CALCIJEX SIDE EFFECTS

SIDE EFFECTS

Adverse Drug Reaction Overview

The following adverse reactions have been reported in association with CALCIJEX® (calcitriol injection) treatment.

The most frequently reported adverse effect is hypercalcemia (35% approximately after the 4th week of treatment).

The less frequently reported adverse effects were headache, nausea, vomiting, constipation, abdominal cramp, pruritis, conjunctivitis, agitation, extremity pain, apprehension, polyuria, insomnia, elevated serum glutamic oxaloacetic transaminase (SGOT) and/or serum glutamic pyruvic transaminase (SGPT), elevated alkaline phosphatase, hypercalciuria, hypermagnesemia, hyperphosphatemia, elevated lymphocytes, elevated hematocrit, elevated neutrophils, and elevated hemoglobin.

The adverse effects of CALCIJEX® are, in general, similar to those encountered with excessive vitamin D intake. The early and late signs and symptoms associated with vitamin D intoxication and hypercalcemia are:

Early

Asthenia, headache, somnolence, nausea, cardiac arrhythmias, excessive thirst, vomiting, dry mouth, constipation, myalgia, bone pain, dysgeusia, decreased appetite, abdominal pain, and dyspepsia.

Late

Polyuria, polydipsia, decreased appetite, weight decreased, nocturia, conjunctival deposit, pancreatitis, photophobia, rhinorrhoea, pruritus, hyperthermia, libido decreased, blood urea increased, albuminuria, hypercholesterolemia, aspartate aminotransferase increased, alanine aminotransferase increased, calcinosis, hypertension, cardiac arrhythmias, muscular weakness, paresthesia, dehydration, apathy, urinary tract infections, and rarely, overt psychosis.

Clinical Trial Adverse Drug Reactions

Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates.

CALCIJEX® was studied in 20 patients undergoing maintenance hemodialysis for chronic renal disease. This open-label study had no comparator; each patient served as his/her own control. Patients received CALCIJEX® three times weekly, post-dialysis over a treatment period of 4 to 8 weeks. Doses were titrated for each patient based upon serum total calcium response.

Abnormal Hematologic And Clinical Chemistry Findings

The most frequently reported adverse effect is hypercalcemia (35% approximately after the 4th week of treatment).

Post-Market Adverse Drug Reactions

Hypersensitivity reactions have been commonly reported in Post-Market Clinical Trials at a frequency of 2.3%. Rare postmarketing reports of anaphylaxis have also been received. Occasional mild pain and localized redness at the injection site have been observed. The adverse drug reactions occurring in patients receiving CALCIJEX® in seven Post Market Clinical Studies are summarized for a total of 485 subjects randomized to CALCIJEX® (Table 1).

Table 1: Summary of ADRs Occurring in Patients Receiving Calcitriol in CALCIJEX® Post Market Clinical Trials