Issue link: https://beckershealthcare.uberflip.com/i/1511501
MenACWY-CRM). Serious Adverse Events In Study 1, during the 30 days after vaccination visit 1 (at 0 months), <0.1% (1/1763) of PENBRAYA and 0% (0/649) of Trumenba + MenACWY-CRM participants reported at least 1 SAE. During the 30 days after vaccination visit 2 (at 6 months), 0.1% (2/1558) of PENBRAYA and 0% (0/562) of Trumenba participants reported at least 1 SAE. None of the SAEs were determined to be related to PENBRAYA vaccination. In Study 2, during the 30 days after vaccination visit 1 (at 0 months), 0.4% (2/543) of PENBRAYA and 0% (0/1057) of Trumenba + MenACWY-CRM participants reported at least 1 SAE. During the 30 days after vaccination visit 2 (at 6 months), 0.2% (1/486) of PENBRAYA and 0% (0/946) of Trumenba participants reported at least 1 SAE. None of the SAEs were determined to be related to PENBRAYA vaccination. In non-controlled Study 3, no SAEs (0/294) were reported within 30 days after either vaccination (0, 12 months). Postmarketing Experience The postmarketing safety experience with Trumenba and a non-U.S.- licensed Meningococcal Groups A, C, W, and Y polysaccharide tetanus toxoid (TT) conjugate vaccine (MenACWY-TT vaccine; Pfizer Inc.) is relevant to PENBRAYA since PENBRAYA includes the same group A, C, W, and Y TT-conjugated polysaccharide components and MenB recombinant protein components. Because these events are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to vaccination. The following adverse reactions have been spontaneously reported during postmarketing use of Trumenba and MenACWY TT and may also be seen in postmarketing experience with PENBRAYA. Immune System Disorders: allergic reactions, including anaphylaxis Nervous System: syncope (fainting) USE IN SPECIFIC POPULATIONS 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. PATIENT COUNSELING INFORMATION Prior to administration of PENBRAYA: • Inform vaccine recipient of the potential benefits and risks of vaccination with PENBRAYA. • 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/. This product's labeling may have been updated. For the most recent prescribing information, please visit https://dailymed.nlm.nih.gov/dailymed/. US License No. 2060 LAB-1512-0.9 PP-PBI-USA-0077 CPT Code 90623 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 % >38.4° to 38.9°C 1.6 0.3 2.8 0.9 >38.9° to 40.0°C 0.6 0.2 0.9 0.2 >40.0°C 0.0 0.0 0.0 0.0 Vomiting b Any c 3.2 1.5 3.0 0.9 Mild 2.5 1.4 2.0 0.8 Moderate 0.6 0.1 0.9 0.2 Severe 0.0 0.0 0.0 0.0 Diarrhea d Any c 11.0 8.2 13.5 8.5 Mild 8.7 6.9 11.9 6.0 Moderate 2.0 1.4 1.6 2.4 Severe 0.3 0.0 0.0 0.0 Headache e Any c 46.8 39.8 46.9 37.8 Mild 25.7 21.3 24.5 21.1 Moderate 19.2 16.8 20.4 16.2 Severe 1.9 1.7 2.0 0.6 Fatigue e Any c 52.1 47.6 54.7 43.6 Mild 23.5 22.8 25.7 22.0 Moderate 25.5 21.8 25.7 19.9 Severe 3.2 2.9 3.3 1.7 Chills e Any c 20.1 16.4 19.6 16.2 Mild 12.6 9.9 10.2 8.8 Moderate 6.7 6.0 7.8 5.8 Severe 0.8 0.4 1.6 1.5 Muscle pain (other than muscle pain at the injection site) e Any c 25.7 22.8 27.4 22.2 Mild 13.6 10.0 13.5 10.0 Moderate 10.5 11.9 11.9 11.5 Severe 1.6 0.8 2.0 0.8 Joint pain e Any c 20.2 18.3 22.6 15.6 Mild 10.7 9.6 12.9 7.9 Moderate 8.6 8.3 8.6 6.8 Severe 1.0 0.4 1.1 0.9 Use of antipyretic medication 29.5 25.1 28.1 20.5 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. Trumenba and MenACWY-CRM were administered at 0 month followed by Trumenba alone at 6 months. b. Mild (1 to 2 times in 24 hours); Moderate (>2 times in 24 hours); Severe (requires intravenous hydration). c. "Any" is defined as the cumulative frequency of participants who reported a reaction as "mild", "moderate", or "severe" within 7 days of vaccination. d. Mild (2 to 3 loose stools in 24 hours); Moderate (4 to 5 loose stools in 24 hours); Severe (6 or more loose stools in 24 hours). e. Mild (does not interfere with activity); Moderate (interferes with activity); Severe (prevents daily activity).