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Discover Beyfortus<regular>®</regular> (nirsevimab-alip) 50 mg and 100 mg Injection

Beyfortus is the only antibody designed for season-long RSV disease protection that extends through 5 months<regular>¹</regular>

Single-dose protection against RSV lower respiratory tract disease<regular>¹*</regular>

Antibody administration directly to infant; does not rely on infant’s maturing immune system¹

Direct

<ul><li>Long-acting antibody: modified to extend its half-life¹</li>
<li>RSV disease protection through 5 months based on clinical data¹</li></ul>

Long-Acting

Monoclonal antibody (mAb) that provides passive immunity by inhibiting RSV F (fusion) protein to prevent viral entry into cells¹

Antibody

*Based on clinical and pharmacokinetic data.1

Direct, Long-Acting Antibody<regular>¹</regular>

<ul><li>Neonates and infants born during or entering their first RSV season</li>
<li>Children up to 24 months who remain vulnerable to severe RSV disease through their second RSV season</li></ul>{br}
FDA approved for a broad range of infant populations entering their first season, including¹:

Healthy or With Underlying Conditions

Full Term or Preterm

During or Entering the RSV season*

Beyfortus was approved to prevent RSV lower respiratory tract disease by the FDA in July of 2023<regular>¹˒²</regular>:

<ul><li>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.</li>
<li>Use in Individuals with Clinically Significant Bleeding Disorders: As with other IM injections, Beyfortus should be given with caution to infants and children with thrombocytopenia, any coagulation disorder or to individuals on anticoagulation therapy.</li></ul>

Warnings and Precautions

*Epidemiology research will further define when local RSV seasons start.

The first and only antibody designed to protect all infants¹

Healthy term and late preterm infants (≥35 wGA)

<regular>Trial 04</regular> {br}(Phase 3 MELODY)

Healthy preterm infants (≥29 to <35 wGA)

<regular>Trial 03</regular>{br}(Phase 2b)

Preterm Infants (<35 wGA) and infants born with CLD of prematurity or hemodynamically significant CHD

<regular>Trial 05</regular> {br}(Phase 2/3 MEDLEY)

CHD, congenital heart disease; CLD, chronic lung disease; wGA, weeks gestational age.

The efficacy and safety of Beyfortus was evaluated in randomized, double-blind, multicenter trials for the prevention of RSV lower respiratory tract infection:

Cost and Coverage With Beyfortus

Demonstrated Safety and Efficacy Profile¹

Watch the experts speak about key points to know about RSV.

Experts discuss severe RSV disease

Articles

Take a closer look at RSV and Beyfortus<regular>®</regular>

RSV affects each infant differently

The danger to infants with RSV

A pilot prospective observational study estimating the quality of life (QoL) for otherwise healthy term US infants with RSV-LRTI and their caregivers.

Quality of life burden on United States infants and caregivers due to lower respiratory tract infection and adjusting for selective testing

A surveillance study of 600 infants across 39 hospitals requiring intensive care for RSV infection found that most were delivered full-term and previously healthy.

Infants admitted to US intensive care units for RSV infection during the 2022 seasonal peak

A study to assess the time from birth hospitalization discharge to the first outpatient visit among US infants in order to determine optimal site of administration for the extended half-life antibody.

Optimal site of care for administration of extended half-life respiratory syncytial virus (RSV) antibodies to infants in the United States (US)

Take a deeper dive into RSV

RSV is a common, highly contagious respiratory virus, the transmission of which occurs through the nasopharyngeal or conjunctival mucosa with respiratory secretions from infected individuals—mostly other children, older siblings, and other family members.²⁻⁴ Although most of the time RSV will cause mild cold-like symptoms, we cannot predict which infants will develop RSV lower respiratory tract disease.<regular>¹</regular>

What is RSV?

RSV is the leading cause of hospitalization in infants under 12 months.⁵*

2 out of 3 <regular>infants will be</regular> infected <regular>{br}with RSV by age 1⁶</regular>

<regular>Infants younger than 1 year are on average{br}</regular> 16x <regular>more likely to be hospitalized due to RSV than for</regular> influenza<regular>⁷†</regular>

<regular>Among children hospitalized due to RSV:{br}</regular>~75%<regular> were born at full term with no{br} underlying conditions1,8,9‡</regular>

*Based on data between 1993 and 2008 (routine recommendation for influenza vaccines in infants 6 months and older began in 2004).7,10{br}
†These data based on infants born April 2016 to February 2020 in the MarketScan Commercial (644,116), MarketScan Medicaid (1,025,286), and Optum Clinformatics (460,426) data sets; data October 2014 to April 2015 among 1,176 RSV-hospitalized infants aged younger than 12 months; data based on surveillance conducted in 2,149 hospitalized infants from October-March during the years 2000 through 2005.

RSV incidence and hospitalization rate in infants

RSV, respiratory syncytial virus.{br}{br}*Based on leading primary diagnosis (RSV bronchiolitis, Oct 2015-Dec 2019, rank 1, 165,930 cases [9.3%]){br}†Based on data between 1993 and 2008 (routine recommendation for influenza vaccines in infants 6 months and older began in 2004).7,10{br}‡These data based on infants born April 2016 to February 2020 in the MarketScan Commercial (644,116), MarketScan Medicaid (1,025,286), and Optum Clinformatics (460,426) data sets; data October 2014 to April 2015 among 1,176 RSV-hospitalized infants aged younger than 12 months; data based on surveillance conducted in 2,149 hospitalized infants from October-March during the years 2000 through 2005.

RSV—Hospitalization, Seasonality, and Pathophysiology

All infants are at risk for RSV lower respiratory tract disease<regular>¹</regular>

RSV is <primary><a.seasonal>seasonal</a.seasonal></primary>, with infections peaking at certain times throughout the year.4,11 A typical RSV season runs roughly from Fall through Spring, with some exceptions, such as in Florida, where the RSV season may start earlier.¹² Epidemiology monitoring can identify research when local RSV seasons begin.{br}{br}One common misperception is that an infant born before the RSV season is better protected against the virus than one born during it. However, infants born during the season are exposed to the virus for less time than those born before it. As a result, the number of RSV-hospitalized infants born in season vs before the season is roughly equal.13*{br}{br}

*Based on a 2019 UK study of the number of hospitalized infants born in-season (Oct-Mar: 48%) and born before the season (Apr-Sept: 50%).

Learn about RSV seasonality

Droplets containing RSV from infected contact enter infant’s nasopharynx. There is usually no manifestation of symptoms at this point.¹⁴

At Days 1 and 2

Nasopharyngeal cells are sloughed and may be aspirated, carrying RSV to lower respiratory tract cells.¹⁴ Symptoms can include congestion, runny nose, fever, irritability, and poor feeding.

At Days 3 Through 5

RSV-infected epithelial cells can travel deeper into the infant's lungs, infecting the bronchioles and alveoli, causing bronchiolitis and/or pneumonia.¹⁴ Symptoms can include cough, excess phlegm, rapid/difficult breathing, wheezing and/or grunting noises, nasal flaring, and abnormal chest movement when breathing.{br} {br}
Ultimately, 2 to 3 out of every 100 infants with RSV infection may need to be hospitalized. Those who are hospitalized may require supportive care such as oxygen, intubation, and/or mechanical ventilation.¹⁵

At Days 6 Through 8

*This is one example of progression, which can vary in each individual infant.

RSV pathophysiology—see how RSV symptoms progress*

Watch the experts discuss the burden of RSV disease

RSV-LRTI, respiratory syncytial virus lower respiratory tract infection.

Demonstrated Safety and Efficacy Profile¹⁶

Want to Know More About Beyfortus?

