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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
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900 Northbrook Drive, Suite 200
Trevose, PA 19053
Phone: +1 610-254-9200