ALIANARLIN Anamorelin Hydrochloride

[Key Drug Information]

Generic Name: Anamorelin Tablets

English Name: Anamorelin Hydrochloride

Brand Names: Adlumiz (Japanese: エドルミズ錠), ALIANARLIN

Other Names: Anamorelin, Anamorelin Hydrochloride Tablets

Specification: 50 mg/tablet; 100 tablets/box

Manufacturer: Lao United Pharmaceutical Group Co., Ltd.

Lao National Drug Administration Approval No.: 07L1370/25

Chemical Classification: An oral, non-peptide, highly selective ghrelin receptor agonist.

[Indications and Mechanism of Action]

Approved Indications: Indicated for the treatment of cancer cachexia in patients with unresectable advanced or recurrent non-small cell lung cancer, gastric cancer, pancreatic cancer, or colorectal cancer. It is the first drug globally to be approved for this specific indication.

Mechanism of Action: By mimicking endogenous ghrelin, it activates the growth hormone secretagogue receptor (GHSR), thereby stimulating the pituitary gland to release growth hormone (GH) and subsequently increasing levels of insulin-like growth factor-1 (IGF-1). Its primary effects include improving appetite, increasing food intake, promoting weight gain (specifically lean body mass), and potentially reducing cancer-related pro-inflammatory cytokines.

[Dosage and Administration (Based on Clinical Studies)]

Standard Dosage: The standard oral dosage is 100 mg, taken once daily.

Timing of Administration: It is generally recommended to take the medication on an empty stomach, at least one hour prior to the first meal of the day.

Important Note: Specific dosage and administration instructions should strictly adhere to the final approved official prescribing information. Treatment must be conducted under the supervision of an experienced oncologist.

[Important Precautions and Adverse Reactions]

1. Efficacy Profile: Clinical studies consistently demonstrate that Anamorelin significantly improves appetite, body weight, and lean body mass in patients with cancer cachexia. However, studies also indicate that it does not significantly improve patients' muscle function or physical performance (e.g., handgrip strength, 6-minute walk test).

2. Major Adverse Reactions: Known major adverse reactions include elevated gamma-glutamyltransferase (GGT) levels and elevated glycated hemoglobin (HbA1c) levels. Other potential risks requiring monitoring include effects on blood glucose levels and the occurrence of possible cardiovascular events.

3.  Global Regulatory Status Discrepancies: Regional variations exist in the assessment of the drug's benefit-risk balance. For instance, its marketing application was not approved in Europe, nor has it yet received approval in the United States. This underscores the necessity of administering the drug under strict medical supervision and restricting its use to appropriate patient populations.

[Additional Information]

Pharmacokinetics: Administered orally; the elimination half-life is approximately 6–7 hours.

Drug Interactions: Concomitant use with potent CYP3A4 enzyme inhibitors should be avoided. Additionally, the use of other medications intended to stimulate appetite or promote weight gain should be avoided during treatment.

[Summary and Recommendations]

Anamorelin represents a breakthrough therapeutic agent for the challenging condition of cancer cachexia, exerting its primary effects by improving appetite and promoting weight gain.

Product Name: Anamorelin Tablets 50mg (100 Tablets/Box) | ALIANARLIN | Anamorelin Hydrochloride

Common Name: Anamorelin Tablets

Composition: Anamorelin

Dosage Form: Tablets

Specification: 50mg/tablet; 100 tablets/box

Manufacturer: Lao United Pharmaceutical Group Co., Ltd.

Indications: Indicated for the treatment of cancer cachexia in patients with unresectable advanced or recurrent non-small cell lung cancer, gastric cancer, pancreatic cancer, or colorectal cancer. It is the first drug globally to be approved for this specific indication.

Dosage and Administration: Standard Dosage: The usual oral dose is 100 mg, taken once daily.

Timing of Administration: It is generally recommended to take the medication on an empty stomach, at least one hour prior to the first meal of the day.