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Macrilen™ is designed for in-office administration1

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. Use the Macrilen™ solution within 30 minutes of preparation.

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 recommended dose

Determine the recommended dose to be administered by multiplying the patient weight in kilograms by 0.5 mg/kg. 

Example: A patient weighing 70 kg will need a 35-mg dose 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

Determine and measure the exact volume

Determine the volume of prepared Macrilen™ solution to be administered by dividing the recommended dose by 0.5 mg/mL.

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.

Three steps to complete the test1

Three steps to complete the test1

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

Drink

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

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

Diagnose

After preparing the serum samples according to instructions from the lab (where samples will be sent), you will receive the 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.1

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.

AGHDiagnose Kit

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

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™.

Macrilen™ Solution

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

To obtain Macrlien™, complete the form on the Order and Support page. You can also find resources here for you and your patients, from co-pay help to communication tools.

Selected 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

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 cont’d

Warnings and Precautions

  • 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; 2019.