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12/1/2000

Company Strongly Warns Against Using Capecitabine in Patients With Severe Renal Impairment

Cheryl A. Thompson

The antineoplastic agent capecitabine must not be administered to patients with severe renal impairment, and reduced doses should be given to patients with moderate renal impairment, the drug's manufacturer announced recently in a "Dear Doctor" letter (PDF).

Roche Laboratories Inc. said it revised the labeling for capecitabine, also known by the brand name Xeloda, on the basis of results from a recently completed clinical pharmacology study and a subsequent analysis of the clinical database for the drug.

The revised labeling states that patients with a calculated creatinine clearance of less than 30 mL/min must not receive the drug. Analyses of the data indicated that serious adverse events occurred at a high rate in patients with severe renal impairment. Creatinine clearance was calculated with the Cockcroft and Gault equation.

Patients with a calculated creatinine clearance of 30 to 50 mL/min should receive 75 percent of the recommended starting dosage. According to the revised labeling, the starting dosage of capecitabine for these patients is 1900 mg per square meter of body-surface area per day for 14 days followed by seven days without therapy. As with the full dosage, the reduced daily dose should be taken in two equally divided portions, preferably 12 hours apart.

Previous labeling for Xeloda indicated little information had been reported on use of the drug by patients with renal impairment.

Capecitabine itself has little antineoplastic activity. The drug is metabolized in the liver to fluorouracil, the active agent.

Xeloda is marketed for the treatment of metastatic breast cancer resistant to paclitaxel and a regimen containing doxorubicin or another anthracycline. The drug is also marketed for the treatment of paclitaxel-resistant metastatic breast cancer in women who have received the maximum allowable lifetime dose of an anthracycline—400 mg of doxorubicin per square meter of body-surface area or an equivalent amount.