AdultPediatricDosage Forms & Strengths IM suspension 0.5mL/syringe Meningococcal Serogroup B Immunization To prevent invasive meningococcal disease caused by Neisseria meningitides serogroup B in adults at increased risk for meningococcal disease Current vaccination schedules available at http://www.cdc.gov/vaccines/schedules/hcp/index.htm Trumenba Two-dose schedule: 0.5 mL IM at 0 and 6 months OR Three-dose schedule: 0.5 mL IM at 0, 1–2, and 6 months; if the second dose is administered <6 months after first dose, a third dose should be administered at least 4 months after the second dose Choice of dosing schedule may depend on patient risk of exposure and susceptibility to meningococcal serogroup B disease Bexsero 0.5 mL IM as a 2-dose series administered at least 1 month apart ACIP recommendations for at risk adults Immunize at risk adults with primary series (use same product for all doses in series) Booster dose: Administer 1 year after primary series completed and repeat booster dose every 2-3 yr if risk remains At risk individuals include Anatomical or functional asplenia, including sickle cell disease Persistent complement component deficiency Complement inhibitor use (eg, eculizumab, ravulizumab) Microbiologists routinely exposed to Neisseria meningitidis ACIP recommendations for adults not at risk Need for primary series vaccination in adults not at high risk is based on shared decision making between patient and clinician Dosing Considerations MenB vaccines are not interchangeable (use same product for all doses in series) Approval for each vaccine was based on the demonstration of immune response, as measured by serum bactericidal activity against 3 serogroup B strains representative of prevalent strains in the United States Trumenba: Vaccine is a suspension composed of 2 recombinant lipidated factor H binding protein (fHbp) variants from N meningitidis serogroup B – 1 from fHbp subfamily A and 1 from subfamily B (A05 and B01, respectively) Bexsero: Vaccine is a suspension composed of 4 distinct antigens including factor H binding protein (fHbp), Neisserial adhesin A (NadA), Neisserial heparin-binding antigen (NHBA), and PorA P1.4 immunodominant antigen of OMV NZ (strain NZ98/254)Dosage Forms & Strengths IM suspension 0.5mL/syringe Meningococcal Serogroup B Immunization To prevent invasive meningococcal disease caused by Neisseria meningitides serogroup B in individuals ≥10 years at increased risk for meningococcal disease Current vaccination schedules available at http://www.cdc.gov/vaccines/schedules/hcp/index.htm Trumenba Two-dose schedule: 0.5 mL IM at 0 and 6 months OR Three-dose schedule: 0.5 mL IM at 0, 1-2, and 6 months; if the second dose is administered <6 months after first dose, a third dose should be administered at least 4 months after the second dose Bexsero 0.5 mL IM as a 2-dose series administered at least 1 month apart ACIP recommendations for ages 10 yr or older at risk Immunize at risk individuals with primary series (use same product for all doses in series) Booster dose: Administer 1 year after primary series completed and repeat booster dose every 2-3 yr if risk remains At risk individuals include Anatomical or functional asplenia, including sickle cell disease Persistent complement component deficiency Complement inhibitor use (eg, eculizumab, ravulizumab) ACIP recommendations for adolescents not at risk Need for primary series vaccination in adolescents aged 16-23 yr (preferred age 16-18 yr) who are not at high risk is based on shared decision making between patient and clinician Dosing Considerations MenB vaccines are not interchangeable (use same product for all doses in series) Approval for each vaccine was based on the demonstration of immune response, as measured by serum bactericidal activity against 3 serogroup B strains representative of prevalent strains in the United States Trumenba: Vaccine is a suspension composed of 2 recombinant lipidated factor H binding protein (fHbp) variants from N meningitidis serogroup B – 1 from fHbp subfamily A and 1 from subfamily B (A05 and B01, respectively) Bexsero: Vaccine is a suspension composed of 4 distinct antigens including factor H binding protein (fHbp), Neisserial adhesin A (NadA), Neisserial heparin-binding antigen (NHBA), and PorA P1.4 immunodominant antigen of OMV NZ (strain NZ98/254) >10% Trumenba Injection site pain (≥85%) Fatigue (≥40%) Headache (≥35%) Muscle pain (≥30%) Joint