Medication info

Maqrilene Granules (Masimorelina Acetate)

Prescription medication경구
Ingredient · strength
Macimorelin Acetate›67.6mg / 1 packet
Manufacturer / importer
주식회사엔케이메디텍
Appearance
White or yellowish granules
Packaging
1817.2 milligrams/pack [1 pack/box]
Approval status
Active

MFDS item code 202302677 · Approved 2023.09.07

Summary

Main use
Diagnosis of adult growth hormone deficiency
Who takes it
Adults
Adult dose
The recommended dosage for this medication in its reconstituted solution state is 0.5 mg/kg, administered as a single oral dose after fasting for at least 8 hours. The dosage of this medication should be determined based on the patient’s body weight in kilograms (kg). Patients weighing 120 kg or less should use 1 pack of this medication, while patients exceeding 120 kg should use 2 packs. 1 pack corresponds to 120 mL of water.

Ingredients

Importer
주식회사엔케이메디텍

Efficacy & effects

Diagnosis of adult growth hormone deficiency

View approved original text

Adult growth hormone deficiency refers to a condition resulting from insufficient secretion of growth hormone in adults. This condition can cause various symptoms including fatigue, decreased muscle strength, increased body fat, and decreased bone density. To diagnose growth hormone deficiency, blood tests and stimulation tests are conducted to evaluate growth hormone secretion. An appropriate diagnosis can facilitate the establishment of a treatment plan, which helps improve the quality of life of the patient.

How to take

Adult dose

The recommended dosage for this medication in its reconstituted solution state is 0.5 mg/kg, administered as a single oral dose after fasting for at least 8 hours. The dosage of this medication should be determined based on the patient’s body weight in kilograms (kg). Patients weighing 120 kg or less should use 1 pack of this medication, while patients exceeding 120 kg should use 2 packs. 1 pack corresponds to 120 mL of water.

Precautions

This medication should not be used in certain patients. Individuals allergic to any of the components in this medication should not take it. Additionally, this medication contains lactose, so patients with a genetic condition that prevents them from digesting lactose should avoid it. This medication may prolong the QT interval associated with heartbeats, thus caution is needed in patients with heart disease or those with a prolonged QT interval identified through an electrocardiogram (ECG). Such patients should carefully monitor their condition with ECG tests before and after taking the medication. Co-administration with other medications that prolong the QT interval may increase the risk of side effects, so it should be avoided. Specifically, this medication is not recommended for patients with a history of serious cardiac arrhythmias. Furthermore, taking medications that activate certain enzymes while using this medication may lower its blood concentration and affect test results. If using such medications, they should be discontinued for a certain period before administering this medication. Patients with hypothalamic issues may not receive accurate results in initial tests, requiring multiple tests to establish a definitive diagnosis. Patients with Cushing's syndrome or those receiving high doses of steroid treatment may have inaccurate test results, warranting caution. Side effects may include taste disturbances, dizziness, headaches, fatigue, nausea, a sense of emptiness, diarrhea, cold symptoms, fever, excessive sweating, nasal inflammation, and bradycardia. In particular, QT interval prolongation may be observed in ECG tests, thus careful monitoring of cardiac status is necessary. Avoid co-administration with other medications that prolong the QT interval, and consult a specialist before discontinuing the medication. Moreover, co-administration with medications inducing certain enzymes may decrease the effectiveness of this medication, hence they should not be taken together, and the duration for discontinuation should be discussed with a specialist. Do not take this medication alongside medications affecting growth hormone secretion; this medication should only be used after such drugs have completely cleared from the body. The safety of this medication in pregnant women has not been adequately established, hence it is not recommended for use, and women of childbearing age should ensure appropriate contraception while taking this medication. The safety of this medication in breastfeeding women has also not been confirmed, thus careful consideration is necessary about whether to continue breastfeeding while taking this medication. It is advisable not to use this medication in children, as safety and efficacy have not been established. In elderly patients, growth hormone secretion naturally decreases, thus adjustment of testing criteria may be necessary; however, caution is warranted as there is insufficient clinical research in this age group. If this medication is overdosed, treatment to alleviate symptoms should be conducted, and ECG monitoring should be performed as necessary to assess the patient's condition. This medication should be stored in a refrigerator to maintain its freshness and efficacy, and any unused solution should be discarded within 30 minutes post-preparation. Finally, this medication contains saccharin, a sweetener confirmed to be carcinogenic in animal studies, hence caution is advised for health considerations.

Side effects and when to seek care immediately

Serious side effects

ECG abnormalities due to QT prolongation, increased risk of torsades de pointes

Mild side effects

  • Taste disturbances
  • dizziness
  • headaches
  • fatigue
  • nausea
  • sense of emptiness
  • diarrhea
  • upper respiratory infection
  • fever
  • sweating
Show 2 more
  • nasopharyngitis
  • bradycardia

Not everyone experiences these, and they can vary from person to person.

Storage

This medication requires refrigeration between 2°C and 8°C to maintain freshness and efficacy. Additionally, it should be stored in a sealed container protected from light and air.

Appearance and packaging

Appearance

White or yellowish granules

Package unit

1817.2 milligrams/pack [1 pack/box]

Questions about this medicine

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.