Macrilen is a novel way to diagnose AGHD
First and only FDA-approved oral test for the diagnosis of Adult Growth Hormone Deficiency (AGHD)1
90-minute total test time1
- Requires blood draws at 30, 45, 60, and 90 minutes
- No baseline blood draw required
After supervising the patient drinking the Macrilen solution, observe the patient being tested per routine1
No contraindications with Macrilen1
The most common adverse events (AEs) associated with Macrilen (in 3% to 5% of subjects) included dysgeusia, dizziness, headache, fatigue, nausea, and hunger.*
Please see remaining AEs within Important Safety Information below.
How does Macrilen work?
Macrilen is an oral ghrelin agonist that stimulates the production of growth hormone (GH) in the pituitary gland1,2
- Ghrelin is a peptide hormone known to cause release of GH3
- 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 system1,2
Macrilen is the only oral solution for the diagnosis of AGHD.1
Macrilen Satellite Broadcast
Preview the video featuring Dr. Thomas Blevins, a primary investigator and author of the Macrilen clinical study.
This video has been prerecorded.
Sign up to watch the entire video and to submit questions
References: 1. Macrilen [prescribing information]. Trevose, PA: Strongbridge U.S. Inc.; 2018. 2. Agrawal V, Garcia JM. The macimorelin-stimulated growth hormone test for adult growth hormone deficiency diagnosis. Expert Rev Mol Diagn. 2014;14(6):647-654. 3. Garcia JM, Swerdloff R, Wang C, et al. Macimorelin (AEZS-130)-stimulated growth hormone (GH) test: validation of a novel oral stimulation test for the diagnosis of adult GH deficiency. J Clin Endocrinol Metab. 2013;98(6):2422-2429.
Macrilen is indicated for the diagnosis of adult growth hormone deficiency (AGHD).
Limitations of Use
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
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.
The most common adverse reactions were dysgeusia, dizziness, headache, fatigue, nausea, hunger, diarrhea, upper respiratory tract infection, feeling hot, hyperhidrosis, nasopharyngitis, and sinus bradycardia
Please see Full Prescribing Information.
900 Northbrook Drive, Suite 200
Trevose, PA 19053
Phone: +1 610-254-9200