Innovative Subcutaneous Delivery Designed with Children—and Providers—In Mind
Fensolvi is the first and only subcutaneous (SC), extended-release leuprolide acetate for this indication—offering 6 months of treatment with a single injection, reducing procedural burden and invasiveness through its unique formulation.
As the most prescribed 6-month treatment for CPP4, Fensolvi offers providers and patients key administration advantages, including4:
Subcutaneous administration made possible by in-situ forming gel technology1,2
Shortest needle at only 5/8-inch, to help minimize injection-related discomfort1,5–7
Low injection volume—at 0.375 mL—to reduce tissue disruption1,5–7
Administering Fensolvi: SC injection offers a less invasive alternative to intramuscular (IM) delivery1,5–7
As with other drugs administered by subcutaneous injection, the injection site should vary periodically1,2
- 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.
- 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 (ie, by a belt or clothing waistband) should be avoided.
Novel Delivery1,2
Fensolvi uses an in-situ forming copolymer gel to deliver leuprolide acetate. A single subcutaneous injection provides 6 months of continuous treatment, as the biodegradable copolymer slowly releases the medication over time.
After administration, leuprolide acetate is released in two phases: an initial burst followed by a sustained plateau. with mean serum levels maintained around 0.37 ng/mL from 4 to 48 weeks.
The gel remains at the injection site, slowly biodegrading over the full dosing interval to maintain controlled hormone suppression.
GnRH agonists have been used to treat CPP since the 1980s8
Fensolvi (leuprolide acetate) stands out as a pediatric-approved 6-month SC GnRH therapy.1,4
Long-term Fensolvi administration:
- Suppresses ovarian estradiol production in girls1
- Suppresses testicular testosterone production in boys1
Connect with Fensolvi
Connect with a Fensolvi Representative
By providing your information, you are giving Tolmar, Inc. and other parties working with us permission to communicate with you about Fensolvi or other products, services, and offers from Tolmar, Inc. If you don’t find the information useful, you can opt out at any time. We value your privacy and we encourage you to review our privacy policy for more information.
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Fensolvi Starter Kits
We’re excited to offer Fensolvi starter kits for new patients who have been prescribed Fensolvi. Each kit offers helpful information for caregivers plus engaging activities for children to enjoy during their visits. Contents include a treatment brochure, coloring and iSpy sheets, coloring pencils, a book of jokes, and coping cards—all inside a handy drawstring bag. Order kits for your patients by calling your Tolmar representative or completing the form.
Contact us at 1-866-FENSOLVI (336-7658)
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Contact us to schedule a mixing and administration demonstration
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Contact us at 1-866-FENSOLVI (336-7658)
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Complete the form below to receive emails featuring key updates related to Fensolvi. By providing your information, you are giving Tolmar, Inc. and other parties working with us permission to communicate with you about Fensolvi® or other products, services, and offers from Tolmar, Inc. If you don’t find the information useful, you can opt out at any time. We value your privacy and we encourage you to review our privacy policy for more information.
Contact us at 1-866-FENSOLVI (336-7658)
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IMPORTANT SAFETY INFORMATION
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.
Severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome/toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, and acute generalized exanthematous pustulosis, have occurred in patients receiving GnRH agonists. Monitor for and advise patients of the signs and symptoms of SCARs.
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 reactions 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.
IMPORTANT SAFETY INFORMATION
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.
Severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome/toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, and acute generalized exanthematous pustulosis, have occurred in patients receiving GnRH agonists. Monitor for and advise patients of the signs and symptoms of SCARs.
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 reactions 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.
References
Fensolvi (leuprolide acetate). Package insert. Fort Collins, CO: Tolmar, Inc.; 2025.
Sartor O. A new form of treatment for prostate cancer. European Urology Supplements. 2006;5:905-910.
Popovic J, Geffner M, Rogol A, et al. Gonadotropin-releasing hormone analog therapies for children with central precocious puberty in the United States. Front Pediatr. 2022;10:1-12.
IQVIA data, Jan 2022 to June 2025.
Bird et al 2025 Open Nursing Journal DOI: 10.2174/0118744346388075251027112253.
Leung AK, Chiu AS, Siu TO, et al. Subcutaneous versus intramuscular administration of Haemophilus influenzae type b vaccine. J R Soc Health. 1989;109(2):71-73.
Russo L, Moore WV. A comparison of subcutaneous and intramuscular administration of human growth hormone in the therapy of growth hormone deficiency. J Clin Endocrinol Metab. 1982;55(5):1003-1006.
Carel JC, Eugster E, Rogol A, et al. Consensus statement on the use of gonadotropin-releasing hormone analogs in children. Pediatrics. 2009;123(4):752-762.
FENSOLVI TOTALSOLUTIONS COPAY PROGRAM TERMS AND CONDITIONS
The Fensolvi® Copay Assistance Program (“Program”) is valid ONLY for patients who are prescribed Fensolvi® and are reimbursed exclusively by commercial insurance. This Program is valid only in the United States; but, void where prohibited by law or by the patient’s health insurance provider. This Program is non-transferable, limited to one per person, and cannot be combined with any other coupon, free trial, discount, prescription savings card, or other offer. Restrictions or limits may apply.
Medicare, Medicaid, Tricare and other federal health care program beneficiaries may not participate in this Program. This Program also is neither available for cash paying patients nor where your commercial plan reimburses you for the entire cost of your prescription drug. Patients cannot seek reimbursement from health insurance or any third party for any part of the assistance received through this Program. The patient or his/her guardian is responsible for reporting the receipt of all benefits or reimbursement received under the Program to any insurer, health plan, or other third party, as may be required. This Program is not insurance and is not intended as a substitute for insurance.
With the Program, you pay as little as $5 of your co-pay or co-insurance for Fensolvi®, per prescription. The remainder of your co-pay or co-insurance is covered, up to two prescriptions per calendar year. The Program assists with the cost of Fensolvi only. It does not assist with the cost of other administrations, medicines, procedures or office visit fees.
Tolmar, Inc. (“Tolmar”) reserves the right to terminate, rescind, revoke, or modify this Program at any time without notice. This Program expires at the end of the current calendar year, at which time you must re-enroll. For complete information about the terms and conditions of this Program, including the limitations on use and the amount of assistance call 1 866-FENSOLVI (336-7658).
Program managed by Scripts Rx on behalf of Tolmar.
