Proven 6-month LH Suppression and Well-Tolerated with a Reliable Safety Profile
Study Design
Fensolvi efficacy was demonstrated through a 12-month open-label, single-arm clinical trial with 64 children with CPP (62 girls and 2 boys, 4-9 years old) who were naive to GnRH agonist treatment.1,2
Primary Endpoint:
Percentage of children achieving stimulated LH level of <4 IU/L at Month 6
- Fensolvi is the first GnRHa to use <4 IU/L as the primary endpoint
Key Secondary Endpoints:
- Percentage change from baseline in estradiol for girls
- Percentage change from baseline in testosterone for boys
- Ratio of bone age (BA) to chronological age (CA)
GnRH=gonadotropin, LH=luteinizing hormone
The study involved 64 treatment-naïve children (62 girls, 2 boys) between the ages of 4 and 9 years
Fensolvi pivotal study design
Fensolvi Clinical Study Key Endpoints
CLINICAL RESULTS
97% of children had regression or stabilization of Tanner Staging during 48 weeks of treatment2
Majority of girls had regression or stabilization of Tanner Staging during treatment2
Regression or stabilization of Tanner Staging during treatment
Mean height velocity decreased from Week 4 to Week 48, from 8.9 cm/year to 6.4 cm/year1
Fensolvi demonstrated deceleration of mean height velocity (MHV)1
Over the 48-Week Study Period
Mean height velocity decreased to near pre-pubertal ratea
Mean difference between BA and CA decreased, from 3 years to 2.7 years1
Mean difference between bone age (BA) and chronological age (CA) decreased significantly2
Over the 48-Week Study Period
Mean difference between BA and CA decreased, from 3 years to 2.7 years
biochemical Results
≥97% of girls achieved estradiol suppression to pre-pubertal level throughout 48 weeks of treatment1
Fensolvi demonstrated suppression of estradiol and testosterone to pre-pubertal levels1
Suppression of estradiol in girls and testosterone in boys to pre-pubertal levels with Fensolvi1*
87% of children achieved primary endpoint of peak stim LH of <4 IU/L at Week 241
Fensolvi demonstrated suppression of reproductive hormones to pre-pubertal levels1,2
A significant percentage of children* in the study achieved important endpoints in reproductive hormone levels post GnRH stimulation test
94% of children achieved peak stim LH of <5 IU/L at Week 243
LH levels† achieved by children at Month 6 after only 1 injection
No children withdrew
from the study due to adverse reactions2*
*Children were treatment naive.
Adverse Events1,2
Fensolvi subcutaneous injection every 6 months was well tolerated. No adverse reactions led to withdrawal from the study or discontinuation of study drug. Throughout the 12 months of the clinical trial, no serious adverse events or significant adverse events of clinical relevance occurred. There were also no reports of sterile abscesses occurring4.
Psychiatric Disorders
- Emotional disorder (2%) and irritability (2%)
Injection Site Reactions
82% of patients received local anesthetics for injections. Treatment related injection site reactions occurring within 2 weeks after Fensolvi administration included:
- Injection site pain (31%)
- Injection site erythema (9%)
Adverse reactions occurring in ≥5% of patients treated with Fensolvi in an open-label, single-arm trial
| Adverse reactions | % of patients |
|---|---|
| Injection site pain — All injections site pain was mild/grade 1 (82% injections delivered with numbing agent) | 31% |
| Nasopharyngitis | 22% |
| Pyrexia | 17% |
| Headache | 16% |
| Cough | 13% |
| Abdominal pain | 9% |
| Injection-site erythema | 9% |
| Nausea | 8% |
| Constipation | 6% |
| Vomiting | 6% |
| Upper respiratory tract infection | 6% |
| Bronchospasm | 6% |
| Productive cough | 6% |
| Hot flash | 5% |
| (N = 64) |
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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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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.
Klein K, Freire A, Gryngarten M, et al. Phase 3 trial of a small-volume subcutaneous 6-month duration leuprolide acetate treatment for central precocious puberty. J Clin Endo Metab. 2020;105(10):1-12.
Data on File. Tolmar, Inc.; 2025
Data on file. Clinical study report: TOL2581A. Tolmar, Inc.
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.
