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.

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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.

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

Do not use TRIPTODUR in:

  • Those allergic to gonadotropin releasing hormone (GnRH), GnRH agonist medicines, or any ingredients in TRIPTODUR.
  • children under 2 years of age
  • women who are or may become pregnant

Tell your child’s healthcare provider if any of the above conditions apply to your child.

It is important to stick to the dosing schedule (one injection every 24 weeks) in order for the drug to work. Do not miss or delay a scheduled dose.

Some people taking gonadotropin releasing hormone (GnRH) agonists like TRIPTODUR have had new or worsened mental (psychiatric) problems. Mental (psychiatric) problems may include emotional symptoms such as crying, irritability, restlessness (impatience), anger, or acting aggressive. Call your child’s doctor right away if your child has any new or worsening emotional symptoms while taking TRIPTODUR.

Some people taking GnRH agonists like TRIPTODUR have had seizures. The risk of seizures may be higher in people who have a history of seizures, have a history of epilepsy, have a history of brain or brain vessel (cerebrovascular) problems or tumors, are taking a medicine that has been connected with seizures such as bupropion or selective serotonin reuptake inhibitors (SSRIs). Seizures have also happened in people who have not had any of these problems. Call your child’s doctor right away if your child has a seizure while taking TRIPTODUR.

Some people taking triptorelin, the active ingredient in TRIPTODUR, have had serious allergic reactions. Call your child’s doctor or get emergency medical help right away if your child gets any of the following symptoms of a serious allergic reaction: skin rashes, redness, or swelling, severe itching, hives, trouble breathing or swallowing, fast heartbeat, sweating, throat tightness, hoarseness, swelling of face, mouth, and tongue, dizziness or fainting.

The most common side effects of TRIPTODUR include 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). These are not all the possible side effects of TRIPTODUR. Tell your child’s healthcare provider if they have any side effect that bothers them or that does not go away.

In the first few weeks after your child receives their first TRIPTODUR injection or after additional injections, TRIPTODUR can cause a brief increase in some hormones. During this time you may notice more signs of puberty in your child, including vaginal bleeding. Call your child’s doctor if signs of puberty continue after 2 months of receiving TRIPTODUR.

Reports of pseudotumor cerebri (idiopathic intracranial hypertension) have been observed in pediatric patients receiving GnRH agonists, including triptorelin. Patients and caregivers should contact their healthcare provider if the patient develops any of following symptoms of pseudotumor cerebri, including headache, and vision issues such as blurred vision, double vision, loss of vision, pain behind the eye or pain with eye movement, ringing in the ears, dizziness, and nausea.

These are not all the possible side effects of TRIPTODUR. Call your doctor for medical advice about side effects.

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.