WARNINGS

Irinotecan hydrochloride injection should be administered only under the supervision of a physician who is experienced in the use of cancer chemotherapeutic agents. Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are readily available. Irinotecan hydrychloride injection can induce both early and late forms of diarrhea that appear to be mediated by different mechanisms. Both forms of diarrhea may be severe. Early diarrhea (occurring during or shortly after infusion of irinotecan hydrochloride injection) may be accompanied by cholinergic symptoms of rhinitis, increased salivation, miosis, lacrimation, diaph