LuciCri Crizotinib capsules

Product Name: LuciCriz

Chinese Name: Crizotinib

English Name: Crizotinib

Specification: 250 mg/capsule; 60 capsules/bottle

[Overview]

Crizotinib is an ALK gene inhibitor characterized by high safety and low toxicity. As a novel targeted therapy for advanced non-small cell lung cancer (NSCLC), it not only specifically targets and inhibits EML4-ALK (Anaplastic Lymphoma Kinase) but also effectively inhibits ROS1 and ALK genes, thereby impeding 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 detected by a testing method approved by the CFDA.

[Storage]

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

[Dosage and Administration]

The recommended dosage for the treatment of advanced ALK-positive non-small cell lung cancer is 250 mg per dose, taken twice daily. One capsule should be taken in the morning and one in the evening at approximately the same times each day, for a total daily dose of 500 mg. The capsules are for oral administration; they must be swallowed whole and should not be crushed, dissolved, or opened. Crizotinib may be taken with or without food. Do not consume grapefruit juice while taking this medication.

[Warnings and Precautions]

Assessment of ALK-Positive Status

When assessing a patient's ALK-positive status, a fully validated and reliable testing method must be selected to avoid false-negative or false-positive results. [Adverse Reactions]

Abnormal Liver Function: Please contact your attending physician immediately if you experience any of the following: feeling more tired than usual; yellowing of the skin or the whites of the eyes; dark or brown (tea-colored) urine; nausea, vomiting, or loss of appetite; pain in the right side of the abdomen; or itchy skin, or bruising more easily than usual. Your doctor will perform routine blood tests to monitor your liver function; if the test results are abnormal, the doctor will decide whether to reduce the dosage of Crizotinib or discontinue the medication. Pneumonia: Please contact your attending physician immediately if you experience difficulty breathing, coughing, or fever. Dizziness, Fainting, or Chest Discomfort: Please contact your attending physician immediately if you notice changes in your ECG readings or experience an irregular heartbeat; your doctor will perform an ECG to monitor the effects of Crizotinib treatment on your body. Very Common Adverse Reactions (may affect more than 10% of patients): • Abnormal liver function. • Visual disturbances (flashing lights, blurred vision, double vision; these typically occur shortly after taking Crizotinib). • Neuropathy (numbness or tingling in the nerves, nerve endings, or muscles). • Dizziness and fatigue. • Edema (fluid accumulation in body tissues, causing swelling in the hands and feet). • Gastrointestinal discomfort (nausea, vomiting, diarrhea, constipation, discomfort in the esophagus or throat). • Loss of appetite and altered sense of taste. • Skin rash.

[Special Populations]

Pediatric Patients: Safety and efficacy have not been established.

Pregnancy and Lactation: Safety and efficacy have not been established.

Geriatric Patients: Safety and efficacy have not been established.