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Leucovorin Calcium Injection

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Leucovorin Calcium Injection

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 Leucovorin Calcium Injection (leucovorin calcium) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Folic acid in large amounts may counteract the antiepileptic effect of phenobarbital, phenytoin and primidone, and increase the frequency of seizures in susceptible pediatric patients.

Preliminary animal and human studies have shown that small quantities of systemically administered leucovorin (leucovorin calcium) enter the CSF primarily as 5-methyltetrahydrofolate and, in humans, remain 1 to 3 orders of magnitude lower than the usual methotrexate concentrations following intrathecal administration. However, high doses of leucovorin (leucovorin calcium) may reduce the efficacy of intrathecally administered methotrexate.

Leucovorin (leucovorin calcium) may enhance the toxicity of 5-fluorouracil (see WARNINGS).

Last reviewed on RxList: 2/24/2009
This monograph has been modified to include the generic and brand name in many instances.

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