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Sensipar 60 Mg Tabs 30 By Amgen Inc.

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Sensipar 60 Mg Tabs 30 By Amgen Inc.

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Sensipar 60 Mg Tabs 30 By Amgen Inc. This Item Requires A Valid Order From A Physician Licensed in USA. Item Number.:RXD3565959/RXB10060560/RXA321688
Size : 30
Selling UoM : EA
NDC: 55513-0074-30
UPC Barcode : 355513074308
Supplier: 0050001118 AMGEN INC
Supplier Material : 007430
Generic Code : 053763 CINACALCET HCL ORAL TABLET 60 MG
Fine Line Class : 850085008510 All Rx Products
Product Category : RX Pharmaceuticals
Product Type : BRX Branded RX

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Product Description.:

AMG, 60
tablet , film-coated , green , oval oblong

Sensipar? is indicated for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis.

Sensipar? is indicated for the treatment of hypercalcemia in patients with parathyroid carcinoma.
Important Safety Information

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.

Sensipar? lowers serum calcium therefore, it is important that patients have a serum calcium ? 8.4 mg/dL when initiating therapy.

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.

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