PRECAUTIONS
PRECAUTIONS
General
Therapy with mitoxantrone should be accompanied by close and frequent monitoring of hematologic and chemical laboratory parameters, as well as frequent patient observation.
Systemic infections should be treated concomitantly with or just prior to commencing therapy with mitoxantrone.
Information for Patients
See FDA-approved patient labeling (MEDICATION GUIDE).
Inform patients of the availability of a Medication Guide and instruct them to read the Medication Guide prior to initiating treatment with MitoXANTRONE and prior to each infusion. Review the MitoXANTRONE Medication Guide with every patient prior to initiation of treatment and periodically during treatment. Instruct patients that MitoXANTRONE should be taken only as prescribed.
Advise patients that MitoXANTRONE can cause myelosuppression and inform patients of the signs and symptoms of myelosuppression. Advise patients that MitoXANTRONE can cause congestive heart failure that may lead to death even in people who have never had heart problems before, and inform patients of the signs and symptoms of congestive heart failure. Advise patients receiving MitoXANTRONE to treat multiple sclerosis that they should receive cardiac monitoring prior to each MitoXANTRONE dose and yearly after stopping MitoXANTRONE.
MitoXANTRONE may impart a blue-green color to the urine for 24 hours after administration, and patients should be advised to expect this during therapy. Bluish discoloration of the sclera may also occur.
Laboratory Tests
A complete blood count, including platelets, should be obtained prior to each course of mitoxantrone and in the event that signs and symptoms of infection develop. Liver function tests should also be performed prior to each course of therapy. Mitoxantrone therapy in multiple sclerosis patients with abnormal liver function tests is not recommended because mitoxantrone clearance is reduced by hepatic impairment and no laboratory measurement can predict drug clearance and dose adjustments.
In leukemia treatment, hyperuricemia may occur as a result of rapid lysis of tumor cells by mitoxantrone. Serum uric acid levels should be monitored and hypouricemic therapy instituted prior to the initiation of antileukemic therapy.
Women with multiple sclerosis who are biologically capable of becoming pregnant, even if they are using birth control, should have a pregnancy test, and the results should be known, before receiving each dose of mitoxantrone (see WARNINGS, Pregnancy).
Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenesis
Intravenous treatment of rats and mice, once every 21 days for 24 months, with mitoxantrone resulted in an increased incidence of fibroma and external auditory canal tumors in rats at a dose of 0.03 mg/kg (0.02 fold the recommended human dose, on a mg/m2 basis), and hepatocellular adenoma in male mice at a dose of 0.1 mg/kg (0.03 fold the recommended human dose, on a mg/m2 basis). Intravenous treatment of rats, once every 21 days for 12 months with mitoxantrone resulted in an increased incidence of external auditory canal tumors in rats at a dose of 0.3 mg/kg (0.15 fold the recommended human dose, on a mg/m2 basis).
Mutagenesis
Mitoxantrone was clastogenic in the in vivo rat bone marrow assay. Mitoxantrone was also clastogenic in two in vitro assays; it induced DNA damage in primary rat hepatocytes and sister chromatid exchanges in Chinese hamster ovary cells. Mitoxantrone was mutagenic in bacterial and mammalian test systems (Ames/Salmonella and E. coli and L5178Y TK+/-mouse lymphoma).
Drug Interactions
Mitoxantrone and its metabolites are excreted in bile and urine, but it is not known whether the metabolic or excretory pathways are saturable, may be inhibited or induced, or if mitoxantrone and its metabolites undergo enterohepatic circulation. To date, post-marketing experience has not revealed any significant drug interactions in patients who have received mitoxantrone for treatment of cancer. Information on drug interactions in patients with multiple sclerosis is limited.
Following concurrent administration of mitoxantrone with corticosteroids, no evidence of drug interactions has been observed.
Special Populations
Hepatic Impairment
Patients with multiple sclerosis who have hepatic impairment should ordinarily not be treated with mitoxantrone. Mitoxantrone should be administered with caution to other patients with hepatic impairment. In patients with severe hepatic impairment, the AUC is more than three times greater than the value observed in patients with normal hepatic function.
Nursing Mothers
Mitoxantrone is excreted in human milk and significant concentrations (18 ng/mL) have been reported for 28 days after the last administration. Because of the potential for serious adverse reactions in infants from mitoxantrone, breast feeding should be discontinued before starting treatment.
Geriatric Use
Multiple Sclerosis
Clinical studies of mitoxantrone did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
Hormone-Refractory Prostate Cancer
One hundred forty-six patients aged 65 and over and 52 younger patients (<65 years) have been treated with mitoxantrone in controlled clinical studies. These studies did not include sufficient numbers of younger patients to determine whether they respond differently from older patients. However, greater sensitivity of some older individuals cannot be ruled out.
MEDICATION GUIDE MITOXANTRONE(MITO-XAN-TRONE) INJECTION, USP (CONCENTRATE)
MEDICATION GUIDE MitoXANTRONE (mito-xan-trone) Injection, USP (concentrate)
CONTAINS SODIUM METABISULFITE, A SULFITE THAT MAY CAUSE ALLERGIC-TYPE REACTIONS INCLUDING ANAPHYLACTIC SYMPTOMS AND LIFE-THREATENING OR LESS SEVERE ASTHMATIC EPISODES IN CERTAIN SUSCEPTIBLE PEOPLE. THE OVERALL PREVALENCE OF SULFITE SENSITIVITY IN THE GENERAL POPULATION IS UNKNOWN AND PROBABLY LOW. SULFITE SENSITIVITY IS SEEN MORE FREQUENTLY IN ASTHMATIC THAN IN NONASTHMATIC PEOPLE.
Read this Medication Guide before you start receiving MitoXANTRONE and each time you receive MitoXANTRONE. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment.
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:
- o
- feeling tired
- o
- increased infections
- o
- 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:- o
- shortness of breath
- o
- swelling of your ankles or feet
- o
- sudden weight gain
- o
- fast heartbeat or pounding in your chest
- Before receiving MitoXANTRONE for the first time, you should have the following tests done:
- o
- physical examination
- o
- a test to check your heart's electrical activity (electrocardiogram)
- o
- 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:
- o
- before you receive each MitoXANTRONE dose
- o
- 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:
|
|
- •
- 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:
|
|
What is MitoXANTRONE?
MitoXANTRONE is a prescription medicine used alone or with other medicines to treat people with:
- •
- secondary (chronic) progressive, progressive relapsing, or worsening relapsing-remitting multiple sclerosis (MS)
- •
- pain related to advanced hormone-refractory prostate cancer
- •
- acute nonlymphocytic leukemia (ANLL)
MitoXANTRONE is not for people with primary progressive MS. It is not known if MitoXANTRONE is safe and effective in children.
Who should not receive MitoXANTRONE?
Do not receive MitoXANTRONE if you are allergic to MitoXANTRONE or any of the ingredients in MitoXANTRONE. See the end of this Medication Guide for a complete list of ingredients in MitoXANTRONE.
What should I tell my doctor before receiving MitoXANTRONE?
Before you receive MitoXANTRONE, tell your doctor if you have:
- •
- received MitoXANTRONE in the past
- •
- heart problems
- •
- liver problems
- •
- kidney problems
- •
- low blood cell counts
- •
- an infection
- •
- had radiation treatment in your chest area
- •
- any other medical conditions
- •
- are pregnant or plan to become pregnant. MitoXANTRONE may harm your unborn baby. Women who are able to become pregnant should use effective birth control (contraception) while using MitoXANTRONE and should have a pregnancy test, with known results, before receiving each dose of MitoXANTRONE. Talk to your doctor about using effective birth control while you receive MitoXANTRONE.
- •
- are breastfeeding or plan to breastfeed. MitoXANTRONE can pass into your breast milk and may harm your baby. Talk to your doctor about the best way to feed your baby if you receive MitoXANTRONE. Do not breastfeed while receiving MitoXANTRONE.
Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.
Using MitoXANTRONE with certain other medicines may cause serious side effects.
Especially tell your doctor if you take or have taken:
- •
- medicines for cancer treatment called anthracyclines or anthracenediones
- •
- medicines that may affect your heart
Ask your doctor or pharmacist for a list of these medicines if you are not sure if you take or have taken any of these medicines.
Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.
How should I receive MitoXANTRONE?
- •
- MitoXANTRONE is given by slow infusion through a needle placed in a vein (intravenous infusion) in your arm.
- •
- Your doctor will tell you how often you will receive MitoXANTRONE.
- •
- If you receive MitoXANTRONE to treat MS, your doctor should check how well your heart is working before each MitoXANTRONE dose. Talk to your doctor if you have not had your heart tests done before your MitoXANTRONE dose.
- •
- Your doctor will do blood tests during your treatment with MitoXANTRONE to check your blood cell counts.
- •
- If you are a woman of childbearing age taking MitoXANTRONE to treat MS, your doctor should do a pregnancy test before each MitoXANTRONE dose, even if you are using birth control.
- •
- If you receive MitoXANTRONE to treat MS, there is a limit to the total amount of MitoXANTRONE you can receive during your lifetime. There is a higher risk of heart failure with increasing total lifetime doses of MitoXANTRONE.
What are the possible side effects of MitoXANTRONE?
MitoXANTRONE may cause serious side effects, including:
- •
- See "What is the most important information I should know about MitoXANTRONE?" The most common side effects of MitoXANTRONE include:
| ||
|
| |
Tell your doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of MitoXANTRONE. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of MitoXANTRONE.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.
This Medication Guide summarizes the most important information about MitoXANTRONE. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about MitoXANTRONE that is written for health professionals.
For more information go to www.pfizer.com or call 1-800-615-0187.
What are the ingredients in MitoXANTRONE?
Active ingredient: MitoXANTRONE hydrochloride
Inactive ingredients: sodium chloride, sodium metabisulfite, sodium acetate, and acetic acid
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Distributed by Hospira Inc., Lake Forest, IL 60045 USA
LAB-1312-2.0
Revised: 7/2025
Additional Resources
Chat online with Pfizer Medical Information regarding your inquiry on a Pfizer medicine or vaccine.
Speak with a Pfizer Medical Information Professional regarding your Pfizer medicine or vaccine inquiry.
Available 9AM-5PM ET Monday to Friday; excluding holidays.
Submit a medical question for a Pfizer medicine or a vaccine.
The submission will be reviewed during our standard business hours.
To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this medication, click the link below to submit your information:
Pfizer Safety Reporting Site
*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.
If you cannot use the above website to report an adverse event related to a Pfizer medication, please call (800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatch or by calling (800) 332-1088.