Mixing Fensolvi

Mixing Fensolvi

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Follow the step-by-step instructions below, or watch the full mixing & administration training video.

Mixing Steps

  • To thoroughly mix the product, inject the liquid contents of Syringe A into the leuprolide acetate powder contained in Syringe B.
  • Gently push the contents of both syringes in a horizontal position back and forth for 60 cycles to obtain a homogenous, viscous solution. A cycle is one push of the plunger for both Syringe A and B. Do not bend the syringe system. This may cause leakage as you may partially unscrew the syringes. The suspension may appear colorless to pale yellow once properly mixed. After mixing, Fensolvi must be administered within 30 minutes.
  • After mixing, hold the syringes vertically with Syringe B, the wide syringe, on the bottom. The syringes should remain securely coupled.
  • Transfer all of the mixed product into Syringe B by depressing the Syringe A plunger and slightly withdrawing the Syringe B plunger.
  • While ensuring the Syringe A plunger is fully pushed down, hold the coupling device and unscrew it from Syringe B. Syringe A will remain attached to the coupling device. Small air bubbles will remain in the formulation. This is acceptable. Do not purge the air bubbles from Syringe B, as some product may be lost.
  • Continue to hold syringe B upright with the open end at the top.
  • Hold back the white plunger on Syringe B to prevent loss of the product and attach the safety needle cartridge.
  • Gently screw clockwise with approximately a ¾ turn until the needle is secure. Do not over tighten as this may cause cracking of the needle hub, resulting in leakage of the product during injection.
  • Move the safety shield away from the needle and pull off the protective needle cover prior to administration. Do not operate the safety needle mechanism before administration. Small air bubbles will remain in the formulation. This is acceptable. Do not purge the air bubbles from Syringe B, as some product may be lost.

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.