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BEXSERO
Classes
Meningococcal Vaccines, All Types
Administration
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 patient, parent, or guardian before each immunization. The action is required by the National Childhood Vaccine Injury Act of 1986.
Record in the patient's permanent record the manufacturer, lot number, administration date, and the name and address of the person administering the vaccine. These actions are required by the National Childhood Vaccine Injury Act of 1986.
Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit. After 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.
Prior to administration, clean skin over the injection site with a suitable cleansing agent.
Vigorously shake the prefilled syringe prior to 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; do NOT inject into the gluteal area or other areas where there may be a major nerve trunk.
Adverse Reactions
anaphylactoid reactions / Rapid / Incidence not known
erythema / Early / 45.0-50.0
injection site reaction / Rapid / 28.0-83.0
myalgia / Early / 48.0-49.0
fatigue / Early / 35.0-37.0
headache / Early / 33.0-34.0
nausea / Early / 18.0-19.0
arthralgia / Delayed / 13.0-16.0
fever / Early / 1.0-5.0
pharyngitis / Delayed / 2.0
syncope / Early / Incidence not known
rash / Early / Incidence not known
Common Brand Names
BEXSERO
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
Dosage And Indications
NOTE: The efficacy of meningococcal Group B vaccine is based on the demonstration of immune response, as measured by bactericidal activity against 3 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.
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.[53026]
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.[53026]
0.5 mL IM, preferably in the deltoid region. Give as a 2-dose series, with doses administered at least 1 month apart.
0.5 mL IM, preferably in the deltoid region. Give as a 2-dose series, with doses administered at least 1 month apart.
Dosing Considerations
Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.
Drug Interactions
Deucravacitinib: (Moderate) Patients receiving immunosuppressant medications may have a diminished vaccine response. When feasible, administer indicated vaccines at least two weeks prior to initiating immunosuppressant medications. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Elivaldogene Autotemcel: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to non-live vaccines. When feasible, administer indicated vaccines at least six weeks prior to initiating immunosuppressant medications. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
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 2 weeks before siponimod initiation, whenever possible. Vaccines may be less effective if given during siponimod treatment. Patients should be considered unimmunized if vaccinated within a 14-day period before starting immunosuppresive therapy or during immunosuppressive therapy, and should they be revaccinated at least 3 months after therapy is discontinued if immune competence is restored.
Ublituximab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to non-live vaccines. When feasible, administer indicated vaccines at least two weeks prior to initiating immunosuppressant medications. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
How Supplied
BEXSERO Intramuscular Inj Susp
Maximum Dosage
26 years and older: Safety and efficacy not established.
18 to 25 years: 0.5 mL/dose IM.
Safety and efficacy not established.
0.5 mL/dose IM.
10 to 12 years: 0.5 mL/dose IM.
9 years and younger: Safety and efficacy not established.
Safety and efficacy not established.
Safety and efficacy not established.
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 provides protection against invasive meningococcal disease caused by serogroup B. The meningococcal group B vaccine (3 strain) is composed of the recombinant proteins Neisserial adhesin A (NadA), Neisserial Heparin Binding Antigen (NHBA), factor H binding protein (fHBP), and PorA P1.4 (present in outer membrane vesicles [OMV]). These meningococcal surface proteins contribute to the ability of the bacterium to cause disease. Immunization with meningococcal group B vaccine (3 strain) leads to the production of antibodies directed against NadA, NHBA, fHBP, and PorA, which leads to complement-mediated antibody-dependent killing of N. meningitides serogroup B. The vaccine's 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 meningococci.
Pharmacokinetics
Meningococcal group B vaccine (3 strain) is administered intramuscularly. Vaccination does not ensure immunity. Distribution, metabolism, and excretion of the vaccine have not been defined.
Efficacy of the 2-dose vaccination series was evaluated during clinical trials involving pediatric and young adult patients, ages 11 to 24 years. Serum bactericidal antibodies were measured with hSBA assays using 3 strains selected to measure responses to 1 of 3 vaccine antigens, either fHBP, NadA, or PorA P1.4, prevalent among strains in the U.S. The primary endpoints were the percentage of subjects with >= 4-fold rise in hSBA titers for each of the 3 test strains, and the percentage of subjects who achieved titers >= the lower limit of quantitation (LLOQ) for all 3 strains (composite response). At one month after the second dose, a >= 4-fold rise in hSBA titers was observed in 78—98% for strain fHBP, 94—99% for strain NadA, and 39—67% for strain PorA P1.4; 63—88% of vaccine recipients achieved the composite response of titers >= LLOQ for all 3 strains.
Pregnancy And Lactation
No adequate and well controlled studies with Meningococcal group B vaccine (3 strain) 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. Additionally, the Advisory Committee on Immunization Practices (ACIP) recommends deferring vaccination in pregnant women unless the woman is at increased risk and the benefits of vaccination are considered to outweigh the potential risks. Instruct women who become pregnant at the time of vaccination to report the pregnancy to their health care professional. There is a pregnancy exposure registry that monitors outcomes in pregnant patients exposed to meningococcal group B vaccine (3 strain); information about the registry can be obtained at BexseroPregnancyRegistry.SM@ppdi.com or by calling 1-877-413-4759.
Data are limited regarding use of the meningococcal group B vaccine (3 strain) during breast-feeding, and its excretion in human breast milk is unknown. The manufacturer recommends caution when administering to nursing mothers. Additionally, the Advisory Committee on Immunization Practices (ACIP) recommends deferring vaccination in breast-feeding women unless the woman is at increased risk and the benefits of vaccination are considered to outweigh the potential risks.