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BEYFORTUS nirsevimab 100 mg/mL Injection, 5 syringes — NDC 49281-0575-15 package photo

BEYFORTUS nirsevimab 100 mg/mL Injection, 5 syringes

by Sanofi Vaccines US Inc. · 5 SYRINGE in 1 CARTON (49281-575-15) / .5 mL in 1 SYRINGE
NDC 49281-0575-15
🏷️ FDA NDC (as labeled) 49281-575-15 billing pads the product segment with a zero
This package
Contains5 syringes Pack sizes2 compare ↓
Also comes in: 1 syringe 49281-0575-00
Rx only Brand On market Non-controlled
🗂️ Data synced Sep 3, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 49281-575-15
Product NDC 49281-575
11-digit billing NDC 49281057515
NCPDP billing unit ML — per mL (volume)
RxCUI 2642406, 2642412, 2642414, 2642415
UNII VRN8S9CW5V
Application # BLA761328
SPL Set ID 2f08fa60-f674-432d-801b-1f9514bd9b39
Established class (EPC) Respiratory Syncytial Virus Anti-F Protein Monoclonal Antibody
Mechanism of action Fusion Protein Inhibitors
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-07-18
Route INTRAMUSCULAR
Dosage form INJECTION
Substance NIRSEVIMAB
GCN Seq No 085070
GCN 54466
HICL code 049077
Ingredient (HICL) Nirsevimab-Alip
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W5
Therapeutic class — intermediate (HIC2) Antiviral Agents
HIC3 code W5D
Therapeutic class — specific (HIC3) Antiviral Monoclonal Antibodies
AHFS code 08:18.24.00
AHFS class Monoclonal Antibodies (08:18)
FDB label name BEYFORTUS 50 MG/0.5 ML SYRINGE
FDB brand name Beyfortus
Legend status F — Federal legend — prescription drug or device
Biologic (Purple Book) 351(a)
Why two NDCs? The FDA registers this code as 49281-575-15 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 49281-0575-15. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Respiratory Syncytial Virus Anti-F Protein Monoclonal Antibody class.

Pharmacologic class Respiratory Syncytial Virus Anti-F Protein Monoclonal Antibody
Drug family (ATC) Antiviral monoclonal antibodies
How it works Fusion Protein Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerSanofi Vaccines US Inc.
FDA applicationBLA761328 (BLA)
Labeler code49281
First marketedJul 2023
Product typeHuman Prescription Drug
Portfolio27 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name BEYFORTUS 50 MG/0.5 ML SYRINGE Ingredient Nirsevimab-Alip
📗 Our plain-language guide HelloPharmacist
  • Beyfortus is a shot that helps protect your baby from RSV — a common virus that can cause serious lung infections, especially in young infants. It's not a vaccine in the traditiona...
  • What exactly is Beyfortus and why does my baby need it?
  • It's given as a shot into the muscle of the outer thigh by your baby's healthcare provider — you won't be giving it at home. Most babies tolerate it well. The most common reactions...
  • How is it given, and will it hurt my baby?
📖 Read our full Nirsevimab guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII F7LTH1E20Y
    Arginine hydrochloride is an amino acid salt used as a buffer and pH adjuster in medicines. It helps maintain the correct acidity level to keep the drug stable and effective.
  • UNII 4QD397987E
    An amino acid used as a buffer and stabilizer in medications. It helps maintain the pH balance and protects the active drug from breaking down during storage and use.
  • UNII X573657P6P
    Histidine monohydrochloride monohydrate is an amino acid salt used as a buffer in medicines. It helps maintain the proper acidity level of liquid formulations to keep the drug stable and effective.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

6 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 1 syringe
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Beyfortus 100 mg/mL 49281-0574-15 Sanofi 5 syringes — — FDA listed —
Beyfortus 100 mg/mLthis 49281-0575-15 Sanofi 5 syringes — — FDA listed —
About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & biosimilar status

🏛️
2023
First FDA approval
Jul 2023
📍
2026
Currently FDA-listed
3 years listed
🛡️
2035
Latest patent/protection listed
not a guaranteed launch date
🧬Biologic — competition comes from biosimilars

Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Jul 2035. This may affect when biosimilars become widely available, but it is not a guaranteed launch date.
📅 FDA approved Jul 17, 2023 ⏳ ~8.8 yr to latest listed protection

Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.

