CALCIUM

What it is

Calcium Folinate Medsurge Injection contains folinic acid as calcium folinate, available in strengths of 50 mg/5 mL, 100 mg/10 mL, 300 mg/30 mL, and 1000 mg/100 mL. The injection is a sterile, isotonic, clear, yellowish, preservative-free solution. Folinic acid is the 5-formyl derivative of tetrahydrofolic acid, which is a metabolite and the active form of folic acid.

Approved indications

— As rescue therapy to reduce toxicity following high-dose methotrexate therapy — After inadvertent overdosage with methotrexate and in impaired methotrexate elimination — Reducing the toxicity and circumventing the effect of folic acid antagonists, if therapeutically desired — Treatment of certain megaloblastic anaemias resulting from folic acid deficiency, mainly in infants, during pregnancy, in malabsorption syndromes, liver diseases, sprue and malnutrition

Dosing overview

Dosing depends on the clinical indication and individual patient circumstances. For normal methotrexate elimination following high-dose methotrexate therapy, the standard dose is 15 mg intramuscularly or intravenously every six hours for 60 hours (ten doses starting at 24 hours after start of methotrexate infusion). For delayed methotrexate elimination, 15 mg intramuscularly or intravenously is continued every six hours until methotrexate level is less than 0.05 μM. For inadvertent methotrexate overdosage, 10 mg/m² should be administered intravenously or intramuscularly every six hours until the serum methotrexate level is less than 0.01 μM. For megaloblastic anaemias, the dose is up to 1 mg daily.

Key safety warnings

Calcium Folinate Medsurge Injection must not be administered intrathecally; when calcium folinate has been administered intrathecally following intrathecal overdose of methotrexate, death has been reported. Patients who experience delayed early methotrexate elimination are likely to develop reversible renal failure and require hydration and urinary alkalinisation (pH 7.0 or greater), and close monitoring of fluid and electrolyte status until the serum methotrexate concentration has fallen below 0.05 μM and the renal failure has resolved. Calcium Folinate Medsurge may enhance the toxicity profile of fluorouracil, particularly in elderly or debilitated patients, with common manifestations being leucopenia, mucositis, stomatitis and/or diarrhoea, which may be dose limiting. Deaths from severe enterocolitis, diarrhoea and dehydration have been reported in elderly patients receiving fluorouracil and calcium folinate. Seizures and/or syncope have been reported rarely in cancer patients receiving calcium folinate, usually in association with fluoropyrimidine administration, and most commonly in those with CNS metastases.

Contraindications

Calcium Folinate Medsurge Injection is contraindicated in patients with pernicious anaemia or other megaloblastic anaemias secondary to the lack of vitamin B₁₂; when treating these conditions with folinic acid, haematological remission may occur, but neurological manifestations are likely to progress. It is also contraindicated in patients with known hypersensitivity to the active substance or to any of the excipients.

Regulatory history

Calcium Folinate Medsurge Injection received its first approval on 09 September 2025.