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Sensipar (Cinacalcet Hydrochloride) - Indications and Dosage

 
 



INDICATIONS AND USAGE

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.

DOSAGE AND ADMINISTRATION

Sensipar® tablets should be taken whole and should not be divided. Sensipar® should be taken with food or shortly after a meal.

Dosage must be individualized.

Secondary Hyperparathyroidism in Patients with Chronic Kidney Disease on Dialysis

The recommended starting oral dose of Sensipar® is 30 mg once daily. 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®. Sensipar® should be titrated no more frequently than every 2 to 4 weeks through sequential doses of 60, 90, 120, and 180 mg once daily to target iPTH consistent with the NKF-K/DOQI recommendation for CKD patients on dialysis of 150-300 pg/mL. PTH levels should be assessed no earlier than 12 hours after dosing with Sensipar®.

Sensipar® can be used alone or in combination with vitamin D sterols and/or phosphate binders.

During dose titration, serum calcium levels should be monitored frequently and if levels decrease below the normal range, appropriate steps should be taken to increase serum calcium levels, such as by providing supplemental calcium, initiating 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 marked with “AMG” on one side and “30” on the opposite side.

Sensipar® 60 mg tablets are formulated as light-green, film-coated, oval-shaped tablets marked with “AMG” on one side and “60” on the opposite side.

Sensipar® 90 mg tablets are formulated as light-green, film-coated, oval-shaped tablets marked with “AMG” on one side and “90” on the opposite side.

They are supplied by State of Florida DOH Central Pharmacy as follows:

NDC Strength Quantity/Form Color Source Prod. Code
53808-0577-1 30 mg 30 Tablets in a Blister Pack light green 55513-073
53808-0578-1 60 mg 30 Tablets in a Blister Pack light green 55513-074

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.

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