Xalkori (Crizotinib) – NSCLC | HongKong DengYue Medicine

Crizotinib Application Scope

It is indicated for the treatment of:

• ALK-positive advanced or metastatic non-small cell lung cancer (NSCLC)

• ROS1-positive advanced or metastatic NSCLC

It is used as first-line treatment or in patients who have previously received systemic therapy.

Crizotinib Characteristics

• Ingredients: Crizotinib

• Properties:​ Hard gelatin capsules, white opaque/pink opaque, containing white to off-white powder

• Packaging Specification: ​

  • 250 mg × 60 capsules/box

  • 200 mg × 60 capsules/box (depending on market availability)

• Storage:​ Store at 20–25 °C, protect from moisture and light

• Expiry Date: 24 months (see packaging for exact date)

• Executive Standard: ​In accordance with NMPA / US FDA-approved standard

• Approval Number: Refer to country-specific registration (e.g., NMPA: H20150012)

• Date of Revision: See most recent prescribing information

• Manufacturer: Pfizer Inc.

Guidelines for the Use of Xalkori

• Dosage and Administration:

  • Recommended Dose: 250 mg orally twice daily (total daily dose: 500 mg)

  • Administration: Administer orally, with or without food. Swallow capsules whole.

  • Missed Dose:​ If a dose is missed, take it as soon as remembered unless it is <6 hours until next dose. Do not double dose.

• Adverse Reactions:

  • Common Adverse Reactions:

    • Visual disturbances (blurred vision, photophobia)

    • Nausea, vomiting, diarrhea, constipation

    • Edema

    • Fatigue

    • Elevated liver enzymes (ALT/AST)

  • Serious Adverse Reactions:

    • Interstitial lung disease/pneumonitis

    • QT interval prolongation

    • Severe hepatotoxicity

    • Bradycardia

    • Neutropenia

    ​

• Contraindications: Known hypersensitivity to it or any excipient

• Precautions:

  • Monitor liver function tests regularly

  • ECG monitoring recommended for patients at risk of QT prolongation

  • Use caution in patients with bradycardia or on drugs that lower heart rate

  • Ophthalmologic evaluation if vision changes occur

Crizotinib Interactions

• CYP3A Inhibitors: (e.g., ketoconazole, clarithromycin) increase its plasma levels → avoid or monitor closely

• CYP3A Inducers: (e.g., rifampin, carbamazepine) decrease crizotinib exposure → avoid

• CYP3A Substrates: Crizotinib may increase plasma concentration of drugs metabolized by CYP3A (e.g., midazolam)

• QT-prolonging drugs: Avoid concurrent use if possible

Note:

• If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
•  This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.