Medical Editor: John P. Cunha, DO, FACOEP
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
The following serious adverse reactions are described here and elsewhere in the label:
- Initial rise in gonadotropin and sex steroid levels [see WARNINGS AND PRECAUTIONS].
- Psychiatric Events [see WARNINGS AND PRECAUTIONS].
- Convulsions [see WARNINGS AND PRECAUTIONS].
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. The age ranged from 4 to 9 years at start of treatment; 62 patients were female and 2 were male; 53% White; 23% Black; 8% American Indian or Alaska Native; 5% Asian; 2% Native Hawaiian or Other Pacific Islander. 56% of the subjects self-identified as Hispanic or Latino ethnicity. Adverse reactions that occurred in ≥ 5% of patients are shown in Table 2.
Table 2: Adverse Reactions Occurring in ≥ 5% of Patients Treated with FENSOLVI in an Open-Label, Single-Arm Trial
|Adverse Reactions||% of Patients|
|Injection site pain||31|
|Injection site erythema||9|
|Upper respiratory tract infection||6|
Other Adverse Reactions
Emotional disorder (2%) and irritability (2%)
The following adverse reactions have been observed in post-approval use of products containing leuprolide acetate in pediatric patients. 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.
Psychiatric: emotional lability, such as crying, irritability, impatience, anger and aggression has been observed with GnRHa, including FENSOLVI; Depression, including rare reports of suicidal ideation and attempt, has been reported for GnRH agonists in pediatric patients treated for CPP. 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.
Reproductive System: vaginal bleeding, breast enlargement.
Vascular: hypertension, hypotension.
Read the entire FDA prescribing information for Fensolvi (Leuprolide Acetate for Injectable Suspension, for Subcutaneous Use)
© Fensolvi Patient Information is supplied by Cerner Multum, Inc. and Fensolvi Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.