and adults with HIV infection, antipneumococcal opsonophagocytic activity (OPA) geometric mean antibody titers (GMTs) for all vaccine serotypes were higher than pre-vaccination concentrations after the first dose, and were generally comparable after subsequent doses.

    Geriatric, vitamin B12 deficiency

    In a study of 30 geriatric patients, antibody response to pneumococcal vaccine was lower in the 15 subjects with preexisting vitamin B12 deficiency than in the other 15 subjects. Although the effect of vitamin B12 supplementation was not assessed in this study and therefore no recommendation can be made regarding the need for supplementation prior to vaccination, clinicians should be alert to the possibility of impaired antibody response in these patients.

    Children, infants

    The efficacy of pneumococcal 23-valent vaccine (Pneumovax 23) is reduced in children under 5 years, and it is not recommended in infants and children under 2 years of age. The conjugated pneumococcal vaccine (Prevnar 13) is safe and effective for routine pneumococcal prophylaxis in healthy infants > 6 weeks of age and children < 18 years of age. However, safety and efficacy data are limited regarding use of Prevnar 13 in immunocompromised pediatric patients. Immunocompromised patients may display reduced antibody response to the Prevnar 13; therefore, Prevnar 13 does not replace vaccination with Pneumovax 23 in children >= 2 years with sickle cell disease, asplenia, chronic illnesses, or other immune-compromising conditions. In addition, apnea has occurred in some premature infants after intramuscular injections (see prematurity precaution); therefore, carefully consider the possible risks and benefits prior to intramuscular vaccine administration in premature infants. During the 2010-2011 influenza season, there were increased reports of febrile seizures in children 6 months to 4 years of age receiving the inactivated influenza vaccine and the conjugated pneumococcal vaccine (Prevnar 13) concomitantly. At this time, the CDC is not recommending any changes to the childhood immunization schedule, and based on the benefits of timely vaccination against these diseases, separating the vaccines into multiple healthcare visits also is not being recommended. The CDC found that febrile seizures were rare in this group with approximately one additional seizure occurring for every 2000—3000 children vaccinated. Febrile seizures occurred most commonly in children 12—23 months of age who received both vaccines at the same healthcare visit.

    Neonates, premature neonates

    Apnea has occurred in some premature neonates and infants after intramuscular injections. The risks and benefits of intramuscular injections, including vaccination with the pneumococcal vaccine, must be considered on an individual patient basis. In addition, health care providers are advised that immunogenicity may be lower in premature neonates. In one study, premature neonates (< 37 weeks gestational age; n = 100) receiving Prevnar 13 on a non-United States 4 dose schedule displayed lower serotype-specific IgG antibody responses after the 3rd and 4th doses when compared to term neonates (>= 37 weeks gestational age; n = 100). Safety and efficacy have not been established for Prevnar 13 in infants < 6 weeks of age; Pneumovax 23 is not recommended for use in infants.

    Pregnancy

    Pneumovax 23 is classified as FDA pregnancy risk category C; available data on Prevnar 13 administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. No adequate and well controlled studies have been conducted in pregnant women. In rabbits, a dose approximately 20 times the human dose, given prior to mating and during gestation, did not impair female fertility and no fetal malformations were noted. According to the Advisory Committee on Immunization Practices (ACIP), administration of inactivated vaccines to pregnant women have not resulted in adverse effects in the fetus. The ACIP recommends vaccination during pregnancy when the likelihood of disease exposure is high, potential infection would cause harm to mother or fetus, and when the vaccine is unlikely to cause harm. The manufacturer recommends administration of the vaccine only if clearly needed.

    Breast-feeding

    Data are limited regarding use of the pneumococcal vaccine during breast-feeding and its' excretion in human breast milk is unknown. The manufacturer recommends caution when administering to nursing mothers; however according to the Advisory Committee on Immunization Practices (ACIP), inactivated vaccines pose no risk for mothers or their infants. Additionally, breast-feeding does not adversely affect immunization; limited data suggest breast-feeding may enhance the immune response to certain vaccine antigens. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, health care providers are encouraged to report the adverse effect to the FDA.

