Drug Action
Afatinib is a protein kinase inhibitor.
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Drug reference
Afatinib is a protein kinase inhibitor.
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Treatment of locally advanced or metastatic non-small cell lung cancer with activating epidermal growth factor receptor (EGFR) mutations, in patients who have not previously been treated with EGFR tyrosine kinase inhibitor ▶BY MOUTH ▶Adult: 40 mg once daily; increased if tolerated to up to 50 mg once daily, dose increase may be considered after 3 weeks at initial dose; consult product literature for details on dosing and dose adjustment due to side effects
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Cardiac risk factors. conditions which may affect left ventricular ejection fraction—consider cardiac monitoring, including assessment of left ventricular ejection fraction, at baseline and during treatment. diarrhoea—proactive management recommended (consult product literature). exposure to sun (protect skin from exposure to sun). history of keratitis. new pulmonary symptoms (including dyspnoea, cough, fever)—interrupt treatment until interstitial lung disease is excluded. severe dry eyes. signs and symptoms of keratitis— promptly refer to ophthalmologist for assessment. signs and symptoms of skin reaction—treat promptly and interrupt afatinib treatment if severe or if Stevens-Johnson syndrome suspected (consult product literature). ulcerative keratitis . use of contact lenses. worsening pulmonary symptoms (including dyspnoea, cough, fever)—interrupt treatment until interstitial lung disease is excluded
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NICE decisions ▶Afatinib for treating epidermal growth factor receptor mutation-positive locally advanced or metastatic non-small- cell lung cancer (April 2014) NICE TA310 Afatinib is recommended as an option, within its marketing authorisation, for treating locally advanced or metastatic non-small-cell lung cancer in adults: . whose tumour tests positive for the epidermal growth factor receptor tyrosine kinase (EGFR-TK) mutation, and . who have not previously had an EGFR-TK inhibitor, and . if the manufacturer provides afatinib with the discount agreed in the patient access scheme. www.nice.org.uk/guidance/ta310
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RISKS OF INCORRECT DOSING OF ORAL ANTI-CANCER MEDICINES See Cytotoxic drugs p. 938.
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→Appendix 1: afatinib
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▶Common or very common Appetite decreased. cystitis. dehydration. diarrhoea. dry eye. dyspepsia. epistaxis. eye inflammation. fever. hypokalaemia. muscle spasms. nausea. oral disorders. paronychia. renal impairment. rhinorrhoea. skin reactions. taste altered. vomiting. weight decreased ▶Uncommon Interstitial lung disease. pancreatitis ▶Rare or very rare Severe cutaneous adverse reactions (SCARs)
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Ensure effective contraception during and for at least one month after treatment in women of childbearing potential.
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Manufacturer advises avoid. See also Pregnancy and reproductive function in Cytotoxic drugs p. 938.
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Manufacturer advises avoid—present in milk in animal studies.
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Manufacturer advises caution in mild to moderate impairment; avoid in severe impairment (no information available). Dose adjustments Manufacturer advises consider dose interruption if hepatic function worsens in mild to moderate impairment—consult product literature.
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Manufacturer advises avoid in severe renal impairment.
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Tablets should be taken whole on an empty stomach. Food should not be consumed for at least 3 hours before and at least 1 hour after each dose. Giotrif ® tablets may be dispersed in approximately 100 mL of noncarbonated water by stirring occasionally for up to 15 minutes (must not be crushed). The dispersion should be swallowed immediately, and the glass rinsed with the same volume of water which should also be swallowed. The dispersion can also be administered via a gastric tube.
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There can be variation in the licensing of different medicines containing the same drug. Tablet CAUTIONARY AND ADVISORY LABELS 25 ▶Giotrif (Boehringer Ingelheim Ltd) Afatinib (as Afatinib dimaleate) 20 mg Giotrif 20mg tablets | 28 tablet P £2,023.28 Afatinib (as Afatinib dimaleate) 30 mg Giotrif 30mg tablets | 28 tablet P £2,023.28 Afatinib (as Afatinib dimaleate) 40 mg Giotrif 40mg tablets | 28 tablet P £2,023.28 Afatinib (as Afatinib dimaleate) 50 mg Giotrif 50mg tablets | 28 tablet P £2,023.28 Immune system and malignant disease
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Patient counselling advised (administration). Driving and skilled tasks Ocular adverse reactions may affect performance of skilled tasks e.g. driving.
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40 mg once daily; increased if tolerated to up to
First-line fragment. Read the complete Indications and Dose section above.
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