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    Vaccine Combinations with a Tetanus Component

    DEA CLASS

    Rx

    DESCRIPTION

    Intramuscular vaccine
    Used for immunization against diphtheria, tetanus, pertussis, and polio
    Approved for use in children 4—6 years of age

    COMMON BRAND NAMES

    Kinrix, Quadracel

    HOW SUPPLIED

    Kinrix/Quadracel Intramuscular Inj Susp

    DOSAGE & INDICATIONS

    For simultaneous diphtheria prophylaxis, tetanus prophylaxis, pertussis prophylaxis, and poliovirus prophylaxis as the fifth dose in the diphtheria, tetanus, and acellular pertussis (DTaP) vaccine series and the fourth dose in the inactivated poliovirus vaccine (IPV) series in children whose previous DTaP vaccine doses have been with Infanrix and/or Pediarix for the first three doses and Infanrix for the fourth dose.
    Intramuscular dosage
    Children 4—6 years of age

    0.5 mL IM.

    MAXIMUM DOSAGE

    Adults

    Safety and efficacy have not been established.

    Geriatric

    Safety and efficacy have not been established.

    Adolescents

    Safety and efficacy have not been established.

    Children

    > 6 years: Safety and efficacy have not been established.
    4—6 years: 0.5 mL/dose IM.
    < 4 years: Safety and efficacy have not been established.

    Infants

    Safety and efficacy have not been established.

    Neonates

    Safety and efficacy have not been established.

    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

     
    NOTE: According to US federal laws, the health care provider must record the following in the patient's permanent record: the manufacturer, lot number, date of administration, and the name and address of the person administering the vaccine.
     
    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.
    Since the DTaP component is the same as that in Infanrix and Pediarix, and the IPV component is the same as that in Pediarix, if prior doses of Pediarix or Infanrix have been given, question the parent, guardian, or patient about any symptoms or signs of an adverse reaction after the previous dose. Complete a Vaccine Adverse Event Reporting System (VAERS) report form if adverse events have been identified. The reporting of events is required by the National Childhood Vaccine Injury Act of 1986. The toll-free number for VAERS is 1—800—822—7967. Also, report an adverse event to the manufacturer of the specific agent administered. Depending on the adverse reaction, a subsequent dose may be contraindicated.
    The health care professional should have immediate availability of epinephrine (1:1000) injection and other agents used in the treatment of severe anaphylaxis in the event of a serious allergic reaction.

    Injectable Administration

    DTaP; IPV is administered intramuscularly; do not give intravenously or subcutaneously.
    Fractional doses (doses < 0.5 mL) should not be given.
    Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit

    Intramuscular Administration

    Preparation
    Vigorously shake the single-dose vial or the prefilled syringe to obtain a homogeneous, turbid, white suspension. Do not use if resuspension does not occur with vigorous shaking.
    After removal of the dose, discard any vaccine remaining in the vial. No preservatives are present.
    Do not mix with any other vaccine.
     
    Intramuscular Injection
    A separate syringe and needle should be used for each person receiving vaccine.
    Prior to administration, clean skin over the injection site with a suitable cleansing agent.
    The preferred injection site is the deltoid muscle of the upper arm. Do NOT inject into the gluteal area or other areas where there may be a major nerve trunk. Aspirate prior to injection to avoid injection into a blood vessel.

    STORAGE

    Kinrix :
    - Do not freeze
    - Do not use if product has been frozen
    - Refrigerate (between 36 and 46 degrees F)
    Quadracel:
    - Discard if product has been frozen
    - Discard product if it contains particulate matter, is cloudy, or discolored
    - Do not freeze
    - Store between 35 to 46 degrees F

    CONTRAINDICATIONS / PRECAUTIONS

    Intraarterial administration, intravenous administration, subcutaneous administration

    Do not give DTaP; IPV via intravenous administration or subcutaneous administration. The vaccine is for intramuscular (IM) use only. Take care to avoid injecting into a blood vessel (avoid intraarterial 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.

