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    Meningococcal Vaccines, All Types

    DEA CLASS

    Rx

    DESCRIPTION

    Recombinant vaccine comprised of antigenic meningococcal surface proteins
    Used for prevention of N. meningitidis serogroup B infections
    Administer to patients 10 years of age and older who are considered high risk for serogroup B meningococcal disease; vaccine may be administered at the discretion of the treating clinician to adolescents and young adults aged 16 to 23 years; preferred age is 16 to 18 years

    COMMON BRAND NAMES

    TRUMENBA

    HOW SUPPLIED

    TRUMENBA Intramuscular Inj Susp: 0.5mL, 60-60mcg

    DOSAGE & INDICATIONS

    For meningococcal infection prophylaxis due to Neisseria meningitidis serogroup B.
    NOTE: The efficacy of meningococcal Group B vaccine is based on the demonstration of immune response, as measured by bactericidal activity against the 4 serogroup B strains representative of prevalent strains in the U.S. Efficacy of meningococcal Group B vaccine against diverse serogroup B strains has not been established.
    NOTE: The choice of dosing schedule (2 dose or 3 dose) depends on the patients's risk of exposure and susceptibility to meningococcal serogroup B disease.
    For booster dosing or revaccination of patients who remain at increased risk for meningococcal infection†.
    Intramuscular dosage
    Adults

    0.5 mL IM. For continued protection of persons at high risk for meningococcal disease, give booster dose 1 year after primary immunization and repeat every 2 to 3 years thereafter.

    Children and Adolescents 10 to 17 years

    0.5 mL IM. For continued protection of persons at high risk for meningococcal disease, give booster dose 1 year after primary immunization and repeat every 2 to 3 years thereafter.

    Intramuscular dosage (2 dose schedule)
    Adults 18 to 25 years

    0.5 mL IM, preferably in the deltoid region. Give as a 2-dose series, with doses administered on a 0- and 6-month schedule. If the second dose is administered earlier than 6 months, administer a third dose at least 4 months after the second dose.[58317] The 2 dose schedule is preferred for vaccination of adults up to 23 years not at increased risk for meningococcal disease.

    Children and Adolescents 10 to 17 years

    0.5 mL IM, preferably in the deltoid region. Give as a 2-dose series, with doses administered on a 0- and 6-month schedule.If the second dose is administered earlier than 6 months, administer a third dose at least 4 months after the second dose.[58317] The 2 dose schedule is preferred for vaccination of adolescents 16 years and older not at increased risk for meningococcal disease.

    Intramuscular dosage (3 dose schedule)
    Adults 18 to 25 years

    0.5 mL IM, preferably in the deltoid region. Give as a 3-dose series, with doses administered on a 0-, 1- to 2-, and 6-month schedule.[58317] [53026] If the second dose is administered at least 6 months after the first dose, the third dose is not necessary. The 3 dose schedule is preferred for vaccination of patients at high risk for meningococcal disease.[53026]

    Children and Adolescents 10 to 17 years

    0.5 mL IM, preferably in the deltoid region. Give as a 3-dose series, with doses administered on a 0-, 1- to 2-, and 6-month schedule.[58317] [53026] The 3 dose schedule is preferred for vaccination of patients at high risk for meningococcal disease.[53026]

    MAXIMUM DOSAGE

    Adults

    >= 26 years: Safety and efficacy not established.
    18—25 years: 0.5 ml/dose IM.

    Geriatric

    Safety and efficacy not established.

    Adolescents

    0.5 ml/dose IM.

    Children

    10—12 years: 0.5 ml/dose IM.
    <= 9 years: Safety and efficacy not established.

    Infants

    Safety and efficacy not established.

    Neonates

    Safety and efficacy not 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 U.S. federal laws, the health care provider must record in the patient's permanent record the manufacturer, lot number, administration date, 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.
    If a meningococcal vaccine has been previously given, question the patient, parent, or guardian about any symptoms or signs of an adverse reaction.
    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. Depending on the adverse reaction, a subsequent dose may be contraindicated 
    Health care professionals administering vaccines should take appropriate precautions to prevent allergic reactions in vaccine recipients. 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

    Fractional doses (doses < 0.5 ml) should not be administered.
    Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit. Following vigorous shaking, the meningococcal group B vaccine, recombinant is a homogenous white suspension. If discoloration or visible particulate matter are present, discard the syringe.
    Do not mix with any other vaccine or product in the same syringe.

