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Special populations

Special populations

Pregnancy

Risk Summary.

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[1]

Animal studies

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.[1]

Estimated risk

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.[1]

Lactation

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.[1]

Females and males of reproductive potential

Pregnancy Testing.

Exclude pregnancy in women of reproductive potential prior to initiating Fensolvi if clinically indicated.[1]

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.[1]

Infertility

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.[1]
  • Animal studies (prepubertal and adult rats and monkeys) with leuprolide acetate and other GnRH analogs have shown functional recovery of fertility suppression.[1]

Pediatric use

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.[1]

References
  1. Fensolvi® (leuprolide acetate) for injectable suspension 45 mg Prescribing Information. Dublin 2, Ireland: Tolmar International, Ltd.; 2020.

IMPORTANT SAFETY INFORMATION

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FENSOLVI (leuprolide acetate) for injectable suspension is a gonadotropin releasing hormone (GnRH) agonist used to treat patients 2 years of age and older with central precocious puberty (CPP). CPP may be diagnosed when signs of sexual maturity begin to develop in girls under the age of 8 or in boys under the age of 9.

FENSOLVI is contraindicated in individuals with hypersensitivity to any drug that is in the same class as FENSOLVI, in individuals who are allergic to any of the ingredients in FENSOLVI, or in individuals who are pregnant. FENSOLVI may cause fetal harm when administered to a pregnant patient.

During the first few weeks of treatment, increases in gonadotropins and sex steroids above baseline may result in an increase in signs and symptoms of puberty including vaginal bleeding in girls.

Psychiatric events have been reported in patients taking GnRH agonists. Events include emotional lability, such as crying, irritability, impatience, anger, and aggression. Patients should be monitored for development or worsening of psychiatric symptoms.

Convulsions have been observed in patients treated with GnRH agonists with or without a history of seizures, epilepsy, cerebrovascular disorders, central nervous system anomalies or tumors, and in patients on concomitant medications that have been associated with convulsions such as bupropion and SSRIs.

Pseudotumor Cerebri (Idiopathic Intracranial Hypertension) has been reported in pediatric patients treated with GnRH agonists.  Patients should be monitored for headache, papilledema and blurred vision.

The most common adverse events seen with FENSOLVI were: injection site pain, nasopharyngitis, pyrexia, headache, cough, abdominal pain, injection site erythema, nausea, constipation, vomiting, upper respiratory tract infection, bronchospasm, productive cough and hot flush. 

Please see Full Prescribing Information for FENSOLVI for additional important safety information. 

To report suspected adverse reactions contact Tolmar at 1-844-4TOLMAR (486-5627) or the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.