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For further information please call 1-877-TARCEVA (1-877-827-2382).
TARCEVA, it’s logo mark and
are trademarks of OSI Pharmaceuticals, Inc., Melville, NY, 11747, USA.
©2007 OSI Pharmaceuticals, Inc., and Genentech, Inc. All rights reserved.
EGFR pharmDxTM kit is a trademark of DakoCytomation Denmark A/S
Date of Issue: May 2007
DRUG INTERACTIONS Drug interactions
Co-treatment with the potent CYP3A4 inhibitor ketoconazole increases erlotinib AUC by 2/3. Caution should be used when administering or taking TARCEVA with ketoconazole and other strong CYP3A4 inhibitors such as, but not limited to, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin (TAO), voriconazole and grapefruit or grapefruit juice (see DOSAGE AND ADMINISTRATION - Dose Modifications section).
Pre-treatment with the CYP3A4 inducer rifampicin decreased erlotinib AUC by about 2/3 to 4/5, which is equivalent to a dose of about 30 to 50 mg in NSCLC patients. Use of alternative treatments lacking CYP3A4 inducing activity is strongly recommended. If an alternative treatment is unavailable, adjusting the starting dose should be considered. (see DOSING AND ADMINISTRATION - Dose Modifications section). If the TARCEVA dose is adjusted upward, the dose will need to be reduced immediately to the indicated starting dose upon discontinuation of rifampicin or other inducers. Other CYP3A4 inducers include, but are not limited to, rifabutin, rifapentine, phenytoin, carbamazepine, phenobarbital and St. John's Wort (see CLINICAL PHARMACOLOGY - Interactions and DOSAGE AND ADMINISTRATION - Dose Modifications sections).
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OVERDOSAGE
Single oral doses of TARCEVA up to 1,000 mg in healthy subjects and weekly doses up to 1,600 mg in cancer patients have been tolerated. Repeated twice-daily doses of 200 mg single-agent TARCEVA in healthy subjects were poorly tolerated after only a few days of dosing. Based on the data from these studies, an unacceptable incidence of severe adverse events, such as diarrhea, rash, and liver transaminase elevation, may occur above the recommended dose (see Dosage And Administration section). In case of suspected overdose, TARCEVA should be withheld and symptomatic treatment instituted.
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