Renal Dose Adjustment (Based on CrCl)
- Renal impairment (<60 mL/min): Avoid use
Hepatic Dose Adjustment
- Hepatic impairment: Dose adjustments not defined
- Drug should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents [US Black Box Warning]
- Reports of severe dose-limiting renal, liver, pulmonary, and CNS toxicities have been reported in Phase 1 studies that used higher than recommended doses of pentostatin; hence, do not exceed the recommended doses [US Black Box Warning]
- Use of pentostatin in combination with fludarabine for the treatment of refractory chronic lymphocytic leukemia (CLL) is not recommended due to the risk of severe or fatal pulmonary toxicity [US Black Box Warning]
- During the first few courses of therapy, patients may experience myelosuppression
- Patients with infections prior to pentostatin therapy have developed, in some cases, worsening of their condition leading to death, while others have achieved complete response. Therapy should be initiated only when the potential benefits of treatment outweigh the potential risks. Efforts should be made to control the infection prior to initiation of therapy
- In patients with progressive hairy cell leukemia, the initial courses of treatment were associated with worsening of neutropenia; monitor CBC during this time. If severe neutropenia persists beyond the initial cycles, an evaluation of disease status should be considered along with a bone marrow examination
- Cases of renal toxicity have been reported at higher doses
- Rashes, sometimes severe, have been reported and may worsen with continued treatment; withholding of treatment may be necessary
- Therapy may be associated with elevations in liver function tests, which are generally reversible
- Acute pulmonary edema and hypotension, leading to death, have been reported when given in combination with carmustine, etoposide, and high dose cyclophosphamide
- Pregnant women or patients becoming pregnant during therapy should be apprised of the potential hazard of the drug to the fetus
- Advise women of childbearing potential to avoid becoming pregnant while on therapy
- Closely observe patients and monitor hematologic parameters and blood chemistry values at regular intervals. Withhold therapy if severe adverse reactions occur during therapy and initiate appropriate corrective measures
- Withhold or discontinue therapy in patients showing evidence of nervous system toxicity
- Before each dose of pentostatin and at regular periods during therapy, CBC and serum creatinine should be performed. Periodic monitoring of the peripheral blood for hairy cells, to assess the response to treatment, should be performed
Cautions: Use cautiously in
- Renal impairment
- Active infections
Pregnancy Category:D
Breastfeeding: Safety unknown. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, analyzing the importance of the drug to the mother.
