Month: December 2020

Study design

Study design Fensolvi® efficacy demonstrated through a 12-month, uncontrolled, open-label, single-arm clinical trial A 12-month, uncontrolled, open-label, single-arm clinical trial in 64 children with CPP (62 girls and 2 boys, 4–9 years old) who were naïve to GnRH agonist treatment

Pharmacology

Pharmacology Innovative technology in the delivery of leuprolide acetate Fensolvi® (leuprolide acetate) for injectable suspension is the first and only 6-month, subcutaneous injection of leuprolide acetate for CPP. It uses a biodegradable in situ gel delivery system, which contains a unique c...

Contraindications

Contraindications Hypersensitivity reactions Fensolvi is contraindicated in patients with hypersensitivity to gonadotropin releasing hormone, gonadotropin releasing hormone agonists or any of the components of Fensolvi. Anaphylactic reactions to synthetic gonadotropin releasing hormone or gonadot...

Warnings & precautions

Warnings and precautions Initial Rise of Gonadotropins and Sex Steroid Levels During the early phase of therapy, gonadotropins and sex steroids rise above baseline because of the initial stimulatory effect of the drug. Therefore, an increase in clinical signs and symptoms of puberty including vag...

Adverse events

Adverse events 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 o...

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.