Meningococcal Groups A, B, C, W, and Y Vaccine (Monograph)

Brand name: Penbraya
Drug class: Vaccines

Introduction

Meningococcal groups A, B, C, W, and Y vaccine is a meningococcal (groups A, C, W, and Y) polysaccharide tetanus toxoid conjugate vaccine (MenACWY Component) combined with 2 recombinant lipidated factor H-binding protein (fHbp) variants from N. meningitidis serogroup B (MenB Component).¹

Uses for Meningococcal Groups A, B, C, W, and Y Vaccine

Meningococcal groups A, B, C, W, and Y vaccine has the following uses:

Meningococcal groups A, B, C, W, and Y vaccine is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroups A, B, C, W, and Y.¹ The vaccine is approved for use in individuals 10 through 25 years of age.¹

Meningococcal Groups A, B, C, W, and Y Vaccine Dosage and Administration

General

Meningococcal groups A, B, C, W, and Y vaccine is available in the following dosage form(s) and strength(s):

Suspension for IM injection.¹ 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.¹ A single dose after reconstitution is approximately 0.5 mL.¹

Dosage

It is essential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

Adults

Dosage and Administration

• For intramuscular use only.¹

• Administer 2 doses (approximately 0.5 mL each) of meningococcal groups A, B, C, W, and Y vaccine 6 months apart.¹

• To prepare the vaccine, reconstitute the lyophilized MenACWY Component with the MenB Component as described in the manufacturer's prescribing information.¹

Cautions for Meningococcal Groups A, B, C, W, and Y Vaccine

Contraindications

Severe allergic reaction (e.g., anaphylaxis) to any component of meningococcal groups A, B, C, W, and Y vaccine.¹

Warnings/Precautions

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 meningococcal groups A, B, C, W, and Y vaccine.¹

Syncope

Syncope (fainting) may occur in association with administration of injectable vaccines, including meningococcal groups A, B, C, W, and Y vaccine. Procedures should be in place to avoid injury from fainting.¹

Altered Immunocompetence

Some individuals with altered immunocompetence may have reduced immune responses to meningococcal groups A, B, C, W, and Y vaccine.¹

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 meningococcal groups A, B, C, W, and Y vaccine.¹

Limitations of Vaccine Effectiveness

Vaccination with meningococcal groups A, B, C, W, and Y vaccine may not protect all vaccine recipients.¹

Tetanus Immunization

Vaccination with meningococcal groups A, B, C, W, and Y vaccine does not substitute for vaccination with a tetanus toxoid containing vaccine to prevent tetanus.¹

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.¹ The decision by the healthcare professional to administer meningococcal groups A, B, C, W, and Y vaccine to persons with a history of GBS should take into account the expected benefits and potential risks.¹

Specific Populations

Pregnancy

There is a pregnancy exposure registry that monitors pregnancy outcomes in individuals exposed to meningococcal groups A, B, C, W, and Y vaccine during pregnancy.¹ Individuals who received meningococcal groups A, B, C, W, and Y vaccine 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.¹

All pregnancies have a risk of birth defect, loss, or other adverse outcomes.¹ 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. ¹

There are no clinical studies of meningococcal groups A, B, C, W, and Y vaccine in pregnant individuals.¹ Available human data in pregnant individuals are insufficient to inform vaccine-associated risks in pregnancy.¹

There were no developmental toxicity studies performed with meningococcal groups A, B, C, W, and Y vaccine.¹

Lactation

There are no data available to assess the effects of meningococcal groups A, B, C, W, and Y vaccine on the breastfed infant or on milk production/excretion.¹ The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for meningococcal groups A, B, C, W, and Y vaccine and any potential adverse effects on the breastfed child from the vaccine or from the underlying maternal condition.¹ For preventive vaccines, the underlying maternal condition is susceptibility to disease prevented by the vaccine.¹

Pediatric Use

The safety and effectiveness of meningococcal groups A, B, C, W, and Y vaccine have not been established in individuals <10 years of age.¹ 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.¹ Meningococcal groups A, B, C, W, and Y vaccine contains the same MenB component, in the same quantity, as Trumenba.¹

Geriatric Use

The safety and effectiveness of meningococcal groups A, B, C, W, and Y vaccine have not been established in individuals >65 years of age.¹

Common Adverse Effects

The most commonly reported (≥15%) solicited 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%).¹

Drug Interactions

Specific Drugs

It is essential that the manufacturer's labeling be consulted for more detailed information on interactions with this drug, including possible dosage adjustments. Interaction highlights:

Please see product labeling for drug interaction information.

Actions

Mechanism of Action

Protection against invasive meningococcal disease is conferred mainly by complement-mediated antibody-dependent killing of N. meningitidis.¹ Vaccination with meningococcal groups A, B, C, W, and Y vaccine 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.¹ 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. ¹

Advice to Patients

• Inform vaccine recipient of the potential benefits and risks of vaccination with meningococcal groups A, B, C, W, and Y vaccine.¹

• Advise vaccine recipient to report any adverse events to their healthcare provider or to the Vaccine Adverse Event Reporting System at 1-800-822-7967 and https://vaers.hhs.gov/.¹

Additional Information

AHFSfirstRelease^™. For additional information until a more detailed monograph is developed and published, the manufacturer's labeling should be consulted. It is essential that the manufacturer's labeling be consulted for more detailed information on usual uses, dosage and administration, cautions, precautions, contraindications, potential drug interactions, laboratory test interferences, and acute toxicity.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

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