BEYFORTUS 100 mg/mL
nirsevimab · INJECTION · Sanofi Vaccines US Inc.
BEYFORTUS is a injection containing nirsevimab at 100 mg/mL, taken intramuscular. Manufactured by Sanofi Vaccines US Inc..
Key Facts
- Brand Name
- BEYFORTUS
- Generic Name
- nirsevimab
- NDC Code (Product)
49281-574- Manufacturer
- Sanofi Vaccines US Inc.
- Strength
- 100 mg/mL
- Dosage Form
- INJECTION
- Route
- INTRAMUSCULAR
- Marketing Status
- Application #
- BLA761328
- Drug Class
- Respiratory Syncytial Virus Anti-F Protein Monoclonal Antibody [EPC]
- Marketing Start
- 07/18/2023
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE BEYFORTUS is indicated for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in: Neonates and infants born during or entering their first RSV season. Children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. BEYFORTUS is a respiratory syncytial virus (RSV) F protein-directed fusion inhibitor indicated for the prevention of RSV lower respiratory tract disease in: Neonates and infants born during or entering their first RSV season. ( 1 ) Children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Administer as an intramuscular injection. ( 2.1 ) Recommended dosage: Neonates and infants born during or entering their first RSV season: 50 mg if less than 5 kg in body weight. ( 2.1 ) 100 mg if greater than or equal to 5 kg in body weight. ( 2.1 ) Children who remain vulnerable through their second RSV season: 200 mg (2 × 100 mg injections). ( 2.1 ) 2.1 Recommended Dosage First RSV Season for Neonates and Infants For neonates and infants born during the RSV season, administer BEYFORTUS starting from birth. For neonates and infants born outside the RSV season, administer BEYFORTUS once prior to the start of the RSV season considering duration of protection provided by BEYFORTUS [see Clinical Pharmacology (12.2) ] . The recommended dosage of BEYFORTUS for neonates and infants born during or entering their first RSV season is based on body weight (see Table 1 ) and is administered as a single intramuscular (IM) injection. Table 1 Recommended Dosage of BEYFORTUS for the First RSV Season Body Weight at Time of Dosing Recommended Dosage Less than 5 kg 50 mg by IM injection 5 kg and greater 100 mg by IM injection Second RSV Season for Children Who Remain at …
Contraindications
4 CONTRAINDICATIONS BEYFORTUS is contraindicated in infants and children with a history of serious hypersensitivity reactions, including anaphylaxis, to nirsevimab-alip or to any of the excipients [see Warnings and Precautions (5.1) and Description (11) ] . BEYFORTUS is contraindicated in infants and children with a history of serious hypersensitivity reactions, including anaphylaxis, to nirsevimab-alip or to any of the excipients. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS 7.1 Interference with RT-PCR or Rapid Antigen Detection RSV Diagnostic Assays Nirsevimab-alip does not interfere with reverse transcriptase polymerase chain reaction (RT-PCR) or rapid antigen detection RSV diagnostic assays that employ commercially available antibodies targeting antigenic site I, II, or IV on the RSV fusion (F) protein. For immunological assay results which are negative when clinical observations are consistent with RSV infection, it is recommended to confirm using an RT-PCR-based assay.
Adverse Reactions
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 great…
Frequently Asked Questions
What is BEYFORTUS used for?
BEYFORTUS contains nirsevimab. It is a injection taken intramuscular. Consult your doctor for specific uses.
Is BEYFORTUS a controlled substance?
BEYFORTUS is not classified as a controlled substance by the DEA.
What is the generic name for BEYFORTUS?
The generic name for BEYFORTUS is nirsevimab. There are no other listed brand versions of nirsevimab.
What is the NDC code for BEYFORTUS 100 mg/mL?
The NDC (National Drug Code) for BEYFORTUS 100 mg/mL is 49281-574, listed by Sanofi Vaccines US Inc..
Other BEYFORTUS Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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