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HomeAbout AboutWhy PENBRAYA?Risks of Meningococcal DiseaseGaps in Vaccination CoverageDosing & Recommendations Effectiveness & Safety Effectiveness
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PENBRAYA offers simple needle-free* reconstitutionPENBRAYA includes an all-in-one, needle-free reconstitution kit1PENBRAYA includes an all-in-one, needle-free reconstitution kit1 The PENBRAYA Needle-Free Reconstitution Kit is2:

SIMPLE: Reconstitution in just a few steps
RELIABLE: Delivering the right dose
HCP-PREFERRED: In a survey of 56 HCPs, approximately 9 out of 10 preferred reconstituting with the PENBRAYA Needle-Free Reconstitution Kit over traditional, two-vial, needle-based reconstitution2† (see Study Description)

Based on a simulation of reconstitution systems performed by 56 participants comparing traditional, two-vial, needle-based reconstitution versus needle-free vial adapter reconstitution. The simulation was intended only to assess comparative usability and overall user preference between these two systems. It was not meningococcal vaccine specific and PENBRAYA was not used. 89.3% of participants (n=50) expressed a preference for the vial adapter system. 5.4% (n=3) expressed a preference for the two-vial system.3

Based on a simulation of reconstitution systems performed by 56 participants comparing traditional, two-vial, needle-based reconstitution versus needle-free vial adapter reconstitution. The simulation was intended only to assess comparative usability and overall user preference between these two systems. It was not meningococcal vaccine specific and PENBRAYA was not used. 89.3% of participants (n=50) expressed a preference for the vial adapter system. 5.4% (n=3) expressed a preference for the two-vial system.

The PENBRAYA Needle-Free Reconstitution Kit is2:

SIMPLE: Reconstitution in just a few steps
RELIABLE: Delivering the right dose
HCP-PREFERRED: In a survey of 56 HCPs, approximately 9 out of 10 preferred reconstituting with the PENBRAYA Needle-Free Reconstitution Kit over traditional, two-vial, needle-based reconstitution2† (see Study Description)

Based on a simulation of reconstitution systems performed by 56 participants comparing traditional, two-vial, needle-based reconstitution versus needle-free vial adapter reconstitution. The simulation was intended only to assess comparative usability and overall user preference between these two systems. It was not meningococcal vaccine specific and PENBRAYA was not used. 89.3% of participants (n=50) expressed a preference for the vial adapter system. 5.4% (n=3) expressed a preference for the two-vial system.
Click, Mix, Prep: Reconstitution in just a few simple steps1Click, Mix, Prep: Reconstitution in just a few simple steps1ClickClick
Step 1. Open and attach vial adapter
 
  • Open the vial adapter packaging by peeling off the top cover, but do not remove the adapter
     
  • Align the adapter spike over the center of the vial’s rubber stopper
     
  • Holding the base of the vial on a flat surface, connect the vial adapter to the vial with a straight downward push, locking it into place. Do not push at an angle
Step 2. Remove cap and connect syringe
  • Shake the prefilled syringe of MenB component to obtain a white homogenous suspension
     
  • Remove the syringe cap while holding the Luer lock
     
  • Continue holding the syringe by the Luer lock and connect it to the vial by turning clockwise. Do not overtighten
MixMixStep 3. Inject suspension and gently swirl
  • Inject the entire contents of the syringe into the vial. Do not remove the empty syringe
     
  • While holding the plunger rod down, gently swirl the vial until the powder is completely dissolved. Do not shake
PrepPrepStep 4. Withdraw the contents
  • Slowly withdraw the entire contents of the vial into the syringe to ensure an approximately 0.5 mL dose for administration
Step 5. Disconnect syringe and attach needle
  • Disconnect the syringe from the vial by holding the Luer lock adapter and turning counterclockwise
  • Attach a sterile needle suitable for intramuscular injection to the syringe
  • Prior to administration, the vaccine should appear as a white homogenous suspension. If it is not a homogenous suspension, shake to resuspend. Discard if the vaccine has particulate matter or discoloration. Do not use if either is present
PENBRAYA™ preparation for administrationPENBRAYA™ preparation for administration

Follow the instructions below to reconstitute and prepare PENBRAYA by viewing the video or reading the steps below:

Study description2Study description2Vaccine vial reconstitution method evaluation studyVaccine vial reconstitution method evaluation study
  • Two-simulation comparison study with healthcare providers (N=56) designed to assess comparative usability and overall user preference between traditional, two-vial, needle-based reconstitution and needle-free vial adapter reconstitution
     