    Guillain-Barre syndrome

    If Guillain-Barre syndrome has occurred within 6 weeks of receipt of a prior vaccine containing tetanus toxoid, the decision to give subsequent doses of any vaccine containing tetanus toxoid, including DTaP; IPV should be based on careful consideration of the potential benefits and possible risks.

    Neomycin hypersensitivity, polymyxin hypersensitivity, polysorbate 80 hypersensitivity

    DTaP; IPV is contraindicated for use if a severe allergic reaction occurred after a previous dose of any other tetanus toxoid, diphtheria toxoid, pertussis-containing vaccine, or inactivated poliovirus vaccine, or to any component of DTaP; IPV. This includes patients with neomycin hypersensitivity, polymyxin hypersensitivity, and polysorbate 80 hypersensitivity. Each 0.5 mL dose may contain polysorbate 80 (< 100 mcg in Kinrix, approximately 10 ppm in Quadracel), neomycin (<= 0.05 ng in Kinrix, < 4 pg in Quadracel), and polymyxin B (<= 0.01 ng in Kinrix, < 4 pg in Quadracel). With any biologic product, the prescriber or health care professional should take precautions to prevent allergic reactions. The health care professional should have immediate availability of epinephrine (1:1000) injection and other agents used in the treatment of severe anaphylaxis.

    Latex hypersensitivity

    The tip caps on the Kinrix prefilled syringes may contain dry natural latex rubber; thus, health care professionals should administer this vaccine with caution to patients with a history of latex hypersensitivity or a condition with the potential for latex hypersensitivity (e.g., spina bifida). The plungers and vial stoppers do NOT contain latex. The health care professional should have immediate availability of epinephrine (1:1000) injection and other agents used in the treatment of severe anaphylaxis.

    Coma, encephalopathy, fever, neurological disease, seizure disorder, seizures

    Administration of a pertussis-containing vaccine is contraindicated in patients with encephalopathy (coma, decreased level of consciousness, prolonged seizures) occurring within 7 days of a previous dose of a pertussis-containing vaccine and not attributable to another identifiable cause. Additionally, pertussis-containing vaccines are contraindicated in neurological disease such as progressive neurologic disorders, infantile spasms, uncontrolled epilepsy (seizures), or progressive encephalopathy. However, once a treatment regimen has been established and the condition has stabilized, DTaP; IPV receipt may occur if deemed appropriate by the physician after consideration of all relevant factors, risks, and benefits. The ACIP recognizes that children with a personal or family history of seizure disorder may have an increased seizure risk following immunization with a vaccine containing DTP (e.g. Kinrix or Quadracel) versus children without such histories. The ACIP recognizes that vaccination of infants or children with stable neurological disease, including well-controlled seizures, may not contraindicate immunization with a vaccine containing DTP. Consideration of deferral of vaccination is recommended in unstable, deteriorating, or progressive neurologic disorders, and ACIP and AAP guidelines should be reviewed. If the decision to administer Pediarix is made, the parent or guardian should be informed of the potential risks. For children at higher risk of seizures than the general population, the ACIP recommends that acetaminophen or ibuprofen be administered at the time of vaccination and for 24 hours after to reduce the possibility of postvaccination fever.

    Shock

    Certain events were previously regarded as contraindications to continuation of DTP immunization but are now considered precautions to subsequent DTP doses. If any of the following events occur in temporal relation to DTP or DTaP; IPV, the decision to give subsequent doses of vaccine containing the pertussis component should be carefully considered: a collapse or shock-like state such as a hypotonic-hyporesponsive episode within 48 hours, fever of >= 40.5 degrees C (105 degrees F) for 48 hours or less after vaccination and not attributable to other causes, seizures with or without fever within 3 days, or persistent and inconsolable crying for >= 3 hours occurring within 48 hours of vaccination. If a decision is made to withhold the pertussis vaccine (or combination DTaP; IPV), vaccination with the other antigen components of DTaP; IPV may be indicated.

