Challenging Goals

Achieving the KDOQI™ goals for dialysis patients has been challenging with traditional therapies for secondary hyperparathyroidism (HPT)^1,2

Optimal management of secondary HPT requires simultaneous control of all 4 key KDOQI™ secondary HPT parameters. In patients on dialysis, parathyroid hormone (PTH), serum calcium and phosphorus, and calcium-phosphorus product (Ca x P) levels are usually outside the KDOQI™ target values.^2,3

With Sensipar®, more dialysis patients achieve the 4 key KDOQI™ secondary HPT goals.⁴

KDOQI™ Clinical Practice Guidelines for Bone Metabolism and Disease in Chronic Kidney Disease (Stage 5). KDOQI™ is a trademark of the National Kidney Foundation, Inc.

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KDOQI^™ is a trademark of the National Kidney Foundation, Inc.

Improving Care for Patients
Monitoring and Titration Are Key
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Important Safety Information

Sensipar® treatment should not be initiated if serum calcium is less than the lower limit of the normal range (8.4 mg/dL).

Sensipar® lowers serum calcium; therefore, it is important that patients are carefully monitored for the occurrence of hypocalcemia.

Significant reductions in calcium may lower the threshold for seizures. Secondary hyperparathyroidism (HPT) patients, particularly those with a history of seizure disorder, should be carefully monitored for the occurrence of low serum calcium or symptoms of hypocalcemia.

In Sensipar® postmarketing use, isolated, idiosyncratic cases of hypotension, worsening heart failure, and/or arrhythmia were reported in patients with impaired cardiac function. The causal relationship to Sensipar® therapy could not be completely excluded and may be mediated by reductions in serum calcium levels.

Adynamic bone disease may develop if intact parathyroid hormone (iPTH) levels are suppressed below 100 pg/mL.

Patients with moderate to severe hepatic impairment should be monitored throughout treatment with Sensipar®, as cinacalcet exposure assessed by area under the curve (AUC) was higher than in patients with normal hepatic function.

Serum calcium and serum phosphorus should be measured within 1 week and PTH should be measured 1 to 4 weeks after initiation or dose adjustment of Sensipar®. Once the maintenance dose has been established, serum calcium and serum phosphorus should be measured approximately monthly, and PTH every 1 to 3 months.

The most commonly reported side effects were nausea, vomiting, and diarrhea.

References

National Kidney Foundation. K/DOQI clinical practice guidelines for bone metabolism and disease in chronic kidney disease. Am J Kidney Dis. 2003;42(suppl 3):S1-S201.
Kim J, Pisoni RL, Danese M, Satayathum S, Klassen P, Young EW. Achievement of proposed NKF-K/DOQI bone metabolism and disease guidelines: results from the Dialysis Outcomes and Practice Patterns Study (DOPPS). J Am Soc Nephrol. 2003;14:269A-270A. Abstract F-PO942 and poster.
Wald R, Tentori F, Tighiouart H, Zager PG, Miskulin DC. Impact of the Kidney Disease Outcomes Quality Initiative (KDOQI) clinical practice guidelines for bone metabolism and disease in a large dialysis network. Am J Kidney Dis. 2007;49:257-266.
Block GA, Martin KJ, de Francisco ALM, et al. Cinacalcet for secondary hyperparathyroidism in patients receiving hemodialysis. N Engl J Med. 2004;350:1516-1525.

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Challenging Goals

Achieving the KDOQI™ goals for dialysis patients has been challenging with traditional therapies for secondary hyperparathyroidism (HPT)1,2

Important Safety Information

References

Achieving the KDOQI™ goals for dialysis patients has been challenging with traditional therapies for secondary hyperparathyroidism (HPT)^1,2