Leucovorin Calcium Injection
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Leucovorin Calcium Injection
Leucovorin Calcium Injection Side Effects Center
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 |
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Read the entire FDA prescribing information for Leucovorin Calcium Injection (Leucovorin Calcium) »
Additional Leucovorin Calcium Injection Information
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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