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System Formulary Update
leuprolide Acetate Injection Suspension (Fensolvi® /Tolmar)

Situation

Leuprolide acetate injection suspension (Fensolvi®/Tolmar) has been approved for addition to the UNC Health Medication Formulary.

Background

The most common pathophysiological mechanism of Central precocious puberty (CPP) is the early activation of pulsatile gonadotropin-releasing hormone (GnRH). Leuprolide acetate, a GnRH agonist, acts as a potent inhibitor of gonadotropin secretion, including luteinizing hormone (LH) and follicle stimulating hormone (FSH), when given continuously. Fensolvi® is an injectable suspension form of leuprolide designed to release the drug over a 6 month period that was approved by the FDA in May 2020.

Assessment/Recommendations

The P&T Committee voted to APPROVE the addition of leuprolide acetate (Fensolvi®) to System Formulary WITH RESTRICTION to outpatient/clinic encounters only (ie, no inpatient use) and patients diagnosed with CPP (idiopathic or neurogenic).  

Formulary/Epic changes will Go-Live on Tuesday, September 13, 2022.