Study design

The efficacy and safety of TRIPTODUR were demonstrated in a multicenter phase 3 study1,2

Presence of unstable intracranial tumors at screening was excluded by MRI or CT scans of the brain, unless they had been performed within 3 months prior to treatment initiation.2

  • Study was conducted in 44 patients (n=39 girls; n=5 boys) with CPP aged 2 to 9 years who were naive to previous GnRH-agonist treatment1,2

  • Primary efficacy end point: Percentage of children with serum LH suppression to prepubertal levels (serum LH ≤5 IU/L thirty minutes after GnRH-agonist stimulation) at month 61,2

LH suppression to prepubertal levels1

TRIPTODUR demonstrated LH suppression to prepubertal levels as early as month 11

  • 3 patients presented with nonsuppressed LH levels at month 62

    • 2 of these nonresponders showed prepubertal levels at month 12, one of whom had a borderline LH value of 5.1 IU/L at month 6 but a suppressed testosterone level of 2 ng/dL. The other encountered a technical problem with the first injection, which is likely to have played a significant role regarding this treatment failure

    • The third nonresponder was a 9-year-old overweight boy with a BMI of 23.1 kg/m2, who may have required a higher drug dose for adequate hormonal suppression, or may represent one of the rare children with CPP who do not achieve suppression with GnRH agonists

Long-lasting suppression means fewer injections

Effective suppression of stimulated LH3

TRIPTODUR demonstrated effective suppression of stimulated LH throughout the study3

Effective suppression of gonadotropins and sex steroids2

TRIPTODUR demonstrated effective suppression of gonadotropins and sex steroids2

Clinical signs of puberty

TRIPTODUR arrested or reversed progression of clinical signs of puberty1,2


* At month 6, 93% of children achieved LH suppression with TRIPTODUR (primary end point).1

BA, bone age; BMI, body mass index; CA, chronological age; CPP, central precocious puberty; CT,computerized tomography; FSH, follicle-stimulating hormone; GnRH, gonadotropin-releasing hormone; IM, intramuscular; ITT, intent-to-treat; LH, luteinizing hormone; MRI, magnetic resonance imaging.

INDICATION

TRIPTODUR is indicated for the treatment of pediatric patients 2 years of age and older with central precocious puberty (CPP).

IMPORTANT SAFETY INFORMATION

The following Warnings and Precautions have been associated with TRIPTODUR: Initial rise of gonadotropins and sex steroid levels, psychiatric events, and convulsions. The most common adverse reactions were 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).

INDICATION

TRIPTODUR is indicated for the treatment of pediatric patients 2 years of age and older with central precocious puberty (CPP).

IMPORTANT SAFETY INFORMATION
Contraindications

TRIPTODUR is contraindicated in:

  • Individuals with a known hypersensitivity to triptorelin or any other component of the product, or other GnRH agonists or GnRH.
  • Women who are or may become pregnant. Expected hormonal changes that occur with TRIPTODUR treatment increase the risk for pregnancy loss and fetal harm when administered to a pregnant woman. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be advised of the potential risk to the fetus.

Warnings and Precautions

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.

Adverse Reactions

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).

Please see full Prescribing Information for TRIPTODUR.

Reference: 1. Triptodur [package insert]. Atlanta, GA: Arbor Pharmaceuticals, LLC.