Nirsevimab-Alip: uses, dosing, side effects & brands
Nirsevimab-Alip is a medicine sold in the U.S. under one brand. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Available as
- Injectable
- Sold as
- Beyfortus
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
How nirsevimab-alip is dosed
From the FDA label for Beyfortus (application BLA761328). Other nirsevimab-alip products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
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 Increased Risk for Severe RSV Disease For children up to 24 months of age, regardless of body weight, who remain at increased risk for severe RSV disease in their second RSV season, refer to Table 2 below for recommended…
Nirsevimab-Alip side effects
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…
Who shouldn’t take nirsevimab-alip
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 )
Nirsevimab-Alip 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.
Every nirsevimab-alip product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Beyfortus.
What people report to the FDA about nirsevimab-alip
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 8 reports naming nirsevimab-alip, and the FDA flagged 75% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- adverse drug reaction1 reports
- aplastic anaemia1 reports
- crying1 reports
- incorrect route of product administration1 reports
- infantile apnoea1 reports
- injection related reaction1 reports
- injection site erythema1 reports
- mucosal inflammation1 reports
Read these as a signal, not a rate. A report does not mean nirsevimab-alip caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 25, 2026.
Related calculators
Frequently asked questions
What is nirsevimab-alip?
Beyfortus (Nirsevimab-Alip) is a medication supplied as an injection.
Can you take nirsevimab-alip with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run nirsevimab-alip against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does nirsevimab-alip come in?
Across the brands we track, nirsevimab-alip is currently marketed as injectable, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic nirsevimab-alip?
We do not currently list a generic-labelled nirsevimab-alip product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Nirsevimab-Alip: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/nirsevimab-alip
- MLA
- “Nirsevimab-Alip: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/nirsevimab-alip.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for nirsevimab-alip on DailyMed (NIH) ↗.