What Is
Triptodur®?

Young girl in a green top blowing bubbles in front of a corkboard with a calendar marking injections spread six months apart
Young girl in a green top blowing bubbles in front of a corkboard with a calendar marking injections spread six months apart

Fewer Injections, Less Burden

Triptodur is an injectable prescription medicine used for the treatment of children 2 years of age or older with central precocious puberty (CPP).1 It is administered as a single intramuscular (IM) injection just once every 24 weeks, making it the first FDA-approved medicine for CPP to offer once-every-six-months dosing. Treatment with Triptodur does not require surgery.

Silhouette of a child’s head with brain overlaid. Gonadotropin-Releasing Hormone (GnRH) and Pituitary Gland are labelled

How Can Triptodur Help My Child?

To understand how Triptodur works, it helps to know a little about what causes puberty. The process of puberty starts in the brain with the creation of a hormone called gonadotropin-releasing hormone (GnRH). GnRH causes the pituitary gland — a small bean-shaped gland at the base of the brain — to release 2 more hormones called luteinizing hormone (LH) and follicle-stimulating hormone (FSH). LH and FSH are involved in the growth and development of female and male sexual characteristics.3

Treatments for CPP weaken the effects of GnRH signaling on the pituitary gland, reducing the release of hormones that cause puberty. By stopping the signaling of these hormones, the puberty process will be delayed until the end of the treatment. The effect of Triptodur on pituitary and gonadal function is expected to disappear within six to twelve months after treatment is stopped.1

Triptodur is effective in suppressing LH to prepubertal levels (≤5 IU/L).

  • In a phase 3 clinical trial, 93% of patients receiving Triptodur had their LH suppressed to prepubertal levels at month 6, and 98% of patients maintained these levels at 12 months.1
  • Triptodur was also found to be well tolerated with no unexpected side effects.1,2

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).

Percentage of Patients Achieving
Prepubertal LHa
(GnRH-Stimulated LH ≤5 IU/L)1,b

Month 1

Month 1 circular bar chart reaching 95% of the way around the circle. The center of the chart reads n/N=42/44

Month 6
(primary end point)

Month 6 circular bar chart reaching 93% of the way around the circle. The center of the chart reads n/N=41/44

Month 12

Month 12 circular bar chart reaching 98% of the way around the circle. The center of the chart reads n/N=43/44

44 children (39 females) with CPP, 2 to 9 years of age, who were naive to previous GnRH-agonist therapy, were administered Triptodur 22.5 mg at a dosing interval of 24 weeks and were evaluated over 2 dosing intervals for a total of 12 months.1,2

95% of children (n/N=42/44) achieved prepubertal LH levels at months 2, 3, and 9.
aSerum LH ≤5 IU/L thirty minutes after GnRH-agonist stimulation.
bResults are from intent-to-treat (ITT) population.

Icon of calendar with a 2x icon in the corner with text: Given only twice a year as an intramuscular injection [footnote 1]
Icon of hourglass with text: Long-lasting LH suppression [footnote 1,2]
Icon of hand holding scalpel making a cut: No surgery required
Icon of calendar with a 2x icon in the corner with text: Given only twice a year as an intramuscular injection [footnote 1]
Icon of hourglass with text: Long-lasting LH suppression [footnote 1,2]
Icon of hand holding scalpel making a cut: No surgery required
Over 4 years on the market
Over 9,000 prescriptions filled
Mother with son on her lap at a doctor’s visit smiling as the doctor in the foreground reads from his clipboard

What to Expect During Treatment

Triptodur must be administered under the supervision of a physician. 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.1

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 perform 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.

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). Tell your child's healthcare provider if they have any side effect that bothers them or that does not go away.

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

Get Help Talking to Your Child About CPP

References 

  1. Triptodur [package insert]. Atlanta, GA: Arbor Pharmaceuticals, LLC. 
  2. Klein K, 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.
  3. What causes normal puberty, precocious puberty, & delayed puberty? Eunice Kennedy Shriver National Institute of Child Health and Human Development website.
    https://www.nichd.nih.gov/health/topics/puberty/conditioninfo/Pages/causes.aspx Accessed April 20, 2020.
  4. Data on file. Arbor Pharmaceuticals, LLC.

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.