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Keep Childhood
Simple

Fensolvi delivers an all-in-one treatment experience for Central Precocious Puberty (CPP). [1]
  • 6-month dosing
  • Subcutaneous injection
  • Leuprolide acetate
  • Comprehensive patient support
Designed with the child in mind

Fensolvi delivers a simple, all-in-one treatment experience for Central Precocious Puberty (CPP). [1]

Novel delivery of leuprolide acetate
Subcutaneous injection
6-month dosing schedule
Proven effective for 6 months
Easily mixed and administered
Short needle, low injection volume
Favorable safety and tolerability profile
Full support with Fensolvi TotalSolutions

Clinical
Information

Class: Fensolvi (leuprolide acetate) for injectable suspension, is the only subcutaneously delivered leuprolide acetate in the class of Gonadotropin Releasing Hormone (GnRH) agonists.

Indication: Fensolvi is indicated for the treatment of pediatric patients 2 years of age and older with central precocious puberty.

NDC: 62935-153-50 

Fensolvi delivers leuprolide acetate through a novel, in-situ polymeric gel extended delivery system.

The biodegradable polymer combines with leuprolide acetate to form a solid after interacting with water in the subcutaneous tissue.

This innovative delivery offers your patients more time to be kids.

A single subcutaneous injection delivers 6 months of treatment. With our unique leuprolide extended release system, the biodegradable polymer combines with leuprolide acetate to form a solid after interacting with water in the subcutaneous tissue. This traps 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.

Full prescribing information can be found here

Simple steps for preparation and injection

For complete mixing and administration instructions, view this video or download this detailed guide.

To obtain Fensolvi for your patients, please submit a completed patient enrollment form via fax 1-412-520-3442 or through the Fensolvi® portal at www.FensolviTotalSolutions.com.

For product orders or benefit verification inquiries, please call 1-866-FENSOLVI (336-7658).

Click here to download the Fensolvi TotalSolutions Patient Enrollment Form.

Fensolvi® is supplied in a single-use kit consisting of a two-syringe-mixing system with a sterile safety needle.  [1]

Fensolvi 45 mg (6-month dose) NDC: 62935-153-50

Fensolvi is a refrigerated product. However, once removed from refrigeration, it can be stored at room temperature (59-86°F) in original packaging for up to 8 weeks. [1]

Innovative technology in the delivery of leuprolide acetate 

Fensolvi (leuprolide acetate) for injectable suspension is the first and only extended-release subcutaneously administered leuprolide acetate formulation for this indication. It uses a biodegradable gel delivery system, which contains a unique polymer of poly(DL-lactide-co-glycolide), dissolved in N-methyl-2-pyrrolidone. After injection, the polymeric gel suspension delivery system forms an in-situ solid, enabling sustained and controlled release of leuprolide acetate as it safely biodegrades.

Absorption occurs in two phases, a burst phase followed by a plateau phase. The mean plateau serum leuprolide level from 4 to 48 weeks was approximately 0.37 ng/mL with a range of 0.18 to 0.63 ng/mL.

Figure 4. SC injection

The benefits of subcutaneous injections (Figure 4) for healthcare providers and patients:

  • Suitable for young patients with little muscle mass
  • Shorter needle with less distance from the skin surface; reduced risk of bone or nerve damage
  • Provides a wider range of injection site options
  • Allows for flexibility in site of care

Fensolvi efficacy was demonstrated through a 12-month, uncontrolled, open-label, single-arm clinical trial. The clinical trial included 64 children with CPP (62 girls and 2 boys, 4–9 years old) who were naïve to GnRH agonist treatment.

Fensolvi® pivotal study design

Fensolvi clinically demonstrated sustained suppression of stimulated luteinizing hormone (LH) level to <4 IU/L1.

Mean LH levels over 12 months with Fensolvi post GnRH agonist stimulation [4]

Fensolvi demonstrated suppression of reproductive hormones to prepubertal levels. [1]

Effectively impacted clinical sign of pubertal progression. [1]

Fensolvi has a favorable safety and tolerability profile.

