Explore diabetes
Explore obesity
Explore rare bleeding disorders
Explore growth-related disorders
Explore hormone replacement therapy
Medical Information | Non-US Health Care Professionals
Important Safety Information
Prescribing Information
Macrilen™ (macimorelin) 60 mg for oral solution logo

For the diagnosis of adult growth hormone deficiency.

Prescribing Information
Important Safety Information

In-office diagnostic testing for adult growth hormone deficiency1

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.

In-office testing for adult growth hormone deficiency1

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.

Preparing the test

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.1

≤120 kg=1 pouch
>120 kg=2 pouches1

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

1 pouch=120 mL water
2 pouches=240 mL water1

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 to 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.1

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.1

Example: A patient weighing 70 kg will need a 35-mg dose of reconstituted Macrilen™ solution. Note: 2.2 lb=1 kg.1

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.1

Draw up the exact volume of reconstituted solution in milliliters using the dose-measurement syringe.1

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.1

Administering the test

Macrilen™ (macimorelin) 60 mg icon for step 1

Drink
The patient must drink the Macrilen™ solution within 30 seconds and then be observed for the duration of the test.1

Macrilen™ (macimorelin) 60 mg icon for step 2

Draw
No baseline blood draw is required with Macrilen™. After administering the test, draw venous blood samples at 30, 45, 60, and 90 minutes.1

Macrilen™ (macimorelin) 60 mg icon for step 3

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

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

Help your patients prepare

Our patient preparation form serves as an appointment reminder as well as a helpful primer on the steps involved in taking Macrilen™.
Macrilen™ Test Patient Preparation Form
PDF

Selected Important Safety Information for Macrilen™

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

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 Macrilen™ Prescribing Information.

 

Reference:

  1. Macrilen [prescribing information]. Plainsboro, NJ: Novo Nordisk Inc; 2021.