Clesrovimab interacts in the following cases:
As with any other intramuscular injections, clesrovimab should be given with caution to infants with thrombocytopenia or any coagulation disorder, because bleeding or bruising may occur following an intramuscular administration in these individuals.
Not relevant.
Not relevant.
Not relevant.
Not relevant.
The most frequent adverse reactions were injection-site pain (6.5%), injection-site erythema (4.4%), injection-site swelling (3.2%) and rash (2.3%). Most (>96%) of the adverse reactions were mild or moderate.
Safety was evaluated in 2 854 infants who received clesrovimab in phase 2b/3 and phase 3 clinical studies (Study 004 and Study 007, respectively). The table below presents the adverse reactions reported in 2 409 preterm and full-term infants (GA ≥29 weeks) who received clesrovimab.
Adverse reactions reported with clesrovimab are listed by MedDRA system organ class and in decreasing order of frequency. Frequencies 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), and very rare (<1/10 000) and not known (cannot be estimated from available data).
Adverse reactions:
| System organ class | Adverse reaction | Frequency |
| Skin and subcutaneous tissue disorders | Rash* | Common |
| Urticaria | Uncommon | |
| General disorders and administration site conditions | Injection-site pain† | Common |
| Injection-site erythema† | Common | |
| Injection-site swelling† | Common |
* Rash was defined by the following grouped preferred terms occurring within 14 days post-dose: rash, rash erythematous, rash papular, rash maculo-papular, rash vesicular, dermatitis allergic, and drug eruption
† Solicited on Day 1 through Day 5 post-dose
The safety profile of clesrovimab in 445 infants at increased risk of severe RSV disease entering their first season (Study 007) was similar to palivizumab (450 infants) and consistent with the safety profile of clesrovimab in infants in Study 004.
Serious adverse events reported in early preterm infants GA <29 weeks were similar in number and pattern between recipients of clesrovimab (21/97 participants) and palivizumab (31/108 participants).
Subgroup analyses by age groups at randomisation (<3 months; ≥3 to ≤6 months and >6 months) in Study 004 and Study 007 showed similar safety results in the clesrovimab and control arms across the age-groups in each study.
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