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Leucovorin Calcium Injection

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Leucovorin Calcium Injection

Leucovorin Calcium Injection Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Leucovorin Calcium for Injection is a derivative of folic acid used to reduce the side effects of large doses or accidental overdose of medications that can reduce the effects of folic acid in the body. These medications include methotrexate, pyrimethamine, trimethoprim, and others. It is also used in combination with 5-fluorouracil to prolong survival in the palliative treatment of patients with advanced colorectal cancer. Leucovorin is available in generic form. Common side effects include hives. Seek immediate medical attention if you notice symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Dosage of Leucovorin Calcium is based on the patient's medical condition and response to treatment. Leucovorin Calcium may interact with phenytoin, phenobarbital, or primidone. Tell your doctor all medications and supplements you use. During pregnancy, Leucovorin Calcium should be used only when prescribed. It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Our Leucovorin Calcium for 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 Prescribing information?

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

Leucovorin Calcium Injection FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Allergic sensitization, including anaphylactoid reactions and urticaria, has been reported following the administration of both oral and parenteral leucovorin (leucovorin calcium) . No other adverse reactions have been attributed to the use of leucovorin (leucovorin calcium) per se.

The following table summarizes significant adverse events occurring in 316 patients treated with the leucovorin (leucovorin calcium) /5-fluorouracil combinations compared against 70 patients treated with 5-fluorouracil alone for advanced colorectal carcinoma. These data are taken from the Mayo/NCCTG large multicenter prospective trial evaluating the efficacy and safety of the combination regimen.

PERCENTAGE OF PATIENTS TREATED WITH LEUCOVORIN (leucovorin calcium) /FLUOROURACIL FOR ADVANCED COLORECTAL CARCINOMA REPORTING ADVERSE EXPERIENCES OR HOSPITALIZED FOR TOXICITY

  (High LV)/5-FU
(N=155)
(Low LV)/5-FU
(N=161)
5-FU Alone
(N =70)
Any
(%)
Grade 3+
(%)
Any
(%)
Grade 3+
(%)
Any
(%)
Grade 3+
(%)
Leukopenia 69 14 83 23 93 48
Thrombocytopenia 8 2 8 1 18 3
Infection 8 1 3 1 7 2
Nausea 74 10 80 9 60 6
Vomiting 46 8 44 9 40 7
Diarrhea 66 18 67 14 43 11
Stomatitis 75 27 84 29 59 16
Constipation 3 0 4 0 1 -
Lethargy/Malaise/Fatigue 13 3 12 2 6 3
Alopecia 42 5 43 6 37 7
Dermatitis 21 2 25 1 13 -
Anorexia 14 1 22 4 14 -
Hospitalization for Toxicity 5% 15% 7%
High LV = Leucovorin (leucovorin calcium) 200 mg/m2, Low LV = Leucovorin (leucovorin calcium) 20 mg/m2
Any = percentage of patients reporting toxicity of any severity
Grade 3+ = percentage of patients reporting toxicity of Grade 3 or higher

Read the entire FDA prescribing information for Leucovorin Calcium Injection (Leucovorin Calcium) »

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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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