May 27, 2016
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Calcijex

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Calcijex Injection




Calcijex Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 2/11/2016

Calcijex (calcitriol injection) is a man-made form of vitamin D3 used to treat or prevent low calcium levels in patients undergoing long-term kidney dialysis. Calcijex is usually used along with diet, supplements, and sometimes other medications. Calcijex is available in generic form. Common side effects of Calcijex include nausea, headache, constipation, pain/discomfort at the injection site, dry mouth, loss of appetite, or stomach upset.

The optimal dose of Calcijex is individually determined for each patient. Calcijex may interact with digoxin, steroids, magnesium-containing medications, phosphate binders, diuretics, supplements that contain vitamin D, or anticonvulsants. Tell your doctor all medications and supplements you use. During pregnancy, Calcijex should be used only if prescribed. It is unknown if Calcijex passes into breast milk. Consult your doctor before breastfeeding.

Our Calcijex (calcitriol injection) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Calcijex Overview - Patient Information: Side Effects

SIDE EFFECTS: Nausea, headache, constipation, or pain/discomfort at the injection site may occur. If any of these effects persist or worsen, notify your doctor promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: back/bone/joint/muscle pain, dry mouth, metallic taste, vomiting, sleepiness, weakness, loss of appetite, dizziness, eye pain/redness/sensitivity to light, fever, fast/slow/irregular heartbeat, decreased interest in sex, mental/mood changes (e.g., confusion), stomach/abdominal pain, swelling of the ankles/feet/hands (edema), increased thirst, change in the amount of urine, weight loss.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any of the following symptoms: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Calcijex (Calcitrol)

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Calcijex FDA Prescribing Information: Side Effects
(Adverse Reactions)

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 entire FDA prescribing information for Calcijex (Calcitrol)

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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