    Anticoagulant therapy, coagulopathy, hemophilia, thrombocytopenia, vitamin K deficiency

    The pneumococcal vaccine, polyvalent is indicated for intramuscular administration. Therefore, the vaccine should be given cautiously to persons receiving anticoagulant therapy. Also, patients with thrombocytopenia, coagulopathy (e.g., hemophilia), other bleeding disorders, or vitamin K deficiency should be monitored closely for bleeding at the IM injection site. Steps to avoid hematoma formation are recommended.

    ADVERSE REACTIONS

    Severe

    seizures / Delayed / 0-1.0
    bronchospasm / Rapid / 0-1.0
    aplastic anemia / Delayed / Incidence not known
    hemolytic anemia / Delayed / Incidence not known
    Guillain-Barre syndrome / Delayed / Incidence not known
    serum sickness / Delayed / Incidence not known
    erythema multiforme / Delayed / Incidence not known
    anaphylactic shock / Rapid / Incidence not known
    angioedema / Rapid / Incidence not known
    anaphylactoid reactions / Rapid / Incidence not known

    Moderate

    erythema / Early / 10.8-70.0
    dyspnea / Early / 0-1.0
    lymphadenopathy / Delayed / Incidence not known
    thrombocytopenia / Delayed / Incidence not known
    Arthus reaction / Early / Incidence not known
    hypotonia / Delayed / Incidence not known

    Mild

    irritability / Delayed / 14.3-85.6
    headache / Early / 15.9-81.4
    fatigue / Early / 13.2-80.5
    drowsiness / Early / 2.6-71.5
    myalgia / Early / 11.9-61.8
    anorexia / Delayed / 10.4-56.7
    insomnia / Early / 6.8-47.7
    chills / Rapid / 2.7-38.1
    fever / Early / 0.3-36.5
    arthralgia / Delayed / 9.7-31.5
    infection / Delayed / 0.5-2.6
    nausea / Early / 1.8-1.8
    pruritus / Rapid / 0.2-1.6
    ecchymosis / Delayed / 1.1-1.1
    dyspepsia / Early / 1.1-1.1
    pharyngitis / Delayed / 0.4-1.1
    urticaria / Rapid / 0-1.0
    back pain / Delayed / 0.9-0.9
    rash (unspecified) / Early / 1.0
    diarrhea / Early / 0.7
    vomiting / Early / 0.9
    injection site reaction / Rapid / Incidence not known
    malaise / Early / Incidence not known
    petechiae / Delayed / Incidence not known
    purpura / Delayed / Incidence not known
    leukocytosis / Delayed / Incidence not known
    paresthesias / Delayed / Incidence not known
    pallor / Early / Incidence not known
    dizziness / Early / Incidence not known
    syncope / Early / Incidence not known