pain (17-21.6%) Chills (≥15%) Diarrhea (8.9-15.2%) Bexsero Myalgia, severe (12-13%) Pain, severe (20-29%) Any severity Pain (83-90%) Erythema (45-50%) Myalgia (48-49%) Fatigue (35-37%) Headache (33-34%) nduration (28-32%) Nausea (18-19%) Arthralgia (13-16%) Moderate severity Pain (37-44%) Myalgia (16-19%) Fatigue (10-14%) Mild severity Erythema,1-25 mm (36-41%) Pain (18-27%) Induration,1-25 mm (22-24%) Fatigue (18-19%) Headache (19-21%) Myalgia (16-21%) Nausea (10-12%) Arthralgia (8-9%) 1-10% Trumenba Vomiting (2.5-7.4%) Fever ≥38°C (1.1-6.4%) Bexsero Fever,≥38°C (1-5%) Moderate severity Headache (6-9%) Nausea (4-5%) Erythema, >50-100mm (3-5%) Fever, 38-38.9°C (1-4%) Arthralgia (2%) Induration, >50-100mm (1-2%) Severe severity Headache (4-6%) Fatigue (4-6%) Fever, 39-39.9°C (1%) Contraindications Severe allergic reaction after a previous dose of meningococcal B vaccine Cautions Epinephrine and other appropriate agents used to manage immediate allergic reactions must be immediately available should an acute anaphylactic reaction occur following administration Syncope reported; procedures should be in place to avoid injury from fainting Reduced immune response may occur in immunosuppressed individuals Persons with certain complement deficiencies and persons receiving treatment that inhibits terminal complement activation (eg, eculizumab) are at increased risk for invasive disease caused by N meningitidis serogroup B even if they develop antibodies following vaccination Sufficient data are not available on the safety and effectiveness of interchanging meningococcal group B vaccines to complete the vaccination series Bexsero: The tip caps of the prefilled syringes contain natural rubber latex which may cause allergic reactions in latex sensitive individuals (Trumenba's caps are not made with natural rubber latex) Pregnancy There are no adequate and well-controlled studies of meningococcal B vaccine in pregnant women Animal studies have not revealed evidence of harm Lactation Data are not sufficient to assess the effects on the breastfed infant or on milk production/excretionPregnancy Categories A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk. B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available. Mechanism of Action Protection against invasive meningococcal disease is conferred mainly by complement-mediated antibody-dependent killing of N meningitidis IM Preparation Shake syringe vigorously to ensure that a homogenous white suspension is obtained Do not use the vaccine if it cannot be resuspended Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit Do not use if particulate matter or discoloration is found IM Administration Inject each 0.5-mL dose IM using a sterile needle attached to the supplied prefilled syringe Preferred site for injection is the deltoid muscle of the upper arm Do not mix with any other vaccine in the same syringe Storage Upon receipt, store refrigerated at 2-8°C (36-46°F) Store syringes in the refrigerator horizontally (ie, lay flat on the shelf) to minimize the redispersion time Do not freeze Discard if the vaccine has been frozen BRAND FORM. UNIT PRICE PILL IMAGE Bexsero intramuscular- 50-50-50-25 mcg/0.5 mL solutionCopyright © 2010 First DataBank, Inc.A Patient Handout is not currently available for this monograph.Print FormularyPatient DiscountsAdding plans allows you to compare formulary status to other drugs in the same class.To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.Create Your List of PlansAdding plans allows you to:View the formulary and any restrictions for each plan.Manage and view all your plans together – even plans in different states.Compare formulary status to other drugs in the same class.Access your plan list on any device – mobile or desktop. The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information. View explanations for tiers and restrictions Tier Description 1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs. 2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs. 3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs. 4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. 5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. 6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. NC NOT COVERED – Drugs that are not covered by the plan. Code Definition PA Prior Authorization Drugs that require prior authorization. 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