FDA Purple Book — biosimilars & interchangeables ⓘ
Reference product
Beyfortusnirsevimab-alip
🔒 No FDA-licensed biosimilars or interchangeable biosimilars are listed yet for this biologic. It currently has no biosimilar competition in the FDA Purple Book.
Source: FDA Purple Book (purplebooksearch.fda.gov), matched on the reference product’s active ingredient.
Patents & exclusivity — FDA Purple Book
Exclusivity RefProduct
2023 2025 2027 2029 2031 2033 2035
Today
LOE
Biologic patent Exclusivity
🏛️Reference-product exclusivity
A flat 12 years of FDA market protection from first licensure. No biosimilar can be licensed before it ends — regardless of patents.
🧪Listed biologic patents
Patents the reference maker lists covering the molecule, formulation, or manufacturing. A biosimilar generally can’t launch until these resolve.
🔁Interchangeability
An interchangeable biosimilar may be substituted at the pharmacy (state laws vary). The first one can earn its own exclusivity period.
🛈 What do these terms mean?
Biologic patent
A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
Reference-product exclusivity
A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
Interchangeable exclusivity
The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
Earliest biosimilar (LOE)
The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.

Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.

FDA exclusivity
CodeWhat it grantsExpires
RefProductReference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this dateJul 17, 2035
Common questions
Is there a biosimilar for BEYFORTUS 50 MG/0.5 ML SYRINGE?
No FDA-licensed biosimilar is currently listed for this biologic in the FDA Purple Book.
Why do different websites show different biosimilar dates?
Biosimilar availability isn’t based on one single date. Some sources use the reference-product exclusivity, some use the last listed patent, and patent litigation, settlements, and licenses can all change the real-world launch date. This page shows the underlying Purple Book dates so you can see why estimates differ.
Can a biosimilar launch before the last patent expires?
Sometimes. A biosimilar maker may settle with the reference manufacturer or receive a license to launch earlier. In other cases, the last listed protection delays competition.
What does “current Purple Book estimate” mean?
It means we’re using the latest patent and exclusivity dates currently listed in the FDA Purple Book. It is not a guaranteed launch date.
What does “FDA listed” mean?
It means the product appears in the FDA’s official directory. That’s a good sign a product exists for the U.S. market, but on its own it does not confirm a pharmacy can get it today. Where we have recent retail pricing data, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Purple Book for a patent or exclusivity on the reference biologic. It can affect when a biosimilar becomes widely available — but it is not a guaranteed launch date. Settlements and licenses can move the real date earlier or later.
Built from the FDA Purple Book Patent List (patents the reference-product sponsor has publicly listed under the BPCIA) plus reference-product exclusivity. Biosimilars cannot launch until these clear; patent litigation and settlements can shift the real date. Biologics have no small-molecule generics — competition comes from FDA-licensed biosimilars, not the Orange Book.
Where does this data come from?
Patents and exclusivity from the FDA Purple Book (biologics), refreshed from public FDA data. Biosimilar launch timing is an estimate, not a guarantee.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
49281-0575-00 1 SYRINGE in 1 CARTON (49281-575-00) / .5 mL in 1 SYRINGE 2023-07-18 Active
49281-0575-15 You're viewing this 5 SYRINGE in 1 CARTON (49281-575-15) / .5 mL in 1 SYRINGE 2023-07-18 Active

Pack size FAQ

What quantity is in NDC 49281-0575-15?
NDC 49281-0575-15 contains 5 syringes — 5 syringe in 1 carton / .5 ml in 1 syringe.
What is the difference between NDC 49281-0575-15 and NDC 49281-0575-00?
Both are BEYFORTUS nirsevimab 100 mg/mL Injection — the drug itself is identical. NDC 49281-0575-15 is the 5 syringes package, while NDC 49281-0575-00 is the 1 syringe package.
What NDC number is used to bill for this package of BEYFORTUS nirsevimab 100 mg/mL Injection?
Bill NDC 49281-0575-15 — the 11-digit billing format is 49281057515. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 49281-575-15, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 49281-0575-15, written without dashes as 49281057515. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 49281-0575-15, the first segment (49281) is the labeler code FDA assigned to Sanofi Vaccines US Inc.; the middle segment (0575) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (15) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Sanofi Vaccines US Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 syringe (49281-0575-00). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Sanofi Vaccines US Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 108 words ▾

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 and Administration ~3 min read ▾

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 )

2.1Recommended 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 dosage. Table 2 Recommended Dosage of BEYFORTUS for the Second RSV Season for Children Who Remain at Increased Risk for Severe RSV Disease Child's Age at Time of Dosing Recommended Dosage Up to 24 months of age Regardless of body weight 200 mg administered as two IM injections of (2 × 100 mg) First and Second RSV Season for Children Undergoing Cardiac Surgery with Cardiopulmonary Bypass For children undergoing cardiac surgery with cardiopulmonary bypass, an additional dose of BEYFORTUS is recommended as soon as the child is stable after surgery to ensure adequate nirsevimab-alip serum levels.

