MITOXANTRONE- mitoxantrone injection, solution, concentrate 
Hospira, Inc.

----------

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:

  • feeling unusually tired and weak
  • increased infections
  • bruising and bleeding easily
  • fever
  • pain in your bones
  • trouble breathing
  • unexplained weight loss
  • night sweats
  • redness
  • swelling
  • pain
  • burning
  • skin turns a bluish color

What is MitoXANTRONE?

MitoXANTRONE is a prescription medicine used alone or with other medicines to treat people with:

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:

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:

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?

What are the possible side effects of MitoXANTRONE?

MitoXANTRONE may cause serious side effects, including:

  • blue-green colored urine for about 24 hours after receiving MitoXANTRONE. This color change is harmless.
  • bluish coloring of the whites of your eyes for about 24 hours after receiving MitoXANTRONE. This color change is harmless.
  • nausea
  • constipation
  • diarrhea
  • stomach pain
  • hair loss
  • fever and chills due to infections
  • cough and sore throat due to upper respiratory tract infection
  • mouth sores due to mouth infection
  • loss of your menstrual period

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.hospira.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.

Mfd by: Zydus Hospira Oncology Private Ltd., Gujarat, India.

Logo

Dist. by: Hospira, Inc. Lake Forest, IL 60045 USA
Product of India GUJ-DRUGS/G/28/1267

4/2016

Revised: 4/2017
Hospira, Inc.