Learn how Beyfortus® (nirsevimab-alip) is the first and only long-acting antibody indicated for the prevention of RSV lower respiratory tract disease in term and preterm infants¹⁶

Power to Help Prevent RSV Disease

As a healthcare professional, it is important you receive the correct reimbursement for the care you provide. The information and resources on this page will give you and your staff everything needed to ensure you are billing and reimbursed correctly for administering Beyfortus.

Cost & Coverage

Beyfortus<regular>®</regular> (nirsevimab-alip) 50 mg and 100 mg injection reimbursement resources

The resources you need to be properly reimbursed for administering Beyfortus

CPT® codes 90380 and 90381 are specifically for Beyfortus. Beyfortus CPT codes can be found in the Immune Globulin section. On all claims for Beyfortus, choose one of these codes based on the size of the dose provided.¹{br}{br}<ul><li>Use CPT code 90380 when a single 0.5 mL dose is administered</li><li>Use CPT code 90381 when a single 1 mL dose or a 2 mL dose (two 1 mL doses) are administered</li></ul>

Beyfortus passive immunization product codes

Use this letter if you have been denied your VFC Administration Fee for administering Beyfortus.{br}<primary><a.VFC>VFC</a.VFC></primary> {iconDownload}

Sample letter for VFC Administration Fee denial for Beyfortus

Use this letter to request that a Capitated Plan reimburse your administration of immunizations separately from the agreed upon reimbursement structure.{br}<primary><a.CapitatedPlansLetter>Capitated Plans letter</a.CapitatedPlansLetter></primary> {iconDownload}

Sample letter for communicating with Capitated Plans

On October 6, 2023 CPT released 2 new codes to report the administration of Beyfortus, effective immediately. Report the administration service with code 96380 or 96381 based on if a physician or other qualified healthcare professional (QHCP) provided counseling on the same date as the administration of Beyfortus.{br}{br}<ul><li>Use CPT code 96380 when counseling is performed by a provider who independently bills, such as a physician or other qualified health care professional</li>{br}<li>Use CPT code 96381 when counseling is not performed by a provider who independently bills, such as a physician or other qualified health care professional</li></ul>{br}During the transition to these new codes, payer policies may require reporting administration CPT code 96372 for therapeutic, prophylactic, or diagnostic injection until their coverage policies and payment systems are ready to accept claims using CPT 96380 and 96381. Contact the health plans that you work with to verify their coding requirements and to see when they will be ready to accept the new administration codes 96380 and 96381.

NEW Beyfortus administration codes effective October 6, 2023

To ensure correct billing and reimbursement it is important to provide the correct Beyfortus NDC code. The Beyfortus NDC codes are{br}{br}<ul><li>50 mg/0.5 mL prefilled syringe: Carton of 5, NDC 49281-575-15 (Unit of Sale NDC)</li><li>100 mg/1 mL prefilled syringe: Carton of 5, NDC 49281-574-15 (Unit of Sale NDC)</li></ul>

Unit of Sale NDC

Unit of Use NDC

Presentation

Five 50 mg/0.5 mL single-dose pre-filled syringes in a carton

Five 100 mg/mL single-dose pre-filled syringes in a carton

Beyfortus National Drug Code (NDC)²

To ensure correct reimbursement for Beyfortus administration, be sure to use ICD-10-CM diagnosis code Z29.11 when submitting a claim. This ICD-10 code should be used following an encounter for prophylactic immunotherapy for respiratory syncytial virus (RSV).

Beyfortus ICD-10 Code

<primary>Q: What is a CPT code?</primary>{br}A: Current Procedural Terminology (CPT) codes are a set of medical codes maintained by the American Medical Association and used by various entities to describe and report medical, surgical, and diagnostic services and procedures.{br}{br}<primary>Q: Why does Beyfortus have 2 CPT codes?</primary>{br}A: Beyfortus has 2 weight-based dosing options (50 mg and 100 mg). Therefore, to ensure proper billing and reimbursement, 2 CPT codes are necessary.{br}{br}<primary>Q: When billing, should I use the unit of use or carton NDC number?</primary>{br}A: Each individual payer will determine which NDC number you should use when submitting for reimbursement.{br}{br}<primary>Q: What ICD-10 codes should I use when submitting for reimbursement?</primary>{br}A: The ICD-10-CM diagnosis code Z29.11 should be used when submitting a claim for Beyforttus administration. The description for this ICD-10 code is an encounter for prophylactic immunotherapy for respiratory syncytial virus (RSV).{br}{br}<primary>Q: Where do I find the Immune Globulin section?</primary>{br}A: Beyfortus product codes can be found in the Immune Globulin/mAb section of the CPT code book. This will be the first time that CPT and administration codes for a product on the immunization schedule will be in the Immune Globulin section.{br}{br}<primary>Q: Why is Beyfortus reimbursed using immune globulin administration codes instead of vaccine administration codes?</primary>{br}A: Although ACIP has added Beyfortus to the infant immunization schedule, it is a monoclonal antibody.³ Therefore, to be accurately reimbursed, the immune globulin administration codes must be used when submitting a claim.{br}{br}<primary>Q: Why do I need to provide the Beyfortus administration code when submitting a claim?</primary>{br}A: The administration code must be provided in addition to the product code to be reimbursed for the service of administering Beyfortus. {br}{br}<primary>Q: Why do I need to provide the Beyfortus NDC code when submitting a claim?</primary>{br}A: Beyfortus has 2 weight-based dosing options (50 mg and 100 mg) available in a carton of 5 pre-filled syringes. Some payers, to ensure proper billing and reimbursement, will require the NDC code for the dosing option administered.{br}{br}<primary>Q: How do I bill for the 2 mL dose?</primary>{br}A: The 2 mL dose requires two 1 mL doses to be administered. When billing for a 2 mL dose you must bill for two 1 mL doses by billing 2 units of CPT code 90381. You must also include the appropriate administration coding to be reimbursed accurately.

Beyfortus reimbursement FAQs

Comprehensive, on-demand training for the correct coding, billing, and reimbursement of Beyfortus is available at no cost.{br} <primary><a.crackingTheCodesTraining>crackingthecodestraining.com.</a.crackingTheCodesTraining></primary>

Cracking the Codes training

The Provider Coverage Tool can be used to determine the coverage and reimbursement status of Beyfortus in your specific area and across the country.{br}This easy-to-use tool can be accessed through <primary><a.crackingTheCodesTraining>crackingthecodestraining.com.</a.crackingTheCodesTraining></primary>

Provider Coverage Tool

Use this letter to proactively request coverage for Beyfortus from a specific health plan.{br}<primary><a.ProactiveRequest>Proactive Request</a.ProactiveRequest></primary> {iconDownload}

Sample letter for proactive request for Beyfortus

Use this letter to appeal to a health plan’s low or denied payment for administering Beyfortus.{br}<primary><a.LetterOfAppeal>Letter of Appeal</a.LetterOfAppeal></primary> {iconDownload}

Sample letter of appeal for low or denied payment of Beyfortus

Ready to Learn More?{br}Contact a Beyfortus Representative

How and when to use the Beyfortus codes

Neonates and infants entering their first RSV season who weigh <5 kg should be administered a 50 mg dose

100 mg for >= 5 kg

Neonates and infants who weigh ≥5 kg should be administered a 100 mg dose

For children up to 24 months of age who remain at increased risk for severe RV in their second RSV season, the recommended dosage of Beyfortus is a single 200 mg dose administered as 2 IM injections.

Only for second RSV season

200mg

Recommended Dosage

Store Beyfortus in its original carton to protect from light until time of use. Store refrigerated 36 °F to 46 °F (2 °C-8 °C)

Beyfortus may be kept at room temperature 68 °F to 77 °F (20 °C-25 °C) for a maximum of 8 hours After removal from the refrigerator, Beyfortus must be used within 8 hours or discarded

Do not freeze, shake, or expose Beyfortus to heat.