The recommended dosage of BEYFORTUS is administered as an IM injection. First RSV season: If surgery is within 90 days after receiving BEYFORTUS, the additional dose should be based on body weight at the time of the additional dose. Refer to Table 1 for weight-based dosing.

If more than 90 days have elapsed since receiving BEYFORTUS, the additional dose should be 50 mg regardless of body weight. Second RSV season: If surgery is within 90 days after receiving BEYFORTUS, the additional dose should be 200 mg, regardless of body weight. If more than 90 days have elapsed since receiving BEYFORTUS, the additional dose should be 100 mg, regardless of body weight.

2.2Administration Instructions BEYFORTUS must be administered by a healthcare provider. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. BEYFORTUS is a clear to opalescent, colorless to yellow solution.

Do not inject BEYFORTUS if the liquid is cloudy, discolored, or it contains large particles or foreign particulate matter. Do not use if the BEYFORTUS pre-filled syringe has been dropped or damaged, the security seal on the carton has been broken, or the expiration date has passed. BEYFORTUS is available in a 50 mg and a 100 mg pre-filled syringe.

Check the labels on the BEYFORTUS carton and pre-filled syringe to ensure the correct 50 mg or 100 mg product is being used. Co-administration with Childhood Vaccines and Immunoglobulin Products BEYFORTUS can be given concomitantly with childhood vaccines [see Clinical Pharmacology (12.3) ] . When administered concomitantly with injectable vaccines, they should be given with separate syringes and at different injection sites.

Do not mix BEYFORTUS with any vaccines or medications in the same syringe or vial. There is no information regarding co-administration of BEYFORTUS with other immunoglobulin products. Palivizumab should not be administe…

💊 Dosage Forms and Strengths 57 words ▾

3 DOSAGE FORMS AND STRENGTHS BEYFORTUS is a clear to opalescent, colorless to yellow solution available as follows: Injection: 50 mg/0.5 mL in a single-dose pre-filled syringe. Injection: 100 mg/mL in a single-dose pre-filled syringe. Injection: 50 mg/0.5 mL in a single-dose pre-filled syringe. ( 3 ) 100 mg/mL in a single-dose pre-filled syringe. ( 3 )

⛔ Contraindications 63 words ▾

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 )

⚠️ Warnings and Cautions 140 words ▾

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 )

5.1Hypersensitivity 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.

5.2Use in Individuals with Clinically Significant Bleeding Disorders As with any other IM injections, BEYFORTUS should be given with caution to infants and children with thrombocytopenia, any coagulation disorder, or to individuals on anticoagulation therapy.

🤒 Adverse Reactions ~3 min read ▾

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.

6.1Clinical 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.

Trial 04 enrolled subjects sequentially into two cohorts: the Primary Cohort was used for the primary efficacy analysis [see Clinical Studies (14.3) ] and for assessment of safety, and the Safety Cohort was used primarily for safety assessment. All subjects from both cohorts of Trial 04 were included in the safety analysis (BEYFORTUS N=1,997 and placebo N=997). Subjects in Trial 04 weighing less than 5 kg received a single 50 mg IM dose of BEYFORTUS and infants weighing greater than or equal to 5 kg received a single 100 mg IM dose.

Infants who received the recommended dose in Trial 03 and infants in Trial 04 were pooled to evaluate the safety of BEYFORTUS (N=2,570) compared to placebo (N=1,284). At randomization, in this pooled Safety Population from Trials 03 and 04 cohorts, 22% of infants were born at less than 35 weeks GA, 10% of infants were GA greater than or equal to 35 weeks and less than 37 weeks; 68% were GA greater than or equal to 37 weeks; 52% were male; 57% were White; 15% were Black; 4% were American Indian/Alaskan native; 4% were Asian; 1% were Pacific Islander; and 19% were Other or Mixed Race; 30% were Hispanic or Latino; 73% were from Northern Hemisphere; and 53% weighed less than 5 kg.

