Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2016 Publisher: Pfizer Ltd, Ramsgate Road, Sandwich, Kent, CT13 9NJ
Leucovorin (folinic acid) is the formyl derivative of tetrahydrofolic acid and is an intermediate product of the metabolism of folic acid.
Leucovorin is used in cytotoxic therapy as an antidote to folic acid antagonists such as methotrexate.
Leucovorin is effective in the treatment of megaloblastic anaemia.
Although leucovorin calcium may also be available as a solution for injection, leucovorin calcium should not be administered intrathecally.
Depending upon the dose of methotrexate administered, dosage regimens of leucovorin calcium vary. Up to 120 mg leucovorin calcium are generally given, usually in divided doses over 12-24 hours by intramuscular injection, bolus intravenous injection or intravenous infusion in normal saline. This is followed by 12-15 mg intramuscularly or 15 mg orally every 6 hours for 48 hours. Rescue therapy is usually started 24 hours after the commencement of methotrexate administration.
If overdosage of methotrexate is suspected, the dose of leucovorin calcium should be equal to or greater than the dose of methotrexate and should be administered within one hour of the methotrexate administration.
15 mg (one tablet) leucovorin per day.
To be given orally.
There have been no reported sequelae in patients who have received significantly more calcium folinate then the recommended dosage. However, excessive amounts of calcium folinate may nullify the chemotherapeutic effect of folic acid antagonists.
Should overdosage of the combination of 5-fluorouracil and calcium folinate occur, the overdosage instructions for 5-FU should be followed.
5 years.
Store below 25°C. Do not refrigerate or freeze.
The tablets are contained in white high density polyethylene containers with polyethylene screw closures. The bottles contain 30 or 100 tablets.
Not all pack sizes may be marketed.
The tablets are contained in white high density polyethylene containers with polyethylene screw closures. The bottles contain 30 or 100 tablets.
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