Alectinib is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.

Alectinib capsules (LuciAle) simple instructions

Please use under the guidance of a physician

Product Name: LuciAle

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

Chinese name: Alectinib capsules

English name: Alectinib capsules

Drug approval number: 06 L 1127/24

【Indications】

LuciAle is a kinase inhibitor indicated for:

•Adjuvant treatment for adult patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (tumor ≥ 4 cm or lymph node-positive) following tumor resection as detected by an FDA-approved test.

• Adult patients with ALK-positive metastatic non-small cell lung cancer detected by an FDA-approved test.

【Usage and Dosage】

Take orally twice daily, 600 mg each time, with meals.

【Specification】

150mg/capsule, 56 capsules/box.

【Contraindications】

none

【Warnings and precautions】

• Hepatotoxicity: Monitor liver laboratory parameters every 2 weeks during the first 3 months of treatment, then monthly, and more frequently as clinically indicated for patients with elevated transaminases and bilirubin. If ALT, AST, or bilirubin are severely elevated, LuciAle should be withheld or reduced in dose, or permanently discontinued.

•Interstitial Lung Disease (ILD)/Pneumonitis: LuciAle should be discontinued immediately in patients diagnosed with ILD/pneumonitis and permanently if no other underlying cause of the ILD/pneumonitis is found.

• Renal Impairment: Withhold LuciAle in the event of severe renal impairment and resume at a reduced dose upon recovery or permanently discontinue LuciAle.

• Bradycardia: Monitor heart rate and blood pressure regularly. If symptoms occur, temporarily withhold LuciAle, then reduce dose, or permanently discontinue.

• Severe myalgia and creatine phosphokinase (CPK) elevations: During the first month of treatment, assess CPK every two weeks and evaluate patients reporting unexplained muscle pain, tenderness, or weakness. If CPK is severely elevated, withhold use and then evaluate and decide whether to resume or reduce the dose.

•Hemolytic Anemia: If hemolytic anemia is suspected, withhold LuciAle. If hemolytic anemia is confirmed, consider resuming at a reduced dose after resolution or permanently discontinue.

• Embryo-Fetal Toxicity: LuciAle can cause fetal harm. Inform females of reproductive potential of the potential risk to a fetus and to use effective contraception.

【Adverse Reactions】

The most common adverse reactions (incidence ≥20%) were hepatotoxicity, constipation, fatigue, myalgia, edema, rash, and cough.

【Use by specific groups】

Lactation: Do not breastfeed.

【Storage】

Storage temperature is 20℃ to 25℃ (68℉ to 77℉), short-distance transportation is allowed between 15℃ to 30℃ (59℉ to 86℉). Protect from moisture.