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Sensipar

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Sensipar

Indications
Dosage
How Supplied

INDICATIONS

Secondary Hyperparathyroidism

Sensipar (cinacalcet) is indicated for the treatment of secondary hyperparathyroidism (HPT) in patients with chronic kidney disease (CKD) on dialysis [see Clinical Studies].

Parathyroid Carcinoma

Sensipar (cinacalcet) is indicated for the treatment of hypercalcemia in patients with parathyroid carcinoma [see Clinical Studies].

Primary Hyperparathyroidism

Sensipar (cinacalcet) is indicated for the treatment of severe hypercalcemia in patients with primary HPT who are unable to undergo parathyroidectomy [see Clinical Studies].

DOSAGE AND ADMINISTRATION

Sensipar (cinacalcet) tablets should be taken whole and should not be divided. Sensipar (cinacalcet) 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 (cinacalcet) is 30 mg once daily. Serum calcium and serum phosphorus should be measured within 1 week and intact parathyroid hormone (iPTH) should be measured 1 to 4 weeks after initiation or dose adjustment of Sensipar (cinacalcet) . Sensipar (cinacalcet) should be titrated no more frequently than every 2 to 4 weeks through sequential doses of 30, 60, 90, 120, and 180 mg once daily to target iPTH levels of 150 to 300 pg/mL. Serum iPTH levels should be assessed no earlier than 12 hours after dosing with Sensipar (cinacalcet) .

Sensipar (cinacalcet) 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 WARNINGS AND PRECAUTIONS].

Parathyroid Carcinoma and Primary Hyperparathyroidism

The recommended starting oral dose of Sensipar (cinacalcet) is 30 mg twice daily.

The dose of Sensipar (cinacalcet) should be titrated every 2 to 4 weeks through sequential doses of 30 mg twice daily, 60 mg twice daily, and 90 mg twice daily, and 90 mg 3 or 4 times daily as necessary to normalize serum calcium levels [see WARNINGS AND PRECAUTIONS].

HOW SUPPLIED

Dosage Forms And Strengths

Sensipar (cinacalcet) tablets are formulated as light-green, film-coated, oval-shaped tablets marked with “AMG” on one side and “30” or “60” or “90” on the opposite side of the 30 mg, 60 mg, or 90 mg strengths, respectively.

Storage And Handling

Sensipar (cinacalcet) 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, packaged in bottles of 30 tablets. (NDC 55513-073-30)

Sensipar (cinacalcet) 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, packaged in bottles of 30 tablets. (NDC 55513-074-30)

Sensipar (cinacalcet) 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, packaged in bottles of 30 tablets. (NDC 55513-075-30)

Storage

Store at 25°C (77°F); excursions permitted from 15°C to 30°C (59°F to 86°F). [See USP controlled room temperature].

Manufactured by: Amgen Inc. One Amgen Center Drive Thousand Oaks, California 91320-1799. Revised: 02/2011

Last reviewed on RxList: 4/19/2011
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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