Adverse reactions : תופעות לוואי

4.8   Undesirable effects
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 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).

Infants who remain vulnerable to severe RSV disease in their second season Safety was evaluated in MEDLEY in 220 children with chronic lung disease of prematurity or haemodynamically significant congenital heart disease who received nirsevimab or palivizumab in their first RSV season and went on to receive nirsevimab entering their second RSV season (180 subjects received nirsevimab in both Season 1 and 2, 40 received palivizumab in Season 1 and nirsevimab in Season 2). The safety profile of nirsevimab in children who received nirsevimab in their second RSV season was consistent with the safety profile of nirsevimab in term and preterm infants GA ≥29 weeks (D5290C00003 and MELODY).

Safety was also evaluated in MUSIC, an open label, uncontrolled, single dose trial in 100 immunocompromised infants and children ≤24 months, who received nirsevimab in their first or second RSV season. This included subjects with at least one of the following conditions: immunodeficiency (combined, antibody, or other etiology) (n=33); systemic high-dose corticosteroid therapy (n=29); organ or bone marrow transplantation (n=16); receiving immunosuppressive chemotherapy (n=20); other immunosuppressive therapy (n=15), and HIV infection (n=8). The safety profile of nirsevimab was consistent with that expected for a population of immunocompromised children and with the safety profile of nirsevimab in term and preterm infants GA ≥29 weeks (D5290C00003 and MELODY).

The safety profile of nirsevimab in children during their second RSV season was consistent with the safety profile of nirsevimab observed during their first RSV season.


Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il