Macimorelin

Macimorelin helps to trigger the release of growth hormone (GH) in the body.

Macimorelin is used during a medical test to check the levels of growth hormone (GH).

Macimorelin may also be used for other reasons that are not mentioned in this medication guide.

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 learn more about your condition.

Follow all instructions on your medicine label and package. Inform each of your healthcare providers about all your medical conditions, allergies, and all medicines you are taking.

Tell your doctor about all medications you are taking. Using some medications during your GH test could lead to incorrect 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.

Inform your doctor if you are pregnant or breastfeeding.

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 right away if you experience:

• a light-headed feeling, as if you might faint;
• slow heartbeats;
• shortness of breath; or
• fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (as if you might faint).

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 can report side effects to the FDA at 1-800-FDA-1088.

Usual Adult Dose for Growth Hormone Reserve Test:

0.5 mg/kg orally, after fasting for at least 8 hoursComments:-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

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

Since macimorelin is administered by a healthcare professional in a medical setting, an overdose is unlikely to happen.

Follow your doctor's instructions regarding any limitations on food, drinks, or activities.

Tell your doctor about all the other medicines you are taking. Certain medications can lead to false test results during your GH test. You may need to stop taking your other medications for a specific period before you use macimorelin.

Macimorelin can lead to a serious heart issue. Your risk may increase if you are also taking certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

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