TRIPTODUR SIDE EFFECTS
- Generic Name: triptorelin for extended-release injectable suspension
- Brand Name: Triptodur
- Drug Class: Antineoplastics, GNRH Agonists
SIDE EFFECTS
The following serious adverse reactions are described here and elsewhere in the label:
- Initial Rise of Gonadotropins and Sex Steroid Levels
- Psychiatric Events
- Convulsions
- Pseudotumor Cerebri (Idiopathic Intracranial Hypertension)
Clinical Trials Experience
Because clinical trials 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.
The safety of TRIPTODUR was evaluated in one uncontrolled, open-label single-arm clinical trial in which 44 children with central precocious puberty received two doses of TRIPTODUR and were observed for 12 months. The median age of the study population was 8 years (range 2-9 years) at treatment start; 88.6% of subjects were female, 59.1% were White, 27.3% were Black and 4.5% were Asian. Table 1 shows all the adverse reactions that occurred in at least 2 patients (≥4.5%) during the open-label single-arm trial.
Table 1: Adverse Reactions1 Occurring in ≥ 2 Patients Treated with TRIPTODUR in an Open-Label Single-Arm Trial
| Adverse Reactions | Number of Patients Reporting Event (%) (Total N=44) |
| Infections & Infestations | |
| Bronchitis | 2 (4.5) |
| Gastroenteritis | 3 (6.8) |
| Influenza | 2 (4.5) |
| Nasopharyngitis | 6 (13.6) |
| Otitis externa | 2 (4.5) |
| Pharyngitis | 2 (4.5) |
| Sinusitis | 2 (4.5) |
| Upper respiratory tract infection | 4 (9.1) |
| Nervous System Disorders | |
| Headache | 6 (13.6) |
| Reproductive System & Breast Disorders | |
| Menstrual (Vaginal bleeding)2 | 3 (7.7) |
| Respiratory, Thoracic & Mediastinal Disorder Cough | 3 (6.8) |
| Vascular Disorders Hot flush | 2 (4.5) |
| 1Injection site reactions are presented separately 2Includes % of patients with vaginal bleeding or menstrual disorder (“menstrual cycle returned”) in 39 females out of N=44. |
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Other Selected Adverse Reactions
Injection Site Reactions
Injection site reactions occurring in patients immediately and/or 2 hours after injection include pain (45%), redness (14%), pruritus (2.3%) and swelling (2.3%).
Psychiatric Disorders
Anxiety (2.3%) and mood altered (2.3%)
Postmarketing Experience
The following adverse reactions have been identified during postapproval use of triptorelin. 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.
Hypersensitivity Reactions: Anaphylactic shock, anaphylactoid reaction, angioedema, urticaria.
Cardiovascular: 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.
Nervous System: Convulsions, pseudotumor cerebri (idiopathic intracranial hypertension)
Vision Disorders: Visual impairment, visual disturbance.
SRC: NLM .