Indications:

Treatment of ALK-positive metastatic non-small cell lung cancer (NSCLC) in adults.

Dosage & Administration

Standard Dosage:

            ● Initial dose: 90 mg once daily for the first 7 days.

            ● After 7 days: If tolerated, increase to 180 mg once daily.

            ● Take with or without food.

            ● Swallow tablet whole with water—do not crush, split, or chew.

Missed Dose:

            ● If a dose is missed by ≤12 hours, take it immediately.

            ● If >12 hours late, skip the dose and resume the next scheduled dose.

            ● Never double dose.

Dose Adjustments:

            ● For severe side effects, may reduce to:

                                        ■ First reduction: 120 mg once daily

                                        ■ Second reduction: 90 mg once daily

                                        ■ Third reduction: 60 mg once daily

                                        ■ Discontinue if unable to tolerate 60 mg dose.

Precautions

1. Pulmonary Toxicity (ILD/Pneumonitis)

            ● Monitor for new/worsening cough, shortness of breath, fever.

            ● Interrupt treatment immediately if suspected; may require steroids.

2. Hypertension (High Blood Pressure)

            ● Check blood pressure after 1 week, then at least monthly.

            ● May require antihypertensive therapy.

3. Bradycardia (Slow Heart Rate)

            ● Monitor heart rate and blood pressure regularly.

            ● Avoid with other bradycardia-causing drugs (e.g., beta-blockers).

4. Elevated Pancreatic Enzymes

            ● Monitor amylase/lipase periodically.

5. Drug Interactions

            ● Avoid strong CYP3A inhibitors (e.g., ketoconazole)—may increase toxicity.

            ● Avoid strong CYP3A inducers (e.g., rifampin)—may reduce effectiveness.

Common Side Effects

·       Nausea, diarrhea, vomiting

·       Fatigue, headache

·       Cough, shortness of breath

·       Muscle/joint pain

·       High blood pressure

Storage

Store at room temperature (20–25°C) in original packaging.

Note: ALK testing required before treatment.