Introducing a new, unique J-code for Fensolvi: J1951

CMS has established a new, permanent Healthcare Common Procedure Coding System (HCPCS) code for FENSOLVI®️ (leuprolide acetate) for injectable suspension, effective July 1, 2021.

Visit our J-code page for helpful references on Fensolvi J-code usage.
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02266082-F7AD-41EB-B534-D9C2AC74229B@1x

Efficacy

Efficacy

Clinical efficacy

Fensolvi® demonstrated sustained suppression of luteinizing hormone (LH) level to <4 IU/L. [1]

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  1. Data on file. Tolmar Pharmaceuticals, Inc.
  2. FENSOLVI® (leuprolide acetate) for injectable suspension 45 mg Prescribing Information. Dublin 2, Ireland: Tolmar International, Ltd.; 2020.
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  1. Screening random (pre GnRHa stimulation test) LH data

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

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  1. FENSOLVI® (leuprolide acetate) for injectable suspension 45 mg Prescribing Information. Dublin 2, Ireland: Tolmar International, Ltd.; 2020.

Effectively impacted clinical sign of pubertal progression. [1]

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  1. FENSOLVI® (leuprolide acetate) for injectable suspension 45 mg Prescribing Information. Dublin 2, Ireland: Tolmar International, Ltd.; 2020.

Efficacy in-depth

Fensolvi delivers an effective and safe therapy for patients with central precocious puberty, with benefits of subcutaneous administration and twice-yearly dosing. [1]

The efficacy of Fensolvi was evaluated in an uncontrolled, open-label single arm clinical trial in which 64 pediatric patients (62 females and 2 males), with central precocious puberty received at least one dose of Fensolvi at a dosing interval of 24 weeks, and were observed for 12 months. [1]

The mean age was 7.5 years (range 4-9 years) at the start of treatment

Subjects in the safety data set included: 53% White; 23% Black; 8% American Indian or Alaska Native; 5% Asian; and 2% Native Hawaiian or Other Pacific Islander. Additionally, 56% of the subjects self-identified as Hispanic or Latino ethnicity [1]

There was a transient surge in circulating levels of LH, FSH, estradiol and testosterone following the first administration. A decrease in basal and GLH and FSH levels along with reductions in estradiol and testosterone were observed within several weeks and after repeat administration of Fensolvi. [2] Suppression of peak stimulated luteinizing hormone concentrations to <4 IU/L was achieved in 87% of subjects at month 6 and in 85% of patients at month 3, 9, and 12 (See Table 3). [1]

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  1. Data on File. Tolmar Pharmaceuticals, Inc. Clinical Study Report 20191030. CPP Phase 3 Study; Updated as of Feb 25, 2020
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  1. Klein K, Mauras, N, et al. Phase 3 trial of a small volume subcutaneous 6-month duration leuprolide acetate treatment for central precocious puberty.

97% of girls achieved suppression of estradiol concentration to prepubertal levels at the six-month assessment (See Table 3). [1]

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  1. FENSOLVI® (leuprolide acetate) for injectable suspension 45 mg Prescribing Information. Dublin 2, Ireland: Tolmar International, Ltd.; 2020.

Eight female patients out of 62 did not meet the primary efficacy criteria for LH <4 IU/L at 6 months.

In four of the eight patients, the LH level at 6 months was between 4.2 and 4.8 IU/L. The remaining four patients had LH levels >5 IU/L. [1]

Post stimulation estradiol was suppressed to prepubertal levels (<20 pg/mL) in seven of the eight patients at month 6 and was maintained through month 12. [1]

Fensolvi suppressed LH to < 4 IU/L post GnRH stimulation test in at least 85% of subjects, and estradiol and testosterone were suppressed to prepubertal levels in 97% of subjects. Progression of growth velocity was successfully arrested or reversed in majority of patients (57/59) by Tanner staging. [1]

Predicted adult height in untreated patients may be reduced by up to 13.7 cm and 8.3 cm in boys and girls, respectively. [3]

Fensolvi reduced growth velocity (Figure 6A) and reduced the difference between bone age and chronological age (Figure 6B). After initiation of therapy, mean growth velocity decreased steadily at each time point: at 4 weeks it was 8.9 ± 13.1 cm/yr and it decreased by approximately 28% by week 48 to 6.4 ± 1.9 cm/yr.  [4] Treatment reduced mean height growth velocity to near prepubertal levels.

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  1. Klein K, Mauras, N, et al. Phase 3 trial of a small volume subcutaneous 6-month duration leuprolide acetate treatment for central precocious puberty.
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  1. Klein K, Mauras, N, et al. Phase 3 trial of a small volume subcutaneous 6-month duration leuprolide acetate treatment for central precocious puberty.

The progression of clinical signs of puberty was arrested or reversed in 57/59 patients (97%) at month 6.

  • Regression in pubertal stage for breast development was observed in 46% (26/57) of girls by week 48, and stabilization of breast stage was seen in another 51% (29/57).
  • At the week 48 assessment, both boys regressed from Tanner 3 to Tanner 2 for external genitalia development (Figure 7). [5]
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  1. Data on File. Tolmar Pharmaceuticals, Inc. Clinical Study Report 20191030. CPP Phase 3 Study; Updated as of Feb 25, 2020
References
  1. FENSOLVI® (leuprolide acetate) for injectable suspension 45 mg Prescribing Information. Dublin 2, Ireland: Tolmar International, Ltd.; 2020.
  2. Data on File. Tolmar Pharmaceuticals, Inc. Clinical Study Report 20191030. CPP Phase 3 Study; Updated as of Feb 25, 2020
  3. Guaraldi F, Beccuti G, Gori D, Ghizzoni L. Management of endocrine disease: Long-term outcomes of the treatment of central precocious puberty. Eur J Endocrinol 2016;174:R79-87.
  4. Schally AV, Engel JB, Pinski J, Block NL. LHRH analogs. In: Handbook of Biologically Active Peptides. Elsevier Inc. 2013;531-540. doi:10.1016/b978-0-12-385095-9.00073-7
  5. Klein K, Mauras, N, et al. Phase 3 trial of a small volume subcutaneous 6-month duration leuprolide acetate treatment for central precocious puberty. (Manuscript in review)

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.