Beyfortus · 4.8 Undesirable effects · 1

HOS-099463 · has-adverse-reaction-information · PDF-Seite 5

Summary of the safety profile 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. Tabulated list of adverse reactions Table 1 presents the adverse reactions reported in 2 966 term and preterm infants (GA ≥29 weeks) who received nirsevimab in clinical trials, and in post-marketing setting (see section 4.4). 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 a Immune system disorders Hypersensitivity Not known b Skin and subcutaneous tissue disorders Rash Uncommon General disorders and administration Injection site reactionc Uncommon site conditions 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 in

Auszug; vollständigen Abschnitt im Original lesen.

HOS-099459 · has-contraindication-information · PDF-Seite 3

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

HOS-099458 · has-indication-information · PDF-Seite 2

Beyfortus is indicated for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in: i. Neonates and infants during their first RSV season. ii. Children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season (see section 5.1). Beyfortus should be used in accordance with official recommendations. 2

HOS-099461 · has-interaction-information · PDF-Seite 4

No interaction studies have been performed. Monoclonal antibodies do not typically have significant interaction potential, as they do not directly affect cytochrome P450 enzymes and are not substrates of hepatic or renal transporters. Indirect effects on cytochrome P450 enzymes are unlikely as the target of nirsevimab is an exogenous virus. Nirsevimab 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. Concomitant administration with vaccines Since nirsevimab is a monoclonal antibody, a passive immunisation specific for RSV, it is not expected to interfere with the active immune response to co-administered vaccines. There is limited experience of co-administration with vaccines. In clinical trials, when nirsevimab was given with routine childhood vaccines, the safety and reactogenicity profile of the co-administered regimen was similar to the childhood vaccines given alone. Nirsevimab can be given concomitantly with childhood vaccines. Nirsevimab should not be mixed with any vaccine in the same syringe or vial (see section 6.2). When administered concomitantly with injectable vaccines, they should be given with separate syringes and at different injection sites.

HOS-099462 · has-pregnancy-information · PDF-Seite 4

Not applicable.

HOS-099460 · has-warning-information · PDF-Seite 3

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. 3 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. Immunocompromised children In some immunocompromised children with protein-losing conditions, a high clearance of nirsevimab has been observed in clinical trials (see section 5.2), and nirsevimab may not provide the same level of protection in those individuals. Polysorbate 80 (E433) This medicine contains 0.1 mg of polysorbate 80 in each 50 mg (0.5 mL) dose and 0.2 mg in each 100 mg (1 mL) dose. Polysorbates may cause allergic reactions.