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Administration (Subcutaneous)

Administration (Subcutaneous)

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Choose & prepare injection site

Select an injection site on the upper buttocks or another location with adequate amounts of subcutaneous tissue that does not have excessive pigment, nodules, lesions, or hair and hasn’t recently been used.
Cleanse the injection site area with an alcohol swab (not included with Fensolvi).

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Administer injection

Using the thumb and forefinger of your non-dominant hand, grab and bunch the area of skin around the injection site.

Using your dominant hand, insert the needle quickly at a 90° angle to the skin surface. The depth of penetration will depend on the amount and fullness of the subcutaneous tissue and the length of the needle.

After the needle is inserted, release the skin.

Inject the drug using a slow, steady push and press down on the plunger until the syringe is empty.

Withdraw the needle quickly at the same 90° angle used for insertion.

Activate needle safety shield

Immediately following the withdrawal of the needle, activate the safety shield using a finger/thumb or flat surface and push until it completely covers the needle tip and locks into place.

An audible and tactile “click” verifies a locked position.

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Discard used needle

Check to confirm the safety sheath is fully engaged. Discard all components safely in an appropriate biohazard container.

Mixing & Administration summary

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References
  1. Fensolvi® (leuprolide acetate) for injectable suspension 45 mg Prescribing Information. Dublin 2, Ireland: Tolmar International, Ltd.; 11/2022.

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.