[Drug Name] Crizotinib Capsules

[English Name] Crizotinib Capsules

[Specification] 250 mg × 60 capsules/box

[Manufacturer] State Pharmaceutical Factory No. 2, Lao People's Democratic Republic

[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, it not only specifically inhibits EML4-ALK (Anaplastic Lymphoma Kinase) but also effectively suppresses ROS1 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 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) for short-term transport.

[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 at a specific time in the morning and one at a specific time in the evening, 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. The medication may be taken with or without food. Do not take with grapefruit juice.

[Warnings and Precautions]

Assessment of ALK-Positive Status

When assessing whether a patient is ALK-positive, 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-colored urine (tea-colored); 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 conduct 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: If you experience difficulty breathing, coughing, or fever, please contact your attending physician immediately. Dizziness, Fainting, or Chest Discomfort: If you notice changes in your ECG readings or experience an irregular heartbeat, please contact your attending physician immediately. The doctor will perform an ECG to monitor the effects of Crizotinib treatment on your body. Very Common Adverse Reactions (may occur in more than 10% of patients): • Abnormal liver function. • Visual effects (flashing lights, blurred vision, double vision; these typically appear shortly after taking Crizotinib). • Neuropathy (numbness or tingling sensations 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 diminished sense of taste. • Skin rash.

[Special Populations]

Precautions for Children: Not yet established.

Precautions for Pregnancy and Lactation: Not yet established.

Precautions for the Elderly: Not yet established.

[Manufacturer Introduction]

Pharmaceutical Factory No. 2 of the Lao People's Democratic Republic (PHARMA 2 VIENTIANE)—hereinafter referred to as "Lao Pharma 2"—is a state-owned pharmaceutical enterprise in Laos, operating directly under the supervision of the Lao Ministry of Health. Established in the 1970s, Lao Pharma 2 boasts a history spanning over 40 years. It stands as the largest, oldest, and most comprehensive pharmaceutical manufacturing enterprise in Laos, producing the widest variety of medicinal products. Laos Pharmaceutical Factory No. 2 provides patients with a comprehensive range of over 160 different pharmaceutical products annually, including intravenous infusions, injectables, oral tablets, oral capsules, oral syrups, and ointments. Keeping pace with the times and actively engaging in exploration, Laos Pharmaceutical Factory No. 2 continuously introduces advanced foreign technologies. The facility seeks breakthroughs in both manufacturing processes and pharmaceutical R&D to ensure that its own research and production capabilities remain aligned with international standards. Currently, Laos Pharmaceutical Factory No. 2 holds ISO 9001:2008 certification for its manufacturing processes. The mission of Laos Pharmaceutical Factory No. 2 is to provide high-quality, internationally benchmarked pharmaceutical products and services to an ever-expanding base of customers and patients through continuous progress and active innovation.

**Product Specifications**

**Product Name:** Crizotinib Capsules 250mg (60 capsules/box)

**Common Name:** Crizotinib Capsules

**Active Ingredient:** Crizotinib

**Dosage Form:** Capsules

**Specification:** 250mg (60 capsules/box)

**Manufacturer:** National Pharmaceutical Factory No. 2, Lao People's Democratic Republic

**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 diagnostic test approved by the CFDA.

**Dosage and Administration:** The recommended dosage for the treatment of advanced ALK-positive non-small cell lung cancer is 250 mg. This consists of one capsule taken twice daily—one capsule in the morning and one in the evening at specific, consistent times—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. The medication may be taken with or without food. Do not take with grapefruit juice.