LuciAnam Anamorelin

Product Name

Generic Name: Anamorelin

Active Ingredient: Anamorelin Hydrochloride

Brand Names: Adlumiz, LuciAnam

English Name: Anamorelin

Specification: 50 mg/tablet; 100 tablets/bottle

Description: Oral film-coated tablets

Manufacturer: Lucius Pharmaceutical (Laos) Co., Ltd.

National Drug Approval No.: 02 L 1063/24

Pharmacological Actions

Mechanism of Action: Anamorelin is a novel, orally active ghrelin receptor agonist. It mimics the physiological effects of endogenous ghrelin by selectively binding to and activating ghrelin receptors in the hypothalamus and gastrointestinal tract. This action potently stimulates appetite, and by modulating the growth hormone secretion axis, promotes protein synthesis and increases muscle mass.

Pharmacodynamics: In patients with cancer cachexia, it significantly improves symptoms such as weight loss, loss of appetite, and muscle wasting.

Indications

Indicated for the treatment of cancer cachexia—a condition commonly observed in patients with malignant tumors such as non-small cell lung cancer, gastric cancer, pancreatic cancer, and colorectal cancer—specifically characterized by:

Weight loss (defined as a weight reduction of more than 5% within the past 6 months, or a BMI < 20 kg/m²);

Loss of appetite;

And where nutritional support alone is insufficient to improve the condition.

Dosage and Administration

Standard Dosage: For adults, 100 mg once daily (i.e., two 50 mg tablets).

Timing of Administration: To be taken on an empty stomach, at least one hour before breakfast.

Duration of Treatment: Treatment should be continued as directed by a physician. The maximum duration of treatment typically does not exceed 12 weeks; the specific duration should be determined based on an assessment of the individual patient's condition.

Adverse Reactions

Common adverse reactions include:

Blood Glucose Abnormalities: Hyperglycemia (very common) or hypoglycemia may occur; blood glucose levels should be monitored regularly.

Liver Function Abnormalities: May cause elevated levels of gamma-glutamyl transferase (GGT), aspartate aminotransferase (AST), alanine aminotransferase (ALT), etc.

Others: Tachycardia, tremors, sweating, etc.

Contraindications

The use of this drug is contraindicated in the following patients:

1. Patients with a known hypersensitivity to any component of this drug. 2.  Patients with diagnosed or suspected interstitial pneumonia.

3.  Patients with severe hepatic impairment (Child-Pugh Class C).

4.  Patients with severe renal impairment.

5.  Patients currently taking, or likely to take, medications known to prolong the QT interval.

6.  Patients with a history of congestive heart failure.

Precautions

1.  Blood Glucose Monitoring: Blood glucose levels must be monitored regularly during treatment; for patients with diabetes, adjustments to their anti-diabetic regimen may be required.

2.  Liver Function Monitoring: Liver function tests should be performed periodically.

3.  ECG Monitoring: Electrocardiograms (ECGs) should be monitored prior to and during treatment, with particular attention paid to changes in the QT interval.

4.  Risk of Interstitial Pneumonia: If symptoms such as fever, cough, or dyspnea occur during treatment, discontinue the medication immediately and seek medical attention.

5.  Special Populations: Use in children, pregnant women, and breastfeeding women is not recommended, as safety and efficacy in these populations have not been established.

Drug Interactions

QT-Interval Prolonging Drugs: Concomitant use with medications such as fluoroquinolones, antiarrhythmics, or tricyclic antidepressants increases the risk of cardiac arrhythmias; such concomitant use is contraindicated.

Strong CYP3A4 Inhibitors/Inducers: These agents may affect the plasma concentrations of anamorelin; caution should be exercised when using them concomitantly.

Storage

Store at room temperature. Keep out of the reach of children.