Macrilen is prepared as an oral, reconstituted solution1
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
Dissolve Macrilen granules in water
Fill beaker with appropriate volume of water. Tap water can be used. Add granules into beaker to dissolve.
- 1 pouch=120 mL water
- 2 pouches=240 mL water
Stir gently (2-3 minutes)
A small amount of undissolved particles will remain. The final concentration is 0.5 mg/mL.
Example: A patient weighing 70 kg will need 70 mL of reconstituted Macrilen solution.
Note: 2.2 lb = 1 kg
Use the helpful dosing and volume calculatorto determine the number of pouches and volume of reconstituted solution.
Measure exact volume
Draw up the exact volume of reconstituted solution in milliliters using the dose measurement syringe.
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.
Dosing and volume calculator
To dose Macrilen properly, you must first determine your patient's weight in kilograms. Use this helpful tool to determine the number of Macrilen pouches your patient requires for the test, as well as the volume in milliliters of reconstituted solution. Simply enter your patient's weight in pounds to display the necessary dosing and volume of reconstituted Macrilen solution.
Enter weight (lb):
(Note: 2.2 lb = 1 kg)
After test preparation, go from drink, to draw, to diagnose1
The patient must drink the entire volume of Macrilen solution within 30 seconds. Observe patient for duration of test.
Draw blood samples
No baseline blood draw is required for Macrilen. After administering Macrilen, draw venous blood samples at specified time intervals.
Prepare serum samples according to instructions from lab (where samples will be sent) and send for growth hormone (GH) determinations.
How to interpret test results1
Test results are considered positive for Adult Growth Hormone Deficiency (AGHD) if the maximum serum GH level observed after stimulation is less than 2.8 ng/mL for the 4 blood draws.
Order a complimentary AGHDiagnose Kit that comes with the tools you will need to help you prepare and administer Macrilen solution. Macrilen is ordered separately. This kit is not required to prepare Macrilen. To order the kit, please click the link below.
Order AGHDiagnose Kits for your office
Dose measurement syringe
Macrilen is indicated for the diagnosis of adult growth hormone deficiency (AGHD).
Limitations of Use
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
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.
The most common adverse reactions were dysgeusia, dizziness, headache, fatigue, nausea, hunger, diarrhea, upper respiratory tract infection, feeling hot, hyperhidrosis, nasopharyngitis, and sinus bradycardia
Please see Full Prescribing Information.
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