The median age was 2 months; 65% were less than or equal to 3 months; 28% were greater than 3 to less than or equal to 6 months, and 7% were greater than 6 months of age. (Refer to Sections 14.2 and 14.3, Clinical Studies, for a description of the efficacy populations in Trials 03 and 04). In both trials, infants received a single dose of IM BEYFORTUS or placebo on Study Day 1 and were monitored for at least 60 minutes post-dose.

Subjects were followed for 360 days post-dose to assess safety. Adverse reactions were reported in 1.2% of subjects who received BEYFORTUS; most (97%) of adverse reactions were mild to moderate in intensity. Table 3 summarizes the adverse reactions that occurred in Trial 03 and Trial 04 (Safety Population) in subjects who received the recommended dose of BEYFORTUS.

Table 3 Adverse Reactions Reported at an Incidence Higher Than Placebo in the Safety Population The Safety Population includes all subj…

🔄 Drug Interactions 74 words ▾

7 DRUG INTERACTIONS

7.1Interference 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.

👥 Use in Specific Populations ~2 min read ▾

8 USE IN SPECIFIC POPULATIONS The safety and effectiveness of BEYFORTUS in children older than 24 months of age have not been established. ( 8.4 )

8.1Pregnancy BEYFORTUS is not indicated for use in females of reproductive potential.

8.2Lactation BEYFORTUS is not indicated for use in females of reproductive potential.

8.4Pediatric Use The safety and effectiveness of BEYFORTUS have been established for the prevention of RSV lower respiratory tract disease in neonates and infants born during or entering their first RSV season and in children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. The safety and efficacy of BEYFORTUS for this indication and populations are discussed throughout the labeling. Use of BEYFORTUS for this indication is supported by evidence from adequate and well-controlled studies in neonates and infants from birth up to 12 months of age with additional pharmacokinetic and safety data in children up to 24 months of age [see Adverse Reactions (6.1) , Clinical Pharmacology (12.3) , and Clinical Studies (14) ].

Use of BEYFORTUS in this population is supported by the following: - Trial 03, a randomized, double-blind, placebo-controlled multicenter trial for the prevention of MA RSV LRTI conducted in preterm infants born at GA greater than or equal to 29 weeks and less than 35 weeks entering their first RSV season; - Trial 04, a double-blind, placebo-controlled multicenter trial, for the prevention of MA RSV LRTI in term and late preterm infants GA greater than or equal to 35 weeks entering their first RSV season; - Trial 05, a Phase 2/3 randomized, double-blind, palivizumab-controlled multicenter trial in pediatric subjects born less than 35 weeks GA and infants with CLD of prematurity or hemodynamically significant CHD entering their first or second RSV season.

In addition, BEYFORTUS was evaluated in an open-label, uncontrolled, single-dose trial (Trial 08) in 100 infants and children who were less than or equal to 24 months of age, who received BEYFORTUS in their first or second RSV season, and who had a wide variety of underlying diseases or treatments resulting in immune compromise. The safety profile of BEYFORTUS administered in Trial 08 was consistent with the safety profile of other trials of BEYFORTUS in infants and children [see Clinical Pharmacology (12.3) ]. Trial 09 is a Phase 3b randomized, open-label trial of BEYFORTUS compared to no intervention for the prevention of hospitalization in term and preterm infants (GA greater than or equal to 29 weeks) born during or entering their first RSV season [see Adverse Reactions (6.1) and Clinical Studies (14.5) ].

The safety and effectiveness of BEYFORTUS have not been established in children older than 24 months of age.

🤰 Pregnancy 13 words ▾

8.1Pregnancy BEYFORTUS is not indicated for use in females of reproductive potential.

🧒 Pediatric Use ~2 min read ▾

8.4Pediatric Use The safety and effectiveness of BEYFORTUS have been established for the prevention of RSV lower respiratory tract disease in neonates and infants born during or entering their first RSV season and in children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. The safety and efficacy of BEYFORTUS for this indication and populations are discussed throughout the labeling. Use of BEYFORTUS for this indication is supported by evidence from adequate and well-controlled studies in neonates and infants from birth up to 12 months of age with additional pharmacokinetic and safety data in children up to 24 months of age [see Adverse Reactions (6.1) , Clinical Pharmacology (12.3) , and Clinical Studies (14) ].

