IMPORTANT SAFETY INFORMATION
TRIPTODUR® (triptorelin) for extended-release injectable suspension, for intramuscular use
Indication and Usage
TRIPTODUR is an injectable prescription gonadotropin releasing hormone (GnRH) medicine used for the treatment of children with central precocious puberty (CPP).
• It is not known if TRIPTODUR is safe and effective in children under 2 years of age. ADDITION
AL IMPORTANT SAFETY INFORMATION
TRIPTODUR should not be taken if your child is:
• allergic to gonadotropin releasing hormone (GnRH), GnRH agonist medicines, or any ingredients in 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
• pregnant or becomes pregnant. If your child becomes pregnant call your doctor. What is the most important information I should know about Triptodur? 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. 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
• 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. Severe cutaneous (skin) adverse reactions can happen during treatment with GnRH agonists like TRIPTODUR. Stop TRIPTODUR and call your child’s doctor right away if your child has any of the following signs or symptoms during treatment with TRIPTODUR:
• skin rash or acne
• dry skin
• itching
• blisters on your skin
• redness or swelling of your face, hands, or soles of your feet
• blisters or sores in your mouth
• peeling of your skin
• fever
• muscle or joint aches
• swollen glands
Increased pressure in the fluid around the brain can happen in children taking GnRH agonists medicines including TRIPTODUR. Call your child’s doctor right away if your child has any of the following symptoms during treatment with TRIPTODUR:
• headache
• ringing in the ears
• eye problems, including blurred vision, double vision and decreased eyesight
• dizziness
• nausea
• eye pain
What are the possible side effects of TRIPTODUR? TRIPTODUR may cause serious side effects. 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. Call your doctor for medical advice about side effects. Before your child receives TRIPTODUR, tell your child’s doctor about all of your child’s medical conditions, including:
• Have a history of mental (psychiatric) problems.
• Have a history of seizures.
• Have a history of epilepsy.
• Have a history of brain or brain vessel (cerebrovascular) problems or tumors.
• Are breastfeeding or plan to breastfeed. It is not known if TRIPTODUR passes into breastmilk. Tell your doctor about all the medicines your child takes, including:
• Prescription and over-the-counter medicines
• Vitamins and herbal supplements
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The Important Safety Information does not include all the information needed to use TRIPTODUR safely and effectively. Please see accompanying full Prescribing Information for TRIPTODUR.
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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. TRIPTODUR® is a registered trademark of Debiopharm International SA.
©2025 Azurity Pharmaceuticals, Inc. PP-TRIP-5313-US-EN-v2
