May 30, 2016
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Calcijex

"A drug candidate developed by researchers at the NIH's National Center for Advancing Translational Sciences (NCATS) and its collaborators to treat sickle cell disease has been acquired by Baxter International's BioScience business. The drug c"...

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Calcijex Injection




Indications
Dosage
How Supplied

INDICATIONS

Indications And Clinical Use

CALCIJEX® (calcitriol injection) is indicated for:

It has been also shown to significantly reduce elevated parathyroid hormone levels (PTH) in many of these patients. Reduction of PTH has been shown to result in an improvement in renal osteodystrophy.

Geriatrics ( ≥ 65 Years of Age)

Clinical studies of CALCIJEX® did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects.

Pediatrics ( < 18 Years of Age)

Safety and efficacy of CALCIJEX® have not been established in the pediatric population.

DOSAGE AND ADMINISTRATION

Dosing Considerations

  • 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 daily intake of calcium. The recommended daily allowance for calcium in adults is in the order of 1 g.
  • 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 appropriate dietary measures. However, because of improved calcium absorption from the gastrointestinal tract, some patients may be maintained on a lower calcium intake or no supplementation at all.

Recommended Dose And Dosage Adjustment

The recommended initial dose of CALCIJEX® is 0.5 mcg (0.01 mcg/kg) administered three times weekly, every other day. If a satisfactory response in the biochemical parameters and clinical manifestations of the disease state is not observed, the dose may be increased by 0.25 to 0.50 mcg at two to four week intervals. During this titration period, serum calcium and phosphorous 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 normalize. The CALCIJEX® dose should then be reinitiated at a lower dose. Doses may need to be reduced as the PTH levels decrease and commensurate with PTH, serum calcium and phosphorous levels.

Most patients undergoing hemodialysis respond to doses between 0.5 and 3 mcg (0.01 to 0.05 mcg/kg) three times per week.

Administration

CALCIJEX® can be administered as a bolus dose intravenously through the catheter at the end of hemodialysis.

HOW SUPPLIED

Storage And Stability

Store between 15 and 25°C; however, brief exposure up to 40°C does not adversely affect the product. Protect from light.

Special Handling Instructions

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

Discard unused portion.

Dosage Forms, Composition And Packaging

CALCIJEX® (calcitriol injection) is a sterile, isotonic, clear, aqueous solution for intravenous injection and is supplied in 1 mL ampoules available in 2 strengths: 1 mcg or 2 mcg of calcitriol.

Listing Of Non-Medicinal Ingredients

Each 1 mL ampoule contains 1 or 2 mcg calcitriol, anhydrous dibasic sodium phosphate (buffer), edetate disodium, monobasic sodium phosphate monohydrate (buffer), polysorbate 20, sodium ascorbate and sodium chloride. The pH of the solution is approximately 7. It does not contain a preservative.

AbbVie Corporation., 8401 Trans-Canada Highway, St-Laurent, Qc H4S 1Z1 Revised: Aug 2015

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 2/23/2016

Indications
Dosage
How Supplied

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