Issue link: https://beckershealthcare.uberflip.com/i/1511501
BRIEF SUMMARY OF FULL PRESCRIBING INFORMATION This brief summary does not include all of the information needed to use PENBRAYA safely and effectively. Before prescribing, please consult the full Prescribing Information for PENBRAYA. 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. CONTRAINDICATIONS Do not administer PENBRAYA to individuals with a history of severe allergic reaction (e.g., anaphylaxis) to any component of PENBRAYA. WARNINGS AND 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 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. 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. ADVERSE REACTIONS 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%). Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect the rates observed in practice. The safety of PENBRAYA in individuals 10 through 25 years of age was evaluated in 3 clinical studies (2 active-controlled and 1 non-controlled study). In the controlled studies, 2306 participants received at least 1 dose of PENBRAYA. Of 946 participants who had previously received a meningococcal conjugate vaccine (categorized as MenACWY conjugate vaccine-exposed), 802 participants had received 1 dose of any U.S.-licensed Meningococcal Groups A, C, W, and Y conjugate vaccine, 51 participants had received a non U.S.-licensed monovalent Meningococcal Group C conjugate vaccine (MenC conjugate vaccine), and 93 participants had received an unspecified U.S.-licensed or non-U.S.-licensed MenACWY conjugate or a MenC conjugate vaccine at least 4 years prior to enrollment. In the non controlled study, 300 participants received a single dose of PENBRAYA. Study 1 (NCT04440163) was an active-controlled, observer-blinded, multicenter study in which participants 10 through 25 years of age in the U.S. and Europe received at least 1 dose of PENBRAYA (N=1763) or Meningococcal Group B Vaccine (Trumenba) (N=650) at 0 and 6 months. Meningococcal Groups A, C, Y, and W-135 Oligosaccharide Diphtheria CRM 197 Conjugate Vaccine (MenACWY-CRM, GSK Vaccines, SRL) was concomitantly administered with Trumenba at Month 0. All participants were MenB vaccine-naïve. Both MenACWY conjugate vaccine-naïve and MenACWY conjugate vaccine-exposed participants were part of the study. Study 2 (NCT03135834) was an active-controlled, observer-blinded, multicenter study in which participants 10 through 25 years of age in the U.S. and Europe received at least 1 dose of PENBRAYA (N=543) or Trumenba (N=1057) at 0 and 6 months. MenACWY-CRM was co-administered with Trumenba at Month 0. All participants were MenB vaccine-naïve. Both MenACWY conjugate vaccine-naïve and MenACWY conjugate vaccine- exposed participants were part of this study. Study 3 (NCT04440176) was a descriptive non-controlled study in which participants 11 through 14 years of age in the U.S. received PENBRAYA 12 months apart. All participants were naïve to any meningococcal vaccine. In Study 1 and Study 2, solicited local and systemic adverse reactions were monitored for 7 days after study vaccination using an electronic diary. In all studies, spontaneous reports of adverse events (AEs) were collected through at least 1 month after the last vaccination, and through 6 months after the last vaccination for serious adverse events (SAEs). In controlled studies, demographic characteristics were generally similar with regard to gender, race, and ethnicity among participants who received PENBRAYA and those who received control (Trumenba and MenACWY-CRM). Among participants who received PENBRAYA in controlled studies, 47.4% were male, 79.4% were White, 10.2% were Black or African-American, 2.1% were Asian, and 2.6% were of other racial groups, and 21.6% were of Hispanic/Latino ethnicity. Solicited Local and Systemic Adverse Reactions Table 1 presents the solicited local adverse reactions and Table 2 presents the solicited systemic adverse reactions and use of antipyretic medication reported within 7 days following each dose of PENBRAYA in Study 1. Table 1. Percentage of Participants Reporting Solicited Local Adverse Reactions Within 7 Days After PENBRAYA or Trumenba Vaccination in Study 1 a Injection Site Reactions PENBRAYA Trumenba + MenACWY-CRM b Dose 1 N=1724- 1725 % Dose 2 N=1456 % Dose 1 N=630- 631 % Dose 2 N=529 % Pain c Any d 89.3 84.4 85.1 78.6 Mild 32.3 29.1 31.1 33.1 Moderate 49.4 48.8 47.7 40.3 Severe 7.5 6.5 6.3 5.3 Redness e Any d 25.9 23.2 19.5 14.7 Mild 8.9 7.7 7.3 6.6 Moderate 14.4 12.6 10.0 7.2 Severe 2.6 3.0 2.2 0.9 Swelling e Any d 25.0 24.2 21.4 14.7 Mild 10.6 10.4 8.3 6.4 Moderate 13.3 12.8 12.4 8.1 Severe 1.2 1.0 0.8 0.2 Abbreviations: N = number of participants; MenACWY-CRM = meningococcal (serogroups A, C, W and Y) oligosaccharide diphtheria CRM 197 conjugate vaccine; Trumenba = meningococcal serogroup B factor H binding protein. a. NCT04440163 b. Trumenba and MenACWY-CRM were administered at 0 month followed by Trumenba alone at 6 months. Local reactions were recorded only for PENBRAYA and Trumenba injection sites. c. Mild (does not interfere with activity); Moderate (interferes with activity); Severe (prevents daily activity). d. "Any" is defined as the cumulative frequency of participants who reported a reaction as "mild", "moderate", or "severe" within 7 days of vaccination. e. Mild (2.0 to 5 cm); Moderate (>5 to 10 cm); Severe (>10 cm). Table 2. Percentage of Participants Reporting Solicited Systemic Adverse Reactions and Use of Antipyretic Medications Within 7 Days After Each Vaccination in Study 1 Systemic Reactions PENBRAYA Trumenba + MenACWY-CRM a Dose 1 N=1739- 1740 % Dose 2 N=1459 % Dose 1 N=638 % Dose 2 N=532 % Fever (≥38°C) ≥38.0°C 5.9 2.4 5.8 1.5 38.0° to 38.4°C 3.7 1.9 2.0 0.4 Table Abbreviations: (serogroups vaccine; a. b. c. d. e.