Drug Action
Erlotinib is a tyrosine kinase inhibitor.
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Individual generic drug information
Extracted information for Erlotinib only.
Erlotinib is a tyrosine kinase inhibitor.
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Treatment of locally advanced or metastatic non-small cell lung cancer after failure of previous chemotherapy | Monotherapy for maintenance treatment of locally advanced or metastatic non-small cell lung cancer with stable disease after four cycles of platinum-based chemotherapy ▶BY MOUTH ▶Adult: 150 mg once daily Treatment of metastatic pancreatic cancer (in combination with gemcitabine) ▶BY MOUTH ▶Adult: 100 mg once daily
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DUE TO INTERACTIONS ▶Manufacturer advises if concurrent use of potent inducers of CYP3A4 is unavoidable, increase dose to 300 mg daily, if well tolerated for more than 2 weeks, further increase to 450 mg daily could be considered with close monitoring.
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Smoking Dose adjustment may be necessary if smoking started or stopped during treatment.
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NICE decisions ▶Erlotinib monotherapy for maintenance treatment of non- small-cell lung cancer (June 2011) NICE TA227 Erlotinib (Tarceva ®) monotherapy is not recommended for maintenance treatment in patients with locally advanced or metastatic non-small-cell lung cancer who have stable disease after platinum-based first-line chemotherapy. Patients currently receiving erlotinib monotherapy for maintenance treatment should have the option to continue treatment until they and their clinician consider it appropriate to stop. Immune system and malignant disease www.nice.org.uk/guidance/ta227 ▶Erlotinib for the first-line treatment of locally advanced or metastatic EGFR-TK mutation-positive non-small-cell lung cancer (June 2012) NICE TA258 Erlotinib (Tarceva ®) is recommended as an option in patients for the first-line treatment of locally advanced or metastatic non-small-cell lung cancer if: . they test positive for the epidermal growth factor tyrosine kinase (EGFR-TK) mutation, and . the manufacturer provides erlotinib at the discounted price agreed under the patient access scheme (as revised in 2012). www.nice.org.uk/guidance/ta258 ▶Erlotinib and gefitinib for treating non-small-cell lung cancer that has progressed after prior chemotherapy (December 2015) NICE TA374 Erlotinib is not recommended for treating locally advanced or metastatic non-small-cell lung cancer that has progressed after non-targeted chemotherapy in patients with tumours that are EGFR-TK mutation- negative. Patients whose treatment was started within the NHS before this guidance was published should have the option to continue treatment until they and their NHS clinician consider it appropriate to stop. www.nice.org.uk/guidance/ta374 ▶Erlotinib and gefitinib for treating non-small-cell lung cancer that has progressed after prior chemotherapy (December 2015) NICE TA374 Erlotinib is recommended as an option for treating locally advanced or metastatic non-small-cell lung cancer that has progressed after non-targeted chemotherapy in patients with tumours of unknown epidermal growth factor receptor tyrosine kinase (EGFR-TK) mutation status, only if: . the result of an EGFR-TK mutation diagnostic test is unobtainable because of an inadequate tissue sample or poor-quality DNA, and . the treating clinician considers that the tumour is very likely to be EGFR-TK mutation-positive, and . the patient’s condition responds to the first 2 cycles of treatment with erlotinib, and . the manufacturer provides erlotinib with the discount agreed in the patient access scheme. Patients whose treatment was started within the NHS before this guidance was published should have the option to continue treatment until they and their NHS clinician consider it appropriate to stop. www.nice.org.uk/guidance/ta374
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Extracted information for Erlotinib only.
Immune system and malignant disease MHRA/CHM ADVICE: EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) INHIBITORS: SERIOUS CASES OF KERATITIS AND ULCERATIVE KERATITIS (MAY 2012) Keratitis and ulcerative keratitis have been reported following treatment with epidermal growth factor receptor (EGFR) inhibitors for cancer (cetuximab, erlotinib, gefitinib and panitumumab). In rare cases, this has resulted in corneal perforation and blindness. Patients undergoing treatment with EGFR inhibitors who present with acute or worsening signs and symptoms suggestive of keratitis should be referred promptly to an ophthalmology specialist. Treatment should be interrupted or discontinued if ulcerative keratitis is diagnosed. RISKS OF INCORRECT DOSING OF ORAL ANTI-CANCER MEDICINES See Cytotoxic drugs p. 938.
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→Appendix 1: erlotinib
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▶Common or very common Alopecia. diarrhoea. eye inflammation. haemorrhage. increased risk of infection. renal failure. skin reactions ▶Uncommon Brittle nails. eye disorders. gastrointestinal disorders. hair changes. interstitial lung disease. nephritis. proteinuria ▶Rare or very rare Hepatic failure. severe cutaneous adverse reactions (SCARs) ▶Frequency not known Appetite decreased. chills. cough. depression. dyspnoea. fatigue. fever. gastrointestinal discomfort. headache. nausea. neuropathy sensory. stomatitis. vomiting. weight decreased
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Effective contraception required during and for at least 2 weeks after treatment.
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Manufacturer advises avoid—toxicity in animal studies. See also Pregnancy and reproductive function in Cytotoxic drugs p. 938.
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Manufacturer advises avoid breast- feeding during treatment and for at least 2 weeks after the last dose.
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Manufacturer advises caution in mild to moderate impairment—monitor liver function and interrupt treatment if changes in liver function are severe (increased risk of hepatic failure); avoid in severe impairment—no information available. Dose adjustments Manufacturer advises consider dose reduction or interruption if serious adverse effects occur.
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Manufacturer advises avoid in severe impairment.
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Extracted information for Erlotinib only.
There can be variation in the licensing of different medicines containing the same drug. Tablet CAUTIONARY AND ADVISORY LABELS 23 ▶Erlotinib (Non-proprietary) Erlotinib (as Erlotinib hydrochloride) 25 mg Erlotinib 25mg tablets | 30 tablet P £200.00–£378.33 | 30 tablet P £378.33 (Hospital only) Erlotinib (as Erlotinib hydrochloride) 100 mg Erlotinib 100mg tablets | 30 tablet P £704.00–£1,324.24 | 30 tablet P £378.33 (Hospital only) Erlotinib (as Erlotinib hydrochloride) 150 mg Erlotinib 150mg tablets | 30 tablet P £815.00–£1,631.59 | 30 tablet P £378.33 (Hospital only) ▶Tarceva (Roche Products Ltd) Erlotinib (as Erlotinib hydrochloride) 25 mg Tarceva 25mg tablets | 30 tablet P £378.33 Erlotinib (as Erlotinib hydrochloride) 100 mg Tarceva 100mg tablets | 30 tablet P £1,324.14 Erlotinib (as Erlotinib hydrochloride) 150 mg Tarceva 150mg tablets | 30 tablet P £1,631.53
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Filter the extracted dose blocks for this individual drug.
First line only; read the complete Indications and dose section above.
150 mg once daily
This is a first-line fragment. Read the full Indications and Dose section above.
Candidate age grouping · source page 1055
First line only; read the complete Indications and dose section above.
100 mg once daily
This is a first-line fragment. Read the full Indications and Dose section above.
Candidate age grouping · source page 1055