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Macrilen

Last reviewed on RxList: 4/21/2020
Macrilen Side Effects Center

What Is Macrilen?

Macrilen (macimorelin) is a growth hormone (GH) secretagogue receptor agonist indicated for the diagnosis of adult growth hormone deficiency.

What Are Side Effects of Macrilen?

Common side effects of Macrilen include:

Dosage for Macrilen

The recommended dose of Macrilen is 0.5 mg/kg as a single oral dose, after fasting for at least 8 hours.

What Drugs, Substances, or Supplements Interact with Macrilen?

Macrilen may interact with:

Macrilen During Pregnancy and Breastfeeding

Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using Macrilen; it is unknown how it would affect a fetus. It is unknown if Macrilen passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Macrilen (macimorelin) for Oral Solution Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Macrilen Professional Information

SIDE EFFECTS

Clinical Studies Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trial of another drug and may not reflect the rates observed in practice.

The data in Table 1 are derived from an open-label, randomized, cross-over study that compared the diagnostic performance of MACRILEN to the insulin tolerance test (ITT) for the diagnosis of adult growth hormone deficiency [see Clinical Studies]. A total of 154 subjects with a high to low pretest probability of having adult growth hormone deficiency received a single oral dose of 0.5 mg/kg MACRILEN. Out of 154 subjects, 58% were male, 42% female, and 86% of white origin. Median values were for age 41 years (range: 18 - 66 years) and body mass index was 27.5 kg/m² (range: 16 - 40 kg/m²). Common adverse reactions presented in Table 1 were adverse reactions that were not present at baseline and occurred during MACRILEN dosing in at least two individuals.

Table 1: Common Adverse Reactions Reported in at Least Two Individuals Dosed with MACRILEN in an Open-Label Study

Number of Subjects
(n = 154)
Proportion of Subjects (%)
Dysgeusia74.5
Dizziness63.9
Headache63.9
Fatigue63.9
Nausea53.2
Hunger53.2
Diarrhea31.9
Upper respiratory tract infection31.9
Feeling hot21.3
Hyperhidrosis21.3
Nasopharyngitis21.3
Sinus bradycardia21.3

Read the entire FDA prescribing information for Macrilen (Voretigene Neparvovec-rzyl Intraocular Suspension for Injection)

Related Resources for Macrilen

© Macrilen Patient Information is supplied by Cerner Multum, Inc. and Macrilen Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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