960 mg once daily until disease progression or unacceptable toxicity. 1st dose reduction: 480 mg once daily. 2nd dose reduction: 240 mg once daily. Max: 2 dose reductions if ARs occur.
May be taken with or without food: Swallow whole. Do not chew/crush/split. For patients w/ difficulty swallowing, disperse tab in 120 mL non-carbonated room temp water w/o crushing & stir until dispersed into small pieces. Drink immediately or w/in 2 hr. Rinse glass w/ additional 120 mL water & drink.
Special Precautions
Hepatotoxicity leading to drug-induced liver injury & hepatitis. Immediately withhold use in patients w/ suspected ILD/pneumonitis & permanently discontinue if no other potential causes of ILD/pneumonitis are identified. Monitor LFTs (ALT, AST & total bilirubin) prior to, every 3 wk for 1st 3 mth then once mthly or as clinically indicated. Monitor for new or worsening pulmonary symptoms indicative of ILD/pneumonitis eg, dyspnea, cough, fever. Avoid co-administration w/ PPIs & H2-receptor antagonists. Pregnancy. Not to be used in lactation during & 1 wk after final dose. Childn.
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