MITOXANTRONE - mitoxantrone hydrochloride injection, solution 
Fresenius Kabi USA, LLC




Injection, USP


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:

                o      feeling tired

                o      increased infections

                o      bruising and bleeding easily

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

Symptoms of AML can include:

               o   feeling unusually tired and weak

               o   increased infections

               o   bruising and bleeding easily

               o   fever

               o   pain in your bones

               o   trouble breathing

               o   unexplained weight loss

               o   night sweats

                o   redness

                o   swelling

                o   pain

                o   burning

                o   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:

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, call 1-800-551-7176.

What are the ingredients in mitoXANTRONE?

Active ingredient: mitoXANTRONE hydrochloride

Inactive ingredients: sodium chloride, sodium acetate, and acetic acid

This Medication Guide has been approved by the U.S. Food and Drug Administration.



Revised: October 2016

Revised: 6/2017
Fresenius Kabi USA, LLC