45 mg once daily until disease progression or unacceptable toxicity occurs. Recommended dose modification for adverse drug reactions Recommended starting dose: 45 mg once daily; 1st dose reduction: 30 mg once daily; 2nd dose reduction: 15 mg once daily. Severe hepatic impairment (Child-Pugh class C) Initially 30 mg once daily, may be increased to 45 mg once daily based on individual safety & tolerability after at least 4 wk of treatment.
Assessment of EGFR mutation status. Perform careful assessment of patients w/ acute onset &/or unexplained worsening of pulmonary symptoms to exclude interstitial lung disease/pneumonitis. Permanently discontinue treatment if interstitial lung disease/pneumonitis is confirmed. Risk of diarrhoea, including severe diarrhoea; rash, erythematous & exfoliative skin conditions; increased transaminases (eg, AST, ALT) & hepatotoxicity. Advise patients to use protective clothing & sunscreen before sun exposure. Periodic LFT is recommended. Interrupt treatment in patients who develop severe elevated transaminases during therapy. Avoid concomitant use w/ CYP2D6 metabolised medicinal products & proton-pump inhibitors. Not to be taken by patients w/ rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption. May affect ability to drive or operate machinery. Women of childbearing potential should use effective contraception during & at least 17 days after completing therapy. Not to be used during pregnancy. Lactation. Childn <18 yr.
Increased mean exposure of dextromethorphan; other medicinal products primarily metabolised by CYP2D6. Avoid co-administration of CYP2D6 substrates w/ narrow therapeutic index (eg, procainamide, pimozide, & thioridazine); PPIs. Subtherapeutic exposure of drugs w/ active metabolites formed via CYP2D6 eg, codeine & tramadol. Administer Davizim 2 hr before or at least 10 hr after taking a histamine-2 receptor antagonist. May potentially inhibit P-gp activity, BCRP & organic cation transporter 1.
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