    DRUG INTERACTIONS

    Acetaminophen: Concomitant administration of antipyretics, such as acetaminophen, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Acetaminophen; Aspirin, ASA; Caffeine: Concomitant administration of antipyretics, such as acetaminophen, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen. Concomitant administration of antipyretics, such as aspirin, ASA, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.[
    Acetaminophen; Butalbital: Concomitant administration of antipyretics, such as acetaminophen, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Acetaminophen; Butalbital; Caffeine: Concomitant administration of antipyretics, such as acetaminophen, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Acetaminophen; Butalbital; Caffeine; Codeine: Concomitant administration of antipyretics, such as acetaminophen, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Acetaminophen; Caffeine; Dihydrocodeine: Concomitant administration of antipyretics, such as acetaminophen, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Acetaminophen; Caffeine; Magnesium Salicylate; Phenyltoloxamine: Concomitant administration of antipyretics, such as acetaminophen, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Acetaminophen; Caffeine; Phenyltoloxamine; Salicylamide: Concomitant administration of antipyretics, such as acetaminophen, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Acetaminophen; Chlorpheniramine; Dextromethorphan; Phenylephrine: Concomitant administration of antipyretics, such as acetaminophen, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Acetaminophen; Chlorpheniramine; Dextromethorphan; Pseudoephedrine: Concomitant administration of antipyretics, such as acetaminophen, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Acetaminophen; Chlorpheniramine; Phenylephrine; Phenyltoloxamine: Concomitant administration of antipyretics, such as acetaminophen, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Acetaminophen; Codeine: Concomitant administration of antipyretics, such as acetaminophen, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Acetaminophen; Dextromethorphan: Concomitant administration of antipyretics, such as acetaminophen, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Acetaminophen; Dextromethorphan; Doxylamine: Concomitant administration of antipyretics, such as acetaminophen, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Acetaminophen; Dextromethorphan; Guaifenesin; Phenylephrine: Concomitant administration of antipyretics, such as acetaminophen, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Acetaminophen; Dextromethorphan; Phenylephrine: Concomitant administration of antipyretics, such as acetaminophen, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Acetaminophen; Dextromethorphan; Pseudoephedrine: Concomitant administration of antipyretics, such as acetaminophen, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Acetaminophen; Dichloralphenazone; Isometheptene: Concomitant administration of antipyretics, such as acetaminophen, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Acetaminophen; Diphenhydramine: Concomitant administration of antipyretics, such as acetaminophen, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Acetaminophen; Guaifenesin; Phenylephrine: Concomitant administration of antipyretics, such as acetaminophen, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Acetaminophen; Hydrocodone: Concomitant administration of antipyretics, such as acetaminophen, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Acetaminophen; Oxycodone: Concomitant administration of antipyretics, such as acetaminophen, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Acetaminophen; Pentazocine: Concomitant administration of antipyretics, such as acetaminophen, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Acetaminophen; Propoxyphene: Concomitant administration of antipyretics, such as acetaminophen, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Acetaminophen; Pseudoephedrine: Concomitant administration of antipyretics, such as acetaminophen, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Acetaminophen; Tramadol: Concomitant administration of antipyretics, such as acetaminophen, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Aspirin, ASA: Concomitant administration of antipyretics, such as aspirin, ASA, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.[
    Aspirin, ASA; Butalbital; Caffeine: Concomitant administration of antipyretics, such as aspirin, ASA, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.[
    Aspirin, ASA; Butalbital; Caffeine; Codeine: Concomitant administration of antipyretics, such as aspirin, ASA, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.[
    Aspirin, ASA; Caffeine; Dihydrocodeine: Concomitant administration of antipyretics, such as aspirin, ASA, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.[
    Aspirin, ASA; Carisoprodol: Concomitant administration of antipyretics, such as aspirin, ASA, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.[
    Aspirin, ASA; Carisoprodol; Codeine: Concomitant administration of antipyretics, such as aspirin, ASA, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.[
    Aspirin, ASA; Dipyridamole: Concomitant administration of antipyretics, such as aspirin, ASA, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.[
