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Macrilen™ (macimorelin) 60 mg illustration showing that there are 50,000 cases of adult growth hormone deficiency (AGHD) in the United States
Macrilen™ (macimorelin) 60 mg illustration showing that there are 50,000 cases of adult growth hormone deficiency (AGHD) in the United States

AGHD is a rare disorder associated with increased morbidity and mortality1-4

Macrilen™ (macimorelin) 60 mg illustration showing that there are 50,000 cases of adult growth hormone deficiency (AGHD) in the United States
Macrilen™ (macimorelin) 60 mg illustration showing that there are 50,000 cases of adult growth hormone deficiency (AGHD) in the United States

Potential causes of AGHD

The most common causes of AGHD in adults are damage to the hypothalamus or pituitary gland due to tumors, surgery, cranial radiation, or traumatic brain injury.6

AGHD is a rare disorder associated with increased morbidity and mortality1-4

Potential causes of AGHD

The most common causes of AGHD in adults are damage to the hypothalamus or pituitary gland due to tumors, surgery, cranial radiation, or traumatic brain injury.6

Why it is critical to test for AGHD

Why it is critical to test for AGHD

If left undiagnosed, AGHD may lead to increased risk for premature mortality, significant morbidity, and multiple signs and symptoms, including2,4

  • An increase in abdominal adiposity
  • A decrease in muscle mass
  • Weakness and fatigue
  • Osteoporosis
  • An increased risk of fractures
  • Dyslipidemia
  • Cardiovascular disease
  • Impaired psychological well-being such as isolation, anxiety, or depression
  • An increase in abdominal adiposity
  • A decrease in muscle mass
  • Weakness and fatigue
  • Osteoporosis
  • An increased risk of fractures
  • Dyslipidemia
  • Cardiovascular disease
  • Impaired psychological well-being such as isolation, anxiety, or depression

The clinical findings of AGHD are nonspecific and usually of little diagnostic value.7

The clinical findings of AGHD are nonspecific and usually of little diagnostic value.7

Measuring growth hormone (GH) secretion

Measuring growth hormone (GH) secretion

It can be difficult to measure GH because it is secreted episodically in a pulsatile pattern with peaks and troughs and is influenced by a number of factors, including age, gender, and body mass index. Approximately 65% of GH production occurs at night, activated by slow-wave sleep. Because trough secretion makes up more than half the day, GH secretion may be undetectable by routine testing.8,9

Measuring insulin-like growth factor 1 (IGF-1) is a standard assessment of GH function; however, 50% of patients with AGHD have IGF-1 levels within the normal reference range. At the same time, patients with a normal response to GH evaluation can show low IGF-1 levels.10,11

The landscape for AGHD testinga

Table comparing the Macrilen™ (macimorelin) 60 mg testing to the insulin tolerance testing (ITT) in categories including procedure, number of blood draws, test time for the patient, medical supervision, contraindications, and potential adverse effects

aThis chart is not intended to be a comparison of efficacy or safety.15
bObserve the patient being tested per routine for the duration of the test.

The landscape for AGHD testinga

Insulin tolerance test (ITT)8,12,13

Macrilen™14,15

Procedure

Intravenous

Oral


Number of blood draws

5 to 8

4


Test time for patient

2-hour minimum

1.5 hours


Medical supervision

Intensive

Routineb


Contraindications

Patients with epilepsy, aged >55 years, with cerebrovascular disorders or with ischemic heart disease

None


Potential adverse events (AEs)

  • Hyperhidrosis
  • Somnolence
  • Hunger
  • Feeling hot
  • Dizziness/fatigue
  • Dysgeusia
  • Dizziness
  • Fatigue
  • Headache
  • Nausea
  • Hunger

aThis chart is not intended to be a comparison of efficacy or safety.15
b
Observe the patient being tested per routine for the duration of the test.

What is Macrilen™?

Macrilen™ (macimorelin) 60 mg icon illustrating a patient drinking a prepared oral solution

Find out how this innovative test helps you diagnose patients with AGHD.

What is Macrilen™?

Macrilen™ (macimorelin) 60 mg icon illustrating a patient drinking a prepared oral solution

Find out how this innovative test helps you diagnose patients with AGHD.

How to order

Macrilen™ (macimorelin) 60 mg icon of an order form page representing the ordering process

Learn how you can start ordering Macrilen™ for your patients.

How to order

Macrilen™ icon of an order form page representing the ordering process

Learn how you can start ordering Macrilen™ for your patients.