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

    DTaP; IPV is administered by intramuscular (IM) injection; therefore, it should be used with caution in patients with thrombocytopenia, coagulopathy, or other bleeding disorders. Patients with thrombocytopenia, vitamin K deficiency, a coagulopathy (e.g., hemophilia) or receiving anticoagulant therapy should be monitored closely when given DTaP; IPV because bleeding can occur at the IM injection site. All steps to avoid hematoma formation are recommended.

    Immunosuppression

    Immunosuppressed patients may have a reduced immune response to DTaP; IPV. Practitioners should refer to the most recent CDC guidelines regarding vaccination of immunosuppressed patients. If possible, vaccination should precede chemotherapy or immunosuppression initiation by at least 2 weeks. Patients vaccinated with an inactivated vaccine such as DTaP; IPV within 2 weeks before starting immunosuppressive therapy or while receiving immunosuppressive therapy should be considered unvaccinated and should be revaccinated at least 3 months after therapy is discontinued if immune competence has been restored. Since corticosteroids used in greater than physiologic doses also can reduce the immune response to vaccines, providers should wait at least 1 month after discontinuation of high dose systemically absorbed corticosteroid therapy administered for more than 2 weeks before administering vaccines.

    Infection

    Administration of all vaccines, including DTaP; IPV, in patients with a moderate or severe acute illness such as infection with or without fever is considered a precaution by the ACIP. All vaccines, including DTaP; IPV, may be administered to a patient with a mild acute illness with or without fever. Among the most common conditions often inappropriately considered contraindications are diarrhea, minor upper respiratory tract illnesses such as otitis media with or without fever, current antimicrobial therapy, and the convalescent phase of an acute illness. The decision to administer or delay vaccination because of a current or recent acute illness depends on symptom severity and disease etiology.

    Children, infants, neonates

    Kinrix and Quadracel are only indicated for use in children 4—6 years of age. The safety and effectiveness of these vaccines in other age groups has not be established. Neither DTaP; IPV vaccine is recommended for use in neonates, infants, children under 4 years, or children greater than 6 years of age.

    Pregnancy

    DTaP; IPV is classified as FDA pregnancy risk category C. No adequate and well-controlled studies have been conducted in pregnant women and the ability of the vaccine to cause fetal harm or to affect reproduction capacity is unknown. According to the Advisory Committee on Immunization Practices (ACIP), administration of inactivated virus or bacterial 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.

    Breast-feeding

    According to the Advisory Committee on Immunization Practices, inactivated, recombinant, subunit, polysaccharide, conjugate vaccines and toxoids, such as DTaP; IPV, pose no risk for nursing 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. Kinrix and Quadracel are indicated for use in pediatric patients 4 to 6 years of age, and would likely not be used in women of childbearing age. 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.

    ADVERSE REACTIONS

    Severe

    Guillain-Barre syndrome / Delayed / 0-1.0
    cyanosis / Early / Incidence not known
    anaphylactic shock / Rapid / Incidence not known
    angioedema / Rapid / Incidence not known
    myocarditis / Delayed / Incidence not known
    anaphylactoid reactions / Rapid / Incidence not known
    bronchospasm / Rapid / Incidence not known
    apnea / Delayed / Incidence not known
    seizures / Delayed / Incidence not known
    muscle paralysis / Delayed / Incidence not known
    myelitis / Delayed / Incidence not known

    Moderate

    erythema / Early / 36.6-59.1
    encephalopathy / Delayed / 0-1.0
    hypotension / Rapid / Incidence not known
    dyspnea / Early / Incidence not known
    lymphadenopathy / Delayed / Incidence not known
    hypotonia / Delayed / Incidence not known
    neuritis / Delayed / Incidence not known
    peripheral neuropathy / Delayed / Incidence not known
    edema / Delayed / Incidence not known
    thrombocytopenia / Delayed / Incidence not known

