Introducing a new, unique J-code for Fensolvi: J1951

CMS has established a new, permanent Healthcare Common Procedure Coding System (HCPCS) code for FENSOLVI®️ (leuprolide acetate) for injectable suspension, effective July 1, 2021.

Visit our J-code page for helpful references on Fensolvi J-code usage.
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02266082-F7AD-41EB-B534-D9C2AC74229B@1x

Contents of Packaging

Contents of packaging

Fensolvi is packaged in thermoformed trays containing

  • One sterile Syringe A, prefilled with the polymeric gel delivery system
  • One sterile Syringe B, prefilled with leuprolide acetate powder
  • One long white plunger rod for use with Syringe B
  • One sterile safety needle
  • Desiccant pack(s)
  • Package insert
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One syringe contains the delivery system and the other contains the leuprolide acetate. The polymeric (non-gelatin containing) delivery system consists of a biodegradable poly(DL-lactide-co-glycolide) (PLG) polymer formulation dissolved in the biocompatible solvent, N-methyl-2-pyrrolidone (NMP). The two syringes are joined and the single dose product is mixed until it is homogeneous. Once the leuprolide acetate is reconstituted with the in situ polymeric delivery system, the product must be administered within 30 minutes. Fensolvi is administered subcutaneously, where it then forms a solid in situ. [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.