OTTAWA, CANADA -- June 27, 2007 -- Amgen Canada Inc., in consultation with Health Canada, would like to bring to the attention of health care professionals of changes in the Indication and Clinical Use Section of the Sensipar® (cinacalcet hydrochloride) Product Monograph.
Sensipar® was authorized by Health Canada on August 9th, 2004 for the following indication: "Sensipar® is indicated for the treatment of secondary hyperparathyroidism in patients with Chronic Kidney Disease (CKD). Sensipar® controls parathyroid hormone levels, calcium and phosphorous levels, and the serum calcium-phosphorous product (Ca x P), in patients with Chronic Kidney Disease." This indication included patients with CKD receiving dialysis and not receiving dialysis.
The following information is relevant to physicians and patients using Sensipar®:
· Use of Sensipar® in patients with secondary hyperparathyroidism and CKD not receiving dialysis is no longer indicated.
· The indication for treatment of secondary hyperparathyroidism in patients with CKD has been amended to restrict use to patients with secondary hyperparathyroidism and CKD who are receiving dialysis.
The clinical development program investigating cinacalcet for the treatment of secondary hyperparathyroidism (HPT) in patients with CKD not receiving dialysis began with the conduct of 2 studies, which showed that cinacalcet was highly effective in reducing parathyroid hormone (PTH) levels in this patient population. Comparison of results from these studies with those of studies in subjects with secondary HPT and CKD receiving dialysis demonstrated that cinacalcet-treated subjects not receiving dialysis were more likely to develop serum calcium levels below the lower limit of the normal range (8.4 mg/dL [2.1 mmol/L]) than cinacalcet-treated subjects receiving dialysis. Reduction in serum calcium is an expected physiological response to reductions in PTH levels.
Based on results of these studies and discussions with global regulatory agencies, Amgen initiated a third study, with the intent to provide confirmatory evidence of the efficacy and further assess the safety of cinacalcet in subjects with secondary HPT and CKD not receiving dialysis, and in particular to reduce the incidence of serum calcium below 8.4 mg/dL (2.1 mmol/L) as compared with the previous studies.
Final analyses of the study data indicated that while efficacy endpoints for lowering plasma PTH levels were achieved, the incidence of serum calcium levels below 8.4 mg/dL (2.1 mmol/L) remained consistent with the results of the previous studies. Of note, low serum calcium values were predominantly asymptomatic laboratory findings without discernible clinical sequelae. However, the modifications made to the study design did not appear to reduce the incidence of hypocalcaemia (serum calcium levels < 8.4 mg/dL [2.1 mmol/L]) as Amgen had anticipated. Amgen therefore considers that this study has failed to provide confirmatory evidence of a positive benefit/risk profile for the use of cinacalcet treatment for secondary HPT in patients with CKD not receiving dialysis using the dosing paradigm evaluated in this study.
Based on the results of this study, the "Indications and Clinical Use" section, as well as the "Warnings and Precautions, Adverse Reactions, Dosage and Administration" and "Clinical Trials" sections of the Sensipar® Product Monograph will be updated.
It should be noted that the favorable benefit/risk assessment in patients with secondary HPT and CKD receiving dialysis remains unchanged, and no amendments to the currently approved Product Monograph for this population are considered necessary.
The identification, characterization, and management of marketed health product-related adverse events are dependent on the active participation of health care professionals in adverse drug reaction reporting programmes. Any occurrences of hypocalcemia or other serious and/or unexpected adverse events in patients receiving Sensipar® should be reported to Amgen Canada Inc. or Health Canada at the following addresses:
Amgen Canada Inc.
6755 Mississauga Rd. Suite 400
Mississauga, Ontario
L5N 7Y2
Any suspected adverse reaction can also be reported to:
Canadian Adverse Drug Reaction Monitoring Program (CADRMP)
Marketed Health Products Directorate
HEALTH CANADA
Address Locator: 0701C
OTTAWA, Ontario, K1A 0K9
Tel: 613-957-0337 or Fax: 613-957-0335
To report an Adverse Reaction, consumers and health professionals may call toll free:
Tel: 866-234-2345
Fax: 866-678-6789
cadrmp@hc-sc.gc.ca
The AR Reporting Form and the AR Guidelines can be found on the Health Canada web site or in The Canadian Compendium of Pharmaceuticals and Specialties.
For other inquiries related to this communication, Health Canada should be contacted at:
Bureau of Metabolism, Oncology and Reproductive Sciences (BMORS)
E-mail: bmors_enquiries@hc-sc.gc.ca
Tel.: 613-941-3171
Fax: 613-941-1365
Any questions or further information regarding the use of Sensipar® should be addressed to Amgen Medical Information at 1-866-502-6436.
SOURCE: Health Canada
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