Storage and handling

Beyfortus should be administered : • For neonates and infants barn during or entering the RSV season: starting from birth • For infants barn outside the RSV season: once prior ta the start of the season

The minimum duration of protection offered by a single dose of Beyfortus extends through 5 months.

Administer the entire contents of the Beyfortus pre-filled syringe as an IM injection, preferably in the anterolateral aspect of the thigh. The gluteal muscle should not be used as an injection site because of the risk of damage to the sciatic nerve. Beyfortus can be given concomitantly with childhood vaccines.

Administering Beyfortus

The ideal timing for Beyfortus dosing is just before or near the start of the <primary><a.AboutRsv>RSV season</a.AboutRsv></primary> or from birth for infants born shortly before or during the RSV season.¹

Beyfortus<regular>®</regular> (nirsevimab-alip) 50 mg and 100 mg injection is a single dose timed to the RSV season for the vast majority of infants¹

<primary>Provides passive immunization that extends through 5 months, the typical length of the RSV season, regardless of birth month1,2</primary>

Hospital: If not given at the hospital prior to discharge, administer Beyfortus at the first office visit, within 1 week of birth3{br}{br}

Office: May be given at regularly scheduled 2-, 4-, or 6-month well-baby visits{br}{br}{br}<ul><li>For children undergoing cardiac surgery with cardiopulmonary bypass, an additional dose of Beyfortus is recommended as soon as the child is stable after surgery; please consult the Prescribing Information for complete information on dosing in these circumstances</li>{br}<li>Children up to 24 months of age who remain vulnerable through their second RSV season:{br}- 1 x 200 mg dose administered as 2 IM injections (2 x 100 mg)</li></ul>

Dosing and Administration

Provides passive immunization that extends through 5 months, the typical length of the RSV season, regardless of birth month1

For neonates and infants born during October-March, the optimal timing of Beyfortus® is at birth.
For neonates and infants born during April-September, the ideal timing for Beyfortus® dosing is just before or near the start of RSV season.
*Office: If not given at the hospital prior to discharge, administer Beyfortus® at the first well-baby visit, ideally within 1 week of discharge.
†Office catch-up: During regularly scheduled 2-, 4-, or 6-month well-baby visits.

Scheduling a single dose of Beyfortus¹˒²

<ul><li>Because the timing of the onset, peak, and decline of RSV activity might vary geographically, providers can adjust administration schedules based on local epidemiology</li><ol><ul><li>RSV seasonality in tropical climates (including southern Florida, Guam, Hawaii, Puerto Rico, US-affiliated Pacific Islands, and US Virgin Islands) might differ</li><li>In Alaska, RSV seasonality is less predictable, and the duration of RSV activity is often longer than the national average duration</li></ul></ol>{br}<li>Providers in these jurisdictions should consult state, local, or territorial guidance on timing of Beyfortus administration</li></ul>

ACIP Regional Administration Guidelines³

Infants and children aged 8-19 months with increased risk for severe disease who are recommended to receive Beyfortus when entering their second RSV season include:{br}<ul><li>Children with chronic lung disease of prematurity who required medical support (chronic corticosteroid therapy, diuretic therapy, or supplemental oxygen) any time during the 6-month period before the start of the second RSV season</li><li>Severely immunocompromised children</li><li>Children with cystic fibrosis who have either</li></ul>{br}<ol><li>manifestations of severe lung disease (previous hospitalization for pulmonary exacerbation in the first year of life or abnormalities on chest imaging that persist when stable), or</li><li>weight-for-length <10th percentile</li></ol>{br}<ul><li>American Indian or Alaska Native children</li></ul>

Second RSV Season Guidelines³

< 5kg

≥ 5kg

Due to variability in RSV seasonality, there are regional considerations for Beyfortus administration<regular>³</regular>

The recommended dosage of Beyfortus for neonates and infants born during or entering their first RSV season is based on body weight and is administered as a single intramuscular (IM) injection.

First RSV season: neonates and infants

Dosage of Beyfortus in neonates and infants born during or entering their first RSV season

For children up to 24 months of age who remain at increased risk for severe RSV in their second RSV season, the recommended dosage of Beyfortus is a single 200 mg dose administered as two IM injections (2 x 100 mg).

Second RSV season: children who remain vulnerable to severe RSV disease

For children undergoing cardiac surgery with cardiopulmonary bypass, an additional dose is recommended as soon as the child is stable after surgery. Please consult the Prescribing Information for complete information on dosing in this circumstance.

Children undergoing cardiac surgery with cardiopulmonary bypass

Can be administered concomitantly with any childhood vaccines

There is limited experience of Beyfortus coadministration with vaccines. In clinical trials, when Beyfortus was given with routine childhood vaccines, the safety and reactogenicity profile of the coadministered regimen was similar to the childhood vaccines given alone. Beyfortus should not be mixed with any vaccine in the same syringe or vial. When administered concomitantly with injectable vaccines, they should be given with separate syringes and at different injection sites.

‡For children undergoing cardiac surgery with cardiopulmonary bypass, an additional dose is recommended as soon as the child is stable after surgery. For children who remain vulnerable to severe RSV disease entering their second RSV season, the recommended dosage of Beyfortus is a single 200 mg dose administered as two IM injections (2 x 100 mg). Please consult the <a.PrescribingInformation>Prescribing Information</a.PrescribingInformation> for complete information on dosing in these circumstances.{br}{br}
§There is limited experience of Beyfortus coadministration with vaccines. In clinical trials, when Beyfortus was given with routine childhood vaccines, the safety and reactogenicity profile of the coadministered regimen was similar to the childhood vaccines given alone. Beyfortus should not be mixed with any vaccine in the same syringe or vial. When administered concomitantly with injectable vaccines, they should be given with separate syringes and at different injection sites.

Single-dose, pre-filled syringe for convenient administration<regular>¹</regular>

A single dose for the vast majority of infants based on weight<regular>¹</regular>

<ul><li>Beyfortus is for intramuscular injection only, preferably in the anterolateral aspect of the thigh</li><li>The entire contents of the syringe should be administered intramuscularly</li><li>The gluteal muscle should not be used routinely as an injection site because of the risk of damage to the sciatic nerve</li></ul>

How should Beyfortus be administered?<regular>¹</regular>

Up to 18 months{br}Beyfortus may be kept at room temperature 63° F to 77° (20° C to 25° C) when protected from light for a maximum of 8 hours. After this time, the syringe must be discarded.1

What is the shelf life of Beyfortus?

<ul><li>Store in a refrigerator 36° F to 46° F (2° C to 8° C)</li><li>Beyfortus may be kept at room temperature 68°F to 77°F (20°C to 25°C) for a maximum of 8 hours. After removal from the refrigerator, Beyfortus must be used within 8 hours or discarded</li><li>Do not freeze</li><li>Do not shake or expose to direct heat</li><li>Store in original carton to protect from light until time of use</li></ul>

How should Beyfortus be stored?<regular>¹</regular>

Practical considerations for Beyfortus

Beyfortus is available in a 50 mg and a 100 mg  pre-filled syringe

Dosing & Administration

Included 1,490 late preterm and term infants (≥35 wGA) entering their first RSV season

Trial 04

Conducted in 1,453 preterm infants (≥29 to <35 wGA) entering their first RSV season

Trial 03

included 925 infants: Entering first RSV season: Infants born at <35 weeks GA and infants born with CLD of prematurity or hemodynamically significant CHD Entering second RSV season: Infants with CLD or CHD

Trial 05

Incidence of medically attended RSV lower respiratory tract infections (MA RSV-LRTIs) caused by RT-PCR–confirmed RSV, characterized predominantly as bronchiolitis or pneumonia through 150 days after dosing§

Primary endpoint

Incidence of RSV lower respiratory tract infections (RSV-LRTIs) with hospitalization. RSV hospitalization was defined as hospitalization for LRTI with a positive RSV test

Secondary endpoint

Cl, confidence interval; MA RSV-LRTI, medically attended respiratory syncytial virus lower respiratory tract infection; RRR, relative risk reduction; wGA, gestational age (weeks).
*The primary efficacy analysis for Trial 04 is based on subjects from the Primary Cohort.
†Efficacy for MA RSV-LRTI based on relative risk reduction against placebo adjusted for age at randomization.
‡Efficacy for MA RSV-LRTI based on relative risk reduction against placebo adjusted for age at randomization and hemisphere.
§In a post hoc analysis of all randomized infants in Trial 03 weighing <5 kg at baseline, and who received the recommended dose of Beyfortus, efficacy for MA RSV-LRTI based on relative risk reduction against placebo was 86.2% (95% CI: 68.0, 94.0); efficacy for RSV-LRTI with hospitalization based on relative risk reduction against placebo was 86.5% (95% CI: 53.5, 96.1).

