Macimorelin

MACRILEN is indicated for the diagnosis of adult growth hormone deficiency (AGHD). MACRILEN is a growth hormone (GH) secretagogue receptor agonist indicated for the diagnosis of adult growth hormone deficiency. Limitations of Use: The safety and diagnostic performance has not been established for subjects with BMI > 40kg/m 2. Limitations of Use The safety and diagnostic performance of MACRILEN have not been established for subjects with a body mass index (BMI) > 40 kg/m 2.

Macimorelin stimulates GH release by activating growth hormone secretagogue receptors present in the pituitary and hypothalamus.

Recommended dose is 0.5 mg/kg as a single oral dose, after fasting for at least 8 hours. See Full Prescribing Information for important preparation and administration instructions. Discontinue therapy with strong CYP3A4 inducers, growth hormones and drugs that affect GH release for an adequate length of time before administering MACRILEN. Adequately replace other hormone deficiencies before administering MACRILEN.

None None

QT Prolongation: QT prolongation can lead to development of torsade de pointes-type ventricular tachycardia. Avoid the concomitant use of MACRILEN with drugs that are known to prolong QT interval. Potential for False Positive Test Results with Use of Strong CYP3A4 Inducers: Discontinue and washout strong CYP3A4 inducers before testing. Potential for False Negative Test Results in Recent Onset Hypothalamic Disease: Consider repeat testing if indicated.

The most common adverse reactions were dysgeusia, dizziness, headache, fatigue, nausea, hunger, diarrhea, upper respiratory tract infection, feeling hot, hyperhidrosis, nasopharyngitis, and sinus bradycardia.

Drugs that Prolong QT Interval Co-administration of MACRILEN with drugs that prolong the QT interval (such as antipsychotic medications (e.g., chlorpromazine, haloperidol, thioridazine, ziprasidone), antibiotics (e.g., moxifloxacin), Class 1A (e.g., quinidine, procainamide) and Class III (e.g., amiodarone, sotalol) antiarrhythmic medications or any other medications known to prolong the QT interval) may lead to development of torsade de pointes-type ventricular tachycardia. Avoid concomitant use of MACRILEN with drugs that prolong the QT interval. Sufficient washout time of drugs that are known to prolong the QT interval prior to administration of MACRILEN is recommended.

Store pouches under refrigeration at 2-8°C (36-46°F).