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Macrilen Generic Name & Formulations
Legal Class
Rx
General Description
Macimorelin 60mg; per pouch; granules for oral soln after reconstitution.
Pharmacological Class
Growth hormone (GH) secretagogue receptor agonist.
How Supplied
Pouch—1
Manufacturer
Generic Availability
NO
Macrilen Indications
Indications
For the diagnosis of adult growth hormone deficiency (AGHD).
Limitations of Use
Safety and diagnostic performance in patients with BMI >40kg/m2 is not established.
Macrilen Dosage and Administration
Adult
See full labeling. Base dose on patient's weight in kg and determine the number of pouches needed to prepare the dose. If weight ≤120kg: use 1 pouch; if weight >120kg: use 2 pouches. Dissolve entire contents of 1 pouch in 120mL of water (240mL for 2 pouches); stir gently for 2–3mins and use within 30mins after preparation. Administer 0.5mg/kg as a single dose after patient fasted for ≥8hrs. Have patient drink entire volume within 30secs.
Children
Not established.
Macrilen Contraindications
Not Applicable
Macrilen Boxed Warnings
Not Applicable
Macrilen Warnings/Precautions
Warnings/Precautions
Replace deficiencies in sex hormones, thyroid hormone and/or glucocorticoid prior to Macrilen use. Risk of QT prolongation. Potential for false (–) test results in recent onset hypothalamic disease (repeat testing may be warranted). Pregnancy. Nursing mothers.
Macrilen Pharmacokinetics
See Literature
Macrilen Interactions
Interactions
Avoid concomitant drugs known to prolong QT interval (eg, chlorpromazine, haloperidol, thioridazine, ziprasidone, moxifloxacin, Class IA & III antiarrhythmics, others). Antagonized by strong CYP3A4 inducers and may lead to false (+) results (eg, carbamazepine, enzalutamide, mitotane, phenytoin, rifampin, St. John’s wort, bosentan, efavirenz, etravirine, modafinil, armodafinil, rufinamide); discontinue and allow sufficient washout time prior to test administration. Discontinue GH therapy ≥1 week prior to testing. Avoid concomitant drugs that may affect pituitary GH secretion (eg, somatostatin, insulin, glucocorticoids, cyclooxygenase inhibitors) or drugs that may transiently elevate GH concentration (eg, clonidine, levodopa, insulin). Avoid concomitant drugs that may blunt the GH response of Macrilen (eg, muscarinic antagonists, anti-thyroids, GH products).
Macrilen Adverse Reactions
Adverse Reactions
Dysgeusia, dizziness, headache, fatigue, nausea, hunger, diarrhea, upper respiratory tract infection, feeling hot, hyperhidrosis, nasopharyngitis, sinus bradycardia.
Macrilen Clinical Trials
See Literature
Macrilen Note
Not Applicable
Macrilen Patient Counseling
See Literature
