Macrilen Approval History
FDA Approved: Yes (First approved December 20, 2017)
Brand name: Macrilen
Generic name: macimorelin
Dosage form: for Oral Solution
Company: Aeterna Zentaris, Inc.
Treatment for: Diagnosis of Adult Growth Hormone Deficiency
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Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.
Tell your doctor about all medications you use. Using certain medications at the time of your GH test could cause false results.
You should not be treated with Macrilen if you are allergic to it.
Tell your doctor if you have ever had:
- a hormonal disorder;
- a thyroid disorder; or
- a hypothalamus disorder.
At least 1 week before your GH test, stop using any growth hormone medication.
You must be fasting when you take Macrilen. Do not eat or drink anything but water for at least 8 hours before your GH test.
Macrilen is given as a single dose. A healthcare provider will mix this medicine into a drink that you will consume within 30 seconds.
After you drink Macrilen, your blood will be drawn 30 minutes, 45 minutes, 60 minutes, and 90 minutes later. This will help your doctor determine more about your condition.
Macrilen is used as a single dose and does not have a daily dosing schedule.
- Since Macrilen is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.
Follow your doctor’s instructions about any restrictions on food, beverages, or activity.
Macrilen side effects
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have:
- a light-headed feeling, like you might pass out;
- slow heartbeats;
- shortness of breath; or
- fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out).
Common side effects may include:
- headache, dizziness;
- hunger, nausea, diarrhea;
- increased sweating, feeling hot;
- feeling tired;
- changes in your sense of taste; or
- cold symptoms such as stuffy nose, sinus pain, sore throat.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.