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U.S. Department of Health and Human Services

Safety

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Camptosar (irinotecan hydrochloride)

Audience: Oncologists and others caring for patients with metastatic colorectal cancer

The prescribing information in the BOXED WARNING, WARNINGS, and PRECAUTIONS sections were revised to identify patients at higher risk of severe toxicity, to clarify dose modification guidelines, and to augment information about management of treatment-related toxicities, including severe and occasionally life-threatening diarrhea.

[May 10, 2002 - Letter - Pharmacia]
[May 2002 - Full, Revised Label - Pharmacia]