Crizotinib is a multi-target tyrosine kinase inhibitor primarily used for the treatment of ALK-positive or ROS1-positive non-small cell lung cancer (NSCLC), ALK-positive anaplastic large cell lymphoma (ALCL), and ALK-positive inflammatory myofibroblastic tumors (IMTs).

Dosage and Administration, Recommended Doses of Crizotinib

Dose Standards for Different Indications

Non-Small Cell Lung Cancer (NSCLC): The recommended dose for adults is 250 mg taken orally twice daily, either with food or on an empty stomach.

Anaplastic Large Cell Lymphoma (ALCL): For pediatric patients aged 1 year and above and young adults, the dose is calculated based on body surface area (BSA), with a standard of 280 mg/m² taken orally twice daily.

Inflammatory Myofibroblastic Tumors (IMTs)

Adult patients: 250 mg taken orally twice daily.

Pediatric patients aged 1 year and above: 280 mg/m² taken orally twice daily.

Dosage Forms, Specifications and Administration Methods

Capsule dosage form: Available in two specifications (200 mg, 250 mg). It must be swallowed whole and must not be chewed, crushed, or split.

Oral pellet dosage form: Available in three specifications (20 mg, 50 mg, 150 mg). For administration, open the capsule shell, pour the pellets directly into the mouth, or use a dosing spoon/cup for assistance. Drink a sufficient amount of water immediately after taking to ensure complete swallowing.

Dose Adjustment of Crizotinib

Adult Patients with NSCLC and IMTs

First dose reduction: 200 mg twice daily.

Second dose reduction: 250 mg once daily.

If the 250 mg once-daily dose is still not tolerable, permanent discontinuation of the drug is required.

Adjustment for Hematological Toxicity

Grade 3: Suspend administration until recovery to Grade 2 or below, then resume the original dose. In case of febrile neutropenia, reduce to the next lower dose level after recovery.

Adjustment for non-hematological toxicity: For specific adverse reactions such as hepatotoxicity, ILD/pneumonitis, QTc interval prolongation, and bradycardia, measures such as suspending administration, dose reduction, or permanent discontinuation should be taken based on the severity.

Patients with Hepatic Impairment

Moderate hepatic impairment: Adopt the first dose reduction plan.

Severe hepatic impairment: Adopt the second dose reduction plan.

Medication for Special Populations of Crizotinib

Patients with Hepatic Impairment

Moderate hepatic impairment (AST and total bilirubin > 1.5 times the upper limit of normal [ULN] and ≤ 3 times ULN): Adopt the first dose reduction plan.

Patients with Renal Impairment

Mild to moderate renal impairment: No dose adjustment is required.

Severe renal impairment: Dose reduction is required.

Pregnant and Lactating Women

Pregnancy: Contraindicated. Based on its mechanism of action, crizotinib may cause fetal harm when administered to pregnant women.