meningococcal group B vaccine (Rx)

Brand and Other Names:Trumenba, Bexsero
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

IM suspension

  • 0.5mL/syringe

Meningococcal Serogroup B Immunization

Indicated for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B in individuals aged 10 through 25 yr

Trumenba

  • Three-dose schedule: 0.5 mL IM at 0, 1–2, and 6 months
  • Two-dose schedule: 0.5 mL IM at 0 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

  • The Advisory Committee on Immunization Practice (ACIP) from the Center for Disease Control and Prevention (CDC) recommends serogroup B meningococcal vaccination (in addition to the current meningococcal vaccines which covers serogroups A, C, Y and W-135) to high risk population aged ≥10 yr
  • High risk populations
    • People with persistent complement component deficiencies
    • Persons receiving the drug eculizumab (Soliris) also are at increased risk because the drug binds to C5 and inhibits the terminal complement pathway
    • Patients with anatomic or functional asplenia
    • Microbiologists who are regularly exposed to Neisseria meningitidis isolates
    • People at increased risk owing to an outbreak of serogroup B meningococcal disease
    • NOTE: The vaccine is not currently recommended for routine use in first-year college students living in residence halls, military recruits, or all adolescents; physicians should determine vaccination needs for 16-23 year olds on an individual basis; recommendations for broader use of MenB vaccines in adolescents and college students will be considered separately by the ACIP
    • Reference: MMWR Morb Mortal Wkly Rep. June 12, 2015/64(22);608-12

Dosing Considerations

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

Indicated for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B in individuals aged 10 through 25 yr

<10 years: Safety and efficacy not established

10-17 years

  • Trumenba
    • Three-dose schedule: 0.5 mL IM at 0, 1–2, and 6 months
    • Two-dose schedule: 0.5 mL IM at 0 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

  • The Advisory Committee on Immunization Practice (ACIP) from the Center for Disease Control and Prevention (CDC) recommends serogroup B meningococcal vaccination (in addition to the current meningococcal vaccines which covers serogroups A, C, Y and W-135) to high risk population aged ≥10 yr
  • High risk populations
    • People with persistent complement component deficiencies
    • Persons receiving the drug eculizumab (Soliris) also are at increased risk because the drug binds to C5 and inhibits the terminal complement pathway
    • Patients with anatomic or functional asplenia
    • Microbiologists who are regularly exposed to Neisseria meningitidis isolates
    • People at increased risk owing to an outbreak of serogroup B meningococcal disease
    • NOTE: The vaccine is not currently recommended for routine use in first-year college students living in residence halls, military recruits, or all adolescents; physicians should determine vaccination needs for 16-23 year olds on an individual basis; recommendations for broader use of MenB vaccines in adolescents and college students will be considered separately by the ACIP
    • Reference: MMWR Morb Mortal Wkly Rep. June 12, 2015/64(22);608-12

Dosing Considerations

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)

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Adverse Effects

>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%)
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Warnings

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

Reduced immune response may occur in immunosuppressed individuals

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)

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Pregnancy & Lactation

Pregnancy Category: B

Lactation: Unknown if distributed in human breast milk

Pregnancy 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.

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Pharmacology

Mechanism of Action

Protection against invasive meningococcal disease is conferred mainly by complement-mediated antibody-dependent killing of N meningitidis

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Administration

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

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Formulary

FormularyPatient Discounts

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Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
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Code Definition
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Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.