What is
Triptodur®?

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Fewer Injections, Less Burden

Triptodur is an injectable prescription medicine used for the treatment of children 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-month dosing. Treatment with Triptodur does not require surgery.

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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 two 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.4

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 III clinical trial, 93% of patients receiving Triptodur had their LH suppressed to prepubertal levels at month six, and 98% of patients maintained these levels at 12 months.1
  • Triptodur was also found to be safe and well tolerated with no unexpected side effects1,3

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 6
(primary end point)
Month 12

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 months1,2

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.

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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.

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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. Parenting. The precocious puberty phenomenon. (2017) Retrieved from: http://parenting.com/article/p...
  2. Department for Children, Schools, and Families. Child Development Overview. (2016). Retrieved from: http://www.keap.org.uk/documen...
  3. MacDonald, A., & Lowrie, T. (2011) Developing measurement concepts within context: Children’s representations of length. Mathematic Education Research Journal, 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. Developmental Psychology, 28(6), 1006.
  5. Helping your child cope with precocious puberty. WebMD website. Available at: https://www.nichd.nih.gov/health... . Accessed October 16, 2017.
  6. Carel JC, Lahlou N, Roger M & Chaussain JL. Precocious puberty and statural growth. Human Reproduction update. 2004; 10: 135-147. 7. Bordini, B. (2017). Precocious Puberty. The MAGIC Foundation. Retrieved from: https://www.magicfoundation.or...

References 

  1. Triptodur [package insert]. Atlanta, GA: Arbor Pharmaceuticals, LLC. 
  2. Magon, N, et al. Gonadotropin releasing hormone agonists: Expanding vistas. Indian J Endocrinol Metab. 2011;15(4);261-267. 
  3. 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.
  4. Precocious Puberty. Eunice Kennedy Shriver National Institute of Child Health and Human Development Web site.
    https://www.nichd.nih.gov/heal.... Accessed August 14, 2017.

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

Contraindications

TRIPTODUR is contraindicated in:

Warnings and Precautions

Initial Rise of Gonadotropins and Sex Steroid Levels - During the early phase of therapy, gonadotropins and sex steroids rise above baseline because of the initial stimulatory effect of the drug. Therefore, a transient increase in clinical signs and symptoms of puberty, including vaginal bleeding, may be observed during the first weeks of therapy or after subsequent doses.

Psychiatric Events - Psychiatric events have been reported in patients taking GnRH agonists. Postmarketing reports with this class of drugs include symptoms of emotional lability, such as crying, irritability, impatience, anger, and aggression. Monitor for development or worsening of psychiatric symptoms during treatment with TRIPTODUR.

Convulsions - Postmarketing reports of convulsions have been observed in patients receiving GnRH agonists, including triptorelin. These included patients with a history of seizures, epilepsy, cerebrovascular disorders, central nervous system anomalies or tumors, and patients on concomitant medications that have been associated with convulsions such as bupropion and SSRIs. Convulsions have also been reported in patients in the absence of any of the conditions mentioned above.

Adverse Reactions

In clinical trials for TRIPTODUR, the most common adverse reactions (≥4.5%) are 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).

For additional safety information, please consult the 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

Contraindications

TRIPTODUR is contraindicated in:

  • Individuals with a known hypersensitivity to triptorelin or any other component of the product, or other GnRH agonists or GnRH.
  • Women who are or may become pregnant. Expected hormonal changes that occur with TRIPTODUR treatment increase the risk for pregnancy loss and fetal harm when administered to a pregnant woman. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be advised of the potential risk to the fetus.

Warnings and Precautions

Initial Rise of Gonadotropins and Sex Steroid Levels - During the early phase of therapy, gonadotropins and sex steroids rise above baseline because of the initial stimulatory effect of the drug. Therefore, a transient increase in clinical signs and symptoms of puberty, including vaginal bleeding, may be observed during the first weeks of therapy or after subsequent doses.

Psychiatric Events - Psychiatric events have been reported in patients taking GnRH agonists. Postmarketing reports with this class of drugs include symptoms of emotional lability, such as crying, irritability, impatience, anger, and aggression. Monitor for development or worsening of psychiatric symptoms during treatment with TRIPTODUR.

Convulsions - Postmarketing reports of convulsions have been observed in patients receiving GnRH agonists, including triptorelin. These included patients with a history of seizures, epilepsy, cerebrovascular disorders, central nervous system anomalies or tumors, and patients on concomitant medications that have been associated with convulsions such as bupropion and SSRIs. Convulsions have also been reported in patients in the absence of any of the conditions mentioned above.

Adverse Reactions

In clinical trials for TRIPTODUR, the most common adverse reactions (≥4.5%) are 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).

For additional safety information, please consult the Full Prescribing Information