Label Changes for:

Novantrone (mitoxantrone HCl) injection

June 2010

Changes have been made to the BOXED WARNING and CONTRAINDICATIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – June 2010

BOXED WARNING

Secondary Leukemia: Novantrone therapy in patients with MS and in patients with cancer increases the risk of developing secondary acute myeloid leukemia.

WARNING

Secondary Leukemia
  • Novantrone therapy increases the risk of developing secondary leukemia in patients with cancer and in patients with multiple sclerosis. In a study of patients with prostate cancer, acute myeloid leukemia occurred in 1% (5/487) of mitoxantrone-treated patients versus no cases in the control group (0/496) not receiving mitoxantrone at 4.7 years followup
  • In a prospective, open-label, tolerability and safety monitoring study of Novantrone treated MS patients followed for up to five years (median of 2.8 years), leukemia occurred in 0.6% (3/509) of patients. Publications describe leukemia risks of 0.25% to 2.8% in cohorts of patients with MS treated with Novantrone and followed for varying periods of time. This leukemia risk exceeds the risk of leukemia in the general population. The most commonly reported types were acute promyelocytic leukemia and acute myelocytic leukemia.
Hide
(web5)