Nirsevimab interacts in the following cases:
As with any other intramuscular injections, nirsevimab should be given with caution to infants with thrombocytopenia or any coagulation disorder.
Not applicable.
Not applicable.
Not applicable.
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 0.6% and 0.4% within 7 days post dose, respectively. Injection site reactions were non-serious.
The following table presents the adverse reactions reported in 1 955 term and preterm infants (GA ≥29 weeks) who received nirsevimab in clinical trials.
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).
Adverse reactions:
| MedDRA SOC | MedDRA Preferred Term | Frequency |
|---|---|---|
| Skin and subcutaneous tissue disorders | Rasha | Uncommon |
| General disorders and administration site conditions | Injection site reactionb | Uncommon |
| Pyrexia | Uncommon |
a Rash was defined by the following grouped preferred terms: rash, rash maculo-papular, rash macular.
b 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.
Safety was also 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 (614) or palivizumab (304). The safety profile was comparable to the palivizumab comparator and consistent with the safety profile in term and preterm infants GA ≥29 weeks (D5290C00003 and MELODY).
As with all therapeutic proteins, there is potential for immunogenicity.
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