For the Treatment of Central Precocious
Puberty (CPP) in Children 2 years and older

Put Signs of Puberty on Pause With Triptodur^® (triptorelin)

Actor Portrayals

CPP and Triptodur

Triptodur helps to put signs of premature puberty on pause in children with CPP, and by doing so, gives your child the time they need to play, explore, and grow.

What is CPP?

CPP is when puberty starts too soon.

Puberty begins when a hormone called gonadotropin-releasing hormone, or GnRH, is released by a part of the brain called the hypothalamus. GnRH causes the release of other hormones that cause a lot of the physical changes that happen during puberty, including growth spurts, breast development, and testicle growth.

In children with CPP, this whole process works the same way, but it starts earlier than usual.

What is Triptodur?

Triptodur is a prescription medicine used for the treatment of children 2 years of age or older with central precocious puberty (CPP).

It is given as a single intramuscular (IM) injection just once every 6 months, with no surgery required.

Triptodur is the #1 prescribed and first FDA-approved treatment for CPP to offer twice-yearly dosing.

How does Triptodur work?

Triptodur is a gonadotropin-releasing hormone (GnRH) agonist. GnRH agonists work by telling the brain to ignore GnRH (the hormone that causes puberty to start too soon in children with CPP).

When the brain ignores GnRH signals, the other hormones responsible for the changes that go along with puberty—FSH, LH, estrogen, and testosterone—drop to prepuberty levels, and signs and symptoms of puberty slow down or stop.

Abbreviations: FSH=follicle-stimulating hormome; LH=lutenizing hormone.

Triptodur slowed down signs of puberty in a clinical trial

Triptodur’s ability to slow down the signs of puberty
in children with CPP was studied in a clinical trial.

What is LH?

Luteinizing hormone (LH) is one of the hormones involved in puberty. LH tells the ovaries to release estrogen or the testicles to release testosterone. Estrogen and testosterone, in turn, cause a lot of the physical changes that happen during puberty.

Triptodur lowered, or ‘suppressed’, LH to prepuberty levels  as soon as 1 month after starting treatment

Month 1

95%

95% of children (42/44) achieved LH suppression with Triptodur at month 1

Month 6

93%

After 6 months  of treatment, 93% of children (41 out of 44) had suppressed LH levels

Month 12

98%

After 12 months of treatment, 98% of children (43 out of 44) had suppressed LH levels

Other evidence that signs of puberty were slowed  in the clinical trial:

95%

95% of children (42 out of 44) treated with Triptodur had slowed bone growth by the end of 1 year of treatment

89%

At the 12 month mark, Triptodur stopped or reversed signs of puberty (breast development or testicle growth) in 89% of children (39 out of 44) treated

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).

What to Expect During Treatment

Triptodur must be administered only by a healthcare provider. It is important to stick to the dosing schedule (one injection every 24 weeks) in order for the medicine to work. Do not miss or delay a scheduled dose.

In the first few weeks after treatment, you may see an increase in signs and symptoms of puberty in your child. These signs are temporary and should go away after a few weeks.

Your child should have regular visits with his or her pediatrician or pediatric endocrinologist while undergoing treatment for CPP.

During your child’s treatment, a healthcare professional will complete regular exams and blood tests to check for signs of puberty, measure height and weight, and may take wrist X-rays to track bone growth.

These are not all the possible side effects of Triptodur. For more information, ask your child’s healthcare provider and see the Important Safety Information for more details.

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.

Put Signs of Puberty on Pause With Triptodur® (triptorelin)