Macimorelin: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: August 15, 2025🚩 Report this page

Macimorelin

Tests For Pituitary Function

GB MHRAEU EMA

Drug class: Tests For Pituitary Function
Availability: See label
Markets covered: 2
Products on record: 2

Overview

Macimorelin is an active pharmaceutical ingredient in the Tests For Pituitary Function group (V04CD). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
GB United Kingdom	MHRA	1	August 15, 2025
EU European Union	EMA	1	May 13, 2024

GBUnited Kingdom· MHRA

1 product

Uses

GBOfficial regulatory label· revised August 15, 2025[1]

This medicinal product is for diagnostic use only. 1).

How to take

GBOfficial regulatory label

EUEuropean Union· EMA

1 product

Uses

EUOfficial regulatory label· revised May 13, 2024[2]

This medicinal product is for diagnostic use only. 1).

How to take

EUOfficial regulatory label

Drug interactions

Known interactions involving Macimorelin. Select one for details. This list is informational and not a complete interaction checker.

Abarelix Abiraterone Albuterol Alfuzosin Amiodarone Amisulpride Amitriptyline Amoxapine Anagrelide Apomorphine Arformoterol Arsenic Trioxide Asenapine Astemizole Atomoxetine Azithromycin Bedaquiline Bepridil Bicalutamide Bosutinib Buprenorphine Cabozantinib Ceritinib Chloroquine Chlorpromazine Cilostazol Ciprofloxacin Cisapride Citalopram Clarithromycin Clofazimine Clomipramine Clozapine Crizotinib Dasatinib Daunorubicin Degarelix Desipramine Deutetrabenazine Disopyramide Dofetilide Dolasetron Doxepin Doxorubicin Dronedarone Droperidol Encorafenib Entrectinib Epirubicin Eribulin Erythromycin Escitalopram Ezogabine Fingolimod Flecainide Fluconazole Fluoxetine Fluphenazine Flutamide Formoterol Foscarnet Fostemsavir Gatifloxacin Gemifloxacin Gilteritinib Glasdegib Goserelin Granisetron Grepafloxacin Halofantrine Haloperidol Halothane Histrelin Hydroxychloroquine Hydroxyzine Ibutilide Idarubicin Iloperidone Imipramine Indacaterol Inotuzumab Ozogamicin Isoetharine Isoproterenol Ivabradine Ivosidenib Ketoconazole Lapatinib Lefamulin Lenvatinib Leuprolide Levofloxacin Lisdexamfetamine Lithium Carbonate Lofexidine Lomefloxacin Lopinavir Lumefantrine Maprotiline Mefloquine Mesoridazine Metaproterenol Methadone Methotrimeprazine Midostaurin Mifepristone Mirtazapine Moxifloxacin Nilotinib Nilutamide Norfloxacin Nortriptyline Ofloxacin Oliceridine Olodaterol Ondansetron Osilodrostat Osimertinib Oxaliplatin Oxytocin Ozanimod Paliperidone Palonosetron Panobinostat Papaverine Pasireotide Pazopanib Pentamidine Perphenazine Pimavanserin Pimozide Pirbuterol Pitolisant Posaconazole Probucol Procainamide Prochlorperazine Promazine Promethazine Propafenone Propoxyphene Protriptyline Quetiapine Quinidine Quinine Ranolazine Relugolix Ribociclib Rilpivirine Risperidone Ritodrine Romidepsin Rucaparib Salmeterol Saquinavir Selpercatinib Sertraline Sevoflurane Siponimod Solifenacin Sorafenib Sotalol Sparfloxacin Sunitinib Tacrolimus Tamoxifen Telavancin Telithromycin Terbutaline Terfenadine Tetrabenazine Thioridazine Tizanidine Toremifene Tramadol Trazodone Triclabendazole Trifluoperazine Triflupromazine Trimeprazine Trimipramine Triptorelin Valbenazine Vandetanib Vardenafil Vemurafenib Venlafaxine Vilanterol Voriconazole Ziprasidone Adenosine Aminoglutethimide Amobarbital Apalutamide Aripiprazole Armodafinil Aspirin Atropine Betamethasone Bexarotene Bosentan Brigatinib Bromfenac Budesonide Butabarbital Butalbital Carbamazepine Celecoxib Cenobamate Clonidine Corticotropin Cosyntropin Dabrafenib Deferasirox Deflazacort Dexamethasone Diclofenac Diflunisal Donepezil Efavirenz Elagolix Enzalutamide Eslicarbazepine Etodolac Etravirine Felbamate Fenoprofen Flurbiprofen Fosphenytoin Galantamine Glycerol Phenylbutyrate Griseofulvin Hydrocortisone Ibuprofen Indomethacin Insulin Degludec Insulin Detemir Insulin Glargine Insulin Lispro Ketoprofen Ketorolac

Showing 240 of 305. Type above to find a specific drug.

Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.

Sources & citations

[1]MHRA (UK) · PLGB432520050 · revised August 15, 2025
[2]European Medicines Agency · EMEA/H/C/004660 · revised May 13, 2024

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

The use of MACIMORELIN must be supervised by a physician or healthcare professional experienced in diagnosing growth hormone deficiency. Posology Adult population The dose is calculated based on the patient´s body weight. The recommended single dose of the reconstituted suspension is 500 micrograms macimorelin per kg body weight.
The growth hormone release is to be evaluated with three blood samples collected at 45, 60 and 90 minutes after the administration of the medicinal product. g. somatostatin analogues, clonidine, levopoda and dopamine agonists) should be advised to discontinue such treatment at least 1 month before receiving macimorelin.
5). 2). No data are available. If macimorelin is administered to patients with renal and/or hepatic impairment, the potential for an increased macimorelin plasma concentration cannot be excluded. It is unknown whether this may affect QTc.
4). Based on current understanding, this potential is unlikely to decrease the specificity of the test. Elderly Growth hormone secretion normally decreases with age. The efficacy of macimorelin in patients aged over 65 years has not been established.
In patients with age up to 60 years, diagnostic performance of MAC and ITT were comparable. In the age group 60 years up to 65 years, the limited data available do not indicate the need for a separate cut-off point. 2). No data are available.
Method of administration Oral use MACIMORELIN granules are to be reconstituted with water and must be used within 30 minutes after preparation. Reconstituted suspension should be administered orally to patients fasting for at least 8 hours and who did not have strenuous physical exercises 24 hours before the test, since both could affect growth hormone levels.
The number of test sachets needed is based on body weight. One sachet will be required for a patient ≤ 120 kg, two sachets will be required if the patient weighs more than 120 kg. The entire contents of one sachet is dissolved in 120 mL, and two sachets are dissolved in 240 mL, as applicable.
5 mg/kg equals the patient's body weight in kg. For example, a 70 kg patient will require 70 mL of the macimorelin suspension. Assessment of fasted condition and lack of prior strenuous physical exercise Before using MACIMORELIN it is important to ensure that the patient is in fasting condition for at least 8 hours and did not have strenuous physical exercises 24 hours before the test, since both could affect GH levels.
If either of these conditions is not met, the growth hormone stimulation test must be re- scheduled for a new test day. During the test, the patient needs to stay fasted until the end of the blood sampling. 4). Long-term use Macimorelin is indicated as a single-dose diagnostic test.
No information is available on the safety and effects of macimorelin during long-term use. 6.

Side effects & warnings

GBOfficial regulatory label· Adverse reactions· revised August 15, 2025[1]

1) in 154 patients were dysgeusia (5%), headache fatigue, nausea (each 3%), dizziness (2%), as well as abdominal pain, diarrhoea, feeling hot, feeling cold, hunger, palpitations, sinus bradycardia, somnolence, thirst, tremor, and vertigo (each 1%).
Overall, the adverse reactions reported were mostly of mild intensity and short duration without a specific treatment need. Tabulated list of adverse reactions Adverse reactions reported in Study 052 are listed below by MedDRA body system organ class and by frequency: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from available data).
Description of selected adverse reactions Cardiac electrophysiology During clinical development, two transient ECG abnormalities were observed in one test subject and reported as serious possibly adverse reactions. 4). 5 mg/kg, 1 mg/kg and 2 mg/kg).
1). The mechanism for the observed QTcF prolongation is unknown. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance MedDRA organ class Common Uncommon Not known Dysgeusia (bitter/metallic taste) Somnolence Dizziness Tremor Nervous system disorders Headache Vertigo Ear and labyrinth disorders Palpitations ECG QT prolonged Cardiac disorders Sinus bradycardia ECG T wave abnormal Nausea Abdominal painGastrointestinal disorders Diarrhoea General disorders and administration site conditions Fatigue Feeling hot Feeling cold Hunger Thirst of the medicinal product.
uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

GBOfficial regulatory label· Warnings and precautions· revised August 15, 2025[1]

