Throughout Your Patient’s CPP Journey, Start and Stay on Triptodur

Study Design

LH suppression at 1, 6, and 12 months1

Triptodur suppressed LH to prepubertal levels (GnRH-stimulated LH ≤5 IU/L) as early as month 1 in a clinical trial of treatment-naïve children

95%

95% of children (42/44) achieved LH suppression with Triptodur at month 1

93%

93% of children (41/44) achieved LH suppression with Triptodur at month 6 (primary endpoint)

96%

98% of children (43/44) achieved LH suppression with Triptodur at month 12

Three patients had nonsuppressed LH levels at month 62

  • Two of these nonresponders showed prepubertal LH levels at month 12, 1 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 in 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 who may represent 1 of the rare children with CPP who do not achieve suppression with GnRH agonists

The power to pause with Triptodur

Triptodur arrested or reversed clinical signs of puberty in a clinical trial

95%

95% of children (42/44) demonstrated a slowing of accelerated bone maturation at month 121,2

89%

Sexual maturation (Tanner stage) was stable or reduced in 89% of children (39/44) at month 121,2

Triptodur effectively suppressed
sex steroids2

Mean (+SD) Serum Estradiol Levels in Girls (ITT Population)

Mean (+SD) Serum Testosterone Levels in Boys (ITT Population)

Abbreviation: ITT=intent-to-treat.

Established Safety and Tolerability

In a clinical trial, Triptodur was shown to be well tolerated1,2

No treatment discontinuations in a clinical trial2

All patients completed 48 weeks of treatment with Triptodur, and there were no treatment interruptions

Stable laboratory parameters2

There were no substantial, unexpected, or clinically significant changes in laboratory parameters or vital signs in children receiving Triptodur

Injection-site tolerance rated
as very good2

Local tolerance at the injection site was judged to be very good, both immediately after and 2 hours after the first and second injections of Triptodur

Transient injection site reactions

Injection site reactions occurring in patients immediately and/or 2 hours after injection included1

  • Pain (45%)
  • Redness (14%)
  • Pruritus (2.3%)
  • Swelling (2.3%)

Only 5 adverse events (AEs), reported in 4 patients, were considered as triptorelin-related in the clinical trial, including vaginal or menstrual bleeding in 3 girls.

Adverse Reactions1Number of Patients Reporting Event
n (%)
(N=44)
Infections and Infestations
Nasopharyngitis6 (13.6)
Upper Respiratory Tract Infection4 (9.1)
Gastroenteritis3 (6.8)
Bronchitis2 (4.5)
Otitis Externa2 (4.5)
Pharyngitis2 (4.5)
Sinusitis2 (4.5)
Influenza2 (4.5)
nervous system disorders
Headache6 (13.6)
Reproductive System and Breast Disorders
Menstrual (vaginal bleeding)3 (7.7)
Respiratory, Thoracic, and Mediastinal Disorder
Cough3 (6.8)
Vascular Disorders
Hot Flush2 (4.5)

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.1

IMPORTANT SAFETY INFORMATION FOR TRIPTODUR

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.

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.

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).

To report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc. at 1-800-461-7449, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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.

References:

  1. Triptodur [package insert]. Woburn, MA: Azurity Pharmaceuticals, Inc; 2023.
  2. Klein K, Yang J, Aisenberg J, et al. Efficacy and safety of triptorelin 6-month formulation in patients with central precocious puberty. J Pediatr Endocrinol Metab. 2016;29(11):1241-1248.