ting or increasing the dose of calcium-based phosphate binder, initiating or increasing the dose of vitamin D sterols, or temporarily withholding treatment with Sensipar® (see PRECAUTIONS).
Parathyroid Carcinoma
The recommended starting oral dose of Sensipar® is 30 mg twice daily.
The dosage of Sensipar® should be titrated every 2 to 4 weeks through sequential doses of 30 mg twice daily, 60 mg twice daily, 90 mg twice daily, and 90 mg three or four times daily as necessary to normalize serum calcium levels.
Special Populations
Geriatric patients:
Age does not alter the pharmacokinetics of Sensipar®; no dosage adjustment is required for geriatric patients.
Patients with renal impairment:
Renal impairment does not alter the pharmacokinetics of Sensipar®; no dosage adjustment is necessary for renal impairment.
Patients with hepatic impairment:
Cinacalcet exposures, as assessed by AUC(0-inf), in patients with moderate and severe hepatic impairment (as indicated by the Child-Pugh method) were 2.4 and 4.2 times higher, respectively, than in normals. In patients with moderate and severe hepatic impairment, PTH and serum calcium concentrations should be closely monitored throughout treatment with Sensipar® (see CLINICAL PHARMACOLOGY, Pharmacokinetics and PRECAUTIONS).
Drug Interactions
Sensipar® is metabolized in part by the enzyme CYP3A4. Co-administration of ketoconazole, a strong inhibitor of CYP3A4, caused an approximate 2-fold increase in cinacalcet exposure. Dose adjustment of Sensipar® may be required and PTH and serum calcium concentrations should be closely monitored if a patient initiates or discontinues therapy with a strong CYP3A4 inhibitor (e.g., ketoconazole, erythromycin, itraconazole; see CLINICAL PHARMACOLOGY, Pharmacokinetics and PRECAUTIONS).
HOW SUPPLIED
Sensipar® 30 mg tablets are formulated as light-green, film-coated, oval-shaped tablets printed with “AMGEN” on one side and “30” on the opposite side, packaged in bottles of 30 tablets. (NDC 55513-073-30)
Sensipar® 60 mg tablets are formulated as light-green, film-coated, oval-shaped tablets printed with “AMGEN” on one side and “60” on the opposite side, packaged in bottles of 30 tablets. (NDC 55513-074-30)
Sensipar® 90 mg tablets are formulated as light-green, film-coated, oval-shaped tablets printed with “AMGEN” on one side and “90” on the opposite side, packaged in bottles of 30 tablets. (NDC 55513-075-30)
Storage
Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF). [See USP controlled room temperature].
Rx Only
This product, or its use, may be covered by one or more US Patents including US Patent Nos. 6313146, 6211244, 6031003 and 6011068, in addition to others, including patents pending.
REFERENCES
1. National Kidney Foundation: K/DOQI clinical practice guidelines: bone metabolism and disease in chronic kidney disease. American Journal of Kidney Disease 4 2:S1-S201, 2003
[Amgen Logo]
Manufactured for: Amgen
Amgen Inc.
One Amgen Center Drive
Thousand Oaks, CA 913201799
Issue Date: 04/2007
©2007 Amgen Inc. All rights reserved.
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Sensipar (cinacalcet hydrochloride)
PRODUCT INFO
Product Code 55513-073 Dosage Form TABLET, COATED
Route Of Administra |
