Introduction

Introduction

Simple steps for preparation and injection

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Administration summary

Fensolvi is administered by a healthcare professional as a 45 mg single subcutaneous injection once every six months.[1]

Fensolvi is administered subcutaneously, where it forms a solid in situ, trapping the leuprolide acetate within the biodegradable polymer matrix. The polymeric gel dissolves over time, resulting in sustained and consistent release of leuprolide acetate over the six-month dosing period.[2][3][4]

Subcutaneous injection

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Subcutaneous injection

As with other drugs administered by subcutaneous injection, the injection site should vary periodically. The most commonly used injection sites are buttocks and upper thighs.

The specific injection location should not have excessive pigment, nodules, lesions, or hair. Areas with brawny or fibrous subcutaneous tissue or locations that could be rubbed or compressed (i.e., by a belt or clothing waistband) should be avoided.[1]

Fensolvi is prefilled and supplied in two separate, sterile syringes whose contents are reconstituted.

See contents of packaging

Subcutaneous injection

  • Fensolvi must be brought to room temperature before mixing.

  • Once outside the refrigerator this product may be stored in its original packaging at room temperature 59 – 86 °F (15 – 30 °C) for up to eight weeks prior to mixing and administration.

  • Once mixed, the product must be administered within 30 minutes or it should be discarded.

References
  1. Fensolvi® (leuprolide acetate) for injectable suspension 45 mg Prescribing Information. Dublin 2, Ireland: Tolmar International, Ltd.; 11/2022.
  2. Prettyman J, Engel L, Boldt-Houle D, et al. Personalizing treatment in the delivery of care by nurses to patients with prostate cancer. Urologic Nursing. 2019;39(2):83-99.
  3. Russo LG, Moore WV. 444 Comparison of intramuscular and subcutaneous injections of growth hormone. Pediatric Research 1981 15(4) 514
  4. Leung AK, Chiu AS, Siu TO. Subcutaneous versus intramuscular administration of Haemophilus influenzae type b vaccine. J R Soc Health. 1989;109(2):71-73.

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.