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Mitoxantrone

mitoxantrone

By Bedford Laboratories

What side effects are possible with this medication?

A side effect is an unwanted response to a medication when it is taken in normal doses. A side effect may be mild or severe, temporary or permanent, but does not occur in everyone. The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away over time. If you develop any of these side effects (or any other side effects not listed here) or they change in intensity, speak to your doctor or pharmacist for advice on managing them and on the risks and benefits of the medication.

  • blue-green colored urine (usually lasts about 24 hours after each dose)
  • bluish discoloration of the white of the eye
  • changes in menstrual cycle, including loss of menstrual periods
  • cough
  • darkening or thickening of the nail beds
  • diarrhea
  • fever or chills
  • headache
  • nausea and vomiting
  • sores in the mouth and on the lips
  • swelling, redness, pain, or burning at the injection site
  • swelling of feet and lower legs
  • temporary hair loss
Click here to learn about serious side effects that can potentially occur with any medication. These examples are provided for information purposes only and are not meant to be exhaustive. Always consult your doctor for sound medical advice specific to your particular medication and treatment.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online or by phone at 1-800-332-1088.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

FDA ADVISORY

July 29, 2008

The FDA has issued new information concerning the use of mitoxantrone. To read the full FDA Advisory, visit the FDA's web site at www.fda.gov.

Blood clotting: This medication can reduce the number of platelet cells in the blood. Platelets help the blood to clot, and a shortage could make you bleed more easily. Seek immediate medical attention if you notice unusual or unexplained bleeding. Symptoms include easy bruising; bleeding gums; nosebleeds; spitting or vomiting blood (like ground coffee); brown or discolored urine; or bloody, black, tarry stools.

Blood tests: Your doctor will recommend regular blood tests while you are taking this medication. Be sure to keep all appointments for blood tests, and let your doctor know if you miss an appointment.

Cancer: This medication can, in rare cases, cause a form of leukemia (cancer of the blood), which may not show up for years following treatment. This side effect occurs more commonly in people who are receiving this medication in combination with other chemotherapy medications, or have been previously treated with other chemotherapy regimens or in higher doses.

Eye color: This medication may cause a bluish discoloration of the whites of the eyes.

Gout and kidney stones: Mitoxantrone may increase the levels of uric acid in the body, further increasing the risk for gout or kidney stones in people predisposed to these conditions.

Heart disease: The risk of abnormal heart rhythm, congestive heart failure, and a weakened heart (cardiomyopathy) is increased in people with preexisting heart disease, prior radiation to the chest, previous treatment with other anthracyclines or anthracenediones, or use with other medications that can affect your heart. You may undergo an examination of the heart prior to treatment with mitoxantrone.

Infection: As well as killing cancer cells, this medication can reduce the number of cells that fight infection in the body (white blood cells). Avoid contact with people with contagious infections and tell your doctor if you begin to notice signs of an infection, such as fever or chills.

Liver: People who have liver disease should receive a lower dose of this medication to reduce the chances of having side effects.

Urine: This medication can cause the urine to turn a bluish-green color for about 24 hours following chemotherapy.

Pregnancy: There is a possibility of birth defects if either the man or woman is using mitoxantrone at the time of conception, or if it is taken during pregnancy. Effective birth control should be practiced while using this medication. This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: This medication passes into breast milk. If you are a breast-feeding mother and are taking mitoxantrone, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

What other drugs could interact with this medication?

There may be an interaction between mitoxantrone and any of the following:

  • live vaccines

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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