(95% CI: 50.6, 87.3; P≤0.001)1*†
Beyfortus: 1.2% (12)
Placebo: 5.0% (25)

Infants born at ≥35 wGA - Trial 04

74.9 % RRR

(95% CI: 52.3, 81.2; P<0.001)1‡§
Beyfortus: 2.6% (25)
Placebo: 9.5% (46)

Infants born at ≥29 TO <35 wGA - Trial 03

70.1 % RRR

Incidence of MA RSV-LRTI through 150 days post dose (primary endpoint)

Efficacy

CHD, congenital heart disease; CLD, chronic lung disease.

The safety of Beyfortus was evaluated in Trial 05, a randomized, double-blind, palivizumab-controlled multicenter trial in subjects at high risk for severe RSV disease Adverse reactions reported among Trial 05 subjects who received Beyfortus in their first RSV season were similar to those reported in subjects who received Beyfortus in Trials 03 and 04

RSV season one

Subjects with CLD of prematurity or hemodynamically significant CHD could continue in Trial 05 and receive Beyfortus or palivizumab prior to their second RSV season. All subjects who received Beyfortus in the first RSV season also received Beyfortus in the second RSV season (N=180) The safety profile of Beyfortus in these subjects during their second RSV season was consistent with the safety profile of Beyfortus observed during their first RSV season

RSV season two (Subjects with CLD of prematurity and hemodynamically significant CHD)

Safety studies in a broad range of infants, including those at higher risk of severe disease1

The efficacy of Beyfortus was evaluated in 3 randomized, double-blind, multicenter trials––Trial 04 (Phase 3 MELODY), Trial 03 (Phase 2b), and Trial 05 (Phase 2/3 MEDLEY)––for the prevention of RSV lower respiratory tract infection. A total of 3,224 pediatric subjects received the recommended dose of Beyfortus in Phase 2 and Phase 3 clinical trials.

Take a look at the clinical data

*Based on trials: Trial 03 evaluated the efficacy and safety of a single 50 mg dose of Beyfortus in 1,453 very and moderately preterm (≥29 to <35 wGA) infants (age 12 months or under) entering their first RSV season (N=969) vs placebo (N=484). Trial 04 evaluated the efficacy and safety of a single 50 mg or 100 mg administration of Beyfortus for the prevention of LRTls in 1,490 term and late preterm (≥35 wGA) infants (age 12 months or under) entering their first RSV season (N=994) vs placebo (N=496). Trial 05 evaluated the safety of Beyfortus compared to palivizumab, randomizing a total of 925 infants at higher risk for severe RSV disease, including infants with CLD of prematurity or hemodynamically significant CHD, and preterm infants (<35 wGA) entering their first RSV season.


†Studies included healthy preterm infants, healthy full term infants, and infants with underlying conditions. Higher risk infants included 196 extremely preterm infants (<29 wGA) and 306 infants with CLD, prematurity, or hemodynamically significant CHD.

The safety profile of Beyfortus in infants in their first RSV season was comparable to placebo1*†

Safety1

*For neonates and infants in their first season, the recommended dose is 50 mg for infants <5 kg or 100 mg for infants ≥5 kg via IM administration. For children up to 24 months of age who remain at increased risk for severe RSV disease in their second season, the recommended dose is a single 200 mg dose administered as 2 IM injections (2 x 100 mg).1{br}
†Included 128 preterm infants born at <29 wGA.1{br}
‡Incidence of RSV-LRTI (inpatient or outpatient) due to confirmed RSV through 150 days (descriptive).3

Beyfortus<regular>®</regular> (nirsevimab-alip) 50 mg and 100 mg Injection Efficacy & Safety Profile Overview

Studied across a broad range of infant populations entering their first RSV season<regular>¹</regular>

Trial 04 continued monitoring for the primary cohort and an additional 1,522 subjects to include all subjects.<regular>⁴</regular>

Pre-filled Syringe for Convenient Administration<regular>¹</regular>

The CDC published real-world data estimating the effectiveness of Beyfortus in infants entering their first RSV season.11{br}{br}<ul><li>A multisite analysis of 699 infants hospitalized with acute respiratory illness during their first RSV season</li><li>Provides the first estimate for Beyfortus effectiveness among US infants during their first RSV season</li></ul>

Discover the real-world data about Beyfortus

Primary endpoint: incidence of MA RSV-LRTI vs placebo through 150 days post 1 dose{br}{br}Medically attended (MA) includes all healthcare provider visits such as physician’s office, urgent care, emergency room, and hospitalizations

Trial 04 (Primary Cohort): healthy term and late preterm infants (≥35 wGA)1*†‡

Time to first medically attended RSV lower respiratory tract infection⁹

Post-dose follow-up visits: Day 151 is an efficacy evaluation;{br}Day 361 was a safety evaluation entering second season.

Study design with efficacy monitoring for 151 days and safety monitoring for 361 days¹⁰

Incidence of MA RSV-LRTI through Day 150 vs placebo1

§§For infants in their first RSV season, the recommended dose is 50 mg for infants <5 kg or 100 mg for infants ≥5 kg via intramuscular administration.1

Incidence of MA RSV-LRTI through Day 150 <primary>vs placebo</primary>1

In infants in Trial 03 who received 50 mg of Beyfortus consistent with the recommended weight-based dose, Beyfortus reduced the risk of MA RSV-LRTI by 86.2%1§§ {br} {br} <regular>The Trial 03 analysis included healthy preterm infants ≥29 to <35 wGA who were randomized to receive Beyfortus or placebo</regular>

Incidence of hospitalization was a secondary endpoint in Trial 04 and Trial 03. The incidence of hospitalizations in Trial 04 was 60.2% RRR with a P value of 0.09 and 78.4% RRR with a P value of 0.0002 in Trial 03.1‖‖¶¶{br}{br}

In an exploratory analysis of Trial 04, Beyfortus reduced the risk of MA RSV-LRTI and RSV-LRTI with hospitalization4,8{br}{br}

The Phase 3 trial continued to enroll infants following the primary analysis, and overall, 3,012 infants were randomized to receive Beyfortus (n=2,009) or placebo (n=1,003)

1,490 late preterm and term subjects (≥35 wGA) in the Trial 04 study{b}1,453 preterm subjects (≥29 to <35 wGA) in the Trial 03 study.

Incidence of RSV-LRTI requiring hospitalization through Day 150 vs placebo8

‖‖1,490 late preterm and term subjects (≥35 wGA) in the Trial 04 study{br}¶¶1,453 preterm subjects (≥29 to <35 wGA) in the Trial 03 study.

