Medication Guide

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Prescribing Information

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Before receiving MitoXANTRONE for the first time, you should have the following tests done:

Before receiving MitoXANTRONE for the first time, you should have the following tests done:

o
physical examination
o
a test to check your heart's electrical activity (electrocardiogram)
o
a test to check your heart's ability to pump blood
 
If you receive MitoXANTRONE to treat Multiple Sclerosis (MS), your doctor should also do the tests above:
o
before you receive each MitoXANTRONE dose
o
yearly after you stop receiving MitoXANTRONE treatment
•
acute myeloid leukemia (AML). Receiving MitoXANTRONE increases your risk of AML. AML is a cancer of the blood-forming cells of your bone marrow. Symptoms of AML can include:
o
feeling unusually tired and weak
o
increased infections
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bruising and bleeding easily
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fever
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pain in your bones
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trouble breathing
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unexplained weight loss
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night sweats
•
skin problems at your injection site. If MitoXANTRONE leaks out of your vein, skin problems can happen that may lead to serious skin damage (necrosis). Necrosis may need to be repaired surgically. Tell your doctor right away if you have any of the following problems at your injection site:
o
redness
o
swelling
o
pain
o
burning
o
skin turns a bluish color

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