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Medical Information | Non-US Health Care Professionals
Important Safety Information
Prescribing Information
Macrilen™ (macimorelin) 60 mg for oral solution logo

For the diagnosis of adult growth hormone deficiency.

Prescribing Information
Important Safety Information

What is Macrilen™?

Macrilen™ (macimorelin) for oral solution requires fewer blood draws than other stimulation tests and eliminates the need for infusion in appropriate patients. With Macrilen™, you can test quickly and efficiently if there is a suspicion of AGHD.1

What is Macrilen™?

Macrilen™ (macimorelin) for oral solution requires fewer blood draws than other stimulation tests and eliminates the need for infusion in appropriate patients. With Macrilen™, you can test quickly and efficiently if there is a suspicion of AGHD.1

Macrilen™ is a prescription test that comes in powder form and is mixed with water to form a solution that patients drink in your office.1

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

Short test time1

Short test time1

  • Only 1.5 hours
  • Draw blood samples at 30, 45, 60, and 90 minutes
Macrilen™ (macimorelin) 60 mg cross icon illustrating routine medical supervision during administration

Routine supervision

Routine supervision

Supervise as the patient drinks the Macrilen™ solution, and observe the patient afterward per routine.1

Supervise as the patient drinks the Macrilen™ solution, and observe the patient afterward per routine.1

Attributes of testing with Macrilen™1

Route of administration

Oral

Number of blood draws

4

Test time for patient

1.5 hours

Required supervision

Routinea

Contraindications

None

Illustration showing the success rate of Macrilen™ (macimorelin) 60 mg testing with 99% of tests fully completed on the first attempt

aObserve the patient being tested per routine for the duration of the test.

How does Macrilen™ work?

Macrilen™ is an oral ghrelin agonist that stimulates the production of GH in the pituitary gland.1,2

  • Ghrelin is a peptide hormone known to cause the release of GH2,3
  • 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 system1,3
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 GHS-R1a on pituitary and hypothalamic cells

that binds to 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

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

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

Macrilen™ vs. the ITT

Macrilen™ (macimorelin) 60 mg icon of pages representing data and information found during the clinical trial process

Discover the data that supports the safety and accuracy of Macrilen™.

Questions about Macrilen™? We’re here to help.

Selected Important Safety Information for Macrilen™

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

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 Macrilen™ Prescribing Information.

 

References:

  1. Macrilen [prescribing information]. Plainsboro, NJ: Novo Nordisk Inc; 2021.
  2. 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.
  3. 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.