Studied in a broad infant population {br} including healthy preterm and full term infants and those at higher risk for severe RSV disease1##

The safety profile was similar to that of placebo1,2,5,7***†††

The most common adverse reactions were rash and injection site reactions1

##Studies included healthy preterm infants, healthy term infants, and infants with underlying conditions. Higher risk infants included preterm infants (<29 wGA) and infants with CLD of prematurity or hemodynamically significant CHD.{br}***The most common adverse reactions were rash (0.9%) and injection site reactions (0.3%).{br}†††Based on the trials: Trial 03 evaluated the efficacy and safety of a single 50 mg dose of Beyfortus in 1,453 preterm (GA ≥29 weeks to <35 weeks) infants (age 12 months or under) entering their first RSV season (n=969) vs placebo (n=484). Trial 05 (MEDLEY) evaluated the safety of Beyfortus compared to palivizumab, randomizing a total of 925 infants at higher risk for severe RSV disease, including infants with CLD of prematurity or hemodynamically significant CHD, and preterm infants (GA <35 weeks) entering their first RSV season. Trial 04 (MELODY), which evaluated the efficacy and safety of a single 50 mg or 100 mg administration of Beyfortus for the prevention of LRTIs in 1,490 late preterm and term (GA ≥35 weeks) infants (age 12 months or under) entering their first RSV season (n=994) vs placebo (n=496).{b}

Trial 04 and Trial 03 were pooled to evaluate the safety of Beyfortus (N=2,570) compared to placebo (N=1,284){br}{br}<ul><li>The Beyfortus group included 1,998 healthy term and late preterm infants (≥35 wGA) and 572 preterm infants (≥29 to <35 wGA)</li><li>Adverse reactions were reported in 1.2% of infants who received Beyfortus; most (97%) of adverse reactions were mild to moderate in severity</li></ul>{br}{br}Most Common Adverse Reactions Reported at an Incidence Higher Than Placebo in the Safety Population (Trial 04 and Trial 03)1*{br}{br}

*The Safety Population includes all infants who received the recommended dose of Beyfortus in Trials 04 and 03: Primary and Safety cohorts from Trial 04; infants who weighed <5 kg and who received the recommended dose of Beyfortus (single 50 mg IM dose) in Trial 03.{br}†Rash was defined by the following grouped preferred terms: rash, rash macular, rash maculopapular, rash papular.{br}‡Injection site reaction was defined by the following grouped preferred terms: injection site reaction, injection site pain, injection site induration, injection site edema, injection site swelling.

Adverse reaction

Beyfortus {br} N=2,570

Placebo {br} N=1,284

Rash<regular>†{br}(occurring within 14 days post dose)</regular>

Injection Site Reaction<regular>‡{br} (occurring within 7 days post dose)</regular>

The safety of Beyfortus was evaluated in Trial 05, a Phase 2/3, randomized, double-blind, palivizumab-controlled multicenter trial in infants and children at high risk for severe RSV disease.{br}{br}First RSV season¹: infants born at <35 wGA and infants with CLD of prematurity and hemodynamically significant CHD<ul><li>Adverse reactions reported among Trial 05 infants who received Beyfortus in their first RSV season were similar to those reported in infants who received Beyfortus in Trials 03 and 04</li></ul>{br}{br}Second RSV season¹: children up to 24 months with CLD of prematurity and hemodynamically significant CHD<ul><li>The safety profile of Beyfortus in these children during their second RSV season was consistent with the safety profile of Beyfortus observed during their first RSV season</li></ul>

Trial 05: analysis of Beyfortus vs palivizumab in infants at higher risk of severe RSV disease¹˒²{br}{br}First season study design: randomized, double-blind, palivizumab-controlled multicenter safety study¹˒²

PK, pharmacokinetic.{br}{br}¶¶¶Signs of LRTI involvement included rhonchi, rales, crackles, or wheezing and at least one sign of worsening clinical severity including at least one of the following: increased respiratory rate, hypoxemia, acute hypoxic or ventilatory failure, new onset apnea, nasal flaring, retractions, grunting, or dehydration due to respiratory distress.

Study Design

Forty children who received palivizumab in the first RSV season received Beyfortus in their second RSV season; and 42 children received palivizumab in both first and second RSV seasons.{br}{br}
Baseline characteristics: at randomization, in the preterm cohort, 77 infants (13%) were <29 wGA; and 499 (81%) were ≥29 to <35 wGA. In the CLD/CHD cohort, 70% had CLD; 34% had hemodynamically significant CHD; 123 infants (40%) were <29 wGA, 28% were ≥29 to <35 wGA; and 32% were ≥35 wGA.

PK, pharmacokinetic.{br}{br}*Signs of LRTI involvement included rhonchi, rales, crackles, or wheezing and at least one sign of worsening clinical severity, including at least one of the following: increased respiratory rate, hypoxemia, acute hypoxic or ventilatory failure, new onset apnea, nasal flaring, retractions, grunting, or dehydration due to respiratory distress.

Second season study design: randomized, double-blind, palivizumab-controlled multicenter safety study¹˒²

<ul><li>Trial 05 was not powered for efficacy but efficacy was assessed as a secondary endpoint</li><li>The clinical significance of these data is not known</li></ul>

<primary>Exploratory efficacy: in preterm infants (<35 wGA) or those with CLD/CHD there was a numerically lower incidence of MA RSV-LRTI with Beyfortus compared with palivizumab1,3†</primary>

†Trial 05 was a Phase 2/3, randomized, double-blind, palivizumab-controlled study evaluating the safety of Beyfortus in infants with CLD or CHD and preterm infants (<35 wGA) entering their first RSV season. Children up to 24 months with CLD or CHD could continue in Trial 05 and receive Beyfortus or palivizumab prior to their second RSV season. The efficacy was established based on extrapolation of the efficacy from Trial 04 and Trial 03 to the population enrolled in Trial 05 based on similar Beyfortus exposures among infants enrolled in Trials 04 and 05.

<primary>There were no cases of MA RSV-LRTI through 150 days in the second RSV season</primary>

Beyfortus exhibited a reduction in RSV-LRTI hospitalizations compared with placebo¹˒⁴˒⁷˒⁸{br}{br}Trial 04: incidence of RSV-LRTI requiring hospitalization through Day 150 vs placebo

Primary cohort: hospitalization endpoint¹˒⁶{br}{br}{br}The Primary Cohort of Trial 04 included 1,490 infants randomized to receive Beyfortus (n=994) or placebo (n=496){br}

Medically attended (MA) includes all healthcare provider visits such as physician’s office, urgent care, emergency room, and hospitalizations

RRR based on a comparison of infants hospitalized⁶:{br}6 infants receiving Beyfortus (0.6%){br}8 infants receiving placebo (1.6%)

Full study cohort: exploratory post hoc analysis of the hospitalization endpoint⁴˒⁵{br}{br}Trial 04 continued to enroll infants following the primary analysis; the full study cohort included 3,012 infants randomized to receive Beyfortus (n=2,009) or placebo (n=1,003) in this post hoc analysis

RRR based on a comparison of infants hospitalized:{br}9 infants receiving Beyfortus (0.4%){br}20 infants receiving placebo (2.0%)

The dose given was 50 mg for infants <5 kg or 100 mg for infants ≥5 kg via IM injection{br}

<ul><li>Most common adverse reactions with Beyfortus were rash (0.9%) and injection site reactions (0.3%)¹</li></ul>

Signs of LRTI involvement included rhonchi, rales, crackles, or wheezing and at least one sign of worsening clinical severity including at least one of the following: increased respiratory rate, hypoxemia, acute hypoxic or ventilatory failure, new onset apnea, nasal flaring, retractions, grunting, or dehydration due to respiratory distress.

CI, confidence interval; RRR, relative risk reduction; {br}{br}
*1,490 healthy term and late preterm infants (≥35 wGA) in Trial 04.{br}†The primary efficacy analysis for Trial 04 is based on infants from the Primary Cohort.{br}‡Efficacy for MA RSV-LRTI based on relative risk reduction against placebo adjusted for age at randomization.

