Penbraya

— THERAPEUTIC CATEGORIES —
  • Vaccines
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Penbraya Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Neisseria meningitidis polysaccharide conjugate vaccine; 5mcg each of Group A, C, W, and Y + 44mcg of tetanus toxoid + 60mcg each of 2 recombinant lipidated factor H binding protein (fHbp) variants from N. meningitidis serogroup B; per 0.5mL; susp for IM inj after reconstitution; preservative-free.

    Pharmacological Class

    Meningitis vaccine.

    How Supplied

    Kits (1 vial of lyophilized MenACWY component + 1 prefilled syringe of MenB component + vial adapter)—1, 5, 10

    Storage

    Storage Before Reconstitution

    • Store refrigerated at 2° C to 8° C (36° F to 46° F) in the original carton. During storage, a white deposit and clear supernatant may be observed in the prefilled syringe containing the MenB Component. Store the carton horizontally to minimize the time necessary to resuspend the MenB Component. Do not freeze. 

    Storage After Reconstitution

    • After reconstitution, administer Penbraya immediately or store between 2° C and 30° C (36° F and 86° F) and use within 4 hours. Do not freeze. 

    Manufacturer

    Pfizer Inc.

    Generic Availability

    NO

    Mechanism of Action

    Vaccination with Penbraya induces the production of bactericidal antibodies specific to the capsular polysaccharides of N. meningitidis serogroups A, C, W, and Y and to fHbp subfamily A and B variants of N. meningitidis group B. The susceptibility of group B meningococci to bactericidal antibody is dependent upon both the antigenic similarity of the fHbp subfamily A or subfamily B vaccine antigen to the fHbp protein expressed by the bacterial strain and the amount of fHbp expressed at the bacterial surface.

    Penbraya Indications

    Indications

    Meningitis immunization.

    Penbraya Dosage and Administration

    Adults and Children

    <10yrs: not established. Give by IM inj only. Each dose is approx. 0.5mL. 10–25yrs: 2 doses separated by 6 months.

    Penbraya Contraindications

    Not Applicable

    Penbraya Boxed Warnings

    Not Applicable

    Penbraya Warnings/Precautions

    Warnings/Precautions

    Have epinephrine inj (1:1000) available. Syncope. Immunodeficiency. Complement deficiency, complement inhibitor recipients; increased risk of invasive meningococcal disease despite vaccination with Penbraya. Not substitutable for tetanus toxoid immunization. History of Guillain-Barre Syndrome. Elderly (>65yrs): not established. Pregnancy. Nursing mothers.

    Warnings/Precautions

    Management of Acute Allergic Reactions

    • Have medical treatment immediately available in case of an anaphylactic event following administration.

    Syncope

    • Syncope may occur. Procedures should be in place to avoid injury from fainting.

    Altered Immunocompetence

    • May reduce immune responses in some individuals with altered immunocompetence.

    • Increased risk for invasive disease caused by N. meningitidis groups A, B, C, W, and Y, in persons with certain complement deficiencies and those receiving treatment that inhibits terminal complement activation even if they develop antibodies following vaccination with Penbraya.

    Limitations of Vaccine Effectiveness

    • May not protect all vaccine recipients.

    Tetanus Immunization

    • Penbraya does not substitute for tetanus toxoid immunization.

    Guillain-Barré Syndrome

    • Consider the potential benefits and risks of administering Penbraya in persons with a history of Guillain-Barré Syndrome (GBS).

    Pregnancy Considerations

    Pregnancy Exposure Registry

    • There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Penbraya during pregnancy. To enroll in or obtain information about the registry, contact (877) 390-2953.

    Risk Summary

    • No clinical studies are available for Penbraya administration in pregnant women.

    • Available human data on Penbraya are insufficient to inform vaccine-associated risks in pregnancy. 

    Nursing Mother Considerations

    No available data to assess the effects of Penbraya on the breastfed infant or on milk production/excretion.

    Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Penbraya and any potential adverse effects on the breastfed child from Penbraya.

    Pediatric Considerations

    Safety and efficacy of Penbraya have not been established in individuals <10 years of age.

    Geriatric Considerations

    Safety and efficacy of Penbraya have not been established in individuals >65 years of age. 

    Penbraya Pharmacokinetics

    See Literature

    Penbraya Interactions

    Interactions

    Immunosuppressants may get suboptimal response.

    Penbraya Adverse Reactions

    Adverse Reactions

    Inj site reactions (pain, redness, swelling), fatigue, headache, muscle pain, joint pain, chills.

    Penbraya Clinical Trials

    Clinical Trials

    The approval was based on data from a randomized, active-controlled, observer-blinded phase 3 trial (ClinicalTrials.gov Identifier: NCT04440163), which included more than 2400 healthy individuals 10 through 25 years of age. Participants were randomly assigned to receive either 2 doses of Penbraya or licensed meningococcal vaccines (2 doses of Trumenba plus 1 dose of Menveo).

    Findings showed that Penbraya met the primary endpoint demonstrating noninferiority for all 5 serogroups (serogroups A, B, C, W and Y) compared with 2 doses of Trumenba and 1 dose of Menveo. 

    Among participants who had not previously received a meningococcal vaccine, the proportion of individuals with 4-fold or greater increases in immune responses was observed to be higher following Penbraya vaccination for serogroups A, C, W and Y compared with 1 dose of Menveo.

    Additionally, when compared with 2 doses of Trumenba, the proportion of individuals with 4-fold or greater increases in immune responses was found to be higher against all 4 serogroup B strains following 2 doses of Penbraya.

    Penbraya Note

    Not Applicable

    Penbraya Patient Counseling

    Patient Counseling

    Prior to administration of Penbraya: 

    • Inform vaccine recipient of the potential benefits and risks of immunization with Penbraya. 

    • Advise vaccine recipient to report any adverse reactions to their healthcare provider or to the Vaccine Adverse Event Reporting System at (800) 822-7967 and https://vaers.hhs.gov/.  

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