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Macrilen™ is prepared as an oral reconstituted solution1

The following steps show how to prepare and administer Macrilen™. Refer to Prescribing Information for complete instructions on how to prepare, dose, and administer Macrilen™ oral solution.

Macrilen™ is prepared as an oral reconstituted solution1

The following steps show how to prepare and administer Macrilen™. Refer to Prescribing Information for complete instructions on how to prepare, dose, and administer Macrilen™ oral solution.

Macrilen™ (macimorelin) 60 mg preparation icon of a scale that represents weighing the patient as the first step in the administration process

Verify patient details

Confirm 8-hour fast and then weigh the patient (kg). Determine the number of Macrilen™ pouches needed to prepare the dose.

  • <120 kg=1 pouch
  • >120 kg=2 pouches
Macrilen™ (macimorelin) 60 mg preparation icon showing a beaker with liquid that represents dissolving the Macrilen™ granules during step 2 of the administration process

Dissolve Macrilen™ granules in water

Fill the beaker with the appropriate volume of water. Tap water can be used. Add the granules into the beaker to dissolve.

  • 1 pouch=120 mL water
  • 2 pouches=240 mL water
Macrilen™ (macimorelin) 60 mg preparation icon showing a beaker with a stir stick that represents stirring the solution during step 3 of the process

Stir gently (2-3 minutes)

A small amount of undissolved particles will remain. The final concentration is 0.5 mg/mL.

Macrilen™ (macimorelin) 60 mg preparation icon showing the relationship between patient weight and amount of Macrilen™ solution in mL during step 4 of the process

Determine volume

Example: A patient weighing 70 kg will need 70 mL of reconstituted Macrilen™ solution.
Note: 2.2 lb=1 kg.

Macrilen™ (macimorelin) 60 mg preparation icon showing a syringe extracting the exact amount of solution during step 5 of the process

Measure exact volume

Draw up the exact volume of reconstituted solution in milliliters using the dose-measurement syringe.

Macrilen™ (macimorelin) 60 mg preparation icon showing the syringe transferring the dosage to a cup during step 6 of the process

Transfer exact volume

Transfer the exact required volume of Macrilen™ solution into the drinking cup. Reconstituted solution is stable for up to 30 minutes. Discard any leftover solution.

After test preparation, go from drink, to draw, to diagnose1

Macrilen™ (macimorelin) 60 mg administration icon indicating step one of the process

Administer solution

The patient must drink the entire volume of Macrilen™ solution within 30 seconds. Observe the patient for the duration of the test.

acrilen™ (macimorelin) 60 mg administration icon indicating step two of the process

Draw blood samples

No baseline blood draw is required with Macrilen™. After administering Macrilen™, draw venous blood samples at 30, 45, 60, and 90 minutes.

MMacrilen™ (macimorelin) 60 mg administration icon indicating step three of the process

Prepare samples

Prepare serum samples according to instructions from the lab (where samples will be sent) and send for growth hormone determinations.

After test preparation, go from drink, to draw, to diagnose1

Macrilen™ (macimorelin) 60 mg administration icon indicating step one of the process

Administer solution

The patient must drink the entire volume of Macrilen™ solution within 30 seconds. Observe the patient for the duration of the test.

Macrilen™ (macimorelin) 60 mg administration icon indicating step two of the process

Draw blood samples

No baseline blood draw is required with Macrilen™. After administering Macrilen™, draw venous blood samples at 30, 45, 60, and 90 minutes.

Macrilen™ (macimorelin) 60 mg administration icon indicating step three of the process

Prepare samples

Prepare serum samples according to instructions from the lab (where samples will be sent) and send for growth hormone determinations.

How to interpret test results

How to interpret test results

Test results are considered positive for AGHD if the maximally stimulated serum GH level observed after stimulation is <2.8 ng/mL for the 4 blood draws.

Preparing your patients

The What to Expect Patient Guide gives patients some baseline information to help prepare for their test.

Preparing your patients

The What to Expect Patient Guide gives patients some baseline information to help prepare for their test.

Macrilen™ (macimorelin) 60 mg AGHDiagnose Kit image with icons showing that it comes with a beaker, stirring rod, dosage syringe, and drinking cup
Macrilen™ (macimorelin) 60 mg AGHDiagnose Kit image with icons showing that it comes with a beaker, stirring rod, dosage syringe, and drinking cup

AGHDiagnose Kit

The complimentary AGHDiagnose Kit comes with tools to help you prepare and administer Macrilen™ solution. Macrilen™ is ordered separately. This kit is not required to prepare Macrilen™ and is for one-time use only.

AGHDiagnose Kit

The complimentary AGHDiagnose Kit comes with tools to help you prepare and administer Macrilen™ solution. Macrilen™ is ordered separately. This kit is not required to prepare Macrilen™ and is for one-time use only.

Indication and Limitation of Use

Macrilen™ (macimorelin) 60 mg for oral solution is indicated for the diagnosis of adult growth hormone deficiency (AGHD).

  • The safety and diagnostic performance of Macrilen™ have not been established for subjects with a body mass index (BMI) >40 kg/m2

Important Safety Information

Warnings and Precautions

  • QT Prolongation: Macrilen™ causes an increase of about 11 msec in the corrected QT (QTc) interval. QT prolongation can lead to development of torsade de pointes-type ventricular tachycardia with the risk increasing as the degree of prolongation increases. The concomitant use of Macrilen™ with drugs that are known to prolong the QT interval should be avoided
  • Potential for False Positive Test Results with Use of Strong CYP3A4 Inducers: Concomitant use of strong CYP3A4 inducers with Macrilen™ can decrease macimorelin plasma levels significantly and thereby lead to a false positive result. Strong CYP3A4 inducers should be discontinued and enough time should be given to allow washout of CYP3A4 inducers prior to test administration
  • Potential for False Negative Test Results in Recent Onset Hypothalamic Disease: Adult growth hormone (GH) deficiency caused by a hypothalamic lesion may not be detected early in the disease process. Macimorelin acts downstream from the hypothalamus and macimorelin stimulated release of stored GH reserves from the anterior pituitary could produce a false negative result early when the lesion involves the hypothalamus. Repeat testing may be warranted in this situation

Adverse Reactions

  • The most common adverse reactions are dysgeusia, dizziness, headache, fatigue, nausea, hunger, diarrhea, upper respiratory tract infection, feeling hot, hyperhidrosis, nasopharyngitis, and sinus bradycardia

Please click here for Prescribing Information

References

  1. Macrilen [prescribing information]. Plainsboro, NJ: Novo Nordisk Inc; 2018.