Crizotinib

Indications & Dose:

Treatment of previously treated anaplastic lymphoma kinase (ALK) positive advanced non-small cell lung cancer

BY MOUTH

Adult: 250 mg twice daily for dose adjustments due to side-effect consult product literature

Contraindications:

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Side Effects:

common or very common Bone-marrow suppression . bradycardia . cardiac failure . constipation . decreased appetite . diarrhoea . dizziness . dyspepsia . fatigue . hypophosphataemia . interstitial lung disease . nausea . neuropathy . oedema . pneumonitis . pneumonitis . QTinterval prolongation .rash .renal cyst. syncope .taste disturbance . vision disorder. vomiting

Uncommon Gastrointestinal perforation (fatalities reported) . hepatotoxicity (including fatal hepatic failure) Frequency not known Alopecia . hyperuricaemia . oral mucositis .thromboembolism .tumour lysis syndrome Cardiac failure Consider reducing the dose or interrupting or stopping treatment if symptoms of cardiac failure occur.

CONCEPTION AND CONTRACEPTION Ensure effective contraception during and for at least 90 days after treatment.

PREGNANCY Avoid (toxicity in animal studies). See also Pregnancy and reproductive function in Cytotoxic drugs.

BREAST FEEDING Avoid-no information available.

HEPATIC IMPAIRMENT Manufacturer advises caution in mild to moderate impairment. Avoid in severe impairment.

RENAL IMPAIRMENT Reduce dose to 250 mg once daily in severe impairment not requiring peritoneal dialysis or hemodialysis may be increased to 200 mg twice daily after at least 4 weeks based on individual assessment of safety and tolerability.

MONITORING REQUIREMENTS Monitor liver function once a week during the first 2 months of treatment then at least monthly thereafter and as clinically indicated.

ECG and electrolytes (correct if abnormal) in all patients before starting treatment then periodically and as clinically indicated thereafter. Monitor for signs and symptoms of treatment emergent bradycardia (including syncope, dizziness and hypotension) monitor blood pressure and heart rate regularly.

PATIENT AND CARER ADVICE Counsel all patients on the early signs and symptoms of gastrointestinal perforation-advice to seek immediate medical attention.

Driving and skilled tasks Symptomatic bradycardia (including syncope, dizziness and hypotension) vision disorder and fatigue may affect performance of skilled tasks (e.g. driving or operating machinery).

Cautions:

History of diverticulitis (risk of gastrointestinal perforation-discontinue treatment if gastrointestinal perforation occurs). metastases of gastrointestinal tract (risk of gastro-intestinal perforation-discontinue treatment if gastrointestinal perforation occurs). patients with susceptibility to QTprolongation (including bradycardia, history of cardiac disease, concomitant use of drugs that prolong QT interval and electrolyte disturbances) periodic renal monitoring required .risk of gastro-intestinal perforation-discontinue treatment if gastrointestinal perforation occurs . vision disorders reported-consider full ophthalmological evaluation if vision disorder worsens or persists.

Fatal interstitial lung disease and pneumonitis Fatal interstitial lung disease and pneumonitis reported (monitor patients with pulmonary symptoms withdraw treatment if suspected and permanently discontinue treatment if diagnosed).

Precautions:

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Interaction:

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Warnings:

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Adverse Effects:

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Lactations:

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Special Precautions:

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Counselling:

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Side Effects Or Adverse Reactions:

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Patient And Carer Advice:

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