"Nevro Corp has received an "approvable" letter from the US Food and Drug Administration (FDA) for its spinal cord stimulation (SCS) system for treatment of chronic pain.
The Senza SCS system delivers Nevro's proprietary HF10"...
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.
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 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.
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.
[See Clinical Studies]
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.
Additional Levoleucovorin 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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