An antibiotic/antineoplastic - It targets fast dividing cells, like cancer cells, and causes these c... more
FDA Alerts
Special Alerts:
[Posted 07/29/2008] FDA reminded health care professionals who treat patients with mitoxantrone (Novantrone) about recommendations that left ventricular ejection fraction (LVEF) be evaluated before initiating treatment and prior to administering each dose of mitoxantrone. FDA offered additional recommendations for cardiac monitoring to detect late-occurring cardiac toxicity, and provided information for patients with multiple sclerosis who receive the drug.
These recommendations were established in 2005 in response to post-marketing reports and case reports in the medical literature that described decreases in LVEF or frank congestive heart failure in patients with MS who had received cumulative doses of mitoxantrone that were lower than 100 mg/m2. Since that time, FDA has received information from a post-marketing safety study that demonstrated there is poor adherence to these recommendations in clinical practice. FDA is working with the manufacturers to educate healthcare providers to adhere to cardiac monitoring recommendations for patients with MS. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Mitoxantrone and http://www.fda.gov/cder/drug/InfoSheets/HCP/mitroxantroneHCP.htm.
MITOXANTRONE (MYE toe ZAN trone) is a chemotherapy drug. It targets fast dividing cells, like cancer cells, and causes these cells to die. This medicine is used to treat acute nonlymphocytic leukemia (ANLL) and advanced prostate cancer. It is also used to treat certain types of multiple sclerosis.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
This drug is given as an infusion into a vein. It is administered in a hospital or clinic by a specially trained health care professional. If you have pain, swelling, burning or any unusual feeling around the site of your injection, tell your health care professional right away.
A patient information sheet for the product will be given with each prescription and refill. Read this sheet carefully each time. The sheet may change frequently.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
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