Lovorin Special Precautions

General: Consider the possibility of allergic reactions to folinic acid as these have been reported following parenteral folic acid administration.
There is potential danger in administering folinic acid to patients with undiagnosed anemia. Folinic acid may obscure the diagnosis of pernicious anemia by alleviating hematologic manifestations of the disease while allowing neurologic complications to progress. This may result in severe nervous system damage before the correct diagnosis is made. Adequate doses of vitamin B₁₂ may prevent, halt or improve neurologic changes caused by pernicious anemia.
Folinic Acid/Methotrexate: Folinic Acid should be used with caution when used after methotrexate in the following conditions: Aciduria (urine pH less than 7).
Ascites.
Dehydration.
Gastrointestinal obstruction.
Pleural or peritoneal effusions.
Renal function impairment.
When Folinic Acid rescue is used in conjunction with high-dose methotrexate therapy, it is highly recommended that the drugs be administered only by physicians experienced in cancer chemotherapy and in centers where facilities for measuring blood methotrexate concentrations are available. Folinic Acid is usually effective in counteracting severe methotrexate toxicity in these regimens, but toxic reactions to methotrexate may occur despite Folinic Acid therapy, especially when methotrexate's half-life is increased. Therefore, it is extremely important that Folinic Acid be administered until methotrexate's blood concentration declines to nontoxic concentrations.
Folinic Acid/5-FU: Since Folinic Acid enhances 5-FU's toxicity, it is recommended that adjunctive therapy with Folinic Acid and 5-FU be given only by, or under the supervision of, physicians experienced in cancer chemotherapy and in the use of metabolites.
There is some evidence suggesting that risk of 5-FU-induced GI toxicity may be increased in patients receiving Folinic Acid concomitantly with the drug. Death secondary to severe enterocolitis, diarrhea and dehydration has occurred in geriatric patients receiving the drugs concomitantly. Concomitant granulocytopenia and fever were present but not all cases. Exercise extreme caution in geriatric or debilitated patients administered with combined Folinic Acid and 5-FU therapy since these patients are most likely to develop serious 5-FU toxicity.
Folinic Acid should not be mixed with 5-FU in the same IV injection or infusion.
Effects on Ability to Drive or Use Machines: There is no evidence that Folinic Acid has an effect on the ability to drive or use machines.
Use in Children: Folinic Acid may increase the frequency of seizures in susceptible children.
Use in Elderly: Elderly patients are at a greater risk of developing severe toxicity when treated with the combination of Folinic Acid plus 5-FU for advanced colorectal cancer (see Precautions).