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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.

How to order Macrilen

download icon Fill out the Macrilen Service and Prescription Request form to

*

Coverage is limited to co-pay or co-insurance for Macrilen product only and does not include deductible amounts, other office visits, procedures, or administration costs.

There are 2 options for ordering Macrilen for your practice

Specialty distributor

Available through

Specialty pharmacy

Available through

  • Accredo®
  • AllianceRx Walgreens Prime
  • CVS Specialty™

Macrilen supply and storage

Dosage form and strength

Package size

National Drug Code (NDC) number

Granules, 60 mg

1 pouch per box

71090-002-02

For questions and support, please contact your Strongbridge Field Reimbursement Manager or call Strongbridge CareConnection at 1-844-MAC-AGHD (1-844-622-2443).

Comprehensive support through Strongbridge CareConnection

Patient access and affordability

  • Macrilen Co-Pay Savings Program
    • Eligible patients may pay as little as $0, with an annual co-pay assistance of $1,000. Please call Strongbridge CareConnection at 1-844-MAC-AGHD (Monday through Friday from 8 AM to 8 PM ET) for eligibility information and to enroll your patients
  • Patient assistance program

Macrilen Co-Pay Savings Brochure

Enroll your patients in the Macrilen Co-Pay Savings Program

Reimbursement

  • Coding recommendations and information
  • Resources for denials and appeals

Macrilen Access and Reimbursement Guide

Product distribution

  • Information on authorized distributors
  • Coordinating specialty pharmacy ordering and fulfillment

For more information, please call 1-844-MAC-AGHD (1-844-622-2443).

Strongbridge CareConnection hours of operation are Monday through Friday from 8 AM to 8 PM ET.

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

Macrilen Service and Prescription Request Form

All other trademarks, registered or otherwise, are the property of their respective owners.

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