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  • Generic Name: leuprolide acetate for injectable suspension, for subcutaneous use
  • Brand Name: Fensolvi
  • Drug Class: How Do Antineoplastic GNRH Agonists Work?
Last updated on MDtodate: 10/5/2022


The following serious adverse reactions are described here and elsewhere in the label:

  • Initial rise in gonadotropin and sex steroid levels.
  • Psychiatric Events.
  • Convulsions.

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 1.

Table 1: 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
Nasopharyngitis 22
Pyrexia 17
Headache 16
Cough 13
Abdominal pain 9
Injection site erythema 9
Nausea 8
Constipation 6
Vomiting 6
Upper respiratory tract infection 6
Bronchospasm 6
Productive cough 6
Hot flush 5


Other Adverse Reactions


Emotional disorder (2%) and irritability (2%)

Postmarketing Experience

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.

Respiratory: dyspnea.



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