FENSOLVI SIDE EFFECTS
- Generic Name: leuprolide acetate for injectable suspension, for subcutaneous use
- Brand Name: Fensolvi
- Drug Class: How Do Antineoplastic GNRH Agonists Work?
SIDE EFFECTS
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 (N=64) |
| 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
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.
SRC: NLM .