Experienced Physician

• Should be administered under the supervision of a physician qualified and experienced in the use of cancer chemotherapeutic agents.

Dose Related Toxicities

• 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.

Not Recommended With Fludarabine

• 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

• Nipent

Package Inserts

Pentostatin