  • No adverse reactions led to withdrawal from the study or discontinuation of Fensolvi
  • Throughout the 12 months of the clinical trial, no serious adverse reactions or significant adverse reactions of clinical relevance occurred

Adverse Reactions Occurring in ≥ 5% of Patients treated with Fensolvi® in an Open-Label, Single-Arm Trial [1]

Fensolvi 45 mg subcutaneous administered every 6 months was well tolerated. No adverse reactions led to withdrawal from the study or discontinuation of study drug. Most treatment-emergent adverse reactions were Grade 1 or 2. [2]

Adverse Reactions Occurring in ≥ 5% of Patients treated with Fensolvi® in an Open-Label, Single-Arm Trial [1]

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.

All patient-friendly resources can be found here.

Fensolvi TotalSolutions keeps things simple for your practice, your patients, and their parents.

We offer a full line of patient support services, including:

  • Benefit verification
  • Assistance with prior authorizations, appeals, and billing and coding inquiries
  • Patient education materials
  • Copay Assistance Program
  • Patient Assistance Program

You can reach Fensolvi TotalSolutions at 1-866-FENSOLVI (336-7658) or fensolvitotalsolutions.com.

Learn more

Mixing and Administration

Watch the video below to view mixing and administration instructions. For full dosage and administration guidelines, click here. To schedule a mixing and administration demonstration, please complete the contact form below.

Contact us to schedule a mixing and administration demonstration

We will only use your submission to communicate with you about scheduling a mixing and administration training and to share associated materials. Please see our privacy policy for more information.
Your patients and their families can stay connected to their treatment and your practice through dedicated patient support with Fensolvi TotalSolutions.

See terms and conditions below

We offer a full line of patient support services, including:
  • Benefit verification:

    With our innovative online portal, you can receive the results of benefits investigations in an average of 4 hours, including both pharmacy and medical claims

  • Assistance with inquiries:

    Fensolvi TotalSolutions can provide prior authorization information and support, including appeal support

  • Billing Information:

    The Fensolvi TotalSolutions concierge team is ready to help answer any billing or coding questions you may have

  • Prescription Transfer:

    Fensolvi TotalSolutions concierges will help transfer your patients prescription to a dedicated specialty pharmacy

  • Copay Assistance Program:

    Fensolvi TotalSolutions offers copay assistance for your eligible patients, allowing them to pay as little as $5 for their Fensolvi Prescription

You can reach Fensolvi TotalSolutions at 1-866-FENSOLVI (336-7658) or fensolvitotalsolutions.com.

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Learn more about CPP and Fensolvi

Explore our resources to learn how Fensolvi can help you keep childhood simple for children with CPP.

Connect with a Fensolvi Representative

Looking to get in touch with Fensolvi?

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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 Pharmaceuticals, Inc. and other parties working with us permission to communicate with you about Fensolvi®️ or other products, services, and offers from Tolmar Pharmaceuticals, 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.
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.

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 Expand

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

References

  1. Fensolvi® (leuprolide acetate) for injectable suspension 45 mg Prescribing Information. Dublin 2, Ireland: Tolmar International, Ltd.; 2020.
  2. Klein K, et al. Ped Endo Soc 2019. Accepted abstract.
  3. Prettyman J, et. al. Urologic Nursing. 2019;39(2):83-99.
Fensolvi TotalSolutions Copay program terms and conditions

The Fensolvi® Co-pay Assistance Program (“Program”) is valid ONLY for patients who are prescribed Fensolvi® for on-label use 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 or 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 a $10,000 yearly limit. The total assistance under this Program in any calendar year may not exceed $10,000.

Tolmar Pharmaceuticals, 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, go to: https://www.fensolvitotalsolutions.com or call 1-866-FENSOLVI (336-7658).

Program managed by ConnectiveRx on behalf of Tolmar.