Mitoxantrone (Novantrone)

General information

Class/mechanism: Synthetic antineoplastic anthracenedione, intercalates into DNA, causing crosslinking and strand breaks. Mitoxantrone inhibits topoisomerase II, which helps to uncoil and repair damaged DNA. It also has been observed to interfere with RNA and has activity against resting and proliferating cells. In vitro, it has been observed to interfere with antigen presentation; inhibit B-cell, T-cell, and macrophage proliferation; and decrease secretion of interferon gamma, tumor necrosis factor-alpha (TNF-α), and interleukin-2 (IL-2).
Route: IV
Extravasation: irritant (usually), vesicant (rare)

For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.

Diseases for which it is established (work in progress)

• Non-Hodgkin lymphoma
  • Follicular lymphoma
  • Mantle cell lymphoma

Diseases for which it is used

• B-cell acute lymphoblastic leukemia
  • B-cell acute lymphoblastic leukemia, Ph-positive
• Acute myeloid leukemia
  • Acute myeloid leukemia, FLT3-positive
• Acute promyelocytic leukemia
• Breast cancer
• Non-Hodgkin lymphoma
  • B-cell lymphoma of mucosa-associated lymphoid tissue
  • Diffuse large B-cell lymphoma
  • Classical Hodgkin lymphoma
  • Marginal zone lymphoma
• Prostate cancer
• T-cell acute lymphoblastic leukemia

Diseases for which it was used

• Chronic lymphocytic leukemia

Patient drug information

• Mitoxantrone (Novantrone) patient drug information (Chemocare)
• Mitoxantrone (Novantrone) patient drug information (UpToDate)

History of changes in FDA indication

• 1987-12-23: Initial FDA approval for the initial therapy of acute nonlymphocytic leukemia (ANLL) in adults. This category includes myelogenous, promyelocytic, monocytic, and erythroid acute leukemias. (Based on Arlin et al. 1990)
• 1996-11-13: Approved in combination with corticosteroids as initial chemotherapy for the treatment of patients with pain related to advanced hormone-refractory prostate cancer. (Based on CALGB 9182, CCI-NOV22, Moore et al. 1994)

History of changes in EMA indication

• 1981-06-15: EURD

Also known as

• Generic name: mitozantrone
• Brand names: Nitrol, Novantron, Novantrone