Safety & Tolerability
In a clinical trial, TRIPTODUR (triptorelin) was shown to be well tolerated1,2
- All patients completed 48 weeks of treatment with TRIPTODUR, and there were no treatment interruptions2
- There were no substantial, unexpected, or clinically significant changes in laboratory parameters or vital signs in children receiving TRIPTODUR.2
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Local tolerance at the injection site was judged to be very good both immediately and 2 hours after the first and second injections of TRIPTODUR.2
- 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%).1
- Psychiatric events have been reported in patients taking GnRH agonists. Postmarketing reports with this class of drugs include symptoms of emotional lability, such as crying, irritability, impatience, anger, and aggression. Monitor for development or worsening of psychiatric symptoms during treatment with TRIPTODUR.
| Adverse Reactions | Number of Patients Reporting Event, %a (Total N=44)1 |
|---|---|
| Infections and Infestations | |
| Nasopharyngitis | 6 (13.6) |
| Upper Respiratory Tract Infection | 4 (9.1) |
| Gastroenteritis | 3 (6.8) |
| Bronchitis | 2 (4.5) |
| Otitis Externa | 2 (4.5) |
| Pharyngitis | 2 (4.5) |
| Sinusitis | 2 (4.5) |
| Influenza | 2 (4.5) |
| Nervous System Disorders | |
| Headache | 6 (13.6) |
| Reproductive System and Breast Disorders | |
| Menstrual (vaginal) bleedingb | 3 (7.7) |
| Respiratory, Thoracic, and Mediastinal Disorder | |
| Cough | 3 (6.8) |
| Vascular Disorders | |
| Hot Flush | 2 (4.5) |
aAdverse reactions occurring in ≥2 patients (≥4.5%) treated with TRIPTODUR in the open-label, single-arm study.
bIncludes vaginal bleeding and menstrual disorder (“menstrual cycle returned”) in 39 females (N=44).
