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Sensipar

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Sensipar

Indications
Dosage
How Supplied

INDICATIONS

Secondary Hyperparathyroidism

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

Limitations of Use

Sensipar is not indicated for use in adult patients with CKD who are not on dialysis because of an increased risk of hypocalcemia [see WARNINGS AND PRECAUTIONS].

Parathyroid Carcinoma

Sensipar is indicated for the treatment of hypercalcemia in adult patients with Parathyroid Carcinoma [see Clinical Studies].

Primary Hyperparathyroidism

Sensipar is indicated for the treatment of hypercalcemia in adult patients with primary HPT for whom parathyroidectomy would be indicated on the basis of serum calcium levels, but who are unable to undergo parathyroidectomy [see Clinical Studies].

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 Adult 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 intact parathyroid hormone (iPTH) should be measured 1 to 4 weeks after initiation or dose adjustment of Sensipar [see Monitoring for Hypocalcemia]. Sensipar 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.

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 [seeSecondary Hyperparathyroidism In Adult Patients With Chronic Kidney Disease On Dialysis, Parathyroid Carcinoma And Primary Hyperparathyroidismand WARNINGS AND PRECAUTIONS].

Parathyroid Carcinoma And Primary Hyperparathyroidism

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

The dose of Sensipar 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. Serum calcium should be measured within 1 week after initiation or dose adjustment of Sensipar [see Monitoring for Hypocalcemia and WARNINGS AND PRECAUTIONS].

Monitoring For Hypocalcemia

Once the maintenance dose has been established, serum calcium should be measured approximately monthly for patients with secondary hyperparathyroidism with CKD on dialysis, and every 2 months for patients with parathyroid carcinoma or primary hyperparathyroidism [see Secondary Hyperparathyroidism In Adult Patients With Chronic Kidney Disease On Dialysis and Parathyroid Carcinoma And Primary Hyperparathyroidism].

For secondary hyperparathyroidism patients with CKD on dialysis, if serum calcium falls below 8.4 mg/dL but remains above 7.5 mg/dL, or if symptoms of hypocalcemia occur, calcium-containing phosphate binders and/or vitamin D sterols can be used to raise serum calcium. If serum calcium falls below 7.5 mg/dL, or if symptoms of hypocalcemia persist and the dose of vitamin D cannot be increased, withhold administration of Sensipar until serum calcium levels reach 8.0 mg/dL and/or symptoms of hypocalcemia have resolved. Treatment should be reinitiated using the next lowest dose of Sensipar [see Secondary Hyperparathyroidism In Adult Patients With Chronic Kidney Disease On Dialysis].

HOW SUPPLIED

Dosage Forms And Strengths

Sensipar 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 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 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 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: Nov 2014.

Last reviewed on RxList: 12/11/2014
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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