Fensolvi Drug Information

FENSOLVI ® is indicated for the treatment of pediatric patients 2 years of age and older with central precocious puberty (CPP).

Dosing Information FENSOLVI must be administered by a healthcare provider. The dose of FENSOLVI is 45 mg administered by subcutaneous injection once every six months. Discontinue FENSOLVI treatment at the appropriate age of onset of puberty.

Monitoring

Monitor response to FENSOLVI with a GnRH agonist stimulation test, basal serum luteinizing hormone (LH) levels or serum concentration of sex steroid levels at 1 to 2 months following initiation of therapy and as needed to confirm adequate suppression of pituitary gonadotropins, sex steroids, and progression of secondary sexual characteristics. Measure height (for calculation of growth velocity) every 3 to 6 months and monitor bone age periodically. Noncompliance with drug regimen or inadequate dosing may lead to gonadotropins and/or sex steroids increasing above prepubertal levels resulting in inadequate control of the pubertal process.

If the dose of FENSOLVI is not adequate, switching to an alternative GnRH agonist for the treatment of CPP with the ability for dose adjustment may be necessary.

Reconstitution Instructions

Use aseptic technique including gloves for reconstitution and administration. Allow the product to reach room temperature before reconstitution to allow for easier administration. Once reconstituted, the concentration is 45 mg/0.375 mL.

Administer the product within 30 minutes or discard. FENSOLVI is packaged in a carton containing: Tray containing pre-connected syringe system and desiccant pack Prescribing information Sterile safety needle and cap (located under the tray in carton) Follow the detailed instructions below to ensure correct preparation of FENSOLVI prior to administration: Note: Should the needle hub appear to be damaged, or leak, do not use the product. If the needle hub is damaged or leakage is observed, use a new FENSOLVI carton. admin step2 step3 step4 step5 step6 step7

Administration Instructions 1. Using the thumb and forefinger, grab and bunch the area of skin around the injection site. 4. Withdraw the needle quickly at the same 90° angle used for insertion. 7.

Discard all components safely in an appropriate biohazard container. admin admin step7

Clinical Trials Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. FENSOLVI was evaluated in an uncontrolled, open-label, single-arm clinical trial in which 64 pediatric patients with CPP received at least one dose of FENSOLVI. Adverse reactions that occurred in ≥ 5% of patients are shown in Table 1.

Table 1: Adverse Reactions Occurring in ≥ 5% of Patients Treated with FENSOLVI in an Open-Label, Single-Arm Trial: Psychiatric Emotional disorder (2%) and irritability (2%)

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of FENSOLVI or GnRH agonists. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Allergic Reactions: anaphylactic, rash, urticaria, and photosensitivity reactions.

General: chest pain, weight increase, weight decrease, decreased appetite, fatigue. Laboratory Abnormalities: decreased WBC. Metabolic: diabetes mellitus.

Musculoskeletal and Connective Tissue: arthralgia, epiphysiolysis, muscle spasms, myalgia. Neurologic: neuropathy peripheral, convulsion, paralysis, insomnia, pseudotumor cerebri (idiopathic intracranial hypertension). Psychiatric: emotional lability, such as crying, irritability, impatience, anger and aggression, depression, including rare reports of suicidal ideation and attempt.

Many, but not all, of these patients had a history of psychiatric illness or other comorbidities with an increased risk of depression. Skin and Subcutaneous Tissue: injection site reactions including induration and abscess, flushing, hyperhidrosis, erythema multiforme, bullous dermatitis, dermatitis exfoliative, drug reaction with eosinophilia and systemic symptoms, Stevens-Johnson syndrome and toxic epidermal necrolysis, and acute generalized exanthematous pustulosis. Reproductive System: vaginal bleeding, breast enlargement.

Vascular: hypertension, hypotension. Respiratory: dyspnea.

Pregnancy Risk Summary FENSOLVI is contraindicated in pregnancy. FENSOLVI may cause fetal harm based on findings from animal studies and the drug’s mechanism of action. The available data from published clinical studies and case reports and from the pharmacovigilance database on exposure to leuprolide acetate during pregnancy are insufficient to assess the risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

Based on animal reproduction studies, leuprolide acetate may be associated with an increased risk of pregnancy complications, including early pregnancy loss and fetal harm. In animal reproduction studies, subcutaneous administration of leuprolide acetate to rabbits during the period of organogenesis caused embryo-fetal toxicity, decreased fetal weights and a dose-dependent increase in major fetal abnormalities in animals at doses less than the recommended human dose based on body surface area using an estimated daily dose. A similar rat study also showed increased fetal mortality and decreased fetal weights but no major fetal abnormalities at doses less than the recommended human dose based on body surface area using an estimated daily dose (see Data).

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is respectively. Similar studies in rats failed to demonstrate an increase in fetal malformations.

There was increased fetal mortality and decreased fetal weights with the two higher doses of leuprolide acetate in rabbits and with the highest dose (0.024 mg/kg) in rats.

Pediatric Use The safety and effectiveness of FENSOLVI for the treatment of CPP has been established in pediatric patients 2 years of age and older. Use of FENSOLVI for this indication is supported by evidence from an adequate and uncontrolled open-label, single-arm study of 64 pediatric patients with CPP with an age range of 4 to 9 years. The safety and effectiveness of FENSOLVI have not been established in pediatric patients less than 2 years old.

Hypersensitivity to GnRH, GnRH agonists or any of the components of FENSOLVI. Anaphylactic reactions to synthetic GnRH or GnRH agonists have been reported. Pregnancy: FENSOLVI may cause fetal harm.

Hypersensitivity reactions Pregnancy

No specific antidotes for FENSOLVI are known. Contact Poison Control (1-800-222-1222) for latest recommendations.