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Indication

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

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 were dysgeusia, dizziness, headache, fatigue, nausea, hunger, diarrhea, upper respiratory tract infection, feeling hot, hyperhidrosis, nasopharyngitis, and sinus bradycardia

Please see Full Prescribing Information.

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

Macrilen is the only oral solution for the diagnosis of AGHD.1

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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.

Indication

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

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 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

United States

Phone: +1 610-254-9200

macrilen_info@strongbridgebio.com