    Mild

    myalgia / Early / 53.8-53.8
    injection site reaction / Rapid / 26.0-40.2
    malaise / Early / 35.0-35.0
    drowsiness / Early / 19.1-19.1
    fever / Early / 6.0-16.0
    headache / Early / 15.6-15.6
    anorexia / Delayed / 15.5-15.5
    urticaria / Rapid / Incidence not known
    pruritus / Rapid / Incidence not known
    chills / Rapid / Incidence not known
    rash (unspecified) / Early / Incidence not known
    arthralgia / Delayed / Incidence not known
    maculopapular rash / Early / Incidence not known
    lethargy / Early / Incidence not known
    pallor / Early / Incidence not known
    irritability / Delayed / Incidence not known
    inconsolable crying / Delayed / Incidence not known
    paresthesias / Delayed / Incidence not known
    hypoesthesia / Delayed / Incidence not known
    weakness / Early / Incidence not known
    nausea / Early / Incidence not known
    vomiting / Early / Incidence not known
    diarrhea / Early / Incidence not known
    syncope / Early / Incidence not known

    DRUG INTERACTIONS

    There are no drug interactions associated with Diphtheria Toxoid, Tetanus Toxoid, Acellular Pertussis Vaccine, DTaP; Inactivated Poliovirus Vaccine, IPV products.

    PREGNANCY AND LACTATION

    Pregnancy

    DTaP; IPV is classified as FDA pregnancy risk category C. No adequate and well-controlled studies have been conducted in pregnant women and the ability of the vaccine to cause fetal harm or to affect reproduction capacity is unknown. According to the Advisory Committee on Immunization Practices (ACIP), administration of inactivated virus or bacterial 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.

    According to the Advisory Committee on Immunization Practices, inactivated, recombinant, subunit, polysaccharide, conjugate vaccines and toxoids, such as DTaP; IPV, pose no risk for nursing 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. Kinrix and Quadracel are indicated for use in pediatric patients 4 to 6 years of age, and would likely not be used in women of childbearing age. 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

    DTaP; IPV helps to confer immunity against bacteria that cause diphtheria, tetanus, pertussis, as well as the virus that causes polio.
     
    •Diphtheria Toxoid, Tetanus Toxoid, Acellular Pertussis Vaccine, DTaP: The pathologic sequelae of Corynebacterium diphtheriae infections are mediated by diphtheria exotoxin, an extracellular protein metabolite of toxogenic strains of C. diphtheriae. Diphtheria toxoid induces the production of antibodies against the exotoxin, which inactivate it, presumably by standard antibody-antigen interactions. Infection with C. diphtheriae does not necessarily confer immunity, and previously infected individuals should still receive the toxoid.
     
    Tetanus, the neuromuscular dysfunction associated with C. tetani infections, is caused by exotoxin elaboration. The tetanus toxoid contains antigens that induce the production of antibodies against the exotoxin, and antibodies inactivate the toxin. Natural immunity to C. tetani does not occur in the U.S., and even patients previously infected with C. tetani should receive the tetanus toxoid.
     
    Bordetella pertussis has a variety of cellular components that contribute to the pathogenesis of whooping cough by mechanisms that are poorly understood. The various acellular vaccines contain different pertussis antigens (e.g., agglutinogen, filamentous hemaggutinin, pertactin, and pertussis toxin) derived from B. pertussis, which confer immunity by inducing the production of antibodies against these cellular components. Clinical studies suggest it has an efficacy of 79—93% in protecting against clinical pertussis after household exposure. In addition, pertussis occurring in vaccinees is typically less severe than pertussis in unimmunized patients.
     
    •Inactivated poliovirus vaccine, IPV: Poliovirus vaccine, inactivated, IPV stimulates the immune system to produce antibodies against poliovirus wild-types 1, 2, and 3. Following intramuscular or subcutaneous administration, the antigens (inactivated viruses) get presented to the antigen-presenting cells (e.g., B cells, macrophages). The antigen-presenting cells process and present the antigens and allow B-cells to proliferate, differentiate, and produce anti-poliovirus serum antibodies. The serum anti-poliovirus antibodies are capable of opsonization, neutralization, and complement activation. In natural infection, the polio viruses invade and replicate in mucosal tissues. The virus may invade the blood stream and produce disease at distant systemic sites. Parenteral immunization with non-replicating agents, such as the IPV may fail to induce specific mucosal responses. Vaccination with either IPV or the live attenuated oral poliovirus vaccine (OPV) usually induces secretory antibody (IgA) production in the pharynx and gut, but mucosal immunity induced by IPV is less than mucosal immunity induced by OPV. The development of serum anti-poliovirus antibodies caused by either OPV or IPV are effective in the prevention of systemic disease despite their different routes of administration. The IPV helps reduce pharyngeal acquisition of poliovirus and to a lesser extent, intestinal acquisition. Herd immunity is possible with IPV, including populations vaccinated only with IPV.

