Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS Most common adverse reactions were rash (0.9%) and injection site reactions (0.3%).
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sanofi at 1-855-239-3678 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
A total of 3,224 pediatric subjects received the recommended dose of BEYFORTUS in Phase 2 and Phase 3 clinical trials (Trials 03, 04, and 05) including 2,119 infants who were born at 35 weeks gestational age (GA) or older, and 1,105 infants who were born at less than 35 weeks GA.
A total of 247 infants of any GA with chronic lung disease (CLD) of prematurity or hemodynamically significant congenital heart disease (CHD) in Trial 05 received the recommended dose of BEYFORTUS.
Neonates and Infants Entering Their First RSV Season (Trial 03 and Trial 04) Trial 03 was a randomized, double-blind placebo-controlled trial conducted in preterm infants born at a GA of greater than or equal to 29 weeks to less than 35 weeks.
Subjects were randomized 2:1 to receive BEYFORTUS (N=968) or placebo (N=479) by IM injection.
All subjects randomized to BEYFORTUS received a single 50 mg IM dose regardless of body weight.
Safety data in Trial 03 are presented only for the infants in the BEYFORTUS arm who received the recommended dose [infants who weighed less than 5 kg and who received a single dose of 50 mg BEYFORTUS IM (N=572) or placebo (N=288)].
Trial 04 was a Phase 3, randomized, double-blind, placebo-controlled trial conducted in late preterm and term infants born at greater than or equal to 35 weeks GA.
5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions Including Anaphylaxis: Serious hypersensitivity reactions have been reported following BEYFORTUS administration.
These reactions included urticaria, dyspnea, cyanosis, and/or hypotonia.
Anaphylaxis has been observed with human immunoglobulin G1 (IgG1) monoclonal antibodies.
If signs and symptoms of anaphylaxis or other clinically significant hypersensitivity reactions occur, initiate appropriate treatment.
( 5.1 ) 5.1 Hypersensitivity Reactions Including Anaphylaxis Serious hypersensitivity reactions have been reported following BEYFORTUS administration.
Like all medications, Beyfortus can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: