• Under supervision of qualified physician with experience in use of antineoplastic therapy

Bone Marrow Suppression

• Dose related
• Usually reversible

Neurotoxicity

• Serious neurological toxicity (including irreversible paraparesis and quadraparesis) have been reported with continuous infusion at high doses (4 to 9 times the recommended dose for hairy cell leukemia). Severe neurological toxicity rarely reported with standard dosing regimens.

Nephrotoxicity

• Associated with high dose (4 to 9 times the recommended dose for hairy cell leukemia) and on concurrent nephrotoxic drugs

MONITORING RECOMMENDATIONS RELATED TO BLACK BOX DATA

• Serious neurological toxicity (including irreversible paraparesis and quadraparesis) have been reported with continuous infusion at high doses (4 to 9 times the recommended dose for hairy cell leukemia). Severe neurological toxicity rarely reported with standard dosing regimens.
• Perform hematological testing on regular basis during therapy.
• Perform periodic assessment of renal/hepatic function as clinically needed.

Package Inserts

Cladribine