    PHARMACOKINETICS

    Diphtheria Toxoid, Tetanus Toxoid, Acellular Pertussis Vaccine, DTaP; Inactivated Poliovirus Vaccine, IPV is administered intramuscularly.
     
    Kinrix
    One month after administration of Kinrix (n = 787—851) to pediatric patients 4 to 6 years of age, patient responses to Kinrix were compared to responses to the administration of Infanrix and IPV (n = 237—262) administered as separate injections. The primary immunogenicity endpoints were anti-diphtheria toxoid, anti-tetanus toxoid, anti-PT, anti-FHA, and anti-pertactin booster responses, and anti-poliovirus Type 1, Type 2, and Type 3 geometric mean antibody titers (GMTs); Kinrix was found to be non-inferior to the 2 separate injections in terms of booster responses to DTaP antigens and post-vaccination GMTs for anti-poliovirus antibodies. The following antibody responses were demonstrated: anti-diphtheria toxoid >= 0.1 International Units/mL (100 % vs. 100% for all), anti-tetanus toxoid >= 0.1 International Units/mL (100% vs. 100% for all), anti-pertussis response of >= 5 ELISA units/mL in seronegative infants or at least maintenance of pre-vaccination concentration in seropositive infants, with anti-PT (92.2% Kinrix vs. 92.6% Infanrix + IPV), anti-FHA (95.4% vs. 96.2%), anti-pertactin (97.8% vs. 96.9%), anti-polio Type 1 neutralizing antibody titer >= 1:8 (99.9% vs. 100%), and anti-polio Types 2 and 3 neutralizing antibody titer >= 1:8 (100% vs. 100% all). Booster response rates in both groups were similar.
     
    Booster responses to diphtheria, tetanus, and pertussis antigens and GMTs for poliovirus (Type 1, 2, and 3) were measured one month after administration of Kinrix with either MMR vaccine (n = 237) or MMRV vaccine (n = 239) in children 4—6 years of age. Booster responses after Kinrix administration with MMRV vaccine were non-inferior to immune responses after concomitant administration of Kinrix with MMR vaccine.
     
     
    Quadracel
    The immunogenicity of Quadracel (n = 253—262) was evaluated in pediatric patients aged 4 to 6 years who received the vaccine as the fifth dose in the diphtheria, tetanus, and pertussis vaccination series and the fourth or fifth dose in the inactivated poliovirus vaccination series, with comparison to individual vaccine components (administered as Daptacel + IPOL; n = 248—253). At 28 days after the last dose, immune responses to pertussis antigens (including pertussis toxin (PT), pertactin, and filamentous hemagglutinin (FHA)), diphtheria, tetanus, and poliovirus were non-inferior to those of the individual vaccine components. The following antibody responses were demonstrated: anti-diphtheria toxoid >= 0.1 International Units/mL (100% Quadracel vs. 99.6% Daptacel + IPOL), anti-tetanus toxoid >= 0.1 International Units/mL (100% vs. 99.2%), anti-PT booster response (95.2% vs. 89.9%), anti-FHA booster response (94.9% vs. 87.5%), anti-pertactin booster response (96.9% vs. 93.1%), anti-FIM booster response (97.2% vs. 92.4%), anti-polio Type 1 neutralizing antibody titer >= 1:8 (100% vs. 99.6%), and anti-polio Types 2 and 3 neutralizing antibody titer >= 1:8 (100% vs. 100% all). Booster response rates in both groups were similar.