Dosing & Uses
Dosage 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)
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%)
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; 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 & Lactation
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/excretion
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.Pharmacology
Mechanism of Action
Protection against invasive meningococcal disease is conferred mainly by complement-mediated antibody-dependent killing of N meningitidis
Administration
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
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Bexsero intramuscular - | 50-50-50-25 mcg/0.5 mL solution |  |
Copyright © 2010 First DataBank, Inc.
Formulary
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