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Medical Information | Non-US Health Care Professionals
Important Safety Information
Prescribing Information
Macrilen™ (macimorelin) 60 mg for oral solution logo

For the diagnosis of adult growth hormone deficiency.

Prescribing Information
Important Safety Information

Diagnosis made simpler. Decisions made clear.

Macrilen™ (macimorelin) for oral solution is the first and only FDA-approved Adult Growth Hormone Deficiency (AGHD) oral diagnostic test available for in-office use.1

20-something white male with a happy expression is leaning against a giant glass of reconstituted Macrilen™ (macimorelin) 60 mg oral solution.
Diagnosis made simpler. Decisions made clear.

Macrilen™ (macimorelin) for oral solution is the first and only FDA-approved Adult Growth Hormone Deficiency (AGHD) oral diagnostic test available for in-office use.1

Studied against the ITT

Macrilen™ (macimorelin) 60 mg icon of pages representing data and information found during the clinical trial process

Macrilen™ was studied in 140 adults in a head-to-head trial vs. the insulin intolerance test (ITT).1,a,b

In-office administration

Macrilen™ (macimorelin) 60 mg icon illustrating a patient drinking a prepared oral solution

Prepare, dose, administer, and send for results.

Multiple ways to order

Macrilen™ (macimorelin) 60 mg icon of an order form page representing the ordering process

You can contact a specialty pharmacy directly or use our request form, which also enables us to verify patient benefits and eligibility for co-pay assistance.

aThe diagnostic efficacy of the Macrilen™ test was established in a randomized, open-label, single-dose, cross-over study. The objective of the study was to compare the level of agreement between Macrilen™ test results and ITT results in adult patients with different pre-test probability of growth hormone deficiency and healthy control subjects. Each participant was to undergo the two diagnostic tests and serve as his or her own control. One hundred and fifty-seven subjects underwent at least one of the two tests in this study. Data on both tests were available for 140 subjects. One out of 154 Macrilen™ tests performed failed due to a technical error and 27 out of 157 ITTs performed failed because induction of severe hypoglycemia could not be achieved.1
bStudied in adult subjects with different pretest probabilities of GH deficiency (GHD) and in healthy control subjects.1

Macrilen™ (macimorelin) 60 mg icon representing a patient hand receiving money from the co-pay savings program

Eligible patients may pay as little as $75 with the Macrilen™ Co-pay Savings Program.c,d

Eligible patients may pay as little as $75 with the Macrilen™ Co-pay Savings Program.c,d

cWith an annual co-pay assistance of up to $4425.
dThis is a one-time use offer. Enrollment in the co-pay program is subject to eligibility criteria and terms and conditions, and the enrollment timeframe is based on calendar year. Patient is not eligible if he/she participates in or seeks reimbursement or submits a claim for reimbursement to any Government Program. Patient must be enrolled in a commercial insurance plan. Coverage is limited to co-pay or co-insurance for Macrilen™ product only and does not include deductible amounts or other office visits, procedures, or administration costs. Novo Nordisk has the right to charge, alter, or revoke eligibility criteria and terms and conditions at any time.

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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.

 

References:

  1. Macrilen [prescribing information]. Plainsboro, NJ: Novo Nordisk Inc; 2021.