TRIPTODUR® (triptorelin) sponsored by Azurity Pharmaceuticals, Inc.


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Indications & Usage

INDICATIONS AND USAGE

TRIPTODUR is a gonadotropin releasing hormone (GnRH) agonist indicated for the treatment of pediatric patients 2 years and older with central precocious puberty.

 

The PI Highlights do not include all the information needed to use TRIPTODUR safely and effectively. For additional safety information, please consult the full Prescribing Information for TRIPTODUR.

Dosage & Administration

DOSAGE AND ADMINISTRATION

  • Must only be administered by a healthcare provider.
  • Administer TRIPTODUR as a single intramuscular injection of 22.5 mg once every 24 weeks.
  • Monitor response with LH levels after a GnRH or GnRH agonist stimulation test, basal LH, or serum concentration of sex steroid levels beginning 1 to 2 months following initiation of therapy, during therapy as necessary to confirm maintenance of efficacy, and with each subsequent dose.
  • Measure height every 3-6 months and monitor bone age periodically.
  • See FPI for complete reconstitution and administration instructions.
    • Once TRIPTODUR is mixed, proceed to the next steps and administer without delay.
    • The injection of the suspension should be performed rapidly and in a steady and uninterrupted manner in order to avoid any potential blockage of the needle.

DOSAGE FORMS AND STRENGTHS

For extended-release injectable suspension: 22.5 mg of triptorelin as a powder cake for reconstitution with the co-packaged 2 mL of diluent Sterile Water for Injection.

 

The PI Highlights do not include all the information needed to use TRIPTODUR safely and effectively. For additional safety information, please consult the full Prescribing Information for TRIPTODUR.

Contraindications

CONTRAINDICATIONS

  • Hypersensitivity reactions
  • Pregnancy

 

The PI Highlights do not include all the information needed to use TRIPTODUR safely and effectively. For additional safety information, please consult the full Prescribing Information for TRIPTODUR.

Warnings & Precautions

WARNINGS AND PRECAUTIONS

  • Initial Rise of Gonadotropins and Sex Steroid Levels: An increase in clinical signs and symptoms of puberty may be observed during the first 2-4 weeks of therapy since gonadotropins and sex steroids rise above baseline because of the initial stimulatory effect of the drug.
  • Psychiatric events: Have been reported in patients taking GnRH agonists. Events include emotional lability, such as crying, irritability, impatience, anger, and aggression. Monitor for development or worsening of psychiatric symptoms.
  • Convulsions: Have been observed in patients with or without a history of seizures, epilepsy, cerebrovascular disorders, central nervous system anomalies or tumors, and in patients on concomitant medications that have been associated with convulsions.
  • Pseudotumor Cerebri (Idiopathic Intracranial Hypertension): Have been reported in pediatric patients receiving GnRH agonists, including triptorelin. Monitor patients for headache, papilledema, and blurred vision.

 

The PI Highlights do not include all the information needed to use TRIPTODUR safely and effectively. For additional safety information, please consult the full Prescribing Information for TRIPTODUR.

Adverse Reactions

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 PI Highlights do not include all the information needed to use TRIPTODUR safely and effectively. For additional safety information, please consult the full Prescribing Information for TRIPTODUR.

Triptodur® is manufactured by Debiopharm Research & Manufacturing SA on behalf of Azurity Pharmaceuticals, Inc., and its applicable affiliates. Triptodur® is a registered trademark of Debiopharm International SA. © 2025 Azurity Pharmaceuticals, Inc. All rights reserved. PP-TRIP-US-1286

 

This site is intended for use by US healthcare professionals.

For additional safety information, please consult the full Prescribing Information for TRIPTODUR.

INDICATIONS & IMPORTANT SAFETY INFORMATION

INDICATIONS

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.