Medical Editor: John P. Cunha, DO, FACOEP
What Is Macrilen?
What Are Side Effects of Macrilen?
Common side effects of Macrilen include:
- changes in taste,
- upper respiratory tract infection,
- feeling hot,
- excess sweating,
- runny or stuffy nose,
- and slow heart rate.
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:
- antipsychotic medications,
- antibiotics antiarrhythmic medications or any other medications known to prolong the QT interval,
- St. John's wort,
- cyclooxygenase inhibitors,
- muscarinic antagonists,
- anti-thyroid medication,
- and growth hormone products.
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.
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.
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 (%)|
|Upper respiratory tract infection||3||1.9|
Read the entire FDA prescribing information for Macrilen (Voretigene Neparvovec-rzyl Intraocular Suspension for Injection)