Triptodur® (triptorelin) extended release injectable suspension

Triptodur Care^SM

Dedicated Triptodur Care^SM Team for support to both caregivers and healthcare providers

Access, affordability, and treatment support include our Triptodur Care^SM Copay Assistance Program^c and our new Triptodur Care^SM Bridge^d and Patient Assistance^e Programs

95% insurance approval rates⁴ with Triptodur Care^SM

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:

Triptodur [package insert]. Woburn, MA: Azurity Pharmaceuticals, Inc; 2023.
IQVIA Data, June 2023.
Orange Book: approved drug products with therapeutic equivalence evaluations. Product details for NDA 208956. US Food & Drug Administration. Accessed August 21, 2024. https://www.accessdata.fda.gov/scripts/cder/ob/results_product.cfm?Appl_Type=N&Appl_No=208956#34712
Data on file. Azurity Pharmaceuticals, Inc.
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.

Copay Assistance

Copay assistance is not valid for prescriptions that are eligible to be reimbursed, in whole or in part, by Medicaid, Medicare, or other federal or state healthcare programs (including any state prescription drug assistance programs and the Government Health Insurance Plan).
Copay assistance is not valid for prescriptions that are eligible to be reimbursed, in whole by commercial plans.
Eligible patients may pay as little as $5 out-of-pocket for Triptodur per prescription with the Triptodur Copay Assistance Program.
This copay is valid for eligible cash-paying patients.
Insured must be 18 years of age or older; patients must be 2 years of age or older.
Each patient is limited to 1 active copay assistance offer at a time during this offering period, and the copay assistance offer is not transferable.
Copay assistance cannot be combined with any other rebate or coupon, free trial, or similar offer for the specified prescription.
Copay assistance will be accepted at participating pharmacies.
Copay assistance is not health insurance.
This offer is valid only in the United States and Puerto Rico as allowed by law.
Azurity reserves the right to rescind, revoke, or amend copay assistance without notice.
Offer valid until the end of the current calendar year. No membership fees apply.

Bridge Program

Patient and caregiver must be a United States (U.S) citizen or resident and must physically reside in the U.S or U.S territory.
Patient has been prescribed Triptodur for an on-label, FDA-approved indication.
Prescriber must complete and submit Bridge enrollment form to enroll patient in the program.
Patient has insurance that has been delayed or denied and documented. Prior Authorization (PA) denial and appeal management documentation is required. Failure to include documentation may result in delays. This will be confirmed by the prescriber attestation on the Bridge application.
Patient or provider cannot submit the value of the free product as a claim for payment to any third-party payer.
Patient or provider must contact program if insurance changes or coverage becomes available, at any point during the program year.
Program covers the cost of product only.
No portion of the value of the free product will count towards the patient’s applicable out-of-pocket cost-sharing obligations.

Azurity reserves the right to cancel or modify the program at any time.

Patient Assistance Program

Patient and caregiver must be a United States (U.S) citizen or resident and must physically reside in the U.S or U.S territory.
Patient has been prescribed Triptodur for an on-label, FDA-approved indication.
Prescriber must complete and submit a PAP enrollment form for every patient.
Patients whose health insurance plan or employer requires them to go through a third-party Alternative Funding Program (AFP) and apply to the PAP as a condition of, requirement for, or prerequisite to coverage of Triptodur will not be eligible for assistance from this program.
Income criteria that demonstrate qualifying financial needs and proof of income documentation.
Medical Expenses: Acceptable medical expenses submitted to the program should contain the amount and date of the transaction.

Azurity reserves the right to cancel or modify the program at any time.

Put Clinical Signs of Puberty on Pause Because It’s Their Time to Play

Reach for Triptodur^® (triptorelin):
The #1 Prescribed Twice-yearly GnRH-agonist Injectable.^1,2

7+ years on the market and nearly 3000 patients treated^3,4

Effective and sustained suppression

Generally safe and well tolerated in a clinical trial^1,5,b

Committed to a positive administration experience

Triptodur Care^SM

IMPORTANT SAFETY INFORMATION FOR TRIPTODUR

INDICATION

IMPORTANT SAFETY INFORMATION

Contraindications

Warnings and Precautions

Adverse Reactions

Put Clinical Signs of Puberty on Pause Because It’s Their Time to Play

Reach for Triptodur® (triptorelin):The #1 Prescribed Twice-yearly GnRH-agonist Injectable.1,2

7+ years on the market and nearly 3000 patients treated3,4

Effective and sustained suppression

Generally safe and well tolerated in a clinical trial1,5,b

Committed to a positive administration experience

Triptodur CareSM

IMPORTANT SAFETY INFORMATION FOR TRIPTODUR

INDICATION

IMPORTANT SAFETY INFORMATION

Contraindications

Warnings and Precautions

Adverse Reactions

The information on this site is intended for US healthcare professionals and is not intended for the general public.

Terms and Conditions

Copay Assistance

Bridge Program

Patient Assistance Program

Put Clinical Signs of Puberty on Pause Because It’s Their Time to Play

Reach for Triptodur^® (triptorelin):
The #1 Prescribed Twice-yearly GnRH-agonist Injectable.^1,2

7+ years on the market and nearly 3000 patients treated^3,4

Generally safe and well tolerated in a clinical trial^1,5,b

Triptodur Care^SM