Use of BEYFORTUS in this population is supported by the following: - Trial 03, a randomized, double-blind, placebo-controlled multicenter trial for the prevention of MA RSV LRTI conducted in preterm infants born at GA greater than or equal to 29 weeks and less than 35 weeks entering their first RSV season; - Trial 04, a double-blind, placebo-controlled multicenter trial, for the prevention of MA RSV LRTI in term and late preterm infants GA greater than or equal to 35 weeks entering their first RSV season; - Trial 05, a Phase 2/3 randomized, double-blind, palivizumab-controlled multicenter trial in pediatric subjects born less than 35 weeks GA and infants with CLD of prematurity or hemodynamically significant CHD entering their first or second RSV season.

In addition, BEYFORTUS was evaluated in an open-label, uncontrolled, single-dose trial (Trial 08) in 100 infants and children who were less than or equal to 24 months of age, who received BEYFORTUS in their first or second RSV season, and who had a wide variety of underlying diseases or treatments resulting in immune compromise. The safety profile of BEYFORTUS administered in Trial 08 was consistent with the safety profile of other trials of BEYFORTUS in infants and children [see Clinical Pharmacology (12.3) ]. Trial 09 is a Phase 3b randomized, open-label trial of BEYFORTUS compared to no intervention for the prevention of hospitalization in term and preterm infants (GA greater than or equal to 29 weeks) born during or entering their first RSV season [see Adverse Reactions (6.1) and Clinical Studies (14.5) ].

The safety and effectiveness of BEYFORTUS have not been established in children older than 24 months of age.

🆘 Overdosage 44 words ▾

10 OVERDOSAGE There is limited experience of overdose with BEYFORTUS. There is no specific treatment for an overdose with BEYFORTUS. In the event of an overdose, the individual should be monitored for the occurrence of adverse reactions and provided with symptomatic treatment as appropriate.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action BEYFORTUS is a monoclonal antibody with anti-RSV activity [see Microbiology (12.4) ] .

12.2Pharmacodynamics There is a positive correlation between a serum nirsevimab-alip AUC (based on clearance at baseline) above 12.8 mg*day/mL and a lower incidence of medically attended RSV lower respiratory tract infection (MA RSV LRTI). Following IM administration of nirsevimab-alip in adults, RSV neutralizing antibody levels in serum were approximately 4 times higher than baseline at 8 hours after nirsevimab-alip dosing, and maximum levels were reached by day 6 following IM administration of nirsevimab-alip in adults.

The safety and effectiveness of BEYFORTUS have not been established in adults. Duration of Protection Based on clinical data, the duration of protection offered by a single dose of BEYFORTUS extends through 5 months.

12.3Pharmacokinetics The PK of nirsevimab-alip is dose-proportional following a single IM administration of doses ranging from 25 mg (0.5 times the lowest approved recommended dosage) to 200 mg in pediatric subjects. Following the recommended dose, the nirsevimab-alip serum exposures were similar in neonates and infants born during or entering their first RSV season (Trials 03 and 04), and in neonates and infants born at less than 35 weeks GA (including less than 29 weeks GA) in their first RSV season (Trial 05), and in pediatric subjects up to 24 months of age with CLD or CHD in their first and second RSV season (Trial 05).

Absorption The estimated nirsevimab-alip absolute bioavailability is 84% and the median time (range) to maximum concentration is 6 (1, 28) days. Distribution The estimated nirsevimab-alip total volume of distribution is 477 mL, for an infant weighing 5 kg. Elimination The nirsevimab-alip terminal half-life is approximately 71 days and the estimated clearance is 3.42 mL/day for an infant weighing 5 kg.

Metabolism Nirsevimab-alip is degraded into small peptides by catabolic pathways. Specific Populations No clinically significant differences in the pharmacokinetics of nirsevimab-alip were observed based on race or vulnerability to severe RSV disease (i.e., CLD, CHD, GA <29 weeks). The mean and median serum nirsevimab-alip concentrations in Trial 08 were lower than the concentrations in Trials 04 and 05.

However, Trial 08 exposures were within the range shown to be effective in those who received the recommended dosage in Trials 03, 04, and 05 [see Pediatric Use (8.4) ] . Drug Interaction Studies No formal drug interaction studies have been performed with BEYFORTUS. Nirsevimab-alip is not predicted to be a substrate of, inhibitor or inducer of cytochrome P450 enzymes or transporter systems based on a mechanistic understanding of monoclonal antibodies.

Clinical Studies Vaccines : There is limited experience with co-administration of BEYFORTUS with vaccines. In clinical trials, when BEYFORTUS was given concomitantly with routine childhood vaccines, the safety and reactogenicity profile of the co-administered regimen was similar to the childhood vaccines given alone.

