Generic name: MACIMORELIN 60mg in 1mg
Dosage form: granules for oral solution
Medically reviewed by Drugs.com. Last updated on Jan 11, 2019.
The recommended dose is a single oral dose of 0.5 mg/kg of macimorelin. The dose is administered as a reconstituted solution [see Dosage and Administration (2.3)] in patients fasted for at least 8 hours.
Important Recommendations Before MACRILEN Use
- Discontinue strong CYP3A4 inducers prior to MACRILEN use [see Warning and Precautions (5.2) and Drug Interactions (7.2)].
- Discontinue growth hormone (GH) therapy at least one week before administering MACRILEN [see Drug Interactions (7.3)].
- Avoid the use of MACRILEN with drugs known to affect pituitary GH secretion [see Drug Interactions (7.3)].
- For patients with deficiencies in sex hormones, thyroid hormone and/or glucocorticoid, adequately replace each of the missing hormones before administering MACRILEN.
- Ensure that the patient has fasted for at least 8 hours before MACRILEN use.
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.
More about Macrilen (macimorelin)
- Side Effects
- During Pregnancy
- Drug Interactions
- Pricing & Coupons
- En Español
- Drug class: growth hormones
- FDA Approval History