June 28, 2016
Recommended Topic Related To:

Calcijex

"The U.S. Food and Drug Administration today approved Veltassa (patiromer for oral suspension) to treat hyperkalemia, a serious condition in which the amount of potassium in the blood is too high.

“Too much potassium in the blood can l"...

A A A

Calcijex Injection




Warnings
Precautions

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

General

Since CALCIJEX® (calcitriol injection) is a potent cholecalciferol derivative with profound effects on intestinal absorption of dietary calcium and inorganic phosphate, vitamin D and its derivatives should be withheld during treatment to avoid possible additive effects and hypercalcemia.

Therapy with CALCIJEX® should only be considered when adequate laboratory facilities for monitoring of blood and urine chemistries are available. Overdosage of any form of vitamin D is dangerous. During treatment with CALCIJEX®, progressive hypercalcemia either due to hyper-responsiveness or overdosage may become so severe as to require emergency treatment (see OVERDOSAGE). Chronic hypercalcemia can lead to generalized vascular calcification, nephrocalcinosis, and calcifications of the cornea or other soft tissues. Radiographic evaluation of suspect anatomical regions may be useful in the early detection of this condition. During treatment with calcitriol, the serum total calcium times serum inorganic phosphate product (Ca x P) should not exceed 70 mg2/dL2.

Dialysate calcium level of 7 mg % or above in addition to excessive dietary calcium supplements may lead to frequent episodes of hypercalcemia.

To control serum phosphorus levels and dietary phosphate absorption in patients undergoing dialysis, a non-aluminum phosphate-binding compound should be used. Magnesium-containing antacids may contribute towards hypermagnesemia in patients on chronic renal dialysis and should be avoided during therapy with calcitriol (see DRUG INTERACTIONS).

Patient Selection and Follow-up: Patients with renal osteodystrophy and hypocalcemia, poorly managed by conventional vitamin D therapy, are likely to respond to CALCIJEX®. The desired therapeutic margin of calcitriol is narrow; therefore, the optimal daily dose must be carefully determined for each patient by dose titration to obtain satisfactory response in the biochemical parameters and clinical manifestations (see DOSAGE AND ADMINISTRATION).

Excessive dosage of calcitriol induces hypercalcemia and hypercalciuria; therefore, early in treatment during dosage adjustment, serum calcium and phosphorus should be determined at least twice weekly. A fall in serum alkaline phosphatase values may indicate impending hypercalcemia. Should hypercalcemia develop, the drug should be discontinued immediately until the serum calcium level has normalized. This may take several days to a week.

CALCIJEX® should be used with extreme caution in patients on digitalis. Hypercalcemia in such patients may precipitate cardiac arrhythmias (see DRUG INTERACTIONS).

Carcinogenesis And Mutagenesis

See Toxicology, Mutagenicity and Carcinogenicity.

Special Populations

Pregnant Women

Calcitriol has been reported to be teratogenic in rabbits when given orally in doses 4 and 15 times the dose recommended for human use. All 15 fetuses in 3 litters at these doses showed external and skeletal abnormalities. However, none of the other 23 litters (156 fetuses) showed significant abnormalities compared with controls.

Teratology studies in rats at doses up to 0.45 mcg/kg showed no evidence of teratogenic potential.

There are no adequate and well-controlled studies in pregnant women. CALCIJEX® should not be used during pregnancy unless the potential benefit to the mother justifies the potential risk to the fetus.

Nursing Women

It is not known whether calcitriol is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from calcitriol, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatrics ( < 18 Years of Age)

Safety and efficacy of CALCIJEX® in pediatric patients younger than eighteen years of age have not been established.

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. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosage range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Monitoring And Laboratory Tests

Serum calcium, inorganic phosphorous, magnesium, alkaline phosphatase as well as 24-hour urinary calcium and phosphorous should be determined periodically during maintenance therapy with CALCIJEX®. During the initial phase of the medication, serum calcium and phosphorous should be determined more frequently (at least twice weekly). Periodic ophthalmological examinations and radiological evaluation of suspected anatomical regions for early detection of ectopic classifications are advisable.

Adynamic bone disease may develop if PTH levels are suppressed to abnormal levels. If a biopsy is not being done for other (diagnostic) reasons, PTH levels may be used to indicate the rate of bone turnover. In patients treated with CALCIJEX®, if PTH levels fall below the recommended target range (1.5 to 3 times the upper limit of normal), the calcitriol dose should be reduced or therapy should be discontinued. Discontinuation of CALCIJEX® therapy may result in rebound effect; therefore, appropriate titration downward to a maintenance dose is recommended.

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

Last reviewed on RxList: 2/23/2016

Warnings
Precautions

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Women's Health

Find out what women really need.