12.4Microbiology Mechanism of Action Nirsevimab-alip is a recombinant human IgG1κ monoclonal antibody that provides passive immunity by targeting the prefusion conformation of the RSV F protein. Nirsevimab-alip is long-acting due to a triple amino acid substitution (YTE) in the Fc region which increases binding to the neonatal Fc receptor and thereby extends serum half-life. Nirsevimab-alip binds to a conserved epitope in antigenic site Ø on the prefusion protein with dissociation constants K D = 0.12 nM and K D = 1.22 nM for RSV subtype A and B strains, respectively; it neutralizes RSV by inhibiting conformation changes in the F protein necessary for fusion of the viral and cellular membranes and viral entry.

Antiviral Activity The cell culture neutralization activity of nirsevimab-alip against RSV was measured in a concentration-response model using cultured Hep-2 cells. Nirsevim…

🧬 Mechanism of Action 17 words ▾

12.1Mechanism of Action BEYFORTUS is a monoclonal antibody with anti-RSV activity [see Microbiology (12.4) ] .

📦 How Supplied / Storage and Handling 148 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied BEYFORTUS injection is a sterile, preservative-free, clear to opalescent, colorless to yellow solution supplied as follows: One 50 mg/0.5 mL single-dose pre-filled syringe in a carton: NDC 49281-575-00 Five 50 mg/0.5 mL single-dose pre-filled syringes in a carton: NDC 49281-575-15 One 100 mg/mL single-dose pre-filled syringe in a carton: NDC 49281-574-88 Five 100 mg/mL single-dose pre-filled syringes in a carton: NDC 49281-574-15 Each BEYFORTUS pre-filled syringe is for one time use only.

Storage and Handling Store refrigerated between 36°F to 46°F (2°C to 8°C). BEYFORTUS may be kept at room temperature 68°F to 77°F (20°C to 25°C) for a maximum of 48 hours. After removal from the refrigerator, BEYFORTUS must be used within 48 hours or discarded.

Store BEYFORTUS in original carton to protect from light until time of use. Do not freeze. Do not shake.

Do not expose to heat.

📦 Storage and Handling 69 words ▾

Storage and Handling Store refrigerated between 36°F to 46°F (2°C to 8°C). BEYFORTUS may be kept at room temperature 68°F to 77°F (20°C to 25°C) for a maximum of 48 hours. After removal from the refrigerator, BEYFORTUS must be used within 48 hours or discarded. Store BEYFORTUS in original carton to protect from light until time of use. Do not freeze. Do not shake. Do not expose to heat.

📋 Description 145 words ▾

11 DESCRIPTION Nirsevimab-alip, a respiratory syncytial virus F protein-directed fusion inhibitor, is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. The molecular weight is approximately 146.3 kDa. BEYFORTUS (nirsevimab-alip) injection is a sterile, preservative-free, clear to opalescent, colorless to yellow solution for intramuscular injection.

It is supplied in a single-dose siliconized Luer lock Type I glass pre-filled syringe with a FluroTec coated plunger stopper. Each 0.5 mL contains 50 mg nirsevimab-alip, arginine hydrochloride (8 mg), histidine (1.1 mg), L-histidine hydrochloride monohydrate (1.6 mg), polysorbate 80 (0.1 mg), sucrose (21 mg), and water for injection (USP). The pH is 6.0.

Each 1 mL contains 100 mg nirsevimab-alip, arginine hydrochloride (17 mg), histidine (2.2 mg), L-histidine hydrochloride monohydrate (3.3 mg), polysorbate 80 (0.2 mg), sucrose (41 mg), and water for injection (USP). The pH is 6.0.

💬 Information for Patients 106 words ▾

17 PATIENT COUNSELING INFORMATION Advise the child's caregiver to read the FDA-approved patient labeling (Patient Information). Hypersensitivity Reactions Including Anaphylaxis Inform the patient's caregiver of the signs and symptoms of potential hypersensitivity reactions, and advise the caregiver to seek medical attention immediately if the child experiences a hypersensitivity reaction to BEYFORTUS [see Warnings and Precautions (5.1) ] . Dosage and Administration Advise the caregiver that the child will receive one dose of BEYFORTUS by IM injection by a healthcare provider.

If the child remains at increased risk for RSV, they may receive a second dose in the second RSV season [see Dosage and Administration (2.1) ].

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 49281-0574-15 · Sanofi 49281-0589-05 · Sanofi →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.