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.
Increased pressure in the fluid around the brain can happen in children taking GnRH agonists medicines including TRIPTODUR.
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Call your child's doctor right away if your child has any of the following symptoms during treatment with TRIPTODUR:
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- headache
- eye problems, including blurred vision, double vision and decreased eyesight
- eye pain
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- ringing in the ears
- dizziness
- nausea
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What is TRIPTODUR?
- TRIPTODUR is an injectable prescription 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.
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TRIPTODUR should not be taken if your child is:
- allergic to gonadotropin releasing hormone (GnRH), GnRH agonist medicines, or any ingredients in TRIPTODUR. See the end of this Medication Guide for a complete list of 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:
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- skin rashes, redness, or swelling
- trouble breathing or swallowing
- throat tightness, hoarseness
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- severe itching
- fast heart beat
- swelling of face, mouth, and tongue
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- hives
- sweating
- dizziness or fainting
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- pregnant or becomes pregnant. TRIPTODUR can cause birth defects or loss of the baby. If your child becomes pregnant call your doctor.
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Before your child receives TRIPTODUR, tell your child's doctor about all of your child's medical conditions, including if they:
- 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 the doctor about all the medicines your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements. |
How will your child receive TRIPTODUR?
- Your child's doctor should do tests to make sure your child has CPP before treating them with TRIPTODUR.
- TRIPTODUR must only be given by a healthcare professional.
- TRIPTODUR is given as a single intramuscular (in the muscle) injection 1 time every 24 weeks.
- Keep all scheduled visits to the doctor. Do not delay a scheduled dose. The doctor will do regular exams and blood tests to check for signs of puberty.
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What are the possible side effects of TRIPTODUR?
TRIPTODUR may cause serious side effects. See "What is the most important information I should know about TRIPTODUR?"
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. You may report side effects to FDA at 1-800-FDA-1088. |
What are the ingredients in TRIPTODUR?
Active ingredient: triptorelin
Inactive ingredients: carboxymethylcellulose sodium, mannitol, poly-d,l-lactide-co-glycolide, and polysorbate 80
Distributed by: Azurity Pharmaceuticals, Inc., Woburn, MA 01801
Manufactured by: Debiopharm Research & Manufacturing SA, CH-1920 Martigny, Switzerland
For more information about TRIPTODUR, please contact Azurity Pharmaceuticals, Inc. at 1-800-461-7449. |