Included as part of the PRECAUTIONS section.

Rate of Administration

Because of the Ca⁺⁺ content of the levoleucovorin solution, no more than 16 mL (160 mg of levoleucovorin ) should be injected intravenously per minute.

Potential for Enhanced Toxicity with 5-Fluorouracil

levoleucovorin enhances the toxicity of 5-fluorouracil. Deaths from severe enterocolitis, diarrhea, and dehydration have been reported in elderly patients receiving weekly d,l-leucovorin and 5-fluorouracil.

Potential for interaction with trimethoprim-sulfamethoxazole

The concomitant use of d,l-leucovorin with trimethoprim-sulfamethoxazole for the acute treatment of Pneumocystis carinii pneumonia in patients with HIV infection was associated with increased rates of treatment failure and morbidity in a placebo-controlled study.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment Of Fertility

No studies have been conducted to evaluate the potential of levoleucovorin for carcinogenesis, mutagenesis and impairment of fertility.

Use In Specific Populations

Pregnancy

Pregnancy Category C. It is not known whether levoleucovorin can cause fetal harm when administered to a pregnant woman or if it can affect reproduction capacity. Animal reproduction studies have not been conducted with levoleucovorin. levoleucovorin should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when levoleucovorin is administered to a nursing mother.

Pediatric Use

[See Clinical Studies]

Geriatric Use

Clinical studies of levoleucovorin in the treatment of osteosarcoma did not include subjects aged 65 and over to determine whether they respond differently from younger subjects.

Last reviewed on RxList: 3/31/2008
This monograph has been modified to include the generic and brand name in many instances.