Fensolvi subcutaneous injection every 6 months was well tolerated. No adverse reactions led to withdrawal from the study or discontinuation of study drug.
Throughout the 12 months of the clinical trial, no serious adverse events or significant adverse events of clinical relevance occurred.
There we also no reports of sterile abscesses occurring.
Injection site reactions
82% of patients received local anesthetics for the injections. Treatment related injection site reactions occurring within 2 weeks after Fensolvi administration included:
- Injection site pain (31%)
- Injection site erythema (9%)
Emotional disorder (2%) and irritability (2%)
- Klein K, Mauras, N, et al. Phase 3 trial of a small volume subcutaneous 6-month duration leuprolide acetate treatment for central precocious puberty.
- Fensolvi® (leuprolide acetate) for injectable suspension 45 mg Prescribing Information. Dublin 2, Ireland: Tolmar International, Ltd.; 2020.