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Updated Renal Safety Information on Zometa (Zoledronic Acid) and Aclasta (Zoledronic Acid) - Novartis Pharmaceuticals Canada inc.

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Public Advisory
Health Canada Endorsed Updated Renal Safety Information on Zometa* (Zoledronic Acid) and Aclasta* (Zoledronic Acid)

August 9, 2005

Subject: Updated Renal Safety Information on Zometa* (zoledronic acid) and Aclasta* (zoledronic acid)

Following discussions with Health Canada, Novartis Pharmaceuticals Canada Inc. would like to inform you of changes made to the Zometa* (zoledronic acid 4 mg for intravenous infusion) prescribing information. We would also like to inform you about the new Product Monograph of Aclasta* (zoledronic acid - 5 mg single-dose intravenous infusion).

ZOMETA* (zoledronic acid)

Zometa* is used to treat the following conditions: a) bone metastases (i.e. cancer that has spread from the tumor to the bone) due to different types of tumors, b) multiple myeloma, and c) tumor-induced hypercalcemia (high blood calcium levels caused by tumors).

The changes to the Zometa* Product Monograph are being made to minimize the possible risk of deterioration in kidney function during treatment with Zometa*. The changes affect patients with advanced cancer with mild to moderate impairment in kidney function or patients with high blood calcium levels caused by tumors (tumor-induced hypercalcemia) requiring retreatment.

Worsening of kidney function, which may progress to kidney failure, has been reported with Zometa* and is also known to occur with other drugs of the bisphosphonate class. Therefore, your doctor will measure your kidney function before each dose of Zometa*. The use of Zometa* is not recommended in patients with severe impairment in kidney function. Also, single doses of Zometa* (zoledronic acid) should not exceed 4 mg and the duration of the infusion should be no less than 15 minutes.

Specific changes that will affect your treatment with Zometa* depending on the condition for which Zometa* has been prescribed are as follows:

Bone Metastases of Solid Tumors and Multiple Myeloma

Your doctor will measure your kidney function before you start treatment with Zometa* and if the results of your blood tests show that you have mild to moderate impairment in kidney function, your doctor will reduce the dose of Zometa* depending on the severity of your kidney problem. You doctor will continue to monitor your kidney function prior to each of the subsequent doses of Zometa*. If these tests indicate worsening of kidney function, your doctor will withhold further treatment with Zometa* until these tests return to normal.

Tumor-Induced Hypercalcemia

Patients who show complete or partial response initially may be retreated with Zometa* 4 mg if blood calcium levels do not return to normal or do not remain normal after initial treatment. The use of the 8 mg dose of Zometa* for the retreatment of tumor-induced hypercalcemia is no longer recommended.

ACLASTA* (zoledronic acid)

Health Canada recently approved Aclasta* for the treatment of patients having Paget's disease of bone.

Worsening of kidney function, which may progress to kidney failure, has been reported with drugs of the bisphosphonates class which Aclasta* is part of. Therefore, your doctor will measure your kidney function before your treatment with Aclasta*. The use of Aclasta* is not recommended in patients with severe impairment in kidney function. Also, the duration of the infusion should be no less than 15 minutes.

Novartis Pharmaceuticals Canada Inc. is committed to the delivery of quality pharmaceutical products and to ensuring the timely communication of new information that is important to patients and healthcare professionals.

Novartis Pharmaceuticals Canada Inc. has also issued a letter to health professionals informing them of the above-mentioned updated safety information. The letter that was sent to health professionals can be found on Health Canada website
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/zometa_aclasta_hpc-cps-eng.php

If you have questions about your current prescription, please contact your physician or pharmacist.

If you have had a serious or unexpected reaction to Zometa* or Aclasta* you may notify either Novartis Pharmaceuticals Canada Inc. or Health Canada as follows:

For media inquiries please contact Jason Jacobs at (514) 633-7872.