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Indication

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

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 were dysgeusia, dizziness, headache, fatigue, nausea, hunger, diarrhea, upper respiratory tract infection, feeling hot, hyperhidrosis, nasopharyngitis, and sinus bradycardia

Please see Full Prescribing Information.

Macrilen is prepared as an oral, reconstituted solution1

Prepare1

1

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
2

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
3

Stir gently (2-3 minutes)

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

4

Determine volume

Patient weight

(kg)

=

Macrilen solution

(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 calculator below to determine the number of pouches and volume of reconstituted solution.

5

Measure exact volume

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

6

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):

 lb

Weight:

0kg

Dosing:

0

pouches

Volume:

0mL

solution

(Note: 2.2 lb = 1 kg)

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

Administer

1

Administer solution

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

2

Draw blood samples

No baseline blood draw is required for Macrilen. After administering Macrilen, draw venous blood samples at specified time intervals.

3

Prepare samples

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

Download the What to Expect Patient Guide to help your patients prepare for the Macrilen test

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.

AGHDiagnose Kit

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

Kit contents

Beaker

Stirring rod

Dose measurement syringe

Drinking cup

Order Macrilen

Reference: 1. Macrilen [prescribing information]. Trevose, PA: Strongbridge U.S. Inc.; 2018.

Indication

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

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 were dysgeusia, dizziness, headache, fatigue, nausea, hunger, diarrhea, upper respiratory tract infection, feeling hot, hyperhidrosis, nasopharyngitis, and sinus bradycardia

Please see Full Prescribing Information.

900 Northbrook Drive, Suite 200

Trevose, PA 19053

United States

Phone: +1 610-254-9200

macrilen_info@strongbridgebio.com