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

Macrilen™ is an innovative way to diagnose AGHD

First and only FDA-approved oral test for the diagnosis of AGHD1,2

Macrilen™ is an innovative way to diagnose AGHD

First and only FDA-approved oral test for the diagnosis of AGHD1,2

Macrilen™ (macimorelin) 60 mg icon illustrating the 90-minute administration time for the oral solution

90-minute total test time1

  • Requires blood draws at 30, 45, 60, and 90 minutes
  • No baseline blood draw required
Macrilen™ (macimorelin) 60 mg icon illustrating routine medical supervision during administration

Routine supervision

After supervising the patient drinking the Macrilen™ solution, observe the patient being tested per routine.1

Macrilen™ (macimorelin) 60 mg icon illustrating the 90-minute administration time for the oral solution

90-minute total test time1

  • Requires blood draws at 30, 45, 60, and 90 minutes
  • No baseline blood draw required
Macrilen™ (macimorelin) 60 mg icon illustrating routine medical supervision during administration

Routine supervision

After supervising the patient drinking the Macrilen™ solution, observe the patient being tested per routine.1

How does Macrilen™ work?

Macrilen™ is an oral ghrelin agonist that stimulates the production of GH in the pituitary gland1,3

How does Macrilen™ work?

Macrilen™ is an oral ghrelin agonist that stimulates the production of GH in the pituitary gland1,3

  • Ghrelin is a peptide hormone known to cause the release of GH3,4
  • Macrilen™ mimics endogenous ghrelin and binds to the GH secretagogue receptor 1a (GHS-R1a). This activates the receptors in the hypothalamus and pituitary gland to stimulate GH release into the circulatory system1,4
Illustration representing Macrilen™ (macimorelin) 60 mg as a ghrelin agonist in the first step of the hormone secretion process

Macrilen™ is an oral ghrelin agonist

Illustration showing how Macrilen™ (macimorelin) 60 mg as a ghrelin agonist binds to the pituitary and hypothalamic cells

that binds to the GHS-R1a on pituitary and hypothalamic cells

Illustration representing the release of growth hormone secretions into the blood stream as a result of using Macrilen™ (macimorelin) 60 mg

to stimulate GH secretion into the bloodstream.

Getting started

Want to order Macrilen™ for your office? Learn how to start your order and verify patient eligibility.

How to order

Getting started

Want to order Macrilen™ for your office? Learn how to start your order and verify patient eligibility.

How to order

Macrilen™ (macimorelin) 60 mg icon indicating clinical testing and associated data

Discover the data behind what makes Macrilen™ safe and accurate.

View results

Macrilen™ (macimorelin) 60 mg icon indicating clinical testing and associated data

Discover the data behind what makes Macrilen™ safe and accurate.

View results

Selected 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

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 cont’d

Warnings and Precautions

  • 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. Macrilen [prescribing information]. Plainsboro, NJ: Novo Nordisk Inc; 2018.
  2. 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.
  3. Garcia, JM, Swerdloff R, Wang C, et al. Macimorelin (AEZS-130)-stimulated growth hormone (HG) test: validation of a novel oral stimulation test for the diagnosis of adult GH deficiency. J Clin Endocrinol Metab. 2013;98(6):2422-2429.
  4. 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.