Crizocent 250mg Incepta Crizotinib

English Name: Crizotinib

Generic Name: Crizotinib

Specification: 250 mg × 60 capsules/box

Manufacturer: Isda Pharmaceuticals

[Indications]

Crizotinib is a kinase inhibitor indicated for the treatment of patients with the following conditions:

1. ALK-positive metastatic Non-Small Cell Lung Cancer (NSCLC): Crizotinib is a kinase inhibitor used for the treatment of patients with advanced or metastatic NSCLC whose tumors are confirmed to be Anaplastic Lymphoma Kinase (ALK)-positive by an FDA-approved test.

2. ROS1-positive NSCLC: XALKOR is indicated for the treatment of patients with metastatic NSCLC whose tumors are ROS1-positive.

[Dosage and Administration]

The recommended oral dosage of Crizotinib is 250 mg, taken twice daily until disease progression or patient intolerance. For patients with severe renal impairment [creatinine clearance (CLcr) < 30 mL/min] who do not require dialysis, the recommended oral dosage of Crizotinib is 250 mg, taken once daily. Crizotinib may be taken with or without food. Capsules should be swallowed whole. If a dose of Crizotinib is missed, the missed dose should be taken (unless the next scheduled dose is within 6 hours). If vomiting occurs after taking a dose of Crizotinib, the next dose should be taken at the regularly scheduled time.

[Adverse Reactions]

Adverse drug reactions include: hepatotoxicity, interstitial lung disease (ILD), QT interval prolongation, bradycardia, severe visual impairment, etc.

Common adverse reactions (≥ 25%) include: visual disorders, nausea, diarrhea, vomiting, edema, constipation, elevated transaminases, fatigue, decreased appetite, upper respiratory tract infection, dizziness, and psychiatric disorders.

[Precautions]

1. Hepatotoxicity: Symptoms of hepatotoxicity have been observed in 0.1% of patients taking Crizotinib. Patients require periodic monitoring of liver function and, depending on the clinical situation, may require dosage adjustments: temporary suspension of treatment, dose reduction, or permanent discontinuation of treatment. 2. Interstitial Lung Disease (ILD)/Pneumonitis: Symptoms of interstitial lung disease (ILD) or pneumonitis occurred in 2.9% of patients treated with crizotinib. Treatment should be permanently discontinued in patients who develop ILD or pneumonitis.

3. QT Interval Prolongation: QT interval prolongation occurred in 2.1% of patients treated with crizotinib. ECG and electrolyte monitoring are required for patients with a history of QT interval prolongation or a predisposition to it, as well as for patients who develop QT prolongation during treatment. Dosage adjustments—including temporary interruption, dose reduction, or permanent discontinuation—should be made based on the patient's clinical status.

4. Bradycardia: Crizotinib can cause bradycardia. Patients should undergo regular monitoring of heart rate and blood pressure. Dosage adjustments—including temporary interruption, dose reduction, or permanent discontinuation—should be made based on the patient's clinical status.

5. Severe Visual Impairment: Severe visual impairment has been reported in 0.2% of patients treated with crizotinib. Crizotinib treatment should be discontinued in patients experiencing severe visual impairment, and an ophthalmologic evaluation should be performed.

6. Fetal Toxicity: Crizotinib may cause fetal harm. Women of reproductive potential should be advised to use effective contraception during treatment.

Product Specifications

Product Name: Crizotinib (Xalkori) 250mg x 60 Capsules | Crizocent 250mg 60s | Incepta Crizotinib

Common Name: Crizotinib

Active Ingredient: Crizotinib

Dosage Form: Capsules

Specification: 250mg x 60 capsules per box

Manufacturer: Incepta Pharmaceuticals

Indications: Crizotinib is a kinase inhibitor indicated for the treatment of the following patients:

1. ALK-Positive Metastatic Non-Small Cell Lung Cancer (NSCLC): Crizotinib is a kinase inhibitor used for the treatment of patients with advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors are identified as Anaplastic Lymphoma Kinase (ALK)-positive by an FDA-approved test. 2. ROS1-Positive Non-Small Cell Lung Cancer: XALKORI is indicated for the treatment of patients with metastatic NSCLC whose tumors are ROS1-positive.

Dosage and Administration: The recommended oral dose of crizotinib is 250 mg, taken twice daily until disease progression or until the patient no longer tolerates the therapy. For patients with severe renal impairment [creatinine clearance (CLcr) < 30 mL/min] who do not require dialysis, the recommended oral dose of crizotinib is 250 mg, taken once daily. Crizotinib may be taken with or without food. Swallow the capsules whole. If a dose of crizotinib is missed, take the missed dose (unless the next scheduled dose is within 6 hours). If vomiting occurs after taking a dose of crizotinib, take the next dose at the regularly scheduled time.