Penbraya
(Neisseria meningitidis serogroup B recombinant LP2086 A05 protein variant antigen)Dosage & Administration
Penbraya Prescribing Information
PENBRAYA is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroups A, B, C, W, and Y. PENBRAYA is approved for use in individuals 10 through 25 years of age.
For intramuscular use only.
Dose and Schedule
Administer 2 doses (approximately 0.5 mL each) of PENBRAYA 6 months apart.
Preparation
PENBRAYA is supplied in a kit that includes a vial of Lyophilized MenACWY Component (a sterile white powder), a prefilled syringe containing the MenB Component and a vial adapter.
To form PENBRAYA, reconstitute the Lyophilized MenACWY Component with the MenB Component as described in the instructions below.
 | Step 1. Attachment of the vial adapter to the vial.
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 | Step 2. Resuspension of the MenB Component.
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 | Step 3. Connection of the syringe containing the MenB Component to the vial adapter.
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 | Step 4. Reconstitution of the Lyophilized MenACWY Component with the MenB Component to form PENBRAYA.
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 | Step 5. Withdrawal of PENBRAYA.
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Administration
For intramuscular use only.
After reconstitution, PENBRAYA is a homogeneous white suspension. If the vaccine is not a homogenous suspension, shake to resuspend prior to administration. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard if either condition is present.
Administer PENBRAYA immediately or store between 2°C and 30°C (36°F and 86°F) and use within 4 hours. Discard reconstituted vaccine if not used within 4 hours.
PENBRAYA is a suspension for injection.
A single dose after reconstitution is approximately 0.5 mL.
Pregnancy
Pregnancy Exposure Registry
There is a pregnancy exposure registry that monitors pregnancy outcomes in individuals exposed to PENBRAYA during pregnancy. Individuals who received PENBRAYA during pregnancy are encouraged to contact, or have their healthcare provider contact, 1-877-390-2953 to enroll in or obtain information about the registry.
Risk Summary
All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
There are no clinical studies of PENBRAYA in pregnant individuals. Available human data on PENBRAYA administered to pregnant individuals are insufficient to inform vaccine-associated risks in pregnancy.
There were no developmental toxicity studies performed with PENBRAYA.
Lactation
Risk Summary
There are no data available to assess the effects of PENBRAYA on the breastfed infant or on milk production/excretion. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for PENBRAYA and any potential adverse effects on the breastfed child from PENBRAYA or from the underlying maternal condition. For preventive vaccines, the underlying maternal condition is susceptibility to disease prevented by the vaccine.
Pediatric Use
The safety and effectiveness of PENBRAYA have not been established in individuals <10 years of age. In a clinical study, 90% of infants younger than 12 months of age who were vaccinated with a reduced dosage formulation of Trumenba had fever. PENBRAYA contains the same MenB component, in the same quantity, as Trumenba.
Geriatric Use
The safety and effectiveness of PENBRAYA have not been established in individuals >65 years of age.
Do not administer PENBRAYA to individuals with a history of severe allergic reaction (e.g., anaphylaxis) to any component of PENBRAYA [see Description (11)].
Management of Acute Allergic Reactions
Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an anaphylactic reaction occurs following administration of PENBRAYA.
Syncope
Syncope (fainting) may occur in association with administration of injectable vaccines, including PENBRAYA. Procedures should be in place to avoid injury from fainting.
Altered Immunocompetence
Reduced Immune Response
Some individuals with altered immunocompetence may have reduced immune responses to PENBRAYA.
Complement Deficiency
Individuals with certain complement deficiencies and individuals receiving treatment that inhibits terminal complement activation are at increased risk for invasive disease caused by N. meningitidis groups A, B, C, W, and Y, even if they develop antibodies following vaccination with PENBRAYA [see Clinical Pharmacology (12.1)].
Limitations of Vaccine Effectiveness
Vaccination with PENBRAYA may not protect all vaccine recipients.
Tetanus Immunization
Vaccination with PENBRAYA does not substitute for vaccination with a tetanus toxoid containing vaccine to prevent tetanus.
Guillain-Barré Syndrome
Guillain-Barré syndrome (GBS) has been reported in temporal relationship following administration of another U.S.-licensed meningococcal quadrivalent polysaccharide conjugate vaccine. The decision by the healthcare professional to administer PENBRAYA to persons with a history of GBS should take into account the expected benefits and potential risks.