    Intramuscular Administration

    Before administration, clean skin over the injection site with a suitable cleansing agent.
    The prefilled syringe requires vigorous shaking before administration to ensure a homogenous white suspension; DO NOT administer if the vaccine cannot be re-suspended.
    The preferred injection site is the deltoid muscle of the upper arm for children, adolescents, and adults. Do NOT inject into the gluteal area or other areas where there may be a major nerve trunk. Also, do not inject into an area that has been or will be used for another injection. A separate injection site is needed.[58317]

    STORAGE

    TRUMENBA:
    - Discard if product has been frozen
    - Do not freeze
    - Refrigerate (between 36 and 46 degrees F)

    CONTRAINDICATIONS / PRECAUTIONS

    General Information

    Use of a meningococcal group B vaccine, recombinant is contraindicated in patients with a previous allergic reaction to the vaccine. 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 in the event of a serious allergic reaction to the vaccine. Prior to the administration of the vaccine, the health care personnel should inform the patient, parent, guardian, or responsible adult of the benefits and risks to the patient. This should include the provision of the vaccine information statement from the manufacturer. The patient or responsible adult should report any adverse reaction following vaccine administration to the health care provider. The U.S. 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, infection

    The decision to administer or to delay vaccination with meningococcal group B vaccine, recombinant because of current or recent febrile illness depends on the severity of symptoms and on the etiology of the disease. The Advisory Committee on Immunization Practices has recommended that vaccinations be delayed during the course of a moderate or severe acute febrile illness. All vaccines can be administered to persons with minor illnesses such as diarrhea, mild upper-respiratory infection with or without low-grade fever, or other low-grade febrile illness. Persons with moderate or severe febrile illness should be vaccinated as soon as they have recovered from the acute phase of the illness.

    Agammaglobulinemia, corticosteroid therapy, human immunodeficiency virus (HIV) infection, hypogammaglobulinemia, immunosuppression, neoplastic disease, radiation therapy, severe combined immunodeficiency (SCID)

    Patients suffering significant immunosuppression may not have an adequate antibody response to meningococcal group B vaccine, recombinant. Immunosuppressed persons may include patients with severe combined immunodeficiency (SCID); hypogammaglobulinemia; agammaglobulinemia; altered immune states due to diseases such as generalized neoplastic disease; or an immune system compromised by corticosteroid therapy with greater than physiologic doses, alkylating drugs, antimetabolites, or radiation therapy. Short-term (< 2 weeks) corticosteroid therapy or intra-articular, bursal, or tendon injections with corticosteroids should not be immunosuppressive. Patients vaccinated with meningococcal vaccine 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. In addition, evidence suggests that persons with human immunodeficiency virus (HIV) infection do not respond optimally to a single dose. According to the Advisory Committee on Immunization Practices (ACIP), individuals with HIV infection, functional/anatomical asplenia, or persistent complement deficiencies (i.e., C3, C5—C9, properdin, factor D or factor H) require a 2-dose primary vaccination series administered 8—12 weeks apart.

    Anticoagulant therapy, coagulopathy, hemophilia, thrombocytopenia

    Meningococcal group B vaccine, recombinant is only indicated for intramuscular (IM) administration. This vaccine may not be appropriate for patients with increased risk of bleeding such as thrombocytopenia, bleeding disorders (e.g., hemophilia), coagulopathy, vitamin K deficiency, or for those receiving anticoagulant therapy; caution and appropriate precautions to minimize the risk of bleeding or hematoma formation are advised.

    Children, infants, neonates

    In some premature neonates, apnea has been observed after intramuscular vaccination. Consider the infant’s medical status and the vaccine's potential benefits and possible risks when deciding whether to administer an intramuscular vaccine, such as meningococcal group B vaccine, recombinant, to infants born prematurely. This vaccine is only approved for use in children >= 10 years of age. For children < 10 years of age, consider use of another meningococcal vaccine. The meningococcal polysaccharide vaccine is approved for use in children >= 2 years of age, and the meningococcal diphtheria toxoid conjugate vaccines (Menactra and Menveo) are approved for infants as young as 9 months and 2 months, respectively.

    Pregnancy

    Meningococcal group B vaccine, recombinant is classified as FDA pregnancy risk category B. No adequate and well controlled studies have been conducted in pregnant women and the ability of the vaccine to cause fetal harm or affect the reproductive system is unknown. The manufacturer recommends use during pregnancy only if clearly needed; however 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. Instruct women who become pregnant at the time of vaccination to report the pregnancy to their health care professional.

    Breast-feeding

    Data are limited regarding use of the meningococcal group B vaccine, recombinant 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.

    Geriatric

    Meningococcal group B vaccine, recombinant is indicated for use in adults up to 25 years of age; the vaccine is not approved for administration to geriatric patients. The meningococcal polysaccharide vaccine (Menomune) is the only meningococcal vaccine indicated for use in the elderly.

