New Meningococcal Presentation - Now Available to Order in ASIIS

Arizona Department of Health Services sent this bulletin at 05/06/2024 12:00 PM MST
2019 AIPO

 New Meningococcal Presentation is 

Available to Order in ASIIS

 

PENBRAYA LOGO

Pfizer - NEW PENBRAYA™ A new meningococcal pentavalent vaccine that protects against serogroups (A, B, C, W, and Y) is NOW available in ASIIS for ordering.

INDICATIONS AND USAGE

  • 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.

DOSAGE AND ADMINISTRATION

  • For intramuscular use only.
  • Administer 2 doses (approximately 0.5 mL each) of PENBRAYA 6 months apart.

SAFETY INFORMATION

  • PENBRAYA should not be given to anyone with a history of a severe allergic reaction to any component of PENBRAYA.
  • Fainting may happen after getting injectable vaccines, including PENBRAYA. Precautions should be taken to avoid falling and injury due to fainting.
  • The most common adverse reactions were pain at the injection site, fatigue, headache, injection site redness, muscle pain, injection site swelling, joint pain, and chills.
  • Some individuals with weakened immune systems may have reduced immune responses to PENBRAYA.
  • 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.
  • Guillain-Barré syndrome (GBS) has been reported following administration of other meningococcal vaccines. Ask the healthcare provider about the risks and benefits of PENBRAYA if there is a history of GBS.
  • Discuss the use of PENBRYA with the healthcare provider if the patient is pregnant or plans to become pregnant.

PRESENTATION

  • PENBRAYA; MCV4-MENB; SDV; 1-pack, NDC: 00069-0600-01
  • PENBRAYA; MCV4-MENB; SDV; 5-pack, NDC: 0069-0600-05

PACKAGING

  • The kit includes a vial of lyophilized MenACWY component (a sterile white powder), a prefilled syringe containing the MenB component, and a vial adapter.
Penbraya kit setup

STORAGE AND HANDLING

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. Discard if the carton has been frozen.

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. Discard reconstituted vaccine if not used within 4 hours.

Resource Links:

CDC Recommended Child and Adolescent Immunization Schedule for age 18 years or younger, U.S. 2024

CDC Catch-up Immunization Schedule for persons aged 4 months – 18 years who start late or who are more than 1 month behind, U.S. 2024

Administering Meningococcal Vaccines

Meningococcal ACIP Vaccine Recommendations

PENBRAYA™ Package Insert

The Bureau of Immunization Services (BIZS) has clinical staff to assist with your immunization questions (or contact your local county health department).

Kate Whitman, MSE, BSN  Kathleen.Whitman@azdhs.gov, 480-259-5342

Sharon Sweeney, MPH, BSN Sharon.Sweeney@azdhs.gov, 480-261-5557