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 3 years on the market
Over 4,000 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

Talking to Your Child About Central Precocious Puberty: A Helpful Guide

Going through puberty too early can be a confusing and unsettling time for a child and his or her family. There are changes taking place in your child’s body that he or she may not fully understand.1

As a parent, you play a key role in helping your child understand and cope with central precocious puberty (CPP). Creating a loving, comforting, and reassuring environment may help your child grow up to be strong and secure.2

This guide includes some helpful tips to keep in mind as you discuss CPP with your child.

Side image

For Children Ages 3-6:

Tip #1: Communication. Reinforce that your child’s body is normal.

At such a young age, your child might not be fully aware of the changes happening in his or her body, and may even seem unaffected by it. However, children may ask questions about why they are going to the doctor, or why they have to get tests or treatment. If your child is tall or perhaps more developed for their age, he or she may also have other children or adults comment or ask questions.

How you talk about CPP can go a long way toward shaping your child’s understanding of it, so it is a good idea to think about how you will discuss CPP with your child. It may be helpful to start with something like “Everyone’s body goes through these changes. Your body just started a little early.”

It may also be helpful to use objects to open lines of communication between you and your child about the changes in his or her body. Comparing the size of objects such as toys gives children a chance to play with measurement and helps them learn how to compare and use words such as “taller,” “shorter,” etc.3 For example, directly compare the heights of two stuffed toys and describe one toy as taller/shorter. This not only helps children understand measurement, but can help guide the conversation between you and your child about which parts of his or her body are growing or changing.

Tip #2. Prepare yourself so you can best help your child.

A CPP diagnosis can raise a lot of questions such as: What’s happening to my child’s body? Who do I talk to if I need help? Do I tell my friends and family?

Children often mimic their parent’s behavior – your child is more likely to be anxious if you exhibit signs of stress.4 Understanding CPP, and how you plan to talk with your child, family members, and even your doctors, can empower you to be a reliable support system for your child.

A simple explanation of CPP that can be used with friends and family is “My child has started puberty sooner than normal.”

By talking to your child’s doctor about CPP and what to expect, you can help ease your own uncertainties and anxieties.

Tip #3. Treat them according to their age.

Although your child’s body is developing early, he or she is still a young child. Sometimes adults or other children may treat your child as if they are older because of their appearance.5 If you are worried about family members, teachers, or other adults in your child’s life treating him or her as if they are older, it may be helpful to explain the condition to them. Talk to your healthcare provider for suggestions on explaining CPP or share this helpful guide.

For Children Ages 7 and Up:

Tip #1: Stay positive. Reinforce that your child is going through a natural process that usually happens
at a later age.6

Right now, your child might not understand the changes happening in his or her body or they may have negative feelings about developing early. How you talk about CPP can go a long way toward shaping your child’s understanding of it. When discussing CPP, being honest and open about the changes happening to their bodies can be helpful.7 You can start out by saying something like: “Everybody goes through puberty. You just started a little early.”

Tip #2. Prepare your child for what to expect.

Being diagnosed with CPP can raise a lot of questions such as: What’s happening to my body? Why am I so moody? Why don’t I look like my friends?1 By talking to your child about what CPP is and what to expect from it, you can help ease his or her fears and anxieties. Enlist the help of your child’s healthcare provider to explain what is happening. Be sure to stay involved.

Tip #3. Be there.

Although your child’s body is developing early, he or she is still a child and they need your support and guidance. Reassure your child that you’re there when he or she has questions, concerns, or just wants to talk. It may be helpful to tell your child: “I’m here to help you” or “You can ask me anything.”5

Tip #4: Help your child feel comfortable responding to questions.

Because it’s natural for other people—especially kids—to be curious, it helps to arm your child with some simple responses to questions he or she might get from other kids. A confident, straightforward response to other people’s curiosity can help.7

For example, if one of your daughter’s classmates asks her why she has breasts, you may want to suggest that she smile and say, “Because I’m a girl.” Or your child might choose a more direct approach and simply answer: “I have a medical condition” and leave it at that. The important thing is for your child not to feel ashamed or embarrassed about CPP.5

Children look for guidance on how to think about and respond to CPP. Your love and support means everything and can go a long way to boosting your child’s self-acceptance.5

References

  1. Helping your child cope with precocious puberty. WebMD website. Available at: https://www.webmd.com/parenting/features/helping-your-child-cope#3 Accessed February 13, 2020.
  2. Department for Children, Schools, and Families. Child Development Overview. (2016). Available at: http://www.keap.org.uk/documen... Accessed January 11, 2021.
  3. MacDonald, A., & Lowrie, T. Developing measurement concepts within context: Children’s representations of length. Math Ed Res J. 2011;23(1),27-42. https://doi.org/10.1007/s13339...
  4. Maccoby, E. E. (1992). The role of parents in the socialization of children: An historical overview. Dev Psych, 28(6),1006.
  5. Helping your child cope with precocious puberty. WebMD website. Available at: https://www.webmd.com/parenting/features/helping-your-child-cope#3 . Accessed February 13, 2020.
  6. Carel JC, Lahlou N, Roger M, Chaussain JL. Precocious puberty and statural growth. Hum Reprod Update. 2004;10:135-147.
  7. Bordini, B. (2017). Precocious puberty. The MAGIC Foundation. Available at: https://www.magicfoundation.or... Accessed January 11, 2021.

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.

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

You are encouraged to report side effects of prescription drugs to Arbor Pharmaceuticals, LLC Medical Information at 1-866-516-4950 or to the FDA at www.fda.gov/medwatch or call 1-800-FDA-1088.

For more information, ask your healthcare provider or pharmacist, or consult the TRIPTODUR full Prescribing Information.

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.

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

You are encouraged to report side effects of prescription drugs to Arbor Pharmaceuticals, LLC Medical Information at 1-866-516-4950 or to the FDA at www.fda.gov/medwatch or call 1-800-FDA-1088.

For more information, ask your healthcare provider or pharmacist, or consult the TRIPTODUR full Prescribing Information