Description
Macimorelin is used for the diagnosis of adult growth hormone deficiency (AGHD).
This medicine is to be given only by or under the supervision of a doctor.
Before Using
In deciding to use a diagnostic test, any risks of the test must be weighed against the good it will do. This is a decision you and your doctor will make. Also, other things may affect test results. For this test, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of macimorelin in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of macimorelin in the elderly.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this diagnostic test, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Receiving this diagnostic test with any of the following medicines is not recommended. Your doctor may decide not to use this diagnostic test or change some of the other medicines you take.
- Bepridil
- Cisapride
- Dronedarone
- Fluconazole
- Ketoconazole
- Levoketoconazole
- Mesoridazine
- Pimozide
- Piperaquine
- Posaconazole
- Saquinavir
- Sparfloxacin
- Terfenadine
- Thioridazine
- Ziprasidone
Receiving this diagnostic test with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Abametapir
- Adagrasib
- Alclometasone
- Alfuzosin
- Amcinonide
- Amiodarone
- Amisulpride
- Amitriptyline
- Anagrelide
- Apalutamide
- Apomorphine
- Aripiprazole
- Aripiprazole Lauroxil
- Armodafinil
- Arsenic Trioxide
- Asenapine
- Aspirin
- Astemizole
- Atazanavir
- Atropine
- Avacopan
- Azithromycin
- Beclomethasone
- Bedaquiline
- Betamethasone
- Bosentan
- Budesonide
- Buprenorphine
- Buserelin
- Carbamazepine
- Ceritinib
- Chloroquine
- Chlorpromazine
- Ciclesonide
- Ciprofloxacin
- Citalopram
- Clarithromycin
- Clobetasol
- Clobetasone
- Clocortolone
Receiving this diagnostic test with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Mavacamten
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this diagnostic test. Make sure you tell your doctor if you have any other medical problems, especially:
- Glucocorticoid (steroid) deficiency or
- Sex hormone deficiency or
- Thyroid deficiency—Your doctor may tell you to replace these missing hormones before starting treatment with this medicine.
- Heart rhythm problem (eg, QT prolongation)—Used with caution. May make this condition worse.
- Lesion in the brain (eg, hypothalamus)—Adult growth hormone deficiency caused by this condition may cause a false negative result. Repeat testing may be needed.
Proper Use
A healthcare provider will give you this medicine in a hospital or clinic. 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.
Precautions
It is very important that your doctor check your progress to make sure that this medicine is working properly and to check for unwanted effects.
Do not use a growth hormone medicine for at least 1 week before receiving this medicine.
Do not use armodafinil (Nuvigil®), bosentan (Tracleer®), carbamazepine (Tegretol®), efavirenz (Sustiva®), enzalutamide (Xtandi®), etravirine (Intelence®), mitotane (Lysodren®), modafinil (Provigil®), phenytoin (Dilantin®), rifampin (Rifadin®, Rimactane®), rufinamide (Banzel®), or St. John’s wort together with macimorelin. These medicines may decrease the amount of macimorelin in the blood, which may cause a false positive result to adult growth hormone deficiency test. Your doctor may tell you to stop taking these medicines for a certain period of time before using macimorelin.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
Less common
- Slow heartbeat
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common
- Body aches or pain
- change in taste
- chills
- cough
- diarrhea
- difficulty in breathing
- dizziness
- ear congestion
- feeling hot
- fever
- headache
- hunger
- increased sweating
- loss of taste
- loss of voice
- muscle aches
- nasal congestion
- nausea
- runny nose
- sneezing
- sore throat
- stuffy or runny nose
- unusual tiredness or weakness
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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