8 ng/mL (at the 45, 60 and 90 minutes timepoints) following macimorelin administration confirms a diagnosis of adult growth hormone deficiency. As with all GH stimulation tests, also the macimorelin test results should always be interpreted on basis of the outcome of all examinations within the diagnostic work-up for a patient.
The safety and diagnostic performance of macimorelin have not been established for patients with BMI > 40 kg/m2. Macimorelin induced GH release was lower in patients with higher BMI. In patients with high BMI up to 40 kg/m2, diagnostic performance of MAC and of ITT were comparable.
The cut-off point for macimorelin has not been established in the transition period from late puberty to full adult maturation. In patients between 18 and 25 years of age, the diagnostic performance of MAC and of ITT were comparable.
QTc prolongation During clinical development, two transient ECG abnormalities were observed in one test subject and reported as serious possibly adverse reactions. These ECG abnormalities consisted of T wave abnormalities and QT prolongation.
1). QT prolongation can lead to development of torsade de pointes-type ventricular tachycardia with the risk increasing as the degree of prolongation increases. 5). , history of myocardial infarction, heart failure or prolonged ECG QTc interval, as defined as QTc > 500 ms).
For such patients, ECG controls may be indicated prior to the administration of macimorelin and 1 hour, 2 hours, 4 hours and 6 hours after administration of macimorelin. In patients with known congenital or acquired long QT syndrome and in patients with a history of torsades de pointes, the use of macimorelin may only be considered in a cardiovascular clinical unit.
g. somatostatin analogues, clonidine, levopoda and dopamine agonists) should be advised to discontinue such treatment at least 1 month before receiving a test dose of macimorelin. 5). g. adrenal, thyroidal and/or gonadal insufficiency, diabetes insipidus) should be adequately replaced with the other deficient hormones before any testing for a deficiency of GH stimulation is performed, to exclude a stimulation failure due to a secondary GH deficiency.
Patients with Cushing’s disease or on supra-physiologic glucocorticoid therapy Hypercortisolism has a significant impact on the hypothalamic-pituitary- adrenal axis. g. systemic administration of doses of hydrocortisone (or its equivalent) in excess of 15 mg/m2/day) and lead to false positive test results.

This is not medical advice. Consult a qualified healthcare professional.

The use of GHRYVELIN must be supervised by a physician or healthcare professional experienced in diagnosing growth hormone deficiency. Posology The dose is calculated based on the patient´s body weight. The recommended single dose of the reconstituted suspension is 500 micrograms macimorelin per kg body weight.
The growth hormone release is to be evaluated with three blood samples collected at 45, 60 and 90 minutes after the administration of the medicinal product. g. somatostatin analogues, clonidine, levopoda and dopamine agonists) should be advised to discontinue such treatment at least 1 month before receiving macimorelin.
5). 2). No data are available. If macimorelin is administered to patients with renal and/or hepatic impairment, the potential for an increased macimorelin plasma concentration cannot be excluded. It is unknown whether this may affect QTc.
4). Based on current understanding, this potential is unlikely to decrease the specificity of the test. Elderly Growth hormone secretion normally decreases with age. The efficacy of macimorelin in patients aged over 65 years has not been established.
In patients with age up to 60 years, diagnostic performance of MAC and ITT were comparable. In the age group 60 years up to 65 years, the limited data available do not indicate the need for a separate cut-off point. 2). No data are available.
Method of administration Oral use. GHRYVELIN granules are to be reconstituted with water and must be used within 30 minutes after preparation. Reconstituted suspension should be administered orally to patients fasting for at least 8 hours and who did not have strenuous physical exercises 24 hours before the test, since both could affect growth hormone levels.
The number of test sachets needed is based on body weight. One sachet will be required for a patient ≤ 120 kg, two sachets will be required if the patient weighs more than 120 kg. The entire contents of one sachet is dissolved in 120 mL, and two sachets are dissolved in 240 mL, as applicable.
5 mg/kg equals the patient's body weight in kg. For example, a 70 kg patient will require 70 mL of the macimorelin suspension. Assessment of fasted condition and lack of prior strenuous physical exercise Before using GHRYVELIN it is important to ensure that the patient is in fasting condition for at least 8 hours and did not have strenuous physical exercises 24 hours before the test, since both could affect GH levels.
If either of these conditions is not met, the growth hormone stimulation test must be re- scheduled for a new test day. During the test, the patient needs to stay fasted until the end of the blood sampling. 4). Long-term use Macimorelin is indicated as a single-dose diagnostic test.
No information is available on the safety and effects of macimorelin during long-term use. 6.