mitoxantrone injection, USP What is the most important information I should know about MitoXANTRONE?

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What is the most important information I should know about MitoXANTRONE?

MitoXANTRONE can cause serious side effects, including:

  • decrease in the ability of your bone marrow to make blood cells (myelosuppression). Your doctor may do blood tests during treatment with MitoXANTRONE to check your blood cell counts. The symptoms of myelosuppression can include:
    • feeling tired
    • increased infections
    • bruising and bleeding easily
  • heart problems (congestive heart failure) that may lead to death even in people who have never had heart problems before. Heart failure can happen while you receive MitoXANTRONE, or months to years after you stop receiving MitoXANTRONE. Your risk of heart failure increases the more MitoXANTRONE you receive.
    Call your doctor or get medical help right away if you have any of these problems during or after treatment with MitoXANTRONE:
    • shortness of breath
    • swelling of your ankles or feet
    • sudden weight gain
    • fast heartbeat or pounding in your chest
    Before receiving MitoXANTRONE for the first time, you should have the following tests done:
    • physical examination
    • a test to check your heart's electrical activity (electrocardiogram)
    • 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:
    • before you receive each MitoXANTRONE dose
    • 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:
  • feeling unusually tired and weak
  • increased infections
  • bruising and bleeding easily
  • fever
  • pain in your bones
  • trouble breathing
  • unexplained weight loss
  • 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:
  • redness
  • swelling
  • pain
  • burning
  • skin turns a bluish color

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What is the most important information I should know about MitoXANTRONE?

What is the most important information I should know about MitoXANTRONE?

MitoXANTRONE can cause serious side effects, including:

  • decrease in the ability of your bone marrow to make blood cells (myelosuppression). Your doctor may do blood tests during treatment with MitoXANTRONE to check your blood cell counts. The symptoms of myelosuppression can include:
    • feeling tired
    • increased infections
    • bruising and bleeding easily
  • heart problems (congestive heart failure) that may lead to death even in people who have never had heart problems before. Heart failure can happen while you receive MitoXANTRONE, or months to years after you stop receiving MitoXANTRONE. Your risk of heart failure increases the more MitoXANTRONE you receive.
    Call your doctor or get medical help right away if you have any of these problems during or after treatment with MitoXANTRONE:
    • shortness of breath
    • swelling of your ankles or feet
    • sudden weight gain
    • fast heartbeat or pounding in your chest
    Before receiving MitoXANTRONE for the first time, you should have the following tests done:
    • physical examination
    • a test to check your heart's electrical activity (electrocardiogram)
    • 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:
    • before you receive each MitoXANTRONE dose
    • 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:
  • feeling unusually tired and weak
  • increased infections
  • bruising and bleeding easily
  • fever
  • pain in your bones
  • trouble breathing
  • unexplained weight loss
  • 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:
  • redness
  • swelling
  • pain
  • burning
  • skin turns a bluish color
Prescribing Information
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Health Professional Information

What is the most important information I should know about MitoXANTRONE?

What is the most important information I should know about MitoXANTRONE?

MitoXANTRONE can cause serious side effects, including:

  • decrease in the ability of your bone marrow to make blood cells (myelosuppression). Your doctor may do blood tests during treatment with MitoXANTRONE to check your blood cell counts. The symptoms of myelosuppression can include:
    • feeling tired
    • increased infections
    • bruising and bleeding easily
  • heart problems (congestive heart failure) that may lead to death even in people who have never had heart problems before. Heart failure can happen while you receive MitoXANTRONE, or months to years after you stop receiving MitoXANTRONE. Your risk of heart failure increases the more MitoXANTRONE you receive.
    Call your doctor or get medical help right away if you have any of these problems during or after treatment with MitoXANTRONE:
    • shortness of breath
    • swelling of your ankles or feet
    • sudden weight gain
    • fast heartbeat or pounding in your chest
    Before receiving MitoXANTRONE for the first time, you should have the following tests done:
    • physical examination
    • a test to check your heart's electrical activity (electrocardiogram)
    • 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:
    • before you receive each MitoXANTRONE dose
    • 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:
  • feeling unusually tired and weak
  • increased infections
  • bruising and bleeding easily
  • fever
  • pain in your bones
  • trouble breathing
  • unexplained weight loss
  • 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:
  • redness
  • swelling
  • pain
  • burning
  • skin turns a bluish color

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