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MACRILEN
Miscellaneous diagnostic tests
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Drug Name:

MACRILEN Rx

Generic Name and Formulations:
Macimorelin 60mg; per pouch; granules for oral soln after reconstitution.

Company:
Strongbridge Biopharma

Therapeutic Use:

RECENT UPDATES

Monograph added.

Indications for MACRILEN:

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.

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.

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.

Pharmacological Class:

Growth hormone (GH) secretagogue receptor agonist.

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).

Adverse Reactions:

Dysgeusia, dizziness, headache, fatigue, nausea, hunger, diarrhea, upper respiratory tract infection, feeling hot, hyperhidrosis, nasopharyngitis, sinus bradycardia.

Generic Availability:

NO

How Supplied:

Pouch—1

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