Biofol 5 mg (Tablet)

Indications

• Neutralising the immediate toxic effects of folic acid antagonists, e.g. methotrexate.
• Calcium folinate rescue- a treatment technique using calcium folinate in conjunction with folic acid antagonists, e.g. methotrexate, to minimise systemic toxicity.
• The treatment of megaloblastic anaemias due to sprue, nutritional deficiency, pregnancy, infancy, liver disease and malabsorption syndrome.

Composition

• Calcium Folinate Hydrate BP 6.249 mg equivalent to Folinic Acid 5 mg.
• Calcium Folinate Hydrate BP 18.746 mg equivalent to Folinic Acid 15 mg.

Pharmacology

• Metabolite and active form of folic acid that is involved as a cofactor for 1-carbon transfer reactions in the biosynthesis of purine and pyrimidines of nucleic acids.
• Impairment of thymidylate synthesis in patients with folic acid deficiency.
• Potent antidote for both hematopoietic and reticuloendothelia toxic effects of folic acid antagonists.

Dosage & Administration

• Calcium folinate rescue treatment should commence approximately 24 hours after the beginning of methotrexate infusion.
• Folinic Acid should be administered at a dose of 15 mg (approximately 10 mg/m2) every 6 hours for 10 doses.
• The recommended dose of Folinic Acid to counteract hematologic toxicity from folic acid antagonists with less affinity for mammalian dihydrofolate reductase than methotrexate is substantially less and 5 mg to 15 mg of Folinic Acid per day has been recommended.

Interaction

• Large amounts of folinates may counteract the antiepileptic effect of phenobarbitone, phenytoin and primidone and increase the frequency of seizures in susceptible patients.
• Caution is required during concurrent administration of calcium folinate with fluoropyrimidine.

Contraindications

• Known hypersensitivity to calcium folinate or any other components of this product.
• Pernicious anemia or other megaloblastic anemia where vitamin B12 is deficient.
• Rare hereditary problems of galactose intolerance, the lapp lactase deficiency or glucose-galactose malabsorption.

Side Effects

• Mucositis
• Stomatitis
• Leukopenia
• Diarrhea

Pregnancy & Lactation

• No adequate and well-controlled clinical studies conducted in pregnant women.
• Should only be used in pregnant women if the potential benