g of your legs or ankles, or uneven or fast heartbeat. These problems generally happen in people who get a total lifetime dose of more than 12 doses (usually more than 140 mg/m2) of Novantrone, but can also occur at lower lifetime doses.
Novantrone may cause your white blood cell count to go down, which increases your chance of getting an infection. This risk is greatest within one month after each dose. In addition, Novantrone may cause your platelet count to go down, which increases your chance of bleeding. Call your doctor right away if you begin to have fever, chills, sore throat, cough, pain with urination, urination more often, or if you notice any unusual bleeding or bruising.
Novantrone is dark blue in color, so it may turn your urine a blue-green color for a few days after each dose. The white part of your eyes may also have a slight blue color.
Other side effects may occur. Be sure to tell your doctor about any side effects whether or not they are listed here.
General advice about prescription medicines
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. If you have any concerns about Novantrone, ask your doctor. Your doctor can give you information about Novantrone that was written for health care professionals. For more information, call MS LifeLines toll free at 1-877-447-3243.
Manufactured for:
EMD Serono, Inc.
Rockland, MA 02370 USA
PI 719603
Issued 9/2009
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Novantrone
mitoxantrone hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:44087-1520
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MITOXANTRONE HYDROCHLORIDE (MITOXANTRONE) MITOXANTRONE HYDROCHLORIDE 20 mg in 10 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
SODIUM ACETATE
ACETIC ACID
Packaging
# Item Code Package Description
1 NDC:44087-1520-1 10 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019297 12/23/1987
Labeler - EMD Serono, Inc. (088514898)
Registrant - EMD Serono, Inc. (088514898)
Establishment
Name Address ID/FEI Operations
Pierre Fabre Medicament Production 504638276 ANALYSIS, MANUFACTURE