  • Each participant attempted 2 vaccine reconstitution and administration simulations with each system:
     
    • System 1, Vial adapter (VA) system: a vial adapter–based vaccine reconstitution system consisting of a prefilled Luer lock syringe, drug product powder vial, vial adapter, and 25-gauge administration needle
       
    • System 2, Two-vial reconstitution (2V) system: a typical vaccine reconstitution system consisting of a graduated syringe, diluent vial, drug product powder vial, 21-gauge mixing needle, and 25-gauge administration needle
       
  • Objective data related to observed task performance, use errors, use difficulties, and/or close calls were collected during the simulations. After completing the simulations, HCPs (N=56) were asked a series of questions to solicit feedback on system preferences and root causes of observed use errors, difficulties, and/or close calls. Questions included, but were not limited to the following: “Considering the 2 vaccine reconstitution systems that you used today, which would you prefer to use? Why?” 89.3% of participants (n=50) expressed a preference for the VA system; 5.4% (n=3) expressed a preference for the 2V system
     
  • 76.8% of participants were nurses/vaccine coordinators (n=43) representing the following practices: 32.1% Family/General (n=18), 21.4% Pediatric (n=12), and 23.2% OBGYN (n=13). 23.2% of participants were retail pharmacists (n=13)
HCP=healthcare provider.
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How to Transition to PENBRAYA

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Simplified Combination

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Dosing and Recommendations

Learn about ACIP-recommended dosing for PENBRAYA

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How to Transition to PENBRAYA

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Simplified Combination

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Dosing and Recommendations

Learn about ACIP-recommended dosing for PENBRAYA

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References: 1. PENBRAYA [prescribing information]. New York, NY: Pfizer Inc.; 2023. 2. Moss S, Pickersgill A, Conrad B, Gunther-LaVergne L, Kolhe P. An evaluation of human factors surrounding the usability of a novel vial adapter system versus a traditional 2-vial vaccine reconstitution system. Poster presented at: Meningitis Research Foundation Conference; November 7-8, 2023; London, UK. 3. Data on file. Vaccine vial reconstitution method evaluation study. Pfizer Inc., New York, NY.

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Indications
  • 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
  • TRUMENBA is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B. TRUMENBA is approved for use in individuals 10 through 25 years of age 
Important Safety Information
  • Do not administer PENBRAYA or TRUMENBA to individuals with a history of severe allergic reaction (eg, anaphylaxis) to any component of PENBRAYA or TRUMENBA. Appropriate medical treatment used to manage allergic reactions must be available in the event an anaphylactic reaction occurs immediately following administration of PENBRAYA or TRUMENBA
  • Syncope (fainting) may occur in association with administration of injectable vaccines, including PENBRAYA or TRUMENBA. Procedures should be in place to avoid injury from fainting
  • Some individuals with altered immunocompetence may have reduced immune responses to PENBRAYA or TRUMENBA
  • 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
  • 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 group B, even if they develop antibodies following vaccination with TRUMENBA
  • Vaccination with PENBRAYA or TRUMENBA may not protect all vaccine recipients
  • Vaccination with PENBRAYA does not substitute for vaccination with a tetanus toxoid–containing vaccine to prevent tetanus
  • Guillain-Barré syndrome (GBS) has been reported in temporal relationship following administration of another US-licensed meningococcal quadrivalent polysaccharide conjugate vaccine. The decision by the healthcare professional to administer PENBRAYA to individuals with a history of GBS should take into account the expected benefits and potential risks 
  • For PENBRAYA, 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%)
  • For TRUMENBA, the most common solicited adverse reactions in adolescents and young adults were pain at injection site (≥85%), fatigue (≥60%), headache (≥55%), and muscle pain (≥35%)
  • Data are not available on the safety and effectiveness of using TRUMENBA and other meningococcal group B vaccines interchangeably to complete the vaccination series
  • The safety and effectiveness of PENBRAYA or TRUMENBA have not been established in pregnant individuals
     
Patients should always ask their healthcare providers for medical advice about adverse events. You are encouraged to report negative side effects of vaccines to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Visit http://www.vaers.hhs.gov or call 1-800-822-7967.

Please see full Prescribing Information for PENBRAYA and full Prescribing Information for TRUMENBA.
Indications
  • 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
  • TRUMENBA is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B. TRUMENBA is approved for use in individuals 10 through 25 years of age