Clesrovimab is not indicated for use in females of reproductive potential.
Clesrovimab is not indicated for use in females of reproductive potential.
Carcinogenesis, mutagenesis and reproductive toxicity studies have not been performed with clesrovimab.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of clesrovimab was evaluated in 2,858 infants who received clesrovimab in Phase 2b/3 and Phase 3 clinical trials (Trial 004 and Trial 007).
Trial 004 was a Phase 2b/3, randomized, double-blind placebo-controlled, multisite trial conducted in early and moderate preterm infants (≥29 to <35 weeks gestational age (GA)) and late preterm and full-term infants (≥35 weeks GA). Participants were randomized 2:1 and received a single 105 mg dose of clesrovimab (N=2,412, including 422 early and moderate preterm infants) or saline placebo (N=1,202, including 209 early and moderate preterm infants) by IM injection. Participants were monitored for 30 minutes post-dose. Safety was assessed using an electronic diary device from Days 1 through 42 post-dose. Participants were monitored for serious adverse events (SAEs) through the duration of their participation for up to 365 days post-dose. A subset of participants was monitored for SAEs for up to 515 days post-dose.
Table 1 summarizes the adverse reactions in participants who received clesrovimab. Most (≥97%) of the adverse reactions were toxicity grade 1 (mild) or grade 2 (moderate).
Table 1. Adverse Reactions Reported at an Incidence Higher Than Placebo (Trial 004):
| Adverse Reaction | Clesrovimab N=2,412* % | Placebo N=1,202* % |
|---|---|---|
| Injection-site erythema† (occurring within 5 days post-dose) | 3.8 | 3.3 |
| Injection-site swelling† (occurring within 5 days post-dose) | 2.7 | 2.6 |
| Rash‡ (occurring within 14 days post-dose) | 2.3 | 1.9 |
* Sample size reflects the number of participants included in the safety analysis population.
† Solicited on Day 1 through Day 5 post-dose using an electronic diary device.
‡ Defined by the following grouped preferred terms: rash, rash erythematous, rash macular, rash papular, rash maculo-papular, rash vesicular, rash exfoliative, dermatitis allergic, drug eruption and toxic skin eruption.
Trial 007 was a Phase 3, randomized, partially-blind, palivizumab-controlled, multisite trial conducted in infants at increased risk of severe RSV disease. Participants were randomized and received a single 105 mg dose of clesrovimab (N=446) followed by a dose of placebo one month later or 3 to 5 monthly doses of 15 mg/kg palivizumab (N=450) by IM injection. Of the 446 participants who received clesrovimab, 176 had CLD of prematurity or CHD and 270 were early or moderate preterm infants (≤35 weeks GA) without CLD of prematurity or CHD. Participants were monitored for 30 minutes post-dose. Safety was assessed using an electronic diary device from Day 1 (dose 1) through 14 days post-dose 2, and 14 days after each subsequent dose. Participants were monitored for serious adverse events in the first RSV season for up to 365 days.
The safety profile of clesrovimab in infants at increased risk of severe RSV disease entering their first season was similar to palivizumab and consistent with the safety profile of clesrovimab in infants in Trial 004.
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