.Creatinine clearance should be determined prior to each administration of NIPENT.Liver ImpairmentBecause of limited experience treating patients with abnormal liver function, treatment of such patients should be done with caution.Administration to Elderly PatientsThe recommended dosage of pentostatin for the treatment of hairy cell leukaemia in the elderly is 4 mg/m2 in a single administration every other week. Clinical trials have included patients over 65 years old and no adverse reactions specific to this age group have been reported.Paediatric UseHairy cell leukaemia is a disease affecting adults, most commonly in the sixth decade of life. Safety and effectiveness of Nipent in children have not been established.
Child Dosage
Not recommended.
Contra Indications
Pentostatin is contraindicated in patients who have demonstrated hypersensitivity to the active ingredient or to any of the excipients.Pentostatin is contraindicated in patients with impaired renal function (Creatinine clearance < 60 ml/min).Pentostatin is contraindicated in patients with active infection.Pentostatin is contraindicated in pregnancy.
Special Precautions
WarningsPentostatin should be administered under the supervision of a physician qualified and experienced in the use of cancer chemotherapeutic agents. The use of doses higher than those specified is not recommended. Dose-limiting severe renal, liver, pulmonary, and CNS toxicities occurred in Phase 1 studies that used pentostatin at a higher dose (20-50 mg/m2/course) than recommended.In a clinical investigation in patients with refractory chronic lymphocytic leukaemia using pentostatin at the recommended dose in combination with fludarabine phosphate, four of six patients entered on the study had severe or fatal pulmonary toxicity. The use of pentostatin in combination with fludarabine phosphate is not recommended.Biochemical studies have demonstrated that pentostatin enhances the effects of vidarabine, a purine nucleoside with antiviral activity. The combined use of vidarabine and pentostatin may result in an increase in adverse reactions associated with each drug. The therapeutic benefit of the drug combination has not been established.Patients with hairy cell leukaemia may experience myelosuppression primarily during the first few courses of treatment. Patients with infections prior to pentostatin treatment have in some cases developed worsening of their condition leading to death; whereas others have achieved complete response. Patients with infection should be treated only when the potential benefit of treatment justifies the potential risk to the patient. Efforts should be made to control the infection before treatment is initiated or resumed.In patients with progressive hairy cell leukaemia, the initial courses of pentostatin treatment were associated with worsening of neutropaenia. Therefore, frequent monitoring of complete blood counts during this time is necessary. If severe neutropenia continues beyond the initial cycles, patient should be eva luated for disease status, including a bone marrow examination.Pentostatin might have harmful effects on the genotype. Therefore, it is recommended that men undergoing treatment with pentostatin should not father a child during treatment up to 6 months thereafter. Contraception is to be guaranteed for women of childbearing age. Should a pregnancy occur during treatment, the possibility of a genetic consultation is t
