MACRILEN Granule for solution (2019)

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Novo Nordisk

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1. Indications and Usage

MACRILEN is indicated for the diagnosis of adult growth hormone deficiency (AGHD). Limitations of Use The safety and diagnostic performance of MACRILEN have not been established for subjects with a body ...

2. Dosage and Administration

2.1 Recommended Dose The recommended dose is a single oral dose of 0.5 mg/kg of macimorelin. The dose is administered as a reconstituted solution <em>[see Dosage and Administration (2.3)]</em> in patients ...

3. Dosage Forms and Strengths

For oral solution: 60 mg white to off-white granules in a pouch for reconstitution in 120 mL of water, resulting in a solution of 0.5 mg/mL of macimorelin.

4. Contraindications

None.

5. Warnings and Precautions

5.1 QT Prolongation MACRILEN causes an increase of about 11 msec in the corrected QT (QTc) interval <em>[see Clinical Pharmacology (12.2)]</em>. QT prolongation can lead to development of torsade de pointes-type ...

6.1. Clinical Trials 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 ...

7. Drug Interactions

7.1 Drugs that Prolong QT Interval Co-administration of MACRILEN with drugs that prolong the QT interval (such as antipsychotic medications (e.g., chlorpromazine, haloperidol, thioridazine, ziprasidone), ...

8.1. Pregnancy

Risk summary There are no available data with MACRILEN use in pregnant women to inform a drug associated risk for adverse developmental outcomes. Animal reproduction studies have not been conducted with ...

8.2. Lactation

Risk Summary There are no data on the presence of macimorelin in human or animal milk, the effects on the breastfed infant or the effects on milk production. The lack of clinical data during lactation ...

8.4. Pediatric Use

The safety and efficacy of MACRILEN in pediatric patients have not been established.

8.5. Geriatric Use

Growth hormone secretion normally decreases with age. Therefore, elderly subjects might require a lower cut-off point for diagnosis of adult growth hormone deficiency. Clinical studies of MACRILEN did ...

10. Overdosage

In the event of an overdose, symptomatic and supportive measures should be employed.

11. Description

MACRILEN for oral solution is macimorelin acetate, a synthetic growth hormone secretagogue receptor agonist. Macimorelin acetate is described chemically as D-Tryptophanamide, 2-methylalanyl-N-[(1R)1(formylamino)- ...

12.1. Mechanism of Action

Macimorelin stimulates GH release by activating growth hormone secretagogue receptors present in the pituitary and hypothalamus.

12.2. Pharmacodynamics

GH stimulation Maximum GH levels are observed between 30 to 90 minutes after administration of MACRILEN. Cardiac electrophysiology The effects of macimorelin on ECG parameters were investigated in a dedicated ...

12.3. Pharmacokinetics

The mean plasma macimorelin concentrations are similar between patients with AGHD and healthy subjects for 1.5 hours following administration of a single oral dose of 0.5 mg macimorelin/kg body weight. ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis Long-term carcinogenesis studies in rodents have not been conducted. Mutagenesis Macimorelin did not cause mutations in bacteria under assay conditions with or without metabolic activation. ...

14. Clinical Studies

The 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 ...

16.1. How Supplied

MACRILEN 60 mg is supplied as white to off-white granules in an aluminum pouch. Each pouch contains 60 mg macimorelin (equivalent to 68 mg macimorelin acetate) that when reconstituted with 120 mL of water ...

16.2. Storage and Handling

Store pouches under refrigeration at 2-8°C (36-46°F). The solution must be used within 30 minutes after preparation. Discard unused portion.

17. Patient Counseling Information

Instruct patients to discontinue treatment with GH at least one week before administering MACRILEN. Also, instruct patients to discontinue other medications that may interfere with the diagnostic test ...