Calcium Folinate is indicated for –
● Methotrexate Rescue Therapy: To reduce the toxicity and counteract the effects of high-dose methotrexate therapy in patients undergoing chemotherapy.
● Colorectal Cancer Treatment: Used in combination with 5-fluorouracil to enhance its antitumor activity.
● Megaloblastic Anemia: Used in patients with folic acid deficiency due to conditions such as malabsorption syndromes, pregnancy, infancy, or chronic diseases.
● Folic Acid Antagonist Overdose: Used in cases of accidental or excessive administration of methotrexate or similar folic acid antagonists.
Calcium Folinate is administered by intravenous (IV) injection or intramuscular (IM) injection, depending on the condition being treated.
Methotrexate Rescue Therapy
The recommended dose of Calcium Folinate varies based on serum methotrexate levels and the severity of toxicity. A common regimen is 15 mg (or 10 mg/m²) every 6 hours for 10 doses, beginning 24 hours after methotrexate infusion. The dose is adjusted based on methotrexate clearance.
Colorectal Cancer Treatment
When used with 5-fluorouracil, Calcium Folinate is given at a dose of 200-500 mg/m² IV over 2 hours, followed by 5-fluorouracil administration. Treatment is repeated in cycles depending on the chemotherapy protocol.
Megaloblastic Anemia
A dose of 1-5 mg daily is recommended until the anemia is corrected.
Calcium Folinate should be used under the supervision of a healthcare professional, and treatment should be tailored based on patient response and clinical condition.
Common side effects include –
● Nausea, vomiting, and diarrhea
● Gastrointestinal discomfort
● Allergic reactions such as rash, itching, or fever
● Neurological symptoms (dizziness, headache, syncope in rare cases)
When used with 5-fluorouracil, patients may experience hand-foot syndrome, severe diarrhea, and mucositis, requiring dose adjustments or treatment discontinuation.
Calcium Folinate should not be used in –
● Patients with known hypersensitivity to folinic acid or any excipients.
● Patients with pernicious anemia or other vitamin B12 deficiency states, as it does not replace vitamin B12.
● Patients receiving intrathecal methotrexate, as its concurrent use may lead to serious neurological toxicity.
● Pregnancy: The safety of Calcium Folinate in pregnancy has not been fully established. It should be used during pregnancy only if clearly needed and under medical supervision.
● Lactation: It is unknown whether Calcium Folinate is excreted in human milk. Therefore, caution is advised when administering it to nursing mothers.
Calcium Folinate is safe and effective for use in children receiving methotrexate therapy or suffering from megaloblastic anemia. However, dose adjustments may be necessary based on weight and condition.
● 5-Fluorouracil: Enhances the cytotoxic effects of 5-fluorouracil; dose modifications may be required to reduce toxicity.
● Antiepileptic Drugs: May reduce the efficacy of anticonvulsants such as phenytoin, phenobarbital, and primidone, increasing seizure risk.
● Methotrexate: Should be given at the correct time interval to avoid interference with methotrexate’s therapeutic effects.
There is no known severe toxicity associated with Calcium Folinate overdose. However, excessive doses may reduce the efficacy of methotrexate therapy. If an overdose occurs, medical monitoring and symptomatic treatment are recommended.
● Store in a refrigerator at 2-8°C.
● Do not freeze.
● Protect from light.
● Keep out of reach of children.
