"The U.S. Food and Drug Administration yesterday approved Rixubis [Coagulation Factor IX (Recombinant)] for use in people with hemophilia B who are 16 years of age and older. Rixubis is indicated for the control and prevention of bleeding episodes"...
Adverse Drug Reaction Overview
The following adverse reactions have been reported in association with CALCIJEX® (calcitriol injection) 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:
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|
|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
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
|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|
Interactions with food have not been established.
Interactions with herbal products have not been established.
Interactions with laboratory tests have not been established.
Read the Calcijex Injection Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 2/23/2016
Additional Calcijex Injection Information
- Calcijex Injection Drug Interactions Center: calcitriol iv
- Calcijex Injection Side Effects Center
- Calcijex Injection Overview including Precautions
- Calcijex Injection FDA Approved Prescribing Information including Dosage
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.
Find out what women really need.