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Macrilen™ (macimorelin) 60 mg for oral solution logo
Important Safety Information
Prescribing Information
  • About Macrilen™
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Macrilen™ (macimorelin) 60 mg for oral solution logo

For the diagnosis of adult growth hormone deficiency.

Prescribing Information
Important Safety Information

How to order Macrilen™

How to order Macrilen™

Fill out a Macrilen™ Service and Prescription and Request Form (SRF)

Ordering with the Macrilen™ SRF includes:

  • Benefits verification (pharmacy and medical) completed for your patient 
  • Prior authorization information 
  • Confirmation of patient eligibility for the Macrilen™ Co-pay Savings Program and enrollment 
  • Complimentary AGHDiagnose Kit
You can also order Macrilen™ directly from the following specialty distributors or pharmacies:

Specialty distributor


Available through:

ASD Healthcare® (AmerisourceBergen)
for hospitals
1-800-746-6273

Cardinal Health™
for specialty pharmacies
1-866-476-1340

CuraScript SD
for physician practices
1-877-599-7748

McKesson Plasma and Biologics
for pharmacies
1-615-848-6124

McKesson Specialty Care Distribution
for physician practices
1-855-477-9800

Specialty pharmacy


Available through:

Accredo®

AllianceRx Walgreens Prime

CVS Specialty™

Macrilen™ product specifications


Dosage form and strength
60 mg, supplied as white to off-white granules in an aluminum pouch for reconstitution in 120 mL of water, resulting in a solution of 0.5 mg/mL of Macrilen™.

Package size
1 pouch per box

Note: 1 pouch can be used for a patient weighing ≤120 kg. A patient weighing >120 kg requires 2 pouches.1

Storage requirements
Store pouches under refrigeration at 2°C to 8°C (36°F to 46°F).1

NDC# 0169-1401-01

Intended for use by healthcare professionals only

Contact a Novo Nordisk Representative

Questions about Macrilen™? Your local representative is ready to help with clinical resources, patient educational materials and information on support options.

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.
Growth-Related Disorders
Other Therapy Areas
Explore diabetes
Explore obesity
Explore rare bleeding disorders
Explore growth-related disorders
Explore hormone replacement therapy
  • Growth-Related Disorders Home
  • Product Information
    Products
    • Treatment & Diagnostic Test
    Professional Resources
    • Product Resources Library
      Contact Your Representative
  • Professional Education
    Disease Education
    • Clinical Education Resources
      Pediatric Growth-Related Disorders (Basics)
      Adult Growth Hormone Deficiency
    Treatment Guidelines
    • PES & AACE Guidelines
    Additional Resources
    • Organizations & Conferences
  • Patient Support
    Product Education
    • Product Education Materials
    Disease Education
    • Disease Education Resources
      Advocacy & Support Groups
    Access & Affordability
    • Insurance Support & Prescription Savings

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