Health Canada Endorsed Important Safety Information on SENSIPAR^® (cinacalcet hydrochloride) - Amgen Canada Inc.

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Public Communication
Health Canada Endorsed Important Safety Information on Sensipar (cinacalcet hydrochloride)

June 19, 2007

Subject: Product Update: New Information About SENSIPAR^® (cinacalcet hydrochloride)

The following updated information has been provided recently to healthcare professionals to review with their patients when prescribing Sensipar^®.

Sensipar^® has been authorized in Canada since 2004 for the treatment of secondary hyperparathyroidism (HPT) in patients with chronic kidney disease (CKD). Recently, a study was conducted with the intent of providing further evidence of the efficacy and safety of cinacalcet in patients with secondary HPT and CKD who are not receiving dialysis. The results of this study showed that while cinacalcet effectively lowered PTH, the incidence of serum calcium levels below the lower limit of the normal range (8.4 mg/dL [2.1 mmol/L]) with cinacalcet treatment was higher than that observed in patients with secondary HPT and CKD receiving dialysis. As such, Amgen considers that this study has not provided evidence of a positive risk to benefit profile of use of cinacalcet in patients with secondary HPT and CKD who are not receiving dialysis.

Therefore, the Sensipar^® Product Monograph will be amended to restrict use to patients with secondary HPT and CKD who are receiving dialysis. The efficacy and safety profile of Sensipar^® in these patients remains unchanged.

Patients being treated with Sensipar^® for secondary HPT who are not receiving dialysis should immediately contact their doctor. Patients should NOT discontinue their medication without contacting their doctor first.

Should you have any questions or require further information regarding the use of Sensipar^®, please contact Amgen Medical Information at 1-866-502-6436.

Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any cases of serious hypocalcemia or other serious or unexpected adverse reactions in patients receiving Sensipar^® should be reported to Amgen or Health Canada at the following address: