At a glance

At a glance

Fensolvi® is the first and only 6-month, subcutaneous (SC) injection of leuprolide acetate for CPP.[1]

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Drug class

Fensolvi® (leuprolide acetate) for injectable suspension consists of leuprolide acetate delivered via a unique in-situ polymeric gel delivery system

Leuprolide acetate

  • Leuprolide acetate is a gonadotropin releasing hormone (GnRH) agonist.
  • It is the most commonly prescribed CPP treatment.[2]

Strength

45 mg

Delivery system

A single subcutaneous injection — with small injection volume and short 18 gauge needle — delivers 6 months of treatment.[3]

The innovative delivery system releases leuprolide acetate slowly over time as the polymer dissolves.[1]

Mechanism of action

GnRH agonist

Fensolvi is a GnRH agonist that inhibits the hypothalamic-pituitary-gonadal (HPG) axis, resulting in suppression of gonadotropin production, including luteinizing hormone, and ovarian and testicular production of estradiol and testosterone respectively.

Leuprolide acetate

  • Leuprolide acetate is a potent synthetic nonapeptide analog of naturally occurring GnRH that inhibits pituitary gonadotropin secretion (luteinizing hormone and follicle stimulating hormone) when given continuously in therapeutic doses.
  • Following an initial stimulation of gonadotropin releasing hormone receptors, chronic administration of leuprolide acetate results in downregulation of GnRH receptors, reduction in release of luteinizing hormone, follicle stimulating hormone and consequent suppression of ovarian and testicular production of estradiol and testosterone, respectively.
  • This effect is reversible upon discontinuation of drug therapy.[4]

Indications

Fensolvi is indicated for the treatment of pediatric patients 2 years of age and older with central precocious puberty. Fensolvi treatment should be discontinued at the appropriate age of onset of puberty. Pubertal progression may resume within months and menses may begin from several months to more than 2 years after stopping treatment. [5]

References
  1. Fensolvi® (leuprolide acetate) for injectable suspension 45 mg Prescribing Information. Dublin 2, Ireland: Tolmar International, Ltd.; 11/2022.
  2. IMS Health. Accessed March 2020
  3. Klein K, Freire A, Gryngarten M, et al. Phase 3 trial of a small-volume subcutaneous 6-month duration leuprolide acetate treatment for central precocious puberty. J Clin Endo Metab. 2020;105(10):1-12.
  4. Fensolvi® (leuprolide acetate) for injectable suspension 45 mg Prescribing Information. Dublin 2, Ireland: Tolmar International, Ltd.; 2020. AND Engel JB, Schally AV. Drug Insight: clinical use of agonists and antagonists of luteinizing-hormone-releasing hormone. Nat Clin Pract Endocrinol Metab. 2007;3(2):157-167. AND Schally AV, Engel JB, Pinski J, Block NL. LHRH analogs. In: Handbook of Biologically Active Peptides. Elsevier Inc. 2013;531-540. doi:10.1016/b978-0-12-385095-9.00073-7
  5. Krishna KB, Fuqua JS, Rogol AD, et al. Use of gonadotropin- releasing hormone analogs in children: Update by an international consortium. Horm Res Paediatr 2019;91:357–372.

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.