Precautions and Warnings With Mitoxantrone

If you have problems with your blood cell counts or have certain other medical issues, talk to your healthcare provider about whether mitoxantrone may increase your risk for certain complications. In some people, this drug may increase the risk for infections, heart problems, or other potentially serious problems. There are also important warnings and precautions for women who are pregnant or nursing.

 

What Should I Tell My Healthcare Provider?

You should talk with your healthcare provider prior to taking mitoxantrone (Novantrone®) if you have:
 
  • Kidney disease, such as kidney failure (renal failure)
  • Liver disease, such as hepatitis, cirrhosis, or liver failure
  • Heart problems, such as congestive heart failure
  • Bone marrow problems
  • Low blood cell counts
  • Anemia
  • Frequent infections, or currently have an infection
  • Had cancer treatment or radiation treatment in the past
  • Any allergies, including to foods, dyes, or preservatives.
 
In addition, let your healthcare provider know if you are:
 
  • Pregnant or thinking of becoming pregnant
  • Breastfeeding.
 
You should also tell your healthcare provider about all other medications you are taking, including prescription and nonprescription medicines, vitamins, and herbal supplements.
 

Specific Mitoxantrone Precautions and Warnings

Some warnings and precautions to be aware of prior to taking this drug include the following:
 
  • This medicine is dark blue in color, and can cause your urine to temporarily turn bluish-green for 24 hours after each dose. The whites of your eyes may also appear bluish in color for 24 hours.
 
  • Mitoxantrone can cause myelosuppression, which is a decrease in the ability of the bone marrow to make blood cells. Myelosuppression can lead to abnormally low levels of white blood cells, red blood cells, and platelets, which could increase your risk for infections, anemia, and bleeding problems. You may need blood tests during treatment to check your blood cell counts. Let your healthcare provider know if you have signs of low blood cell counts, such as:
    • Abnormal or easy bleeding or bruising
    • Fatigue or shortness of breath
    • Frequent infections.
 
  • Mitoxantrone can cause heart problems, including congestive heart failure, which can be severe enough to lead to death. Heart problems can develop during treatment, or even years later, and can even occur in people who have never had heart problems before. Your healthcare provider will order tests to check how well your heart works during treatment. If you use this medicine for multiple sclerosis (MS), you will need to have yearly heart monitoring even after you stop using it.
 
  • Because the risk for heart problems increases with the total amount of medication given, people being treated for MS have a limit on the total amount of mitoxantrone they should receive over their lifetime.
 
  • It is unknown whether mitoxantrone is safe for use in people with liver disease. Make sure your healthcare provider knows if you have liver problems before starting this medication.
 
  • This medicine must only be given as an injection into a vein (intravenous, or IV, injection). There have been reports of serious side effects occurring when it was given as an injection under the skin (subcutaneous) or into an artery (intra-arterial), muscle (intramuscular), or the spinal fluid (intrathecal). These side effects have included nerve damage, seizures, and coma.
 
  • Mitoxantrone may increase your risk for developing a type of leukemia known as acute myeloid leukemia (AML). Let your healthcare provider know if you develop signs of AML, such as:
    • Easy bleeding or bruising
    • Frequent infections
    • Fever
    • Bone pain
    • Unexplained weight loss
    • Night sweats.
   
  • Mitoxantrone is a pregnancy Category D medication, which means it may harm an unborn child. Women of childbearing potential who are receiving this medicine for MS should have a negative pregnancy test before each dose (see Novantrone and Pregnancy).
 
  • Mitoxantrone passes through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to receiving the drug (see Novantrone and Breastfeeding).
 
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