Indications & Dose:

Treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)

Orally: 750 mg orally once daily . at least 1 hour before or at least 2 hours after a meal.

Contraindications:

None

Cautions:

-

Precautions:

Severe or Persistent Gastrointestinal Toxicity: can cause severe gastrointestinal toxicity, including fatal gastrointestinal perforation. Dose modification due to diarrhea, nausea, vomiting or abdominal pain occurred in 36% of patients. Withhold if not responsive to antiemetics or antidiarrheals, then dose reduce

Hepatotoxicity: can cause hepatotoxicity. Monitor liver laboratory tests at least monthly. Withhold then dose reduce, or permanently discontinue.

Interstitial Lung Disease (ILD)/Pneumonitis: Occurred in 2.4% of patients. Permanently discontinue in patients diagnosed with treatmentrelated ILD/pneumonitis.

QT Interval Prolongation: can cause QTc interval prolongation.Monitor electrocardiograms and electrolytes in patients with congestive heart failure, bradyarrhythmias, electrolyte abnormalities or those who are taking medications that are known to prolong the QTc interval. Withhold then dose reduce or permanently discontinue.

Hyperglycemia: can cause hyperglycemia. Monitor fasting glucose prior to treatment and periodically thereafter as clinically indicated. Initiate or optimize antihyperglycemic medications as indicated. Withhold then dose reduce or permanently discontinue.

Bradycardia: can cause bradycardia. Monitor heart rate and blood pressure regularly. Withhold then dose reduce or permanently discontinue.

Pancreatitis: Elevations of lipase and/or amylase and pancreatitis can occur. Monitor lipase and amylase prior to treatment and periodically thereafter as clinically indicated.

Embryofetal Toxicity: can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception.

Interaction:

-

Warnings:

-

Adverse Effects:

-

Lactations:

-

Special Precautions:

-

Counselling:

-

Side Effects Or Adverse Reactions:

The most common adverse reactions are diarrhea, nausea, fatigue, vomiting, abdominal pain, decreased appetite and weight loss.

Patient And Carer Advice:

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