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In a clinical trial, TRIPTODUR (triptorelin) was shown to be well tolerated1,2
Number of Patients Reporting Event,
%a (Total N=44)1
|Infections and Infestations|
|Upper Respiratory Tract Infection||4 (9.1)|
|Otitis Externa||2 (4.5)|
|Nervous System Disorders|
|Reproductive System and Breast Disorders|
|Menstrual (vaginal) bleedingb||3 (7.7)|
|Respiratory, Thoracic, and Mediastinal Disorder|
|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).
TRIPTODUR is indicated for the treatment of pediatric patients 2 years of age and older with central precocious puberty (CPP).
Initial Rise of Gonadotropins and Sex Steroid Levels - During the early phase of therapy, gonadotropins and sex steroids rise above baseline because of the initial stimulatory effect of the drug. Therefore, a transient increase in clinical signs and symptoms of puberty, including vaginal bleeding, may be observed during the first weeks of therapy or after subsequent doses.
Psychiatric Events - 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.
Convulsions - Postmarketing reports of convulsions have been observed in patients receiving GnRH agonists, including triptorelin. These included patients with a history of seizures, epilepsy, cerebrovascular disorders, central nervous system anomalies or tumors, and patients on concomitant medications that have been associated with convulsions such as bupropion and SSRIs. Convulsions have also been reported in patients in the absence of any of the conditions mentioned above.
Pseudotumor Cerebri (idiopathic intracranial hypertension) - has been reported in pediatric patients receiving GnRH agonists, including triptorelin. Monitor patients for signs and symptoms of pseudotumor cerebri, including headache, papilledema, blurred vision, diplopia, loss of vision, pain behind the eye or pain with eye movement, tinnitus, dizziness, and nausea.
In clinical trials for TRIPTODUR, the most common adverse reactions (≥4.5%) are injection site reactions, menstrual (vaginal) bleeding, hot flush, headache, cough, and infections (bronchitis, gastroenteritis, influenza, nasopharyngitis, otitis externa, pharyngitis, sinusitis, and upper respiratory tract infection).
The Important Safety Information does not include all the information needed to use TRIPTODUR safely and effectively. For additional safety information, please consult the full Prescribing Information for TRIPTODUR.