Mitoxantrone Injection (Teva Canada): Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

It is used to treat some kinds of cancer:

• metastatic breast cancer;

• relapsed adult leukemia, lymphoma, and

  hepatoma;

• in combination with other drug(s), for acute non-

  lymphocytic leukemia (ANLL).

What it does:

Mitoxantrone belongs to the general group of medicines known as antineoplastics (anticancer). Mitoxantrone seems to interfere with the growth of cancer cells, which are eventually destroyed.

When it should not be used:

• If allergic to MITOXANTRONE INJECTION or

  any of its components, or have demonstrated prior hypersensitivity to anthracycline drugs;

• In patients who have received prior substantial

  anthracycline exposure and have abnormal cardiac function;

• In patients who have NOT recovered from severe

  suppression of the bone marrow activity due to previous treatment with other cytotoxic agents or radiotherapy;

• In patients with severe liver impairment.

What the medicinal ingredient is:

mitoxantrone hydrochloride

What the important nonmedicinal ingredients are:

• Acetic acid
• Sodium acetate
• Sodium chloride
• Water for Injection

What dosage forms it comes in:

2 mg mitoxantrone/mL aqueous solution for intravenous injection available as 10 mL/vial and 12.5 mL/vial.

WARNINGS AND PRECAUTIONS

MITOXANTRONE INJECTION must not be given by intrathecal, subcutaneous, intramuscular, or intra-arterial injection.

Secondary acute myelogenous leukemia has been reported in patients treated with anthracyclines.

Heart muscle toxicity (myocardial/cardiac toxicity) may occur.

BEFORE you use MITOXANTRONE INJECTION talk to your doctor or pharmacist if:

• You are allergic to MITOXANTRONE

  INJECTION, its components, or anthracycline drugs;

• If you have received prior substantial

  anthracycline exposure;

• You are pregnant, if you plan to become pregnant, or if you are breast-feeding a baby;

• You are recently vaccinated or plan to be vaccinated;
• You have heart problems, liver problems, or multiple sclerosis.

INTERACTIONS WITH THIS MEDICATION

Drugs that may interact with MITOXANTRONE INJECTION include:

• Anthracyclines
• Anthracenediones
• Daunorubicin
• Doxorubicin
• Other cardiotoxic drugs

PROPER USE OF THIS MEDICATION

MITOXANTRONE INJECTION should be administered by individuals experienced in the use of antineoplastic therapy and have the facilities to monitor your blood and heart during and after treatment.

MITOXANTRONE INJECTION should be given slowly into a freely flowing intravenous infusion.

It is recommended that MITOXANTRONE INJECTION not be mixed in the same infusion with other drugs.

Usual dose:

The dose of mitoxantrone will be different for different patients. The dose that is used may depend on a number of things, including what the medicine is being used for, body size, and whether or not this drug is being taken in combination with other medication. The proper dose of mitoxantrone will be determined by your doctor.

Overdose:

In case of overdosage, contact a health care practitioner, hospital emergency department or Regional Poison Control Centre immediately, even if there are no symptoms.

There is no known specific antidote for mitoxantrone.

SIDE EFFECTS AND WHAT TO DO ABOUT

THEM

Along with its needed effects, a medicine may cause some unwanted effects that may require medical attention. Discuss these possible effects with your doctor.

Mitoxantrone can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. Talk to your doctor about how to reduce the risk of infection or bleeding.

Mitoxantrone often causes nausea and vomiting. However, it is very important that you continue to receive the medicine, even if your stomach is upset Ask your health care professional for ways to lessen these effects.

Mitoxantrone may cause the urine to turn a blue-green colour. It may also cause the whites of the eyes to turn a blue colour. These effects are normal and last for only 1 or 2 days after each dose is given.

This medicine often causes a temporary loss of hair. After treatment with mitoxantrone has ended, normal hair growth should return.

This is not a complete list of side effects. For any unexpected effects while taking MITOXANTRONE INJECTION, contact your doctor or pharmacist.

HOW TO STORE IT

MITOXANTRONE INJECTION should be stored between 15 and 25°C.

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

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• Report online at

  www.healthcanada.gc.ca/medeffect

• Call toll-free at 1-866-234-2345

• Complete a Canada Vigilance Reporting

  Form and:

  • Fax toll-free to 1-866-678-6789, or

  • Mail to:

    Canada Vigilance Program Health Canada

    Postal Locator 0701D Ottawa, ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be found by contacting, Teva Canada Limited at: 1-800-268-4127 ext. 5005 (English); 1-877-777-9117 (French)

or druginfo@tevacanada.com

Novopharm Limited

30 Novopharm Court

Toronto, Ontario

Canada, M1B 2K9

Last revised: March 5, 2014