Macrilen Dosage
Generic name: MACIMORELIN 60mg in 1mg
Dosage form: granules for oral solution
Drug class: Growth hormones
Medically reviewed by Drugs.com. Last updated on Nov 27, 2023.
Recommended Dose
The recommended dose is a single oral dose of 0.5 mg/kg of macimorelin. The dose is administered as a reconstituted solution in patients fasted for at least 8 hours.
Important Recommendations Before MACRILEN Use
- •
- Discontinue strong CYP3A4 inducers prior to MACRILEN use.
- •
- Discontinue growth hormone (GH) therapy at least one week before administering MACRILEN.
- •
- Avoid the use of MACRILEN with drugs known to affect pituitary GH secretion.
- •
- For patients with deficiencies in sex hormones, thyroid hormone and/or glucocorticoid, adequately replace each of the missing hormones before administering MACRILEN.
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- 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:
- a.
- Weigh the patient in kilograms (i.e., kg).
- b.
- 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.
- c.
- 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).
- d.
- 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.
- e.
- Use the MACRILEN solution within 30 minutes after preparation.
- f.
- Discard any unused MACRILEN solution.
Determine the volume of MACRILEN solution needed for the test:
- g.
- 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.
- h.
- 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.
- i.
- 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:
- j.
- Have the patient being tested drink the entire volume of MACRILEN solution in the drinking glass (i.e., the dose) within 30 seconds.
- k.
- Observe the patient being tested per routine for the duration of the test.
- l.
- Draw venous blood samples for GH determination at 30 minutes, 45 minutes, 60 minutes and 90 minutes after administration of MACRILEN.
- m.
- Prepare serum samples and send to a laboratory for growth hormone determinations.
- n.
- o.
- p.
- q.
- r.
- s.
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- u.
- v.
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