Macimorelin works by stimulating the release of growth hormone (GH) in the body.

Macimorelin is used as part of a medical test to measure growth hormone (GH).

Macimorelin may also be used for purposes not listed in this medication guide.

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.

At least 1 week before your GH test, stop using any growth hormone medication.

You must be fasting when you take macimorelin. Do not eat or drink anything but water for at least 8 hours before your GH test.

Macimorelin is given as a single dose. A healthcare provider will mix macimorelin into a drink that you will consume within 30 seconds.

After you drink macimorelin, 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.

Usual Adult Dose for Growth Hormone Reserve Test:

0.5 mg/kg orally, after fasting for at least 8 hours

Comments:
-Discontinue therapy with strong CYP450 3A4 inducers, growth hormones, and drugs affecting growth hormone release for an adequate length of time before administration of this drug.
-Adequately replace other hormone deficiencies before administration.
-Safety and diagnostic performance have not been established in patients with a body mass index over 40 kg/m2.

Use(s): Diagnosis of adult growth hormone deficiency

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 macimorelin if you are allergic to it.

Tell your doctor if you have ever had:

• a hormonal disorder;

• a thyroid disorder; or

• a hypothalamus disorder.

Tell your doctor if you are pregnant or breast-feeding.

Macimorelin is used as a single dose and does not have a daily dosing schedule.

Since macimorelin 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.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Macimorelin may cause serious side effects. 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 of macimorelin 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.

Tell your doctor about all your other medicines. You could have false test results if you are using certain medications at the time of your GH test. You may need to stop using your other medications for a certain amount of time before you take macimorelin.

Macimorelin can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Many drugs can affect macimorelin. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.