Alectinib capsules LuciAle 150mg

[Product Name] Alectinib Capsules

[English Name] Alectinib Capsules

[Other Names] Alectinib / Alecensa

[Specification] 150 mg/capsule; 56 capsules/box.

[Manufacturer] Lucius Pharmaceutical (Laos) Co., Ltd.

[Indications]

LuciAle is a kinase inhibitor indicated for:

Adjuvant treatment of adult patients with Anaplastic Lymphoma Kinase (ALK)-positive non-small cell lung cancer (tumors ≥ 4 cm or lymph node positive) following tumor resection, as detected by an FDA-approved test method.

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

[Dosage and Administration] Oral administration twice daily at a dose of 600 mg per dose, taken with food.

[Contraindications] None.

[Warnings and Precautions]

Hepatotoxicity: Monitor liver laboratory parameters every 2 weeks during the first 3 months of treatment, then once a month thereafter; perform more frequent monitoring for patients who develop elevations in transaminases and bilirubin, as clinically indicated. If ALT, AST, or bilirubin levels become severely elevated, suspend or reduce the dose, or permanently discontinue LuciAle.

Interstitial Lung Disease (ILD)/Pneumonitis: Immediately suspend LuciAle in patients diagnosed with ILD/pneumonitis; permanently discontinue LuciAle if no other potential causes for the ILD/pneumonitis are identified.

Renal Impairment: Suspend LuciAle in patients with severe renal impairment; upon recovery, resume LuciAle at a reduced dose or permanently discontinue use.

Bradycardia: Periodically monitor heart rate and blood pressure. If symptomatic, suspend LuciAle, then resume at a reduced dose or permanently discontinue the drug.

Severe Myalgia and Creatine Phosphokinase (CPK) Elevation: Assess CPK levels every 2 weeks during the first month of treatment, and evaluate patients who report unexplained muscle pain, tenderness, or weakness. If CPK levels become severely elevated, suspend LuciAle, then resume use or resume at a reduced dose following evaluation.

Hemolytic Anemia: Suspend LuciAle if hemolytic anemia is suspected. If hemolytic anemia is confirmed, consider resuming use at a reduced dose following remission, or permanently discontinuing the drug.

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

[Adverse Reactions]

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

[Use in Specific Populations]

Lactation: Do not breastfeed.

[Storage]

Store at 20°C to 25°C (68°F to 77°F); excursions between 15°C and 30°C (59°F and 86°F) are permitted. Protect from moisture.