PROCHYMAL

The long term effects of PROCHYMAL in growing children are unknown. BEFORE you use PROCHYMAL talk to your doctor if: you are allergic to bovine (cow) or porcine (pig) products. INTERACTIONS WITH THIS MEDICATION Drug interactions between PROCHYMAL and other drugs have not been tested.

There are currently no known drug interactions with PROCHYMAL.

PROPER USE OF THIS MEDICATION Usual dose:

PROCHYMAL should only be administered under the supervision of a health care professional. The dose of PROCHYMAL that is recommended is 2 million cells per kg of body weight. It is recommended that PROCHYMAL be infused at a rate of 4-6 mL per minute.

PROCHYMAL should be delivered 2 times per week and at least 3 days apart for the first 4 weeks. Then PROCHYMAL should be administered 1 time per week for the following 4 weeks if indicated. If a recurrence of aGvHD occurs outside the treatment window, the treatment cycle for PROCHYMAL should be repeated.

Overdose:

Overdose has not been reported and the maximum tolerated dose of PROCHYMAL has not been established in humans. If an overdose does occur, then the patient should be monitored and treated for symptoms. SIDE EFFECTS AND WHAT TO DO ABOUT THEM PROCHYMAL should only be administered under the supervision of a health care professional.

IMPORTANT:

PLEASE READ Prochymal® Product Monograph – NOC/c Page 32 of 33 It is recommended that oxygen saturation (SaO2/SAT) is monitored by pulse oximetry during infusion of the product. Your infusion will be stopped if needed. Undesirable effects, such as allergic reactions or difficulty breathing should be communicated immediately to your caregiver.

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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. HOW TO STORE IT PROCHYMAL should be handled by a health care professional and must be stored at ≤ -135oC in an ultra low temperature freezer.

Cryoprotective gloves should be worn when handling PROCHYMAL at extremely cold temperatures. When PROCHYMAL arrives in a cryoshipper, it can be transferred to a liquid nitrogen freezer for longer term storage if needed. The stem cells will die if storage instructions are not carefully followed.