Tarceva.net

Convenient once-daily tablet

  

• The recommended Tarceva dose is 150 mg once daily¹
• Tarceva is available in tablets of three different strengths, 150 mg, 100 mg and 25 mg¹*

 

*25 mg tablet not available in all countries

Multiple tablet strengths allow for dose titration without discontinuation

If patients experience intolerable adverse events, e.g. severe skin reactions, diarrhea unresponsive to loperamide or that causes dehydration, or severe liver function test abnormalities, consider dose reduction or interruption of Tarceva.¹

The following dose modification guidelines were specified in the pivotal phase III trial, for grade ≥3 rash or diarrhea not able to be medically managed:^1,2

• Withhold therapy until symptom severity is returned to grade ≤1²
• Resume therapy at a dose 50 mg lower than the original dose¹

Tarceva therapy should be suspended if interstitial lung disease is suspected, and discontinued if confirmed.¹

Do not take with food

Food consumption substantially increases the bioavailability of Tarceva and may increase the risk of adverse events.^1–3

 

 

• Tarceva should be taken at least one hour before or two hours after the ingestion of food^1,2
• Taking Tarceva on an empty stomach helps ensure consistent drug plasma levels^1,2

Precautions with Tarceva

• Woman of childbearing potential must be advised to avoid pregnancy while on Tarceva¹
• Current smokers should be advised to stop smoking, as plasma concentrations in smokers are reduced compared with non-smokers¹

Concomitant treatment with CYP3A4 inhibitors and inducers should be avoided

• Potent inducers of CYP3A4 may reduce the efficacy of Tarceva¹
• Potent inhibitors of CYP3A4 may lead to increased toxicity¹

References

1. Tarceva® (erlotinib) Summary of Product Characteristics, F. Hoffmann-La Roche Ltd, 2011.
2. Roche, data on file.
3. Hidalgo M, Sui LL, Nemunaitis J, et al. Phase I and pharmacologic study of OSI-774, an epidermal growth factor receptor tyrosine kinase inhibitor, in patients with advanced solid malignancies. J Clin Oncol 2001; 19:3267–3279.