Why Fensolvi

Why Fensolvi

Designed with a child in mind

Designed to ensure childhood remains as simple as possible for children with CPP.[1]

  • 6-month dosing

    • 2 injections per year
    • May align with office visit schedule

  • Subcutaneous injection

    • No surgery required
    • Flexibility of multiple injection sites[2]
    • Less risk for hematomas[2]

  • Short needle

    • Child injection experience consideration[2]
    • Reduced risk of hitting bone[2]
    • Flexibility of multiple injection sites[2]
    • 18 gauge needle size

  • Small injection volume

    • Low injection volume of 0.375mL
      The lowest injection volume of leuprolide acetate available – 0.375 mL

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    • Child injection experience consideration[2]
    • One injection of Fensolvi® was proven effective for 6 months

Novel delivery

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

Unique leuprolide extended release system

A biodegradable copolymer combine with leuprolide acetate to form a solid after interacting with water in the subcutaneous tissue.

A single subcutaneous injection delivers 6 months of treatment.

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Proven

Fensolvi® clinical study key endpoints summary[1]

  • 0 Patients withdrew from study due to Adverse Reactions
  • Mean growth velocity decreased by 28% to near normal prepubertal rates from week 4 to week 48, from 8.9 cm/year to 6.4cm/year[2]
  • Progression of clinical signs of puberty was arrested or reversed for majority of patients (57/59), as evidenced by regression or stabilization in Tanner staging[3]
  • 87% of patients achieved primary efficacy endpoint of suppression of peak stimulated LH concentrations at Week 24[2]
  • At least 85% of patients achieved LH levels of <4 IU/L at all time points throughout study[2]
  • At least 97% of girls achieved estradiol suppression to prepubertal level throughout 48 weeks of treatment[3]

See full clinical details

Comprehensive support

Fensolvi TotalSolutions

We offer a full line of patient support services, including

Office support
  • Patient enrollment services
  • Benefit verification
  • Billing & coding questions
  • Case management
  • Prior authorization and appeals assistance
Patient support
  • Patient enrollment services
  • Benefit investigation
  • Patient education materials
Adherence support

Support provided to patients who elect to receive additional communications and materials to help with their treatment journey

Financial support

  • Copay assistance program

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      Copay assistance is available for your eligible patients, allowing them to pay as little as $5 for their Fensolvi® Prescription

  • Patient assistance program (PAP)

Learn about Fensolvi TotalSolutions

Full support through the Fensolvi Hub

For questions from mixing and administration to benefit verification and more,

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

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.