Calcijex
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Questions & Answers
Side Effects & Adverse Reactions
Since calcitriol is the most potent metabolite of vitamin D available, prescription-based doses of vitamin D and its derivatives should be withheld or used with caution during treatment to avoid the risk of hypercalcemia.
A non-aluminum phosphate-binding compound should be used to control serum phosphorus levels in patients undergoing dialysis.
Overdosage of any form of vitamin D is dangerous (see also OVERDOSAGE). Progressive hypercalcemia due to overdosage of vitamin D and its metabolites may be so severe as to require emergency attention. Chronic hypercalcemia can lead to generalized vascular calcification, nephrocalcinosis, and other soft-tissue calcification. The serum calcium times phosphate (Ca x P) product should not be allowed to exceed 70 mg2/dL2. Radiographic evaluation of suspect anatomical regions may be useful in the early detection of this condition.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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.
History
There is currently no drug history available for this drug.
Other Information
Calcijex (calcitriol injection) is synthetically manufactured calcitriol and is available as a sterile, isotonic, clear, colorless to yellow, aqueous solution for intravenous injection. Calcijex is available in 1 mL ampuls. Each 1 mL contains calcitriol, 1 mcg; Polysorbate 20, 4 mg; sodium ascorbate 2.5 mg added. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. pH is 6.5 (5.9 to 7.0). Contains no more than 1 mcg/mL of aluminum.
Calcitriol is a crystalline compound which occurs naturally in humans. It is soluble in organic solvents but relatively insoluble in water.
Calcitriol is chemically designated (5Z,7E)-9, 10-secocholesta-5,7,10(19)-triene-1α,3β,25-triol and has the following structural formula:
Molecular Formula: C27H44O3
The other names frequently used for calcitriol are 1α,25-dihydroxycholecalciferol, 1α,25-dihydroxyvitamin D3, 1,25-DHCC, 1,25(OH)2D3 and 1,25-diOHC.
Sources
Calcijex Manufacturers
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Abbvie Inc.
![Calcijex (Calcitriol) Injection, Solution [Abbvie Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Calcijex | Abbvie Inc.
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 maintainParenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Discard unused portion.
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