    Aspirin, ASA; Omeprazole: Concomitant administration of antipyretics, such as aspirin, ASA, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.[
    Aspirin, ASA; Oxycodone: Concomitant administration of antipyretics, such as aspirin, ASA, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.[
    Aspirin, ASA; Pravastatin: Concomitant administration of antipyretics, such as aspirin, ASA, may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.[
    Celecoxib: Concomitant administration of antipyretics, such as nonsteroidal antiinflammatory drugs (NSAIDS), may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Diclofenac: Concomitant administration of antipyretics, such as nonsteroidal antiinflammatory drugs (NSAIDS), may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Diclofenac; Misoprostol: Concomitant administration of antipyretics, such as nonsteroidal antiinflammatory drugs (NSAIDS), may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Diflunisal: Concomitant administration of antipyretics, such as nonsteroidal antiinflammatory drugs (NSAIDS), may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Diphenhydramine; Ibuprofen: Concomitant administration of antipyretics, such as nonsteroidal antiinflammatory drugs (NSAIDS), may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Esomeprazole; Naproxen: Concomitant administration of antipyretics, such as nonsteroidal antiinflammatory drugs (NSAIDS), may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Etodolac: Concomitant administration of antipyretics, such as nonsteroidal antiinflammatory drugs (NSAIDS), may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Famotidine; Ibuprofen: Concomitant administration of antipyretics, such as nonsteroidal antiinflammatory drugs (NSAIDS), may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Fenoprofen: Concomitant administration of antipyretics, such as nonsteroidal antiinflammatory drugs (NSAIDS), may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Flurbiprofen: Concomitant administration of antipyretics, such as nonsteroidal antiinflammatory drugs (NSAIDS), may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Hydrocodone; Ibuprofen: Concomitant administration of antipyretics, such as nonsteroidal antiinflammatory drugs (NSAIDS), may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Ibuprofen: Concomitant administration of antipyretics, such as nonsteroidal antiinflammatory drugs (NSAIDS), may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Ibuprofen; Oxycodone: Concomitant administration of antipyretics, such as nonsteroidal antiinflammatory drugs (NSAIDS), may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Ibuprofen; Pseudoephedrine: Concomitant administration of antipyretics, such as nonsteroidal antiinflammatory drugs (NSAIDS), may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Indomethacin: Concomitant administration of antipyretics, such as nonsteroidal antiinflammatory drugs (NSAIDS), may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Influenza Virus Vaccine: Higher risk of fever has been noted with simultaneous administration of trivalent inactivated influenza vaccine (TIV) and pneumococcal vaccine, polyvalent. An observational study found that that pediatric patients aged 6 to 23 months receiving simultaneous trivalent inactivated influenza vaccine (TIV) and 13-valent pneumococcal vaccine (PCV13) were 2.7 times (CI 1.3 to 5.6) more likely to have a day 0 to 1 temperature of >= 100.4 degrees F than those receiving TIV without PCV13. A temperature of 102.2 degrees F was 3.92 times (CI 1.09 to 14.14) more likely to occur on day 0 to 1 when TIV and PCV13 are administered together vs. TIV alone. If concomitant administration of other vaccines is required with the influenza virus vaccine, the vaccines should be administered at different injection sites.
    Intranasal Influenza Vaccine: Higher risk of fever has been noted with simultaneous administration of trivalent inactivated influenza vaccine (TIV) and pneumococcal vaccine, polyvalent. An observational study found that that pediatric patients aged 6 to 23 months receiving simultaneous trivalent inactivated influenza vaccine (TIV) and 13-valent pneumococcal vaccine (PCV13) were 2.7 times (CI 1.3 to 5.6) more likely to have a day 0 to 1 temperature of >= 100.4 degrees F than those receiving TIV without PCV13. A temperature of 102.2 degrees F was 3.92 times (CI 1.09 to 14.14) more likely to occur on day 0 to 1 when TIV and PCV13 are administered together vs. TIV alone. If concomitant administration of other vaccines is required with the influenza virus vaccine, the vaccines should be administered at different injection sites.
    Ketoprofen: Concomitant administration of antipyretics, such as nonsteroidal antiinflammatory drugs (NSAIDS), may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Ketorolac: Concomitant administration of antipyretics, such as nonsteroidal antiinflammatory drugs (NSAIDS), may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Lansoprazole; Naproxen: Concomitant administration of antipyretics, such as nonsteroidal antiinflammatory drugs (NSAIDS), may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Measles Virus; Mumps Virus; Rubella Virus; Varicella Virus Vaccine, Live: Do not administer the herpes zoster virus vaccine and pneumococcal vaccines ( e.g., Pneumovax 23) concurrently because concomitant use reduces the immunogenicity of the herpes zoster virus vaccine, and may render it less effective. Wait 4 weeks between administration of one vaccine and administration of the other. In studies, 4 weeks after herpes zoster virus vaccine receipt the geometric mean titer of the varicella zoster virus antibody was 338 gpELISA units/ml among patients who got the vaccine concomitantly with pneumococcal vaccine ( i.e., Pneumovax 23) as compared with 484 gpELISA units/ml among patients who received the two vaccines 4 weeks apart.
