IMPORTANT SAFETY INFORMATION
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 boys under the age of 9.
FENSOLVI is contraindicated in individuals with hypersensitivity to any drug that is in the same class as FENSOLVI, or in individuals who are allergic to any of the ingredients in FENSOLVI.
Fensolvi may cause fetal harm when administered to a pregnant patient. There are no available data in pregnant females to inform the drug-associated risk. Expected hormonal changes that occur with Fensolvi treatment increase the risk for pregnancy loss. Advise pregnant patients of the potential risk to the fetus.
Transient increases in serum levels of gonadotropins and sex steroids above baseline during the first few weeks of treatment may result in worsening signs and symptoms, or onset of new signs and symptoms of puberty including vaginal bleeding in girls.
Psychiatric events have been reported in patients taking GnRH agonists. Post-marketing reports with this class of drugs include symptoms of emotional lability, such as crying, irritability, impatience, anger, and aggression. Patients should be monitored for development or worsening of psychiatric symptoms during treatment.
Post-marketing reports of convulsions have been observed in patients treated with GnRH agonists. These reports included patients with 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. Convulsions have also been reported in patients in the absence of any of predisposing factors.
The most common adverse events following FENSOLVI administration were: injection site reactions, nasopharyngitis, headache, pyrexia, cough, abdominal pain, constipation, nausea, upper respiratory tract infections, bronchospasm, productive cough, vomiting, bronchitis, pharyngitis, pharyngitis streptococcal, sinusitis, and hot flashes.
The most common injection site related-adverse events following FENSOLVI administration were transient burning and stinging, pain, bruising, and redness. Patients should be advised to contact their healthcare provider if they experience rash or severe injection site reactions.
Please see Full Prescribing Information for FENSOLVI for additional important safety information.
To report suspected adverse reactions contact Tolmar at 1-833-FENSOLVI (336-7658) or the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.