Smallest Trim size: 7.5” x 10.5” Largest Trim size: 8.125” x 10.875”
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Brief Summary of the Prescribing Information for CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine) ( continued )
PONCE HEALTH SCIENCES UNIVERSITY ORGULLO Y EXCELENCIA ACADÉMICA Pág. 60
Safety With Concomitant Influenza Vaccine Administration In Study 4 (NCT05526716), individuals 50 years of age and older with or without a history of prior pneumococcal vaccination were enrolled and randomized to receive either CAPVAXIVE and quadrivalent influenza vaccine [Fluzone Quadrivalent, (QIV)] concomitantly followed by placebo 30 days later (concomitant group), or QIV and placebo concomitantly followed by CAPVAXIVE 30 days later (sequential group). In Study 4, the rates and severity of solicited systemic adverse reactions and solicited local adverse reactions at the CAPVAXIVE injection site were similar when CAPVAXIVE was administered with or without inactivated QIV. Serious Adverse Events Across studies 1-4, the proportion of individuals reporting 1 or more SAEs within 1-month postvaccination was 0.3% in individuals vaccinated with CAPVAXIVE (n=14) and 0.3% in individuals vaccinated with an active comparator (n=7). The proportion of individuals reporting 1 or more SAEs within 6 months postvaccination was 1.4% in individuals vaccinated with CAPVAXIVE (n=56) and 2.0% in individuals vaccinated with an active comparator (n=40). There were no notable patterns or imbalances between vaccine groups for SAEs. Two individuals who received CAPVAXIVE had SAEs considered related to vaccination. One individual experienced an acute allergic reaction of bronchospasm (Grade 3, required medical intervention) which occurred within 30 minutes postvaccination; one individual experienced injection-site cellulitis (Grade 4, required hospitalization) on Day 6 postvaccination. USE IN SPECIFIC POPULATIONS Pregnancy Risk Summary All pregnancies have a background 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 adequate and well-controlled studies of CAPVAXIVE in pregnant individuals. Data on CAPVAXIVE administered to pregnant individuals are insufficient to inform vaccine-associated risks in pregnancy. A developmental toxicity study has been performed in female rats administered 0.25 mL of a conjugated polysaccharide vaccine formulation on four occasions: twice prior to mating, once during gestation, and once during lactation. This study revealed no adverse effects on fetal or preweaning development. Data Animal Data In a developmental toxicity study, female rats were administered 0.25 mL of a conjugated polysaccharide vaccine formulation containing the same conjugated polysaccharides as in CAPVAXIVE. Animals received 42 mcg polysaccharide per dose (a full human dose of CAPVAXIVE contains 84 mcg polysaccharide/dose) by intramuscular injection on four occasions: 28 and 7 days prior to mating, on gestation day 6, and on lactation day 7. There were no embryofetal deaths or fetal malformations, and no adverse effects on female fertility and preweaning development were observed.
Lactation Risk Summary
Human data are not available to assess the impact of CAPVAXIVE on milk production, its presence in breast milk, or its effects on the breastfed child. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for CAPVAXIVE and any potential adverse effects on the breastfed child from CAPVAXIVE or from the underlying maternal condition. For preventive vaccines, the underlying condition is susceptibility to disease prevented by the vaccine. Pediatric Use The safety and effectiveness of CAPVAXIVE in individuals younger than 18 years of age have not been established. Geriatric Use Across studies 1-4, of the 4,556 individuals who received CAPVAXIVE, 1,487 individuals (32.6%) were 65 years of age and older, and 339 individuals (7.4%) were 75 years of age and older. In Study 1, of the 1,379 individuals who received CAPVAXIVE, 590 individuals (42.8%) were 65 years of age and older, and 126 individuals (9.1%) were 75 years of age and older. No clinically meaningful differences in safety of CAPVAXIVE were observed between these individuals and individuals less than 65 years of age. The opsonophagocytic activity (OPA) responses in individuals 65 years of age and older were generally lower than those observed in individuals less than 65 years of age. NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, Impairment of Fertility CAPVAXIVE has not been evaluated for carcinogenic or mutagenic potential or for Advise the patient to read the FDA-approved patient labeling (Patient Information). • Inform the patient of the benefits and risks associated with vaccination with CAPVAXIVE. • Inform the patient that vaccination with CAPVAXIVE may not protect all vaccine recipients. • Instruct the patient to report any adverse reactions to their healthcare provider or to the vaccine manufacturer or the U.S. Department of Health and Human Services through the Vaccine Adverse Event Reporting System (VAERS), 1-800-822-7967, or report online at www.vaers.hhs.gov. impairment of male fertility in animals. PATIENT COUNSELING INFORMATION The trademarks depicted herein are owned by their respective companies. For more detailed information, please read the Prescribing Information.
uspi-v116-i-2406r000 Revised: 06/2024
Copyright © 2024 Merck & Co., Inc., Rahway, NJ, USA and its affiliates. All rights reserved. US-PVV-00645 11/24
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Revista Puertorriqueña de Medicina y Salud Pública
Revista Puertorriqueña de Medicina y Salud Pública
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