    Meclofenamate Sodium: Concomitant administration of antipyretics, such as nonsteroidal antiinflammatory drugs (NSAIDS), may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Mefenamic Acid: Concomitant administration of antipyretics, such as nonsteroidal antiinflammatory drugs (NSAIDS), may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Meloxicam: Concomitant administration of antipyretics, such as nonsteroidal antiinflammatory drugs (NSAIDS), may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Nabumetone: Concomitant administration of antipyretics, such as nonsteroidal antiinflammatory drugs (NSAIDS), may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Naproxen: Concomitant administration of antipyretics, such as nonsteroidal antiinflammatory drugs (NSAIDS), may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Naproxen; Pseudoephedrine: Concomitant administration of antipyretics, such as nonsteroidal antiinflammatory drugs (NSAIDS), may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Naproxen; Sumatriptan: Concomitant administration of antipyretics, such as nonsteroidal antiinflammatory drugs (NSAIDS), may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Nonsteroidal antiinflammatory drugs: Concomitant administration of antipyretics, such as nonsteroidal antiinflammatory drugs (NSAIDS), may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Oxaprozin: Concomitant administration of antipyretics, such as nonsteroidal antiinflammatory drugs (NSAIDS), may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Piroxicam: Concomitant administration of antipyretics, such as nonsteroidal antiinflammatory drugs (NSAIDS), may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Rituximab: The safety of immunization with live virus vaccines following rituximab therapy has not been studied. Vaccination with live virus vaccines before or during rituximab receipt is not recommended. Before rituximab initiation, review the vaccination status of patients with rheumatoid arthritis and follow the Centers for Disease Control and Prevention guidelines for adult vaccination with non-live vaccines; administer non-live vaccines at least 4 weeks before a course of rituximab.The effect of rituximab on immune responses after vaccination was assessed in a trial of patients with rheumatoid arthritis randomized to receive either methotrexate alone or in combination with rituximab. Responses to pneumococcal vaccination were lower in the rituximab/methotrexate arm than in the methotrexate alone arm (19% v. 61%). Responses to tetanus toxoid vaccination were similar between the two treatment arms (39% v. 42%). Most patients who received rituximab had B-cell counts below the lower limit of normal at the time of immunization. The clinical implications of these findings are not known.
    Rofecoxib: Concomitant administration of antipyretics, such as nonsteroidal antiinflammatory drugs (NSAIDS), may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Sulindac: Concomitant administration of antipyretics, such as nonsteroidal antiinflammatory drugs (NSAIDS), may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Tolmetin: Concomitant administration of antipyretics, such as nonsteroidal antiinflammatory drugs (NSAIDS), may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Valdecoxib: Concomitant administration of antipyretics, such as nonsteroidal antiinflammatory drugs (NSAIDS), may decrease an individual's immunological response to the pneumococcal vaccine. A post-marketing study conducted in Poland using a non-US vaccination schedule (2, 3, 4, and 12 months of age) evaluated the impact of prophylactic oral acetaminophen on antibody responses to Prevnar 13. Data show that acetaminophen, given at the time of vaccination and then dosed at 6 to 8 hour intervals for 3 doses on a scheduled basis, reduced the antibody response to some serotypes after the third dose of Prevnar 13 when compared to the antibody responses of infants who only received antipyretics 'as needed' for treatment. However, reduced antibody responses were not observed after the fourth dose of Prevnar 13 with prophylactic acetaminophen.
    Varicella-Zoster Virus Vaccine, Live: Do not administer the herpes zoster virus vaccine and pneumococcal vaccines ( e.g., Pneumovax 23) concurrently because concomitant use reduces the immunogenicity of the herpes zoster virus vaccine, and may render it less effective. Wait 4 weeks between administration of one vaccine and administration of the other. In studies, 4 weeks after herpes zoster virus vaccine receipt the geometric mean titer of the varicella zoster virus antibody was 338 gpELISA units/ml among patients who got the vaccine concomitantly with pneumococcal vaccine ( i.e., Pneumovax 23) as compared with 484 gpELISA units/ml among patients who received the two vaccines 4 weeks apart.

