Adverse reactions were retrieved from two placebo-controlled clinical studies.
109 patients with short bowel syndrome-intestinal failure were treated with doses of 0.05 mg/kg/day and 0.10 mg/kg/day (0.10 mg/kg/day is not a recommended dose) for up to 24 weeks.
Approximately 52% of the adults treated with Revestive experienced adverse reactions (vs. 36% of the adults given placebo).
The most common adverse events were:
Injection site reactions occurred in 26% of SBS-IF patients treated with Revestive compared with 5% of patients in the placebo arm:
Consistent with the potentially immunogenic properties of medicinal products containing peptides, administration of Revestive may potentially trigger the development of antibodies. However, in Phase 3 studies antibody formation was not associated with clinically relevant safety findings, reduced efficacy, or changed pharmacokinetics of Revestive.
In two completed clinical trials* in children aged 1–17 years-old with short bowel syndrome-intestinal failure treated with Revestive for up to 6 months:
Long-term safety data are not yet available for the paediatric population.
Revestive was studied in a 12-week, open-label, clinical study in 42 paediatric patients aged 1 year through 14 years with SBS who were dependent on PN/IV. Three (3) doses of Revestive, 0.0125 mg/kg/day (n=8), 0.025 mg/kg/day (n=14), and 0.05 mg/kg/day (n=15), were investigated for 12 weeks.
Five (5) patients were enrolled in an SOC cohort. An additional 24-week, randomised, double-blind, multicentre study was conducted in 59 paediatric patients aged 1 year through 17 years who were dependent on PN/IV. Two (2) doses of Revestive were studied: 0.025 mg/kg/day (n=24) and 0.05 mg/ kg/day (n=26); nine (9) patients were enrolled in an SOC arm.
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