Fensolvi

Last reviewed on RxList: 5/13/2020
Fensolvi Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 5/13/2020

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.

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Fensolvi Professional Information

SIDE EFFECTS

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
(N=64)
Injection site pain31
Nasopharyngitis22
Pyrexia17
Headache16
Cough13
Abdominal pain9
Injection site erythema9
Nausea8
Constipation6
Vomiting6
Upper respiratory tract infection6
Bronchospasm6
Productive cough6
Hot flush5

Other Adverse Reactions

Psychiatric

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.

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.

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