Indication and Limitation of Use

Macrilen™ (macimorelin) 60 mg for oral solution is indicated for the diagnosis of adult growth hormone deficiency (AGHD).

  • The safety and diagnostic performance of Macrilen™ have not been established for subjects with a body mass index (BMI) >40 kg/m2

Important Safety Information

Warnings and Precautions

  • QT Prolongation: Macrilen™ causes an increase of about 11 msec in the corrected QT (QTc) interval. QT prolongation can lead to development of torsade de pointes-type ventricular tachycardia with the risk increasing as the degree of prolongation increases. The concomitant use of Macrilen™ with drugs that are known to prolong the QT interval should be avoided
  • Potential for False Positive Test Results with Use of Strong CYP3A4 Inducers: Concomitant use of strong CYP3A4 inducers with Macrilen™ can decrease macimorelin plasma levels significantly and thereby lead to a false positive result. Strong CYP3A4 inducers should be discontinued and enough time should be given to allow washout of CYP3A4 inducers prior to test administration
  • Potential for False Negative Test Results in Recent Onset Hypothalamic Disease: Adult growth hormone (GH) deficiency caused by a hypothalamic lesion may not be detected early in the disease process. Macimorelin acts downstream from the hypothalamus and macimorelin stimulated release of stored GH reserves from the anterior pituitary could produce a false negative result early when the lesion involves the hypothalamus. Repeat testing may be warranted in this situation

Adverse Reactions

  • The most common adverse reactions are dysgeusia, dizziness, headache, fatigue, nausea, hunger, diarrhea, upper respiratory tract infection, feeling hot, hyperhidrosis, nasopharyngitis, and sinus bradycardia

Please click here for Prescribing Information

References

  1. Gupta V. Adult growth hormone deficiency. Indian J Endocrinol Metab. 2011;15(suppl 3):S197-S202.
  2. Rosén T, Bengtsson BA. Premature mortality due to cardiovascular disease in hypopituitarism. Lancet. 1990;336(8710):285-288.
  3. Monson JP, Brooke AM, Akker S. Adult growth hormone deficiency. In: Feingold KR, Anawalt B, Boyce A, et al., eds. Endotext. South Dartmouth, MA: MDText.com, Inc.; 2015.
  4. Carroll PV, Christ ER, Bengtsson BA, et al; Growth Hormone Research Society Scientific Committee. Growth hormone deficiency in adulthood and the effects of hormone replacement: a review. J Clin Endocrinol Metab. 1998;83(2):382-395.
  5. 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.
  6. 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.
  7. Boguszewski CL. Update on GH therapy in adults. F1000Research. 2017;6(F1000 Faculty Rev). doi: 10.12688/f1000research.12057.1. Updated August 15, 2018.
  8. Yuen KCJ, Tritos NA, Samson SL, Hoffman AR, Katznelson L. American Association of Clinical Endocrinologists and American College of Endocrinology disease state clinical review: Update on growth hormone stimulation testing and proposed revised cut-point for the glucagon stimulation test in the diagnosis of adult growth hormone deficiency. Endocr Pract. 2016;22(10):1235-1244.
  9. Melmed S. Idiopathic adult growth hormone deficiency. J Clin Endocrinol Metab. 2013;98(6):2187-2197.
  10. Kreber LA, Griesbach GS, Ashley MJ. Detection of growth hormone deficiency in adults with chronic traumatic brain injury. J Neurotrauma. 2016;33(17):1607-1613.
  11. Lissett CA, Jönsson P, Monson JP, Shalet SM; KIMS International Board. Determinants of IGF-I status in a large cohort of growth hormone-deficient (GHD) subjects: the role of timing of onset of GHD. Clin Endocrinol (Oxf). 2003;59(6):773-778. doi:10.1046/nature01884.
  12. Yuen KCJ. Growth hormone stimulation tests in assessing adult growth hormone deficiency. In: Feingold KR, Anawalt B, Boyce A, et al, eds. Endotext. South Dartmouth, MA: MDText.com, Inc.; 2016.
  13. Agarwal V, Garcia JM. The macimorelin-stimulated growth hormone test for adult growth hormone deficiency diagnosis. Expert Rev Mol Diagn. 2014;14(6):647-654.
  14. Macrilen [prescribing information]. Plainsboro, NJ: Novo Nordisk Inc; 2018.
  15. Data on file. Novo Nordisk Inc; Plainsboro, NJ.