MACRILENTM (macimorelin): Diagnosis of Adult Growth Hormone Deficiency

MACRILEN, a NEW prescription oral drug that has been granted orphan drug designation in the U.S., is the first and only FDA-approved oral growth hormone secretagogue receptor agonist indicated for the diagnosis of Adult Growth Hormone Deficiency (AGHD), a rare endocrine disorder.1

MACRILEN was shown to diagnose AGHD accurately in a clinical trial comparing the diagnostic agreement between MACRILEN and the benchmark, Insulin Tolerance Test (ITT).1

  • The clinical trial was an open-label, randomized, cross-over study (N=154).
  • Overall, MACRILEN and the ITT were in complete agreement among 84% of all subjects.
  • Among those with a high likelihood of AGHD prior to testing, MACRILEN and the ITT were in complete agreement among 89% of subjects.
  • MACRILEN was evaluable in >99% of tests at first try, compared to 83% evaluable with the ITT.
  • Repeatability was observed in 91.2% of the patients (n=34) who underwent two Macrilen tests.

MACRILEN has a Favorable Safety Profile1,2

  • Only 25% of subjects reported any AE after receiving Macrilen compared with 96% reporting an AE during the ITT.
  • The most common side effects, were changed sense of taste, dizziness, headache, fatigue, nausea, hunger, diarrhea, upper respiratory tract infection, feeling hot, excessive sweating, sore nose and throat, and decreased heart rate. These were seen in less than 5% of clinical trial participants who took MACRILEN.
  • There are no contraindications.

MACRILEN is Administered in a Convenient Oral, Reconstituted Solution1

  • The recommended dose of MACRILEN is 0.5 mg/kg as a single oral dose, after fasting for at least eight hours.
  • A healthcare professional must prepare and administer according to the instructions found in the Full Prescribing Information.
  • The safety and diagnostic performance of MACRILEN has not been established for subjects with a body mass index (BMI) > 40 kg/m2.

How does MACRILEN work?1

  • MACRILEN stimulates the secretion of growth hormone from the pituitary gland into the circulatory system.
  • Stimulated growth hormone levels are measured in only four blood samples over ninety minutes after oral administration of MACRILEN (no IV infusions or intramuscular injections).
  • No HCP supervision is required.

Important Safety Information for MACRILEN

What is MACRILEN?

MACRILEN (pronounced ma-kri-len) (macimorelin) is a prescription oral solution that is used to test for adult growth hormone deficiency (AGHD).

What should you know about MACRILEN?

  • Taking MACRILEN with certain other medications may cause irregular changes to your heart rhythm. Before taking MACRILEN, tell your healthcare provider about all your medications, as you may need to temporarily stop taking some medications before you take MACRILEN.
  • Some medications may cause a false positive result when taken with MACRILEN. Before taking MACRILEN, tell your healthcare provider about all the medications you take, including growth hormone.
  • Tell your healthcare provider if you were recently diagnosed with hypothalamic disease, as this can cause a false negative result with MACRILEN.
  • You will need to fast (go without food) for at least 8 hours before taking MACRILEN.

What are the most common side effects with MACRILEN?

The most common side effects were changed sense of taste, dizziness, headache, fatigue, nausea, hunger, diarrhea, upper respiratory tract infection, feeling hot, excessive sweating, sore nose and throat, and decreased heart rate.

These are not all of the possible side effects of MACRILEN. Call your healthcare provider for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch/ or call 1-800-FDA-1088.

Please see MACRILEN Important Safety Information and Full Prescribing Information.

References

  1. MACRILEN Prescribing Information. 2018.
  2. Data on file. Clinical Study Report. Feasterville-Trevose, PA: Strongbridge Biopharma; 2018.

© 2018 Strongbridge Biopharma plc
STRONGBRIDGE BIOPHARMA® is a registered trademark of the Strongbridge Biopharma plc. companies, which include Strongbridge Ireland Limited and Strongbridge U.S. Inc.
KEVEYIS® is a registered trademark licensed exclusively in the U.S. to Strongbridge Biopharma plc.
MACRILEN is a trademark of Aeterna Zentaris GmbH, licensed exclusively in the U.S. and Canada to Strongbridge Ireland Limited.
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