Beyfortus

Posology Infants during their first RSV season 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.

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 the RSV season. 6 kg is based on extrapolation, no clinical data are available.

Exposure in infants <1 kg is anticipated to yield higher exposures than in those weighing more. The benefits and risks of nirsevimab use in infants <1 kg should be carefully considered. There are limited data available in extremely preterm infants (Gestational Age [GA] <29 weeks) less than 8 weeks of age.

1). Children who remain vulnerable to severe RSV disease through their second RSV season The recommended dose is a single dose of 200 mg given as two intramuscular injections (2 x 100 mg). Beyfortus should be administered ideally prior to the start of the second RSV season.

For individuals undergoing cardiac surgery with cardiopulmonary bypass, an additional dose may be administered as soon as the individual is stable after surgery to ensure adequate nirsevimab serum levels. If within 90 days after receiving the first dose of Beyfortus, the additional dose during the first RSV season should be 50 mg or 100 mg according to body weight, or 200 mg during the second RSV season.

If more than 90 days have elapsed since the first dose, the additional dose could be a single dose of 50 mg regardless of body weight during the first RSV season, or 100 mg during the second RSV season, to cover the remainder of the RSV season.

The safety and efficacy of nirsevimab in children aged 2 to 18 years have not been established. No data are available. Method of administration Beyfortus is for intramuscular injection only. It is administered intramuscularly, preferably in the anterolateral aspect of the thigh.

The gluteal muscle should not be used routinely as an injection site because of the risk of damage to the sciatic nerve. If two injections are required, different injection sites should be used. 6.

7%) occurring within 14 days post dose. The majority of cases were mild to moderate in intensity. 3% within 7 days post dose, respectively. Injection site reactions were non-serious. 4). Adverse reactions reported from controlled clinical trials are classified by MedDRA System Organ Class (SOC).

Within each SOC, preferred terms are arranged by decreasing frequency and then by decreasing seriousness. Frequencies of occurrence of adverse reactions are defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1 000 to <1/100); rare (≥1/10 000 to <1/1 000); very rare (<1/10 000) and not known (cannot be estimated from available data).

Table 1:

Adverse reactions MedDRA SOC MedDRA Preferred Term Frequency Immune system disorders Hypersensitivitya Not known Skin and subcutaneous tissue disorders Rashb Uncommon General disorders and administration site conditions Injection site reactionc Uncommon Pyrexia Uncommon a Adverse reaction from spontaneous reporting.

b Rash was defined by the following grouped preferred terms: rash, rash maculo-papular, rash macular. c Injection site reaction was defined by the following grouped preferred terms: injection site reaction, injection site pain, injection site induration, injection site oedema, injection site swelling.

Infants at higher risk for severe RSV disease in their first season Safety was evaluated in MEDLEY in 918 infants at higher risk for severe RSV disease, including 196 extremely preterm infants (GA <29 weeks) and 306 infants with chronic lung disease of prematurity, or haemodynamically significant congenital heart disease entering their first RSV season, who received nirsevimab (n=614) or palivizumab (n=304).

The safety profile of nirsevimab in infants who received nirsevimab in their first RSV season was comparable to the palivizumab comparator and consistent with the safety profile of nirsevimab in term and preterm infants GA ≥29 weeks (D5290C00003 and MELODY).

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. 4 Hypersensitivity including anaphylaxis 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.

Clinically significant bleeding disorders As with any other intramuscular injections, nirsevimab should be given with caution to individuals with thrombocytopenia or any coagulation disorder. 2), and nirsevimab may not provide the same level of protection in those individuals.

2 mg in each 100 mg (1 mL) dose. Polysorbates may cause allergic reactions.

1.