Twice-Yearly Dosing โ€” Fewer Injections May Lessen
the Time Burden for Patients and Providers

TRIPTODUR is administered as a single IM injection just
once every 24 weeks1

Treatment Options for Central Precocious Puberty1,2
Injections Per Year
Injection
Every Month
(4 weeks)
๐Ÿ’‰๐Ÿ’‰๐Ÿ’‰๐Ÿ’‰๐Ÿ’‰๐Ÿ’‰๐Ÿ’‰๐Ÿ’‰๐Ÿ’‰๐Ÿ’‰๐Ÿ’‰๐Ÿ’‰๐Ÿ’‰ Thirteen Injections Per Year
Injection
Every 3 Months
(12 weeks)
๐Ÿ’‰๐Ÿ’‰๐Ÿ’‰๐Ÿ’‰ Four Injections Per Year
Injection
Every 6 Months
(24 weeks)
๐Ÿ’‰๐Ÿ’‰ Two Injections Per Year
Implant
Surgical
Subcutaneous
Implant*
Once Every 12 months
*Surgical procedure involving the use of anesthesia.
The method of anesthesia utilized (ie, local, conscious sedation, general)
is at the discretion of the healthcare provider.

โ€ At month 6, 93% of children achieved LH suppression with TRIPTODUR (primary endpoint).1
CPP, central precocious puberty; IM, intramuscular; LH, luteinizing hormone.

What could twice-yearly IM dosing mean for patients, caregivers, and the clinical staff?

  • Long-lasting LH suppression means fewer injections1โ€ 
  • No coordination of surgical procedures
  • Product acquisition logistics may be minimized
Actor Portrayal

โ€ At month 6, 93% of children achieved LH suppression with TRIPTODUR (primary endpoint).1
CPP, central precocious puberty; IM, intramuscular; LH, luteinizing hormone.

A mother smiles over the shoulder of her son who beams as he sits in his motherโ€™s lap

Click for 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).

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.

Click for IMPORTANT SAFETY INFORMATION FOR TRIPTODUR

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 (โ‰ฅ4.5%) 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 PDF Document: TRIPTODUR (File Size: 153 KB).

References

  1. 1 Triptodur [package insert]. Woburn, MA 01801: Azurity Pharmaceuticals, Inc. 2022.
  2. 2 Carel JC, Eugster EA, Rogol A, et al. Consensus statement on the use of gonadotropin-releasing hormone analogs in children. Pediatrics. 2009;123(4):e752-e762.
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