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Calcijex (Calcitriol) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Calcijex (calcitriol injection) is indicated in the management of hypocalcemia in patients undergoing chronic renal dialysis. It has been shown to significantly reduce elevated parathyroid hormone levels. Reduction of PTH has been shown to result in an improvement in renal osteodystrophy.

DOSAGE AND ADMINISTRATION

Calcijex is for intravenous injection only.

The optimal dose of Calcijex (calcitriol injection) must be carefully determined for each patient.

The effectiveness of Calcijex therapy is predicated on the assumption that each patient is receiving an adequate and appropriate daily intake of calcium. The RDA for calcium in adults is 800 mg. To ensure that each patient receives an adequate daily intake of calcium, the physician should either prescribe a calcium supplement or instruct the patient in proper dietary measures.

The recommended initial dose of Calcijex, depending on the severity of the hypocalcemia and/or secondary hyperparathyroidism, is 1 mcg (0.02 mcg/kg) to 2 mcg administered intravenously three times weekly, approximately every other day. Doses as small as 0.5 mcg and as large as 4 mcg three times weekly have been used as an initial dose. If a satisfactory response is not observed, the dose may be increased by 0.5 to 1 mcg at two to four week intervals. During this titration period, serum calcium and phosphorus levels should be obtained at least twice weekly. If hypercalcemia or a serum calcium times phosphate product greater than 70 is noted, the drug should be immediately discontinued until these parameters are appropriate. Then, the Calcijex dose should be reinitiated at a lower dose. Doses may need to be reduced as the PTH levels decrease in response to the therapy. Thus, incremental dosing must be individualized and commensurate with PTH, serum calcium and phosphorus levels. The following is a suggested approach in dose titration:

PTH Levels Calcijex Dose
the same or increasing increase
decreasing by < 30% increase
decreasing by > 30%, < 60% maintain
decreasing by > 60% decrease
one and one-half to three times
the upper limit of normal
maintain

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Discard unused portion.

HOW SUPPLIED

Calcijex (calcitriol injection) is supplied as follows:

List Container Concentration Fill
8110 Ampul 1 mcg/mL 1 mL

Protect from light.
Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [see USP Controlled Room Temperature]

Mfd. by:

Hospira, Inc.

Lake Forest, IL 60045 USA

For:

AbbVie Inc.

North Chicago, IL 60064 USA

© AbbVie Inc. 2013

Printed in USA

Revised: 05/2013

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