Although patients with severe renal failure have not been studied, Novantrone is extensively tissue bound and it is unlikely that the therapeutic effect or toxicity would be mitigated by peritoneal or hemodialysis.

Novantrone Dosage and Administration
(See also WARNINGS)

Multiple Sclerosis

The recommended dosage of Novantrone is 12 mg/m2 given as a short (approximately 5 to 15 minutes) intravenous infusion every 3 months.  Left ventricular ejection fraction  (LVEF)  should be eva luated by echocardiogram or MUGA prior to administration of the initial dose of Novantrone and all subsequent doses.  In addition,  LVEF eva luations are recommended if signs or symptoms of congestive heart failure develop at any time during treatment with Novantrone  Novantrone should not be administered to multiple sclerosis patients with an LVEF <50%, with a clinically significant reduction in LVEF, or to those who have received a cumulative lifetime dose of ≥ 140 mg/m2. Complete blood counts, including platelets, should be monitored prior to each course of Novantrone and in the event that signs or symptoms of infection develop.  Novantrone generally should not be administered to multiple sclerosis patients with neutrophil counts less than 1500 cells/mm3.  Liver function tests should also be monitored prior to each course.  Novantrone therapy in multiple sclerosis patients with abnormal liver function tests is not recommended because Novantrone clearance is reduced by hepatic impairment and no laboratory measurement can predict drug clearance and dose adjustments.

Women with multiple sclerosis who are biologically capable of becoming pregnant, even if they are using birth control, should have a pregnancy test, and the results should be known, before receiving each dose of Novantrone (see WARNINGS, Pregnancy).

Hormone-Refractory Prostate Cancer

Based on data from two Phase 3 comparative trials of Novantrone plus corticosteroids versus corticosteroids alone, the recommended dosage of Novantrone is 12 to 14 mg/m2 given as a short intravenous infusion every 21 days.

Combination Initial Therapy for ANLL in Adults

For induction, the recommended dosage is 12 mg/m2 of Novantrone daily on Days 1-3 given as an intravenous infusion, and 100 mg/m2 of cytarabine for 7 days given as a continuous 24-hour infusion on Days 1-7.

Most complete remissions will occur following the initial course of induction therapy.  In the event of an incomplete antileukemic response, a second induction course may be given.  Novantrone should be given for 2 days and cytarabine for 5 days using the same daily dosage levels.

If severe or life-threatening nonhematologic toxicity is observed during the first induction course, the second induction course should be withheld until toxicity resolves.

Consolidation therapy which was used in two large randomized multicenter trials consisted of Novantrone, 12 mg/m2 given by intravenous infusion daily on Days 1 and 2 and cytarabine, 100 mg/m2 for 5 days given as a cont