Beyfortus has the power to help reduce the chaos of the RSV season

Profile

Beyfortus® (nirsevimab) is a long-acting monoclonal antibody that offers protection against RSV LRTD for at least five months.¹

**Based on clinical and pharmacokinetic data.¹

The safety profile of nirsevimab has been studied in a broad population, including healthy pre-term/term babies and those at higher risk for severe RSV lower respiratory tract infections (LRTIs).¹

Beyfortus was studied across three pivotal studies that enrolled >3800 infants ^{1, 3-5}
- Phase 2b study: 1453 healthy, pre-term infants randomised 2:1 to receive Beyfortus followed by placebo, or palivizumab.
- Phase 3 MELODY (primary cohort) study: 1490 healthy, term and late pre-term infants randomised 2:1 to receive Beyfortus followed by placebo, or palivizumab.
- Phase 2/3 MEDLEY study:925 infants born very or moderately pre-term, or infants with congenital heart disease (CHD) or chronic lung disease (CLD) randomised 2:1 to receive Beyfortus followed by placebo, or palivizumab.

The most frequent adverse reaction was rash (0.7%) occurring within 14 days post dose. The majority of cases were mild to moderate in intensity. Additionally, pyrexia and injection site reactions were reported at a rate of 0.5% and 0.3% within 7 days post dose, respectively. Injection site reactions were non-serious.¹ For full adverse events information please refer to the Beyfortus Summary of Product Characteristics.

In a post marketing setting serious hypersensitivity reactions have been reported following Beyfortus administration. Anaphylaxis has been observed with human immunoglobulin G1 (IgG1) monoclonal antibodies. If signs and symptoms of anaphylaxis or other clinically significant hypersensitivity reaction occur, immediately discontinue administration and initiate appropriate medicinal products and/or supportive therapy.¹

^†Adverse reaction from spontaneous reporting
*Rash was defined by the following grouped preferred terms: rash, rash maculo-papular, rash macular.¹
**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.¹
‘Uncommon’ defined as ≥1/1,000 to <1/ 100.¹

^†Safety was evaluated in MEDLEY in 918 infants at higher risk for severe RSV disease, including 196 extremely pre-term infants (GA <29 weeks) and 306 infants with chronic lung disease of prematurity, or hemodynamically significant congenital heart disease entering their first RSV season, who received nirsevimab (614) or palivizumab (304)¹

Practical considerations

Understanding the chaos of RSV season

All infants are at risk from respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD),*^,7-13 but we cannot predict who will be affected.¹⁴

RSV LRTD is a leading cause of hospitalisation in infants, regardless of health status, gestational age at birth, or month of birth.**^,7-13,15-18

*Percentage of children born healthy and/or full term among children hospitalised due to RSV in different retrospective analyses: France (2010-2018; in children <5 years of age): 87% healthy and 90% full term;⁷ Spain (2004-2012; in infants): 98% healthy and full term;⁸ Japan (January 2017-December 2018; in children ≤2 years of age): 90% healthy and full term;⁹ Germany (2015-2018; in infants): 90% healthy and 83% full term;¹⁰ China (2007-2015, in children 28 days-13 years of age): 88% healthy and full term (median age 1.4 years);¹¹ UK (Scotland 2000-2011; in children ≤2 years of age): 93% healthy and 82% full term;¹³ US (population-based surveillance 2014-2015; in infants ≤11 months): 72% healthy and full term.¹²

**From retrospective analyses conducted in France (45,225 RSV-associated hospitalisations per season between 2010 and 2018)⁷ and US (243,834) RSV bronchiolitis, 38,064 RSV pneumonia and 15,786 other RSV discharges of infants <1 year of age between 1997 and 1999).¹⁵

†Based on an English study where 51% (n=10,328/20,359) of hospital admissions due to RSV occurred in infants born before the season (April to October);¹⁷ a Spanish study where 54% (n=340/631) of infants hospitalised with RSV were born before the season (April through October);¹⁶ and a French study where 47% (n=85,292/181 ,758) of RSV-hospitalised infants were born before the season (April to October).⁷

‡From a cross-sectional survey of 380 HCPs in 20 European countries conducted between August 2021 and January 2022.¹⁹

HCP, healthcare professional; LRTD, lower respiratory tract disease; LRTI, lower respiratory tract infection; RSV, respiratory syncytial virus.

Dosing & Administration

When and how to use Beyfortus

Beyfortus should be administered from birth for infants born during the RSV season. For others born outside the season Beyfortus should be administered ideally prior to RSV season.¹

Beyfortus is available in a 50 mg and a 100 mg pre-filled syringe based on an infant’s weight at the time of receiving Beyfortus.^*,1 Beyfortus is given as an intramuscular injection ONLY, preferably in the anterolateral aspect of the thigh.^**,1

Different injection sites should be used

*The recommended dose is a single dose of 50 mg administered intramuscularly for infants with body weight <5 kg and a single dose of 100 mg administered intramuscularly for infants with body weight ≥5 kg.¹

Please consult the Summary of Product Characteristics for complete information of full dosing and administration information.

**The gluteal muscle should not be used routinely as an injection site because of the risk of damage to the sciatic nerve.¹

Beyfortus is a long-acting antibody against RSV LRTD¹

Beyfortus confers protection through the delivery of antibodies, rather than depending on the maturation of infants immune system to produce their own antibodies.^1,2

Based on clinical and pharmacokinetic data, the duration of protection afforded by Beyfortus is at least 5 months.¹

Beyfortus Mode of Action¹

Beyfortus is a recombinant neutralising human IgG1ĸ long-acting monoclonal antibody (mAb) to the prefusion conformation of the RSV F protein which has been modified with a triple amino acid substitution (YTE) in the Fc region to extend serum half-life.¹

The Beyfortus development programme was conducted across a broad infant population.^1,3-5

This included healthy infants born at term, premature infants, and those with congenital heart disease and chronic lung disease of prematurity.^1,3-5

- Phase 2b study: 1453 healthy pre-term infants
- Phase 3 MELODY (primary cohort) study: 1490 healthy, term and late pre-term infants
- Phase 2/3 MEDLEY study: 925 infants born very or moderately pre-term, or infants with congenital heart disease (CHD) or chronic lung disease (CLD)