Penbraya (meningococ A,C,Y,W-135,TT comp/N. mening B,fHBP rec comp/PF)

Meningococcal Vaccines - Serogroups A,C,Y,W135 Intramuscular Kit

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Last reviewed · Source: First Databank (FDB) drug data

Overview

Meningococcal groups A, B, C, W, and Y (MenABCWY) vaccine is a pentavalent meningococcal vaccine consisting of a quadrivalent meningococcal serogroup A, C, W, and Y (MenACWY) saccharide-protein conjugate component and a separate serogroup B (MenB) component; both vaccine components are inactivated vaccines containing recombinant antigens from Neisseria meningitidis.

Meningococcal groups A, B, C, W, and Y (MenABCWY) vaccines are inactivated combination vaccines that stimulate active immunity to invasive disease caused by Neisseria meningitidisserogroups A, B, C, W, and Y. Two MenABCWY vaccines are currently available: MenACWY-TT/MenB-FHbp (Penbraya(R)) and MenACWY-CRM/MenB-4C (Penmenvy(R)). Both products combine a MenACWY conjugate component with a MenB component and are supplied as a 2-component product (a lyophilized MenACWY component plus a liquid MenB component) that must be combined before administration.

Protection against invasive meningococcal disease is conferred mainly by complement-mediated antibody-dependent killing of N. meningitidis. MenACWY-TT/MenB-FHbp (Penbraya(R)) induces antibodies against meningococcal serogroups A, C, W, and Y capsular polysaccharides and against meningococcal serogroup B factor H binding protein (FHbp) variants from subfamilies A and B. MenACWY-CRM/MenB-4C (Penmenvy(R)) induces antibodies against meningococcal serogroups A, C, W, and Y capsular oligosaccharides and against meningococcal serogroup B antigens Neisseria heparin binding antigen (NHBA), Neisseria adhesin A (NadA), FHbp, and outer membrane vesicles (OMV).

For both vaccines, coverage of meningococcal serogroup B strains depends on antigenic similarity and antigen expression by circulating strains.

The products differ in carrier protein and MenB antigen composition. MenACWY-TT/MenB-FHbp (Penbraya(R)) uses tetanus toxoid (TT) as the MenACWY carrier protein and contains 2 recombinant lipidated FHbp variants in the MenB component. MenACWY-CRM/MenB-4C (Penmenvy(R)) uses Corynebacterium diphtheriae CRM197 as the MenACWY carrier protein and contains recombinant NHBA, NadA, and FHbp proteins plus OMV in the MenB component.

Both vaccines are administered IM as a 2-dose series given 6 months apart. Immune responses may be reduced in immunocompromised individuals, and persons with complement deficiencies or those receiving terminal complement inhibitors remain at increased risk for invasive meningococcal disease despite vaccination. Vaccine effectiveness may be incomplete, and protection against all serogroup B strains is not assured.

USES: This vaccine is used to help prevent certain serious, sometimes fatal, bacterial infections (meningitis, meningococcemia). These infections may cause severe problems (hearing loss, brain/nerve problems, paralysis, blindness, seizures, loss of limbs), even with antibiotic treatment. Vaccination is the best way to protect against these life-threatening infections.

This vaccine works by increasing the body's natural defense (immunity) against the bacteria. Vaccines may not fully protect everyone who receives them.

Generic name: meningococ A,C,Y,W-135,TT comp/N. mening B,fHBP rec comp/PF
Pronunciation: (MEN-in-go-COC-al)
Drug class: Meningococcal Vaccines - Serogroups A,C,Y,W135
Therapeutic class: Biologicals

Reference product & biosimilars

No reference, biosimilar or interchangeable associated with this drug.

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Indications

The following indications are listed for Penbraya:

  • Meningococcal Vaccination

Also known as: Active Immunization Against Neisseria Meningitidis, Active Immunization For The Prevention Of Meningococcal Disease.

Dosing

When both MenACWY and MenB vaccination are indicated at the same visit, either pentavalent MenABCWY vaccine (Penbraya(R) or Penmenvy(R)) may be used instead of separate MenACWY and MenB injections.

The CDC and ACIP recommend the MenB vaccine series to be completed with a product from the same manufacturer (i.e., MenB-FHbp (Trumenba(R)) to follow MenACWY-TT/MenB-FHbp (Penbraya(R)) and MenB-4C (Bexsero(R)) to follow MenACWY-CRM/MenB-4C (Penmenvy(R))).

Both pentavalent meningococcal vaccines are administered in 0.5-mL doses.

Drug interactions

There is no enhanced messaging for this drug.

Contraindications

*MenACWY-TT/MenB-FHbp (Penbraya(R)): Severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine.

*MenACWY-CRM/MenB-4C (Penmenvy(R)): Severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine or to any other diphtheria toxoid-containing vaccine.

Adverse reactions

MenACWY-TT/Men-FHbp: The most commonly reported (>=15%) adverse reactions after dose 1 and dose 2, respectively, were pain at the injection site (89% and 84%), fatigue (52% and 48%), headache (47% and 40%), muscle pain (26% and 23%), injection site redness (26% and 23%), injection site swelling (25% and 24%), joint pain (20% and 18%), and chills (20% and 16%).

MenACWY-CRM/Men-4C: The most commonly reported (>=10%) solicited adverse reactions after dose 1 and dose 2, respectively, in individuals 10-25 years of age were pain at the injection site (92% and 88%), fatigue (51% and 42%), headache (42% and 36%), myalgia (15% and 12%), nausea (15% and 10%), erythema (13% and 12%), and swelling (13% and 12%); and after dose 1 and 2, respectively, in individuals 15-25 years of age were pain at the injection site (80% and 74%), headache (41% and 33%), fatigue (40% and 33%), myalgia (15% and 13%), and nausea (15% and 12%).

Precautions

No enhanced messaging available.

ICD codes

CodeTypeDescription
Meningococcal vaccination
Z20.811ICD10CMContact with and (suspected) exposure to meningococcus
Z23ICD10CMEncounter for immunization

ICD code information from First Databank (FDB).

Formulary status

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Last reviewed · Source: First Databank (FDB) drug data