Fensolvi is contraindicated in pregnancy. It may cause fetal harm based on findings from animal studies and the drug’s mechanism of action. The available data from published clinical studies and case reports and from the pharmacovigilance database on exposure to leuprolide acetate during pregnancy are insufficient to assess the risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes
Based on animal reproduction studies, leuprolide acetate may be associated with an increased risk of pregnancy complications, including early pregnancy loss and fetal harm.
In animal reproduction studies, subcutaneous administration of leuprolide acetate to rabbits during the period of organogenesis caused embryo-fetal toxicity, decreased fetal weights and a dose-dependent increase in major fetal abnormalities in animals at doses less than the recommended human dose based on body surface area using an estimated daily dose.
A similar rat study also showed increased fetal mortality and decreased fetal weights but no major fetal abnormalities at doses less than the recommended human dose based on body surface area using an estimated daily dose.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Risk Summary. There are no data on the presence of leuprolide acetate in either animal or human milk, the effects on the breastfed infants, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Fensolvi and any potential adverse effects on the breastfed infant from Fensolvi or from the underlying maternal condition.
Females and males of reproductive potential
Exclude pregnancy in women of reproductive potential prior to initiating Fensolvi if clinically indicated.
Contraception in Females
Fensolvi may cause embryo-fetal harm when administered during pregnancy. Fensolvi is not a contraceptive. If contraception is indicated, females should be advised of reproductive potential to use a non-hormonal method of contraception during treatment with Fensolvi.
Based on its pharmacodynamic effects of decreasing secretion of gonadal steroids, fertility is expected to be decreased while on treatment with Fensolvi. Clinical and pharmacologic studies in adults (>18 years) with leuprolide acetate and similar analogs have shown reversibility of fertility suppression when the drug is discontinued after continuous administration for periods of up to 24 weeks.
- There is no evidence that pregnancy rates are affected following discontinuation of Fensolvi.
- Animal studies (prepubertal and adult rats and monkeys) with leuprolide acetate and other GnRH analogs have shown functional recovery of fertility suppression.
The safety and effectiveness of Fensolvi for the treatment of CPP has been established in pediatric patients 2 years of age and older. Use of Fensolvi for this indication is supported by evidence from an adequate and uncontrolled, open-label, single-arm study of 64 pediatric patients with CPP with an age range of 4 to 9 years.
The safety and effectiveness of Fensolvi have not been established in pediatric patients less than 2 years old.
- Fensolvi® (leuprolide acetate) for injectable suspension 45 mg Prescribing Information. Dublin 2, Ireland: Tolmar International, Ltd.; 2020.