Co-Pay Support Contact

For questions and support, please call: 1-844-622-2443.
Our fax number is 1-833-244-2723.
We are open from 8:00 AM to 8:00 PM ET, Monday through Friday, except for the following holidays:

New Year's Eve
New Year's Day
Presidents' Day
Good Friday
Memorial Day
Independence Day
Labor Day
Columbus Day
Thanksgiving
Christmas

All documentation can also be mailed to: The Macrilen Co-Pay Savings Program, 100 Passaic Ave, Suite 245, Fairfield, NJ 07004, or faxed to 1-833-244-2723.

Important Safety Information for Macrilen

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.

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.

STRONGBRIDGE BIOPHARMA® is a registered trademark of the Strongbridge Biopharma plc. companies, which include Strongbridge Ireland Limited and Strongbridge U.S. Inc.

Macrilen™ is a trademark of Aeterna Zentaris GmbH, licensed exclusively in the U.S. and Canada to Strongbridge Ireland Limited.

Macrilen is the subject of U.S. Patent Nos 6,861,409 and 8,192,719.

MAC-0177 08/2018

900 Northbrook Drive, Suite 200
Trevose, PA 19053
United States
Phone: 1-844-622-2443
macrilen_info@strongbridgebio.com

Privacy Statement
Compliance Program
California Statement of Compliance
Strongbridge Biopharma