HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use LuciAnam safely and effectively. See full prescribing information for LuciAnam.

INDICATIONS AND USAGE

Cachexia in the following malignant tumors non-small cell lung cancer, gastric cancer, pancreatic cancer, colorectal cancer.

DOSAGE AND ADMINISTRATION

The usual adult dose is 100 mg of Anamorelin hydrochloride. given orally once daily on an empty stomach.

DOSAGE FORMS AND STRENGTHS

Tablets: 50 mg×100 tablets

CONTRAINDICATIONS

·Patients with a history of hypersensitivity to the components of this drug

·Patients with congestive heart failure [It may suppress cardiac function and aggravate symptoms.]

·Patients with myocardial infarction or angina pectoris[It may suppress cardiac function and aggravate symptoms.]

·Patients with severe conduction system disorders (complete atrioventricular block, etc.) [Since this drug has a sodium channel inhibitory effect, The substance may have a suppressive effect on the conduction system of stimulation and may aggravate it.]

·Patients taking the following drugs: Clarithromycin, Tioconazole, voriconazole, ritonavir-containing preparations, cobicistat-containing preparation, encitrelvir fumarate.

·Patients with moderate or severe hepatic dysfunction (Child-Pugh classification B and C) [The liver is the main contributor to the elimination of this drug from the body. As a result, the blood concentration increases and the stimulation conduction system is suppressed. There is a risk of being caught.

·Oral administration of meals due to organic disorders of the gastrointestinal tract, such as gastrointestinal obstruction Patients who have difficulty feeding.

WARNINGS AND PRECAUTIONS

● Since this drug has sodium channel inhibitory action, it suppresses stimulus conduction  system. ECG abnormalities (e.g., marked PR interval or QRS width prolongation, QT interval prolongation) may occur after administration of this drug. Cardiothoracic ratio,  electrolytes, etc. should be measured periodically, and if any abnormalities are observed, appropriate measures such as discontinuing administration should be taken. Particular caution should be exercised during the early stages of administration of this drug.

●Hyperglycemia may occur, Before starting administration of this drug and during the administration period, blood glucose levels and urinary sugar should be measured periodically.

● Hepatic dysfunction may occur. Liver function tests should be performed before and periodically during administration of this drug.

ADVERSE REACTIONS

Serious side effects

Stimulation conduction system inhibition (10.7%)

Electrocardiogram abnormalities (marked PR interval or QRS width prolongation, QT interval prolongation, etc.), atrioventricular block, tachycardia, bradycardia, palpitations , hypotension, premature supraventricular contraction, etc. may occur.

Hyperglycemia (4.3%), exacerbation of diabetes (4.3%)

Pay attention to the appearance of symptoms such as dry mouth and frequent urination, Appropriate measures such as administration of insulin, oral hypoglycemic drugs, and discontinuation of administration of this drug should be taken as necessary.

Liver dysfunction (6.4%)

Liver dysfunction accompanied by elevation of AST, ALT, ALP, γ-GTP, blood bilirubin, etc. may occur.

USE IN SPECIFIC POPULATIONS

·Pregnancy

Women who may be pregnant should be treated only if the therapeutic benefits are judged to outweigh the risks thing. Administration of ghrelin or ghrelin analogues to mice has been shown to delay embryonic development, lower fetal weight, lower the pregnancy rate, and reduce the number of fetuses. In addition, although the placental crossing of this drug is unknown, it is possible that it crosses the placenta considering its high lipid solubility and its weak basicity.

·Lactation

Consider the therapeutic benefits of lactating women and the benefits of breastfeeding and consider continuation or discontinuation of breastfeeding. Although it is unknown whether this drug migrates into milk, it is possible that it migrates into breast milk considering its high fat solubility and weak basicity.

Storage

Store at 20℃ to 25℃ (68℉ to 77℉), excursions permitted between 15℃ and 30℃ (59℉ and 86℉) [see USP Controlled Room Temperature]. Protect from moisture.