Macimorelin

(ma si moe REL in)

• Macrilen

• Growth Hormone Receptor Antagonist

There are no contraindications listed in the manufacturer's labeling

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Have patient report immediately to prescriber tachycardia, abnormal heartbeat, or passing out (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• A type of abnormal heartbeat (prolonged QT interval) can happen with macimorelin. Call your doctor right away if you have a fast heartbeat, a heartbeat that does not feel normal, or if you pass out.

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.

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.

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.