    ADVERSE REACTIONS

    Severe

    anaphylactoid reactions / Rapid / Incidence not known

    Moderate

    erythema / Early / 11.8-17.1

    Mild

    syncope / Early / Incidence not known

    DRUG INTERACTIONS

    Ocrelizumab: (Moderate) Administer all non-live vaccines at least 2 weeks before ocrelizumab initiation, whenever possible. Ocrelizumab may interfere with the effectiveness of non-live virus vaccines. Attenuated antibody responses to tetanus toxoid-containing vaccine, pneumococcal polysaccharide and pneumococcal conjugate vaccines, and seasonal influenza vaccine were observed in patients exposed to ocrelizumab at the time of vaccination during an open-label study. Infants born to mothers exposed to ocrelizumab during pregnancy may receive non-live vaccines as indicated before B-cell recovery; however, consider assessing the immune response to the vaccine. ACIP recommends that patients receiving any vaccination during immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated a minimum of 3 months after discontinuation of therapy. Passive immunoprophylaxis with immune globulins may be indicated for immunocompromised persons instead of, or in addition to, vaccination.
    Ofatumumab: (Major) Administer all needed non-live vaccines according to immunization guidelines at least 2 weeks before initiation of ofatumumab. Ofatumumab may interfere with the effectiveness of inactivated vaccines due to its actions, which cause B-cell depletion.
    Satralizumab: (Major) Administer all non-live vaccines according to immunization guidelines at least 2 weeks before initiation of satralizumab.
    Siponimod: (Moderate) Administer all non-live vaccines at least 4 weeks before siponimod initiation, whenever possible. Vaccines may be less effective if given during siponimod treatment and for 1 month after discontinuation of siponimod treatment.

    PREGNANCY AND LACTATION

    Pregnancy

    Meningococcal group B vaccine, recombinant is classified as FDA pregnancy risk category B. No adequate and well controlled studies have been conducted in pregnant women and the ability of the vaccine to cause fetal harm or affect the reproductive system is unknown. The manufacturer recommends use during pregnancy only if clearly needed; however 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. Instruct women who become pregnant at the time of vaccination to report the pregnancy to their health care professional.

    Data are limited regarding use of the meningococcal group B vaccine, recombinant 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

    Meningococcal disease is a result of an invasive infection by Neisseria meningitis; the five main N. meningitis serogroups responsible for meningococcal disease are A, B, C, Y, and W-135. Vaccination with meningococcal group B vaccine, recombinant provides protection against invasive meningococcal disease caused by serogroup B. Neisserial adhesin A (NadA), Neisserial Heparin Binding Antigen (NHBA), factor H binding protein (fHBP), and PorA P1.4 (present in outer membrane vesicles [OMV]) are meningococcal surface proteins which contribute to the ability of the bacterium to cause disease. There are 2 immunologically distinct fHBP subfamilies, A and B. The Trumenba vaccine is composed of two recombinant factor H binding protein (fHBP) variants from serogroup B, one from fHBP subfamily A and one from subfamily B. The Bexsero vaccine is composed of NadA, NHBA, fHBP, and PorA P1.4. Immunization with the vaccines induces complement-mediated antibody dependent killing of N. meningitides. The vaccines provide bactericidal activity against serogroup B meningococci; however, vaccine efficacy depends on the antigenic similarity of the bacterial and vaccine antigens, as well as the amount of antigen expressed on the surface of the invading N. meningitides.

    PHARMACOKINETICS

    Meningococcal group B vaccine, recombinant is administered intramuscularly. Vaccination does not ensure immunity. Distrubution, metabolism, and excretion of the vaccine have not been defined.
     
    Efficacy of the 3-dose vaccination series was evaluated during a clinical trial involving pediatric patients, ages 11 to 17 years. These children and adolescents were administered the vaccine on a 0-, 2-, and 6-month schedule, with human complement (hSBA) titers, indicating serum bactericidal activity, measured one month after the 2nd and 3rd doses. The primary endpoints were the percentage of subjects with >= 4-fold rise in hSBA titers for each of the four test strains, and the percentage of subjects who achieved titers >= the lower limit of quantitation (LLOQ) for all four strains (composite response). At one month after the 3rd dose a >= 4-fold rise in hSBA titers were observed in 85.3—86.4% for strain A22, 95—95.3% for strain A56, 83.4—84.8% for strain B24, and 77—80.7% for strain B44; the percentage of vaccine recipients to achieve the composite response of titers >= LLOQ for all four strains was 81—83.9%.