How to Prescribe Mitoxantrone: Novantrone®

James Bowen, MD

Medical Director, Multiple Sclerosis Center

Swedish Neuroscience Institute

Seattle, WA

NovantroneÒ 

• Slows the course of multiple sclerosis when used regularly over long periods of time.
• Does not improve existing symptoms.
• Is not used to treat acute MS attacks.

Generic name: mitoxantrone

How supplied: NovantroneÒ is supplied in vials for multidose use which contain 20, 25, or 30 mg/vial

Initial dose: Dose titration is not required.

Maintenance dose: NovantroneÒ must be administered in a chemotherapy-certified infusion center. Patients receive premedication with an antiemetic such as ondansetron 8 mg po 30 minutes before infusion. A free-flowing peripheral IV is started. Novantrone is then infused at a dose of 12 mg/M² IV diluted in 50-100mg normal saline or D5W. The medication is infused over 15-30 minutes.

The dose is repeated once every three months up to a maximum cumulative total of 140 mg/M².

Doses may need to be decreased in those with leucopenia.

Laboratory testing: Basic chemistry panels, transaminases, and CBCs should be monitored just prior to each infusion. Those with liver abnormalities or neutrophil counts of less than 1500 cells/mm³ should not receive NovantroneÒ.

A urinalysis should be monitored just prior to each infusion. Those with urinary tract infections should not receive NovantroneÒ until the infection has resolved.

Patients with evidence of other infections should not receive the medication until the infection has resolved.

Cardiac ejection fraction should be measured by echocardiogram or nuclear medicine scanning. This monitoring should be done at baseline and before all doses. The medication should not be given to those with ejection fractions <50% or those with a clinically significant reduction in ejection fraction. Annual measurement of ejection fraction is recommended in patients who have finished receiving NovantroneÒ treatment.

Most common side effects:

• NovantroneÒ is an anthracenedione and may be cardiotoxic. This limits the total cumulative dose to 140mg/M². Symptomatic congestive heart failure is rare if ejection fractions are monitored and the medication discontinued in those with significant reductions.
• Leucopenia is expected after each dose and does not require treatment. White blood cell counts typically return to normal within approximately two weeks.
• Nausea and vomiting usually responds to antiemetics.
• Fatigue is often present for 2-3 weeks after each infusion.
• Phlebitis may occur at the injection site.
• Oral ulcerations may develop, but usually resolve without treatment.
• Bleeding/bruising may occur.
• Rarely, allergic reactions may occur during or shortly after the infusion.
• The medication is dark blue and may discolor the sclera blue, or the urine blue-green for a few days after each infusion.
• The hair frequently thins and may occasionally be noticeable.
• Almost all women develop amenorrhea while on the treatment. Some never regain their menses resulting in infertility.
• Secondary leukemia has been reported in patients treated with NovantroneÒ. This is extremely rare.

Company Support:   MS Lifelines - 1-877-447-3243

www.novantrone.com, www.MSlifelines.com

EMD Serono and OSI Oncology

Last Updated: November 2009