Pentostatin for injection should be administered under the supervision of a physician qualified and experienced in the use of cancer chemotherapeutic agents. The use of higher doses than those specified (see DOSAGE AND ADMINISTRATION) is not recommended. Dose-limiting severe renal, liver, pulmonary, and CNS toxicities occurred in Phase 1 studies that used pentostatin at higher doses (20-50 mg/m2 in divided doses over 5 days) than recommended.
In a clinical investigation in patients with refractory chronic lymphocytic leukemia using pentostatin at the recommended dose in combination with fludarabine phosphate, 4 of 6 patients entered in the study had severe or fatal pulmonary toxicity. The use of pentostatin in combination with fludarabine phosphate is not recommended.
MONITORING RECOMMENDATIONS RELATED TO BLACK BOX DATA
- Assess baseline renal function prior to therapy.
- Perform complete blood cell counts and serum creatinine prior to each dose and at other appropriate times during therapy.
Patient Counseling Information