Product forms and resources
Information about Macrilen™ and forms to help with patient support and the testing process.
Product forms and resources
Information about Macrilen™ and forms to help with patient support and the testing process.
Macrilen™ Test Patient Preparation Form
A form you can fill in and provide to your patients to explain how Macrilen™ works and what to expect from the testing process.
Macrilen™ Co-pay Program Brochure for Professionals
Your eligible patients who have been prescribed Macrilen™ may be able to reduce out-of-pocket costs.
Learn about a potential treatment option for your patients with AGHD.
Questions about Macrilen™?
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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.