Macimorelin
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From MedlinePlus, U.S. National Library of Medicine
Growth Hormone Secretagogue Receptor Agonist
Dosing in kidney impairment
This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.
Preparation and administration
Directions for Preparation and Administration Prepare and administer by a healthcare professional exactly as follows. Prepare the MACRILEN solution: Weigh the patient in kilograms (i.e., kg) . Determine the number of MACRILEN pouches needed to prepare the dose: i. For a patient weighing up to 120 kg, use 1 pouch. ii. For a patient weighing more than 120 kg, use 2 pouches.
Use a glass or transparent plastic container with graduation in milliliters (i.e., mL) to dissolve the entire contents of the pouch(es) in the appropriate volume of water. i. For 1 pouch dissolve in 120 mL of water (corresponds to 60 mg/120 mL). ii. For 2 pouches dissolve in 240 mL of water (corresponds to 120 mg/240 mL).
Stir the MACRILEN solution gently for about 2 to 3 minutes (a small amount of un-dissolved particles will remain). The solution will have a final concentration of 0.5 mg/mL . Use the MACRILEN solution within 30 minutes after preparation. Discard any unused MACRILEN solution. Determine the volume of MACRILEN solution needed for the test: Determine the recommended dose to be administered by multiplying the patient weight in kilogram by 0.5 mg/kg.
For example, a 70 kg patient will need a 35 mg dose. Determine the volume of prepared MACRILEN solution to be administered by dividing the recommended dose by 0.5 mg/mL. For example, a patient requiring a dose of 35 mg will need 70 mL of reconstituted MACRILEN solution. Use a syringe (without a needle) with graduations in mL to measure the exact volume of MACRILEN solution to be administered and transfer the required volume of MACRILEN solution into a drinking glass.
Administer the MACRILEN solution and perform the test: Have the patient being tested drink the entire volume of MACRILEN solution in the drinking glass (i.e., the dose) within 30 seconds . Observe the patient being tested per routine for the duration of the test. Draw venous blood samples for GH determination at 30 minutes, 45 minutes, 60 minutes and 90 minutes after administration of MACRILEN.
Prepare serum samples and send to a laboratory for growth hormone determinations.
Drug interactions
Check macimorelin against a medication listLabel text (6 paragraphs)
7 DRUG INTERACTIONS
7.1 Drugs that Prolong QT Interval Co-administration of MACRILEN with drugs that prolong the QT interval (such as antipsychotic medications (e.g., chlorpromazine, haloperidol, thioridazine, ziprasidone), antibiotics (e.g., moxifloxacin), Class 1A (e.g., quinidine, procainamide) and Class III (e.g., amiodarone, sotalol) antiarrhythmic medications or any other medications known to prolong the QT interval) may lead to development of torsade de pointes-type ventricular tachycardia. Avoid concomitant use of MACRILEN with drugs that prolong the QT interval.
Sufficient washout time of drugs that are known to prolong the QT interval prior to administration of MACRILEN is recommended [see Dosage and Administration ( 2.2 ) and Warnings and Precautions ( 5.1 )] .
7.2 Cytochrome P450 (CYP) 3A4 Inducers Co-administration of a strong CYP3A4 inducer with MACRILEN (e.g., carbamazepine, enzalutamide, mitotane, phenytoin, rifampin, St. John's wort, bosentan, efavirenz, etravirine, modafinil, armodafinil, rufinamide) may reduce the plasma macimorelin concentrations and may lead to false positive test results. Discontinue strong CYP3A4 inducers prior to MACRILEN use. Sufficient washout time of strong CYP3A4 inducers prior to administration of MACRILEN is recommended [see Dosage and Administration ( 2.2 ) and Warnings and Precautions ( 5.2 )] .
7.3 Drugs Affecting Growth Hormone Release The following drugs may impact the accuracy of the MACRILEN diagnostic test. Avoid concomitant use of MACRILEN with the following [see Dosage and Administration ( 2.2 )] : Drugs that directly affect the pituitary secretion of growth hormone (such as somatostatin, insulin, glucocorticoids, and cyclooxygenase inhibitors such as aspirin or indomethacin). Drugs that may transiently elevate growth hormone concentrations (such as clonidine, levodopa, and insulin). Drugs that may blunt the growth hormone response to MACRILEN (such as muscarinic antagonists: atropine, anti-thyroid medication: propylthiouracil, and growth hormone products).
Discontinue growth hormone products at least one week before administering the MACRILEN diagnostic test. Sufficient washout time of drugs affecting growth hormone release prior to administration of MACRILEN is recommended.
Contraindications
None None ( 4 )
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk summary There are no available data with MACRILEN use in pregnant women to inform a drug associated risk for adverse developmental outcomes. Animal reproduction studies have not been conducted with MACRILEN. MACRILEN is indicated as a single dose which limits the risk of adverse developmental outcomes from exposure to MACRILEN. The estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S.
general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 – 4% and 15 – 20%, respectively.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
Not the price at the counterThese are not what a patient pays at the pharmacy counter. They are what pharmacies, health plans, and government buyers pay, before manufacturer rebates. A patient's cost depends on their insurance (copay, coinsurance, or deductible) or the pharmacy's cash price.