WHEN CHOOSING A TREATMENT FOR CHILDREN WITH CENTRAL PRECOCIOUS PUBERTY (CPP)

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

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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

Suppressed LH to prepubertal levels and stopped or reversed clinical signs of puberty at 1, 6, and 12 months of treatment^1,a

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^aClinical signs of puberty assessed at 6 and 12 months.

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

No discontinuations or treatment interruptions reported⁵
No known cases of firm or hardened abscess, flushing, or hyperhidrosis related to injection site reactions reported¹

See additional safety information

^bTrial included 44 treatment-naïve patients. All patients completed 48 weeks of treatment.

Committed to a positive administration experience

Given twice-yearly as an IM injection¹
Small 21G, 1.5 inch needle¹
Administration support and training (live in-service support, video, or download) so that your team can administer Triptodur with confidence

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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

Enroll your patients now

^c-eSee Terms and Conditions.

Abbreviations: GnRH=gonadotropin-releasing hormone; IM=intramuscular; LH=Luteinizing hormone.

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.

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

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Terms and Conditions

Copay Program

By using Triptodur Care Copay Program, you certify that you currently meet the eligibility criteria and will comply with the Terms and Conditions described below:

Eligible patients may pay as little as $5 out-of-pocket for Triptodur per prescription with the Triptodur Care Copay Program. Annual maximums apply.
Copay program is not valid for prescriptions that are eligible for reimbursement, 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 available in Puerto Rico [formerly known as “La Reforma De Salud”]).
Copay assistance is not valid for prescriptions that are eligible for reimbursement by private/commercial insurance plans or other health or pharmacy benefit programs that reimburse you for the entire cost of your prescription drugs.
The patient must be 2 years or older.
Each patient is limited to one active co-pay assistance offer at a time during this offer period and the co-pay assistance offer is not transferable.
Copay assistance cannot be combined with any other rebate, coupon, free trial, or similar offer for the specified prescription.
Copay assistance is not health insurance.
This offer is good only in the United States and Puerto Rico as allowed by law.
Offer valid until the end of the current calendar year.
Azurity reserves the right to rescind, revoke, or amend copay assistance without notice.

PP-TRIP-US-1180

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.