Adult Growth
Hormone Deficiency

Adult Growth Hormone Deficiency (AGHD) is a condition which causes premature mortality, as well as cardiovascular, neuromuscular, metabolic, mental health, and skeletal abnormalities.1 The clinical features are nonspecific; growth hormone stimulation testing is required to diagnose AGHD.2

Adult Growth Hormone Deficiency is typically caused by injury to the pituitary. Other causes include inflammatory disease, pituitary gland hemorrhage, or traumatic brain injury.3

More than 50,000 patients are diagnosed with AGHD in the United States.4



Adult Growth Hormone Deficiency Overview

Growth hormone is produced by the pituitary gland and secreted in pulses, so random measurements of growth hormone levels in the blood are not useful for establishing a diagnosis of AGHD.5

Growth hormone stimulation testing provokes the pituitary gland to release levels of growth hormone above normal levels to determine the maximum growth hormone level in a patient suspected of having AGHD.5

Primary Periodic Paralysis Overview
Growth hormone is critical for adults to maintain healthy tissue and organ function.6
Symptoms of AGHD include reduced muscle mass, increased risk of heart disease, decreased bone density, and an increase in body fat.7
Patients may also experience depression, anxiety, and social isolation due to psychological impairments associated with AGHD such as impaired concentration and memory loss, dissatisfaction with body image, and decreased quality of life.8
Treatment with growth hormone improves both the physical and psychological symptoms for patients with AGHD, improving quality of life.9

The First and Only FDA-Approved Drug to Diagnose AGHD:

MACRILEN™ (macimorelin), an oral growth hormone secretagogue receptor agonist, is the first and only FDA-approved oral drug indicated for the diagnosis of Adult Growth Hormone Deficiency.

Adult Growth Hormone Deficiency Treatment:

Endocrine Society Clinical Practice Guidelines recommend suspected AGHD be tested and if positive, treated with recombinant exogenous growth hormone.10


Important Safety Information for MACRILEN

What is MACRILEN?

MACRILEN (pronounced ma-kri-len) (macimorelin) is a prescription oral solution that is used to test for adult growth hormone deficiency (AGHD).

What should you know about MACRILEN?

  • Taking MACRILEN with certain other medications may cause irregular changes to your heart rhythm. Before taking MACRILEN, tell your healthcare provider about all your medications, as you may need to temporarily stop taking some medications before you take MACRILEN.
  • Some medications may cause a false positive result when taken with MACRILEN. Before taking MACRILEN, tell your healthcare provider about all the medications you take, including growth hormone.
  • Tell your healthcare provider if you were recently diagnosed with hypothalamic disease, as this can cause a false negative result with MACRILEN.
  • You will need to fast (go without food) for at least 8 hours before taking MACRILEN.

What are the most common side effects with MACRILEN?

The most common side effects were changed sense of taste, dizziness, headache, fatigue, nausea, hunger, diarrhea, upper respiratory tract infection, feeling hot, excessive sweating, sore nose and throat, and decreased heart rate.

These are not all of the possible side effects of MACRILEN. Call your healthcare provider for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch/ or call 1-800-FDA-1088.

Please see MACRILEN Important Safety Information and Full Prescribing Information.

References

  1. Gupta V. Adult growth hormone deficiency. Indian J Endocrinol Metab. 2011;15(Suppl 3):S197-S202.
  2. Fukuda I, Hizuka N, Muraoka T, Ichihara A. Neurol Med Chir (Tokyo). 2014;54(8):599-605.
  3. Bujanova J, Cummings MH. Drug review: Management of growth hormone deficiency in adults. Prescriber. 2015. http://onlinelibrary.wiley.com/doi/10.1002/psb.1422/pdf. Accessed January 15, 2018.
  4. Monson JP, Brooke AM, Akker S. Adult growth hormone deficiency. In: De Groot L, Chrousos G, Dungan K, et al (eds). Endotext [online]. South Dartmouth, MA; MDText.com, Inc: 2000. https://www.ncbi.nlm.nih.gov/books/NBK278982/. Accessed January 16, 2018.
  5. Garcia J, Biller B, Korbonits M. Validation of macimorelin as a diagnostic test for adult growth hormone deficiency (AGHD): a phase 3 study in comparison with the insulin tolerance test (ITT). Abstract LB SUN 59 (poster presentation). Presented at: Endocrine Society 2017 Annual Meeting (ENDO 2017). April 1-4, 2017; Orlando, FL.
  6. Devesa J, Almengló C, Devesa P. Multiple effects of growth hormone in the body: is it really the hormone for growth? Clin Med Insights Endocrinol Diabetes. 2016;9:47-71.
  7. The Pituitary Society. Growth Hormone Deficiency in Adults and Children: Your Questions Answered. https://www.pituitarysociety.org/sites/all/pdfs/Pituitary_Society_Growth_Hormone_Deficiency_brochure.pdf. Accessed January 15, 2018.
  8. Chrisoulidou A, Kousta E, Beshyah SA, Robinson S, Johnston DG. How much, and by what mechanisms, does growth hormone replacement improve the quality of life in GH-deficient adults? Baillieres Clin Endocrinol Metab. 1998;12(2):261-279.
  9. Brod M, Pohlman B, Højbjerre L, Adalsteinsson JE, Rasmussen MH.  Impact of adult growth hormone deficiency on daily functioning and well-being. BMC Res Notes. 2014;7:813.
  10. Molitch ME, Clemmons DR, Malozowski S, Merriam GR, Vance ML; Endocrine Society. Evaluation and treatment of adult growth hormone deficiency: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2011;96(6):1587-1609.

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STRONGBRIDGE BIOPHARMA® is a registered trademark of the Strongbridge Biopharma plc. companies, which include Strongbridge Ireland Limited and Strongbridge U.S. Inc.
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