    PREGNANCY AND LACTATION

    Pregnancy

    Pneumovax 23 is classified as FDA pregnancy risk category C; available data on Prevnar 13 administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy. No adequate and well controlled studies have been conducted in pregnant women. In rabbits, a dose approximately 20 times the human dose, given prior to mating and during gestation, did not impair female fertility and no fetal malformations were noted. According to the Advisory Committee on Immunization Practices (ACIP), administration of inactivated vaccines to pregnant women have not resulted in adverse effects in the fetus. The ACIP recommends vaccination during pregnancy when the likelihood of disease exposure is high, potential infection would cause harm to mother or fetus, and when the vaccine is unlikely to cause harm. The manufacturer recommends administration of the vaccine only if clearly needed.

    Data are limited regarding use of the pneumococcal vaccine during breast-feeding and its' excretion in human breast milk is unknown. The manufacturer recommends caution when administering to nursing mothers; however according to the Advisory Committee on Immunization Practices (ACIP), inactivated vaccines pose no risk for mothers or their infants. Additionally, breast-feeding does not adversely affect immunization; limited data suggest breast-feeding may enhance the immune response to certain vaccine antigens. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, health care providers are encouraged to report the adverse effect to the FDA.

    MECHANISM OF ACTION

    The high virulence of the pneumococcal organism is largely due to its polysaccharide capsule, which inhibits phagocytosis by white blood cells. There are at least 90 known pneumococcal capsular types. The preponderance of pneumococcal disease, however, is caused by only a minority of these 90 types. Surveillance data revealed that 56% of all deaths due to pneumococcal pneumonia at a New York medical center from 1952—1962 were caused by only 6 different capsular types and that 78% of all pneumococcal pneumonias were caused by 12 capsular types. A similar pattern has been demonstrated throughout the world.
     
    Non-conjugate pneumococcal vaccine, polyvalent: Non-conjugated polyvalent pneumococcal vaccines (Pneumovax 23) contain the capsular polysaccharides from the 23 most virulent and common strains of pneumococcus. The vaccines include the six most-commonly virulent serotypes: 6B, 9V, 14, 19A, 19F, and 23F. These 23 antigens represent roughly 90% of the reported types associated with clinical infection. Studies in humans have demonstrated the immunogenicity of each of the 23 antigens when tested in polyvalent vaccines; although, some of the serotypes are reported to be poor immunogens. Non-conjugated polysaccharide vaccines stimulate a T-cell independent immune response. Vaccine exposure stimulates the immune system to produce pneumococcal capsule-specific antibodies that make the organism more vulnerable to phagocytosis and other host-defenses. The antibody produced by these vaccines is primarily IgM, which affects vaccine efficacy. They do not induce T-cell dependent responses associated with immunologic memory. After revaccination, antibody titers increase, but an anamnestic response does not occur. Clinical trials suggest a protective efficacy of 60—90%.
     
    Conjugated pneumococcal vaccine: Prevnar 13 is a 13-valent conjugate vaccine for use in infants and children; it contains 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). Serotype 1 has been reported to be the most common cause of pneumococcal empyema (24—50% of cases), and serotype 19A is reported to be the most common cause of invasive pneumococcal disease since the introduction of Prevnar into the childhood immunization series.
     
    The polysaccharides of the pneumococcal serotypes are bound to a non-toxic diphtheria protein known as CRM197. By coupling the polysaccharides to this carrier protein, a T-cell dependent immune response is generated. The conjugated polysaccharide (antigen) can then be presented by major histocompatibility complex molecules, which signals the activation of T-helper cells. The T-helper cells are then able to stimulate B-cells to mature into antibody-secreting plasma or memory cells. The exposure to the vaccine produces pneumococcal capsule-specific antibodies that make the organism more vulnerable to phagocytosis and other host-defenses.

    PHARMACOKINETICS

    The immunologic response and duration of immunity conferred by pneumococcal vaccine, polyvalent is dependent upon the serotypes present in the vaccine and whether or not the polysaccharides are coupled/conjugated to various carrier proteins.
     
    Pneumovax 23: Pneumococcal 23-polyvalent vaccine is administered via subcutaneous or intramuscular injection. Immunity after injection occurs in 2 to 3 weeks. Antibodies against the vaccine serotypes develop in more than 80% of vaccinated healthy adults; older adults and patients with chronic illness or immunodeficiency may not respond well. Serotype-specific antibodies decline after 5 to 10 years; however, the rate of decline varies depending on the patient population. In healthy adults, increased antibody concentrations exist for at least 5 years. Data from one epidemiologic study suggest vaccination may provide protection for at least 9 years after the initial dose in adults; however, the correlation between serology and clinical protection is not firm. There is some evidence that revaccination can raise antibody concentrations and can ensure life-long immunity without significantly increasing the risk of adverse reactions. Revaccination is recommended for certain patients, such as those with immunosuppression.
    Prevnar 13: Pneumococcal 13-valent conjugate vaccine is administered via intramuscular injection only. Patients who received Pneumovax 23 within 1 year prior to Prevnar 13 receipt experienced diminished immune responses to Prevnar 13 compared to Pneumovax 23 naive individuals.