CALCIUM FOLINATE INJECTION 10 MG/ML [SIN07916P]

Product Info

CALCIUM FOLINATE INJECTION 10 MG/ML

[SIN07916P]

4.1. Therapeutic Indications

Calcium folinate is indicated in:

1. Neutralising the immediate toxic effects of folic acid antagonists, e.g., Methotrexate.

2. Calcium Folinate Rescue - a treatment technique using calcium folinate in conjunction with folic acid antagonists, e.g., methotrexate, to minimise systemic toxicity.

3. The treatment of megaloblastic anaemias due to sprue, nutritional deficiency, pregnancy, infancy, liver disease and malabsorption syndrome when oral therapy is not possible.

4.2. Posology and Method of Administration

Posology

Calcium Folinate Rescue (Adults and Children)
Calcium folinate may be used in conjunction with folic acid antagonists, e.g., Methotrexate, to reduce their systemic toxicity. It is given 12 to 24 hours after the antineoplastic drug. Doses of up to 120 mg maybe given over 12 to 24 hours by intramuscular injection or intravenous injection or infusion followed by 12 to 15 mg intramuscularly or 15 mg orally, every 6 hours for the next 48 hours. With lower doses of methotrexate, leucovorin 15 mg orally every 6 hours for 48 to 72 hours may be sufficient.

In addition to calcium folinate administration, measures to ensure the prompt excretion of methotrexate (maintenance of high urine output and alkalinisation of urine) are integral parts of the calcium folinate rescue treatment. Renal function should be monitored through daily measurements of serum creatinine.

Delayed methotrexate excretion may be seen in some patients. This may be caused by a third space accumulation (as seen in ascites or pleural effusion for example), renal insufficiency or inadequate hydration (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Under such circumstances, higher doses of calcium folinate and/or prolonged administration may be indicated.

Treatment of Megaloblastic Anaemia
The dose should not exceed 1 mg daily given intramuscularly. When given orally, the recommended dosage is one Calcium Leucovorin Tablet (15 mg) daily. Children up to 12 years: 0.25 mg/kg/day. Normal adult dosage: 10–20 mg daily.

Treatment of Overdosage of Folic Acid Antagonists
In cases of overdosage of folic acid antagonists, calcium folinate may be administered by intravenous infusion in doses of up to 75 mg within 12 hours, followed by 12 mg intramuscularly every 6 hours for 4 doses.

In general, where overdosage is suspected, the dose of calcium folinate should be equal to or greater than the offending dose of the folic acid antagonist administered, and should be given as soon as possible; preferably within the first hour and certainly within 4 hours after which it may not be effective.

Method of Administration

Calcium folinate may be given parenterally by intramuscular injection, intravenous injection or intravenous infusion.

When required for intravenous infusion, it may be diluted with 5% Glucose Injection or 0.9% Sodium Chloride Injection. Diluted solutions should be used immediately, but if this is not possible the diluted solution may be stored for a maximum of 24 hours at 2–8°C, protected from light.

Calcium folinate must not be injected intrathecally (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.3. Contraindications

• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

• Pernicious anaemia or other anaemias due to vitamin B₁₂ deficiency.

Regarding the use of calcium folinate with methotrexate or 5-fluorouracil during pregnancy and lactation, and any additional contraindications relating to these products, refer to section 4.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information and the Summaries of Product Characteristics for methotrexate- and 5-fluorouracil-containing medicinal products.