Macimorelin (ma-si-moe-REL-in)

Used to diagnose adult growth hormone deficiency (AGHD).

Brand Name(s):

When This Medicine Should Not Be Used:

How to Use This Medicine:

Liquid

• A nurse or other trained health professional will give you this medicine.
• You should drink all the medicine within 30 seconds.
• Follow all instructions you are given for your scan or procedure. Your doctor may tell you not to eat or drink anything at least 8 hours before your test.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use growth hormone medicine for at least 1 week before receiving this medicine.
• Do not use armodafinil, bosentan, carbamazepine, efavirenz, enzalutamide, etravirine, mitotane, modafinil, phenytoin, rifampin, rufinamide, St. John's wort during treatment with this medicine.
• Some medicines can affect how macimorelin works. Tell your doctor if you are using any of the following:
  • Aspirin, atropine, indomethacin, insulin, propylthiouracil, somatostatin
  • Medicine to treat heart rhythm problems (including amiodarone, procainamide, quinidine, sotalol)
  • Medicine to treat an infection (including moxifloxacin)
  • Medicine to treat mental illness (including chlorpromazine, haloperidol, thioridazine, ziprasidone)
  • Steroid medicine

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have heart rhythm problems (including QT prolongation), a lesion in the brain, or other hormone problems (including deficiencies in sex hormones, thyroid hormone, steroid).
• This medicine may cause heart rhythm problems.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Fainting, dizziness, lightheadedness
• Fast, pounding, or uneven heartbeat

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088