July 28, 2016
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Calcijex

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Calcijex Injection




Side Effects
Interactions

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 (see Clinical Trials, Study CP5691). 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

System Organ Class Very Common Common Uncommon Not Known
Infections and Infestations   Urinary tract infection    
Immune System Disorders   Hypersensitivity*    
Metabolism and Nutrition Disorders   Decreased appetite Dehydration   Polydipsia Hypercholesterolemia
Psychiatric Disorders       Libido decreased Apathy Psychosis
Nervous System Disorders Headache Somnolence Paresthesia Dysgeusia  
Eye Disorders       Conjuctival deposit Photophobia
Cardiac Disorders       Cardiac arrhythmia
Vascular Disorders   Hypertension    
Respiratory, Thoracic and Mediastinal Disorders     Rhinorrhoea  
Gastrointestinal Disorders   Nausea Vomiting Constipation Abdominal pain Dyspepsia Pancreatitis Dry mouth  
Skin and Subcutaneous Tissue Disorders   Pruritus    
Musculoskeletal and Connective Tissue Disorders   Myalgia Bone pain Muscular weakness  
Renal and Urinary Disorders       Polyuria Nocturia Albuminuria
General Disorders and Administration Site Conditions Pain Injection site pain Asthenia Injection site reaction Calcinosis Hyperthermia
Investigations     Weight decreased Aspartate aminotransferase increased Blood urea increased Alanine aminotransferase increased
*Anaphylaxis has not been observed in clinical trials.

Read the Calcijex Injection (calcitrol) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Drug-Drug Interactions

The drugs listed in Table 1 are based on potential interactions due to the expected magnitude and seriousness of the interaction.

Table 1: Established or Potential Drug-Drug Interaction

Proper name Ref Effect Clinical comment
Anticonvulsants (e.g. diphenylhydantoin and barbiturates) T ↑ calcitriol elimination and
↓ calcitriol effect
Patients under concurrent treatment with such agents may require slightly higher doses of calcitriol.
Corticosteroids T May counteract the effects of vitamin D analogs May worsen bone disease and demineralization.
Digitalis T Possible increase of digitalis toxicity Hypercalcemia in patients on digitalis may precipitate cardiac arrhythmias.
Magnesium-containing preparations (e.g. antacids) T ↑ intestinal absorption of magnesium Magnesium-containing antacids and calcitriol should not be used concomitantly, since such use may lead to the development of hypermagnesemia.
Thiazide diuretics T ↑risk of hypercalcemia Thiazide diuretics act on the distal tubule and inhibit reabsorption of sodium and potassium. This in turn stimulates the reabsorption of calcium, therefore, an increase in calcium level.
Legend: T = Theoretical

Drug-Food Interactions

Interactions with food have not been established.

Drug-Herb Interactions

Interactions with herbal products have not been established.

Drug-Laboratory Interactions

Interactions with laboratory tests have not been established.

Read the Calcijex Injection Drug Interactions Center for a complete guide to possible interactions

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

Last reviewed on RxList: 2/23/2016

Side Effects
Interactions

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.


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