Leucovorin Calcium Injection (Leucovorin Calcium) Drug Information: Side Effects and Drug Interactions

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May 27, 2012

Leucovorin Calcium Injection

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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

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.