Uromitexan: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

UROMITEXAN (mesna) is used for the reduction and prevention of bleeding in the bladder (hemorrhagic cystitis) caused by anti-cancer drugs such as cyclophosphamide and ifosfamide.

What it does:

UROMITEXAN helps to protect the lining of the bladder against damage from anti-cancer drugs. The body breaks down anti-cancer drugs to form products that can harm the bladder. UROMITEXAN works by making these breakdown products less harmful.

When it should not be used:

UROMITEXAN should not be used if:

You have a known allergy to mesna, any thiol-containing compound or to any of the nonmedicinal ingredients in particular benzyl alcohol.

What the medicinal ingredient is:

Mesna

What the nonmedicinal ingredients are:

Ampoules: Disodium Edetate, Sodium Hydroxide and Sterile Water for Injection.

Multi-dose vials: Disodium Edetate, Sodium Hydroxide, Sterile Water for Injection, and Benzyl Alcohol (104 mg in the 10 mL vial; 520 mg in the 50 mL vial) as a preservative.

What dosage forms it comes in:

UROMITEXAN (mesna injection) 100 mg/mL is available in 4 mL and 10 mL ampoules and 1 g and 5 g multi-dose vials.

WARNINGS AND PRECAUTIONS

BEFORE you use UROMITEXAN talk to your doctor or pharmacist if:

• You have any allergies to this drug or other drugs similar

  to UROMITEXAN, such as amifostine, penicillamine and captopril, or to any of its ingredients.

• You are scheduled to undergo urine screening tests.

• You are pregnant or planning to become pregnant.

• You are nursing an infant.

• You plan to drive or operate machinery.

• You have had previous reactions to UROMITEXAN.

  UROMITEXAN does not prevent hemorrhagic cystitis in all patients. Contact your doctor or nurse immediately if you notice that your urine is pink, red, or bloody.

INTERACTIONS WITH THIS MEDICATION

There are no known drug-drug interactions with UROMITEXAN.

PROPER USE OF THIS MEDICATION

Usual dose:

Your doctor will determine what dose of UROMITEXAN is right for you and how often you should receive it.

UROMITEXAN can be taken intravenously or orally (ampoules only).

Overdose:

A specific antidote for mesna is not known.

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

Missed Dose:

If you miss your scheduled treatment, contact your doctor or nurse as soon as possible to schedule your next treatment.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Because UROMITEXAN is used in combination with other chemotherapy drugs, it is often difficult to distinguish side effects that may be caused by UROMITEXAN from those caused by other drugs.

If you notice any changes in the way you feel during or after the treatment, tell your doctor or another member of your medical team immediately.

Like all medicines, UROMITEXAN can cause side effects although not everybody gets them.

The following side effects may happen with this medicine: Very common (affects more than 1 in 10 people):

• Headache
• Reactions at the application site
• Abdominal pain (colic)
• Feeling abnormally sleepy during the day
• Lightheadedness
• Fever
• Skin rash
• Diarrhea
• Nausea
• Flushing
• Flu-like symptoms (e.g., sore throat, fever, chills, shivering, cough, body aches)

If any of these effects persist or worsen, tell your doctor or nurse IMPORTANT: PLEASE READ

UROMITEXAN Product Monograph Page 24 of 24 promptly

UROMITEXAN can cause serious side effects. These include severe skin rash and skin reactions that can cause death. These problems may occur any time during treatment, but more commonly occur during or after a first treatment or after several weeks of treatment with UROMITEXAN. Sometimes the first skin reaction occurs only after several months of treatment.

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

HOW TO STORE IT

Store at 15^oC to 25^oC. Keep out of reach of children.

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:

-------------------------------------------------------------------------- $ 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, Ontario

  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 at:

http://www.baxter.ca

or by contacting the sponsor, Baxter Corporation, at: 1-888-719-9955.

Baxter, Uromitexan, Procytox , and Ifex are trademarks of Baxter International, Inc.

Last revised: August 6, 2013.