Biofol 15

Indications

Calcium Folinate is indicated for:

• Neutralizing the acute toxic effects of folic acid antagonists, such as methotrexate.
• Calcium folinate rescue: A treatment approach using calcium folinate alongside folic acid antagonists to minimize systemic toxicity.
• Treating megaloblastic anemias stemming from conditions like sprue, nutritional deficiencies, pregnancy, infancy, liver disease, and malabsorption syndromes.

Consult a registered physician before use.

Composition

Each tablet contains:

• Calcium Folinate Hydrate BP: 6.249 mg (equivalent to 5 mg of Folinic Acid).
• Calcium Folinate Hydrate BP: 18.746 mg (equivalent to 15 mg of Folinic Acid).

Pharmacology

Calcium Folinate is a calcium salt of folinic acid, a vital metabolite of folic acid involved in critical biosynthetic processes, including the production of nucleic acids. Deficiencies in folic acid can impair DNA synthesis, leading to megaloblastic anemia. Calcium Folinate acts as an antidote to the hematopoietic and reticuloendothelial toxic effects of folic acid antagonists, effectively “rescuing” normal cells from their harmful effects, especially during high-dose methotrexate therapy.

Dosage & Administration

• Calcium Folinate Rescue: Initiate as soon as possible after methotrexate administration, ideally within 24 hours. Dosing varies based on methotrexate levels, with a typical regimen of 15 mg (about 10 mg/m²) every 6 hours for 10 doses for high-dose methotrexate.
• For Megaloblastic Anemia: Recommended doses range from 5 mg to 15 mg daily.

Consult a physician for children and adolescents, as safety and efficacy are not established.

Interactions

High doses of folinates may counteract the effects of certain antiepileptic medications and could increase seizure frequency. Exercise caution when using calcium folinate with fluoropyrimidines due to potential seizure risks.

Contraindications

Avoid use in patients with:

• Known hypersensitivity to calcium folinate or its components.
• Pernicious anemia or vitamin B12 deficiency.
• Rare hereditary conditions affecting galactose metabolism.

Side Effects

Common side effects may include mucositis, stomatitis, leukopenia, and diarrhea, which can limit dosage.

Pregnancy & Lactation

Calcium Folinate should only be used during pregnancy if the benefits outweigh the risks to the fetus. Caution is advised for nursing mothers, as the excretion in breast milk is unknown.

Precautions & Warnings

Calcium Folinate should be administered under the supervision of a healthcare professional experienced in cancer treatments. It’s critical to monitor renal function and serum calcium levels during long-term use, particularly in elderly patients or those on other medications.

Overdose Effects

No significant adverse effects have been reported from calcium folinate overdose, but excessive amounts may negate the effects of folic acid antagonists. Supportive care is advised for overdose cases.

Therapeutic Class

Supportive Care Therapy

Storage Conditions

Store below 30°C, away from light and out of reach of children.