Calcitriol (injection)

Calcitriol (injection)
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]

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Overview

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Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

• 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

• 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:

This image is provided by the National Library of Medicine.

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

• Discard unused portion.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Calcitriol (injection) in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Calcitriol (injection) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Calcitriol (injection) in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Calcitriol (injection) in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Calcitriol (injection) in pediatric patients.

Contraindications

• Calcijex (calcitriol injection) should not be given to patients with hypercalcemia or evidence of vitamin D toxicity.

• Calcijex (calcitriol injection) is contraindicated in patients with previous hypersensitivity to calcitriol or any of its excipients.

Warnings

• 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. 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.

Adverse Reactions

Clinical Trials Experience

• Adverse effects of Calcijex (calcitriol injection) are, in general, similar to those encountered with excessive vitamin D intake. The early and late signs and symptoms of vitamin D intoxication associated with hypercalcemia include:

Early

• Weakness, headache, somnolence, nausea, vomiting, dry mouth, constipation, muscle pain, bone pain, metallic taste, anorexia, abdominal pain, and epigastric discomfort.

Late

• Polyuria, polydipsia, anorexia, weight loss, nocturia, conjunctivitis (calcific), pancreatitis, photophobia, rhinorrhea, pruritus, hyperthermia, decreased libido, elevated BUN, albuminuria, hypercholesterolemia, elevated SGOT and SGPT, ectopic calcification, hypertension, cardiac arrhythmias, nephrocalcinosis, sensory disturbance, dehydration, apathy, and rarely, overt psychosis.

• Occasional mild pain on injection has been observed.

Postmarketing Experience

• Rare cases of hypersensitivity reactions have been reported, including anaphylaxis.

Drug Interactions

There is limited information regarding Calcitriol (injection) Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Calcitriol (injection) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Calcitriol (injection) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Calcitriol (injection) with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Calcitriol (injection) with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Calcitriol (injection) with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Calcitriol (injection) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Calcitriol (injection) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Calcitriol (injection) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Calcitriol (injection) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Calcitriol (injection) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Calcitriol (injection) in patients who are immunocompromised.

Administration and Monitoring

Administration

• Intravenous

Monitoring

There is limited information regarding Monitoring of Calcitriol (injection) in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Calcitriol (injection) in the drug label.

Overdosage

• Administration of Calcijex (calcitriol injection) to patients in excess of their requirements can cause hypercalcemia, hypercalciuria and hyperphosphatemia. High intake of calcium and phosphate concomitant with Calcijex may lead to similar abnormalities.

Treatment of Hypercalcemia and Overdosage in Patients on Hemodialysis

• General treatment of hypercalcemia (greater than 1 mg/dL above the upper limit of normal range) consists of immediate discontinuation of Calcijex therapy, institution of a low calcium diet and withdrawal of calcium supplements. Serum calcium levels should be determined daily until normocalcemia ensues. Hypercalcemia usually resolves in two to seven days. When serum calcium levels have returned to within normal limits, Calcijex therapy may be reinstituted at a dose 0.5 mcg less than prior therapy. Serum calcium levels should be obtained at least twice weekly after all dosage changes.

• Persistent or markedly elevated serum calcium levels may be corrected by dialysis against a calcium-free dialysate.

Treatment of Accidental Overdosage of Calcitriol Injection

• The treatment of acute accidental overdosage of Calcijex should consist of general supportive measures. Serial serum electrolyte determinations (especially calcium), rate of urinary calcium excretion and assessment of electrocardiographic abnormalities due to hypercalcemia should be obtained. Such monitoring is critical in patients receiving digitalis. Discontinuation of supplemental calcium and low calcium diet are also indicated in accidental overdosage. Due to the relatively short duration of the pharmacological action of calcitriol, further measures are probably unnecessary. Should, however, persistent and markedly elevated serum calcium levels occur, there are a variety of therapeutic alternatives which may be considered, depending on the patients' underlying condition. These include the use of drugs such as phosphates and corticosteroids as well as measures to induce an appropriate forced diuresis. The use of peritoneal dialysis against a calcium-free dialysate has also been reported.

Pharmacology

There is limited information regarding Calcitriol (injection) Pharmacology in the drug label.

Mechanism of Action

Structure

• 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:

This image is provided by the National Library of Medicine.

• 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.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Calcitriol (injection) in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Calcitriol (injection) in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Calcitriol (injection) in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Calcitriol (injection) in the drug label.

How Supplied

• Calcijex (calcitriol injection) is supplied as follows:

This image is provided by the National Library of Medicine.

Storage

• Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F).

Images

Drug Images

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Package and Label Display Panel

This image is provided by the National Library of Medicine.

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Patient Counseling Information

Information for the Patient

• The patient and his or her parents should be informed about adherence to instructions about diet and calcium supplementation and avoidance of the use of unapproved non-prescription drugs, including magnesium-containing antacids. Patients should also be carefully informed about the symptoms of hypercalcemia.

Precautions with Alcohol

• Alcohol-Calcitriol (injection) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• CALCIJEX®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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