Baseline characteristics: at randomization, 14% were ≥35 to <37 wGA; 86% were ≥37 wGA.¹

ITT, intention to treat; RT-PCR, reverse transcription polymerase chain reaction.{br}{br}*Signs of LRTI involvement included rhonchi, rales, crackles, or wheezing and at least one sign of worsening clinical severity including at least one of the following: increased respiratory rate, hypoxemia, acute hypoxic or ventilatory failure, new onset apnea, nasal flaring, retractions, grunting, or dehydration due to respiratory distress.

Randomized, double-blind, placebo-controlled multicenter Trial 04<regular>¹˒⁵</regular>

Lower respiratory tract infections (LRTIs) associated with respiratory syncytial virus (RSV)<regular>⁵</regular>

Post-dose follow-up visits: Day 151 is an efficacy evaluation;{br}Day 361 was a safety evaluation entering second season;{br}Final assessment via telephone call.

Study design with efficacy monitoring for 151 days and safety monitoring for 361+ days<regular>⁶</regular>

#1,453 preterm subjects (≥29 to <35 wGA) in the Trial 03 study.{br}**Efficacy for MA RSV-LRTI based on relative risk reduction against placebo adjusted for age at randomization and hemisphere.{br}††A single 50 mg intramuscular injection dose of Beyfortus was administered regardless of body weight.

*1,453 healthy preterm infants (≥29 to <35 wGA) in Trial 03.{br}††Efficacy for MA RSV-LRTI based on relative risk reduction against placebo adjusted for age at randomization and hemisphere.

Baseline characteristics: at randomization, 20% were ≥29 to <32 wGA, 80% were ≥32 to <35 wGA.¹

ITT, intention-to-treat; RT-PCR, reverse transcription polymerase chain reaction.{br}{br}*Signs of LRTI involvement included rhonchi, rales, crackles, or wheezing and at least one sign of worsening clinical severity including at least one of the following: increased respiratory rate, hypoxemia, acute hypoxic or ventilatory failure, new onset apnea, nasal flaring, retractions, grunting, or dehydration due to respiratory distress.

Randomized, double-blind, placebo-controlled multicenter Trial 03¹˒⁹

Proven strong and consistent efficacy against RSV disease<regular>¹</regular>

Beyfortus exhibited a reduction in hospitalizations compared with placebo¹˒²˒⁵˒⁹

Beyfortus has a favorable safety profile<regular>¹˒²˒⁵˒⁷</regular>

Beyfortus demonstrated consistent safety profile across multiple infant cohorts¹˒²˒⁵˒⁹

Safety studied in infants and children at higher risk for severe RSV disease¹

RSV-LRTI Hospitalization

Study design

Time-to-Event Analysis

Randomization and Dosing

Trial 03: healthy preterm infants (≥29 to <35 wGA)1*†

Post hoc Analysis

Efficacy & Safety

Hear from RSV experts

Coming soon: the Beyfortus<regular>®</regular> (nirsevimab-alip) Expert Series

The Beyfortus Expert Series is an ongoing educational program where healthcare experts discuss key topics related to RSV disease and Beyfortus.

<ul><li>Past topics have included MOA, Efficacy and Safety, Formulary Updates, Implementation for Hospitals and Clinics, and more</li>{br}<li>Participate in multiple sessions with live Q&A</li></ul>
{br}{br}
Come back soon for new sessions in 2024!

Join the RSV experts for live sessions as they share their perspectives and facilitate an interactive Q&A

Beyfortus is not a vaccine or maternal immunization. Beyfortus is an RSV F protein-directed fusion inhibitor monoclonal antibody indicated for the prevention of RSV lower respiratory tract disease—directly administered to the infant as well as eligible children via IM injection. This does not require an immune response from the infant.¹
{br}{br}
F protein, fusion protein; IM, intramuscular; RSV, respiratory syncytial virus.

Is Beyfortus a maternal immunization, vaccine, or monoclonal antibody?

<primary>Contraindications</primary>{br}
Beyfortus is contraindicated in individuals with a history of serious hypersensitivity reactions, including anaphylaxis, to nirsevimab-alip or to any of the excipients.<regular>¹</regular>
{br}{br}<primary>Warnings and Precautions</primary>{br}
<primary>Hypersensitivity Reactions Including Anaphylaxis:</primary>{br}
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.
{br}{br}
<primary>Use in Individuals with Clinically Significant Bleeding Disorders</primary>{br}
As with any other IM injections, Beyfortus should be given with caution to individuals with thrombocytopenia, any coagulation disorder or to individuals on anticoagulation therapy.<regular>¹</regular>

What are the Contraindications and Warnings and Precautions for Beyfortus?

Serious allergic reactions have occurred with Beyfortus. The most common adverse reactions are rash (0.9%) and injection site reactions (0.3%).1 You may report side effects to FDA at <primary><call.fdaPhone>1-800-FDA-1088</call.fdaPhone>.</primary>
{br}{br}
<primary><a.EfficacyAndSafety>Review Adverse Reactions</a.EfficacyAndSafety></primary>

What are the adverse reactions of Beyfortus?

<ul><li>Active ingredient: nirsevimab-alip</li><li>Inactive ingredients: arginine hydrochloride, histidine, L-histidine hydrochloride, polysorbate 80, sucrose and water for injection</li></ul>

What are the ingredients in Beyfortus?

For more information and future updates, sign up for Beyfortus emails or request to speak with a representative. For further support, call 1-855-BEYFORTUS <primary><call.beyfortusPhone>(1-855-239-3678)</call.beyfortusPhone>.</primary>
{br}{br}
<primary><a.track.OptIn>Get Beyfortus updates</a.track.OptIn></primary>

Where can I get more information about Beyfortus?

Please refer parents to the <primary><a.cdc>Centers for Disease Control and Prevention (CDC)</a.cdc></primary> for information on RSV and to <primary><a.beyfortus>Beyfortus.com</a.beyfortus></primary> for more information on Beyfortus. 
{br}{br}
RSV, respiratory syncytial virus.

Where should I direct parents to get more information on RSV and Beyfortus?

Beyfortus was approved by the US FDA on July 17, 2023.<regular>³</regular>{br}
<primary><a.viewPressRelease>View press release</a.viewPressRelease></primary>

When did Beyfortus receive its US Food and Drug Administration (FDA) approval?

Yes. The Advisory Committee on Immunization Practices (ACIP) voted unanimously 11 to 0 to include Beyfortus in the Vaccines For Children (VFC) program.<regular>³</regular>{br}
<primary><a.viewPressRelease>View press release</a.viewPressRelease></primary>

Is Beyfortus included for the Vaccines For Children (VFC) program?

Based on clinical data, Beyfortus provides season-long RSV protection that extends through 5 months.<regular>¹</regular>
{br}{br}
RSV, respiratory syncytial virus.

Will Beyfortus protect infants for an entire RSV season?

For children up to 24 months of age who remain vulnerable to RSV disease entering their second RSV season, the recommended dose of Beyfortus is a single 200 mg dose administered as two IM injections (2 x 100 mg).<regular>¹</regular>
{br}{br}
IM, intramuscular.

What should I know about Beyfortus dosing in the second season for children who remain vulnerable to RSV disease?

Beyfortus can be given concomitantly with other childhood vaccines.<regular>¹</regular>{br}{br}There is limited experience of Beyfortus coadministration with vaccines.<regular>¹</regular> {br}{br}In clinical trials, when beyfortus was given with routine childhood vaccines, the safety and reactogenicity profile of the coadministered regimen was similar to the childhood vaccines given alone.<regular>¹</regular>{br}{br}Beyfortus should not be mixed with any vaccine in the same syringe or vial. When administered concomitantly with injectable vaccines, they should be given with separate syringes and at different injection sites.<regular>¹</regular>

Can Beyfortus be co-administered with other pediatric vaccines?

Only 5-pack cartons will be available in the US at this time.<regular>¹</regular>
{br}{br}
<primary><a.OrderBeyfortus>Learn more about ordering Beyfortus</a.OrderBeyfortus></primary>

Are there 1-pack cartons of Beyfortus?

Yes. Beyfortus injection is a sterile, latex-free, preservative-free, clear to opalescent, colorless to yellow solution for intramuscular injection.1,4

Is Beyfortus latex and preservative free?

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.<regular>¹</regular>

Who should not receive Beyfortus?

Beyfortus<regular>®</regular> 50 mg and 100 mg Injection Frequently Asked Questions

Yes, I want to participate in the Reservation Program. (If you do not want to participate, please do not check this box.)

We've created the Beyfortus Reservation Program to help you prepare for the upcoming RSV season. To learn more, click <nextRsvSeason>here</nextRsvSeason>.

Do you want to participate in the Beyfortus Reservation Program?

Would you like to receive future text messages about Beyfortus updates?

Scroll to see the latest real-world data published in the CDC Morbidity and Mortality Weekly Report (MMWR).

<a.track.Obgyn>Click here</a.track.Obgyn> to see more information for OBGYNs.

Protection for any infant

Power to help prevent respiratory syncytial virus (RSV) disease

Start Planning for the 2024/2025 Season Today

ACIP AND AAP RECOMMENDED<regular>¹⁻³*</regular>

Keep Up to Date With Information About Beyfortus via Email or Text

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® (nirsevimab-alip) <regular>is the </regular>first and only long-acting antibody <regular>indicated for the</regular> prevention of RSV lower respiratory tract disease <regular>in⁴:</regular>

<regular>Demonstrated safety and{br} efficacy profile³</regular>

<regular>Pre-filled syringe for{br} convenient administration³</regular>

This Beyfortus® (nirsevimab-alip) 50 mg and 100 mg injection website is for US healthcare professionals only.

By clicking on this link, you will be leaving this Sanofi-hosted US website and going to another, entirely independent website. Sanofi US provides these links as a service to their website visitors and users; however, they take no responsibility for the information on any website but their own.

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National Expert Program & Educational Series

You’re invited! The Beyfortus<regular>®</regular> (nirsevimab-alip) 50 mg and 100 mg Injection Expert Series

The Beyfortus Expert Series is an ongoing educational series where you can learn more about Beyfortus from national experts.

<ul><li>Sessions focus on clinical topics such as MOA, Efficacy and Safety, Formulary Updates, Implementation for Hospitals and Clinics, and more</li><li>Participate in multiple sessions with live Q&A</li></ul>
{br}{br}
Come back soon for new sessions in 2024!

Join the RSV experts for live 30-minute sessions as they share their perspectives and facilitate an interactive Q&A

Discover Mechanism of Action

Pivotal Trials: Exploring Efficacy & Safety

Adding a New Product Into Your Formulary

Activating Simple Implementation for Hospitals and Clinics

Clinic, institution, and hospital-based experts will focus on key topics:

Beyfortus is the first and only long-acting antibody indicated for the prevention of RSV lower respiratory tract disease in¹:{br}{br}<ul><li>Neonates and infants born during or entering their first RSV season</li><li>Children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season</li></ul>

*Time to maximum concentration is 6 days in adults and uptake half-life is 1.7 days in infants.¹˒³

Beyfortus® (nirsevimab-alip) 50 mg and 100 mg information for OBGYNs

Fast-acting passive immunization to help prevent respiratory syncytial virus (RSV) disease, that lasts through 5 months, a typical RSV season¹⁻³*

ACOG guidelines state that clinicians should counsel patients regarding the monoclonal antibody, Beyfortus, as another option for newborns if the maternal RSV vaccine is not received during pregnancy.⁴*{br}{br}<ul><li>When possible, discussions regarding Beyfortus should include information about whether it will be available to the baby after birth</li></ul>

Infants born at <34 weeks should receive Beyfortus regardless of maternal vaccination status.

Infants <34 weeks⁴

Infants born to mothers who still need RSV vaccination ≥14 days before birth may receive Beyfortus based on clinical judgment.

Infants at risk⁴

ACOG, American College of Obstetricians and Gynecologists.{br}{br}†Patient preferences for maternal vs infant immunization against RSV should be considered when deciding to administer Beyfortus.

Recommendations

CDC/ACIP recommends Beyfortus for infants born before the RSV season, as well as those born during the season when⁵

<ul><li>The mother did not receive the RSV maternal vaccine, or</li><li>The mothers vaccination status is not known, or</li><li>The window between maternal vaccination and birth was <14 days, or</li><li>The healthcare provider determines the incremental benefit of Beyfortus is warranted because the infant is at increased risk, or when there are concerns about the adequacy of the maternal immune response or placental antibody transfer.</li></ul>

First RSV season{br}{br}Infants aged <8 months born during or entering their first RSV season are recommended to receive 1 dose of Beyfortus (50 mg for infants <5 kg and 100 mg for infants ≥5 kg)⁶ :{br}{br}<ul><li>For babies born before the season, providers should target administration shortly before the start of the season for infants aged <8 months</li><li>For babies born during the season, Beyfortus should be administered within 1 week of birth, which can be during the birth hospitalization or in the outpatient setting</li></ul>{br}Refer to the most current CDC immunization schedule for additional immunization considerations

AAP, American Academy of Pediatrics; ACIP, Advisory Committee on Immunization Practices; CDC, Centers for Disease Control and Prevention.

Beyfortus recommendations by CDC/ACIP and AAP⁶,⁷

Supply update for 2024/2025: With AstraZeneca, we are expanding the Beyfortus manufacturing network to allow for a significant increase in supply for the coming RSV season to cover the entire US demand

Demonstrated Safety and Efficacy Profile¹

Learn more about how Beyfortus works

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One Last Step

Please follow these steps to complete your registration:

For more information regarding Beyfortus®, call 1-855-BEYFORTUS (1-855-239-3678) or sign up below to receive the latest updates via email or text.

Sanofi is here to help support your patients, their families, and caregivers.

To order Beyfortus, visit VaccineShop.com to log in or set up an account.

There has been an unprecedented demand for Beyfortus. Despite an aggressive supply plan built with the goal of outperforming past pediatric immunization launches, the actual market demand has been much higher across both the 50 mg and 100 mg presentations.{br}{br}At the present time, demand has now consumed the supply currently available for this season for both the 50 mg and 100 mg.{br}{br}The Centers for Disease Control and Prevention (CDC) has issued a Health Alert Network (HAN) Health Advisory to provide options for clinicians to protect infants from RSV in the context of limited Beyfortus supply. Click <primary><a.cdcSupply>here</a.cdcSupply></primary> to learn more about the CDC Health Alert.{br}{br}We understand the significant impact the supply shortage will have on parents and providers and apologize for this unfortunate circumstance. We are working earnestly to help make available future supplies of Beyfortus. Thank you for your patience.{br}{br}Please contact your Sanofi representative to discuss any additional questions or <primary><a.track.OptIn>sign up for updates</a.track.OptIn></primary>.{br}{br}For additional information, read the <primary><a.viewPressReleaseSupply>Sanofi press release</a.viewPressReleaseSupply></primary>.

Important Update Regarding Beyfortus Supply

Beyfortus injection is a sterile, preservative-free, clear to opalescent, colorless to yellow solution supplied as follows:{br}{br}<primary>• Five 50 mg/0.5 mL single-dose pre-filled syringes in a carton: NDC 49281-575-15{br}• Five 100 mg/mL single-dose pre-filled syringes in a carton: NDC 49281-574-15</primary>{br}{br}Each Beyfortus pre-filled syringe is for one-time use only.{br}{br}Only 5-pack cartons will be available in the US at this time.

How Beyfortus is supplied<regular>¹</regular>

Additional ordering details:{br}{br}<primary>• Extended payment terms: 2% Prompt Pay 150, net 151 days{br}• All offers valid on orders received through March 31, 2024{br}• Product is fully returnable upon expiration</primary>

Beyfortus<regular>®</regular> (nirsevimab-alip) 50 mg and 100 mg Injection for Your Practice

For more information regarding Beyfortus, call <primary><call.beyfortusPhone>1-855-BEYFORTUS (1-855-239-3678)</call.beyfortusPhone></primary>

Optimize Your Planning for the 2024/2025 RSV Season

Plan ahead for the 2024/2025 RSV season

Introducing the Beyfortus® (nirsevimab-alip) Reservation Program

The Beyfortus Reservation Program provides critical insight on customer demand, and we are committed to prioritizing fulfillment of requests placed through this program.{br}{br}With AstraZeneca, we are expanding the Beyfortus manufacturing network to allow for a significant increase in supply for the 2024/2025 season and cover the entire US demand. In addition, we are producing Beyfortus well in advance of the RSV season, with the vast majority of doses available by October.{br}{br}The Beyfortus Reservation Program will help to optimize planning and provide access to reserve Beyfortus ahead of the season.

*Contact Customer Service in order to cancel your order.

The Reservation Program unlocks additional benefits, including:

<ul><li>Priority shipping, with reserved doses set aside</li><li>Ability to determine your preferred monthly shipment schedule throughout the RSV season</li><li>90-day payment terms</li><li>Cancellation is possible up to 14 days prior to scheduled shipments*</li></ul>

Once you have qualified for the program by estimating and submitting your Beyfortus forecast, you will be able to take part in the reservation period and receive program benefits.

What is the Beyfortus Reservation Program?

Feb. 5, 2024 – May. 17, 2024{br}{br}First, click the "Request a Representative" button above or below and fill out the form. Make sure to check the box next to "Yes, I want to participate in the Reservation Program".{br}{br}Then click "Get in touch" and a representative will reach out to you soon after. They'll work with you to accurately project and submit the amount of Beyfortus you will need using the Forecast Tool.{br}{br}Leveraging your historical 2023 birth data, the Sanofi representative will help estimate your total doses of 50 mg and 100 mg each as appropriate for your practice, and will generate a summary for your records.{br}{br}<title3><primary>Using the Forecast Tool</primary></title3>{br}The Forecast Tool will help predict your Beyfortus needs for the upcoming RSV season.{br}{br}To help calculate the doses you’ll need for a full RSV season, you will input:<ul><li>An estimate of the number of newborns you see monthly based on your 2023 EHR data</li><li>The anticipated immunization rate for these newborns in your practice</li><li>The percentage of publicly insured patients you see</li></ul>

<title3>Phase 1: Forecast and submit your doses</title3>

Jul. 1, 2024 – Aug. 31, 2024{br}{br}To reserve your supply, you can go to <primary><a.visitSanofiVaccineShop>vaccineshop.com</a.visitSanofiVaccineShop></primary> during the reservation period or work with your Sanofi representative.{br}{br}The Reservation Program offers flexibility based on your needs:<ul><li>Determine the timing of your shipments throughout the RSV season</li><li>Orders placed during the reservation period can be made for any amount, but note they cannot exceed +10% from what you forecasted and submitted with your Sanofi representative</li><li>There is no minimum order required to participate</li></ul>{br}Program not available for Vaccines for Children (VFC) orders. Total order availability may be dependent on overall demand.

<title3>Phase 2: Place your order and schedule your shipment</title3>

Aug. 2024 – Feb. 2025{br}{br}If you placed your order during the reservation period, shipments will begin to arrive as early as August 2024, with additional shipments arriving as you scheduled through February of 2025.{br}<ul><li>After the reservation period ends, cancellation of scheduled shipments are allowed up to 14 days prior to scheduled shipment of doses{br}</li><li>Returns are also accepted on expired product</li></ul>

<title3>Phase 3: Receive your reserved shipments</title3>

Orders can be placed outside of the Reservation Program during the normal order window from September 2024 through February 2025.{br}{br}<ul><li>Go to <primary><a.visitSanofiVaccineShop>vaccineshop.com</a.visitSanofiVaccineShop></primary> and place an order as you usually would beginning in September</li><li>Normal ordering window terms and conditions:{br}- Order Now/Ship Now Only: no ability to schedule future shipments{br}- Payment terms are limited to 60 days</li></ul>{br}Total order availability may be affected by overall demand.

Here's how it works

The Reservation Program has benefits, but it’s not your only chance to order

Thanks for planning ahead for the 2024/2025 RSV season!

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Would you like to learn more about Beyfortus®? Leave us your contact details and a Sanofi representative will be in touch.

Use the following resources for more information about Beyfortus, and to help ensure a seamless integration into your daily practice.

Beyfortus<regular>®</regular> (nirsevimab-alip) 50 mg and 100 mg Injection Resources

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Learn More from Beyfortus Expert-Led Discussions

Explore the Risk of RSV to All Infants

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How common is RSV in all enfants ?

Which respiratory virus leads to more hospitalizations ?

How severe can RSV symptom become ?

How does RSV burden the healthcare system ?

Contraindications: Hypersensitivity to the active substance or to any of the excipients.1

of children were born healthy and at term (across different countries)*,1–7

70% to 100%

of infants were born during the season, and ~50% before it began†,10,11

~50%

Should be used in accordance with official recommendations.

Among those hospitalized due to RSV:

of healthcare professionals (HCPs) reported moderate to extreme disruption to healthcare systems during peak RSV season‡,12

89% (n=338/380)

This puts a strain on healthcare services…

RSV is seasonal, with infections peaking at certain times throughout the year.3,7 A typical RSV season runs roughly from November to March, with some exceptions, such as in Florida, where the RSV season may start earlier.8 Epidemiology research will further define when local RSV seasons start.One common misperception is that an infant born before the RSV season is better protected against the virus than one born during it. However, infants born during the season are exposed to the virus for less time than those born before it. As a result, the number of RSV-hospitalized infants born in season vs before the season is roughly equal.9‡

Seasonality

Beyfortus® is designed to protect against RSV

Droplets containing RSV from infected contact enters infant’s nasopharynx. There is usually no manifestation of symptoms at this point.

Days 1,2

Nasopharyngeal cells are sloughed and aspirated, carryingRSV to lower respiratory tract cells. Symptoms can include: congestion, runny nose, fever, irritability, and poor feeding.

Days 3 to 5

RSV-infected epithelial cells travel deeper into the infant's lungs, infecting the bronchioles and alveoli, causing bronchiolitis and/or pneumonia. Symptoms can include: cough, excess phlegm, rapid/difficult breathing, wheezing and/or grunting noises, nasal flaring, and abnormal chest movement when breathing.

Days 6 to 8

While RSV causes cold-like symptoms in some infants, it can progress to more serious disease in others making it the leading cause of infant hospitalization.

How RSV progresses ?

RSV LRTD is a leading cause of hospitalization in infants up until their first birthday,**,1,9 and doesn’t discriminate by health, gestational age (GA) or birth date.

All infants are at risk from RSV LRTD, but it’s impossible to predict who will be affected.

Discover how simple it can be to protect infants from RSV using Beyfortus®

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We truly appreciate your interest in Beyfortus. A dedicated representative will be in touch with you shortly.{br}{br}Warm regards,{br}The Sanofi Team

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Important safety information

Contraindication

Indication

Important safety information

Contraindication

Warnings and Precautions

Request a Representative

Would you like to learn more about Beyfortus® (nirsevimab-alip) 50 mg and 100 mg injection? Leave us your contact details and a Sanofi representative will be in touch.

Important safety information

Contraindication

Indication

Important safety information

Contraindication

Warnings and Precautions

Would you like to learn more about Beyfortus^® (nirsevimab-alip) 50 mg and 100 mg injection? Leave us your contact details and a Sanofi representative will be in touch.