Crizotinib is a first-generation targeted drug for non-small cell lung cancer with ALK mutation

Crizotinib instruction manual

 

Product Name: LuciCriz

Manufacturer: Lucius Pharmaceuticals

Chinese name: Crizotinib

English Name: Crizotinib

Drug approval number: 04 L 0967/23

 

 

【Summary】

Crizotinib is an ALK gene inhibitor with the characteristics of high safety and low toxicity. As a new targeted drug for the treatment of advanced non-small cell lung cancer, it can not only inhibit EMLA-ALK (anaplastic lymphoma kinase) but also effectively inhibit ROSI and ALK genes, thereby hindering tumor growth and accelerating tumor cell apoptosis.

 

【Indications】

Crizotinib capsules are indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK) positive as determined by a CFDA-approved test method.

 

【Specification】

250mg/capsule, 60 capsules/bottle

 

【Storage】

Store at 20°C to 25°C (68°C to 77°F); short-distance transport is permitted at a temperature range of 15 to 30°C (59–86°F).

 

【Usage and Dosage】

The recommended dose for the treatment of advanced ALK-positive non-small cell lung cancer is 250 mg, one capsule at a time, twice a day, 1 capsule each at a determined time in the morning and evening, and the daily dose is 500 mg; oral, swallow the whole capsule, do not chew it, do not dissolve it, and do not open the capsule; it can be taken with or without food; it should not be taken with grapefruit juice.

 

【Warnings and Precautions】

Evaluation of ALK positivity

When evaluating whether a patient is ALK positive, it is important to choose a method that is well validated and reliable to avoid false-negative or false-positive results.

 

【Adverse Reactions】

Abnormal liver function: Contact your doctor right away if you feel: more tired than usual, yellowing of the skin, yellowing of the whites of the eyes, dark or brown (tea-colored) urine; nausea, vomiting, loss of appetite; pain on the right side of the stomach; itchy skin, or bruising more easily than usual. Your doctor will do a blood test to test liver function. If the test indicators are abnormal, your doctor will decide to reduce the dose of crizotinib or stop taking crizotinib. Pneumonia: If you feel shortness of breath, cough, or fever, contact your doctor right away. Dizziness, fainting, chest discomfort: If you notice changes in the ECG symptom signs or irregular heartbeat, contact your doctor right away. Your doctor will do an ECG to monitor the effects of crizotinib treatment on your body. Very common adverse reactions (may be greater than 10%) • Abnormal liver function. • Visual effects (flashes of light, blurred vision, double vision, usually appear soon after taking crizotinib). • Neuropathy (nerve paralysis, numbness at the junction, end, or muscle of the nerve). • Dizziness, tiredness • Edema (accumulation of fluid in body tissues, causing swelling in the hands and feet). • Gastrointestinal discomfort (nausea, vomiting, diarrhea, constipation, esophageal and throat discomfort). • Loss of appetite, loss of taste • Skin rash.

 

[Special Populations]

Precautions for children: Not yet clear.

 

Precautions during pregnancy and lactation: Not yet clear.

 

Note for the elderly: Not yet clear.