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

Mixing Fensolvi

Mixing Fensolvi

Is your Fensolvi correctly prepared? If not, go back to Preparing Fensolvi

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

Step 1: Prepare all contents

On a clean field open both trays, discard the desiccant packs from each package and ensure all contents are in place.

You are now ready to assemble and mix Fensolvi.

Pull out (do NOT unscrew) the short blue plunger rod with attached gray stopper from Syringe B.

Discard both the blue plunger and attached grey stopper.

Gently screw the white plunger rod into the remaining gray stopper in Syringe B.

Step 2: Remove caps

Remove and discard caps from Syringe A and Syringe B.

Step 3: Join syringes

Join the two syringes together by pushing and gently screwing until secure.

Step 4: Mix contents

Inject the liquid contents of Syringe A into leuprolide acetate powder in Syringe B

Thoroughly mix the product for 45 seconds by pushing the contents back and forth to obtain a uniform suspension. (This is a great time to set expectations for the injection with the patient and caregivers).

When thoroughly mixed, the suspension will appear colorless to pale yellow.

NOTE: Product must be mixed as described. Shaking will NOT provide adequate mixing of the product.

Step 5: Draw all mixed product into Syringe B

After mixing, hold the syringes vertically (upright) with Syringe B (short, wide syringe) on the bottom. The syringes should remain securely coupled.

Draw all of the mixed product into Syringe B by depressing the Syringe A plunger and slightly withdrawing the Syringe B plunger.

Step 6: Uncouple syringes

Continue to hold syringes vertically (upright). Unscrew Syringe A to decouple the syringes while continuing to push down on the Syringe A plunger.

NOTE: Do not attempt to remove small air bubbles that remain in the formulation – this is acceptable for subcutaneous injections.

Step 7: Attach the sterile needle provided

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 three-quarter turn until the needle is secure.

Do not overtighten, as the hub may become damaged resulting in leakage of the product during injection. The safety sheath may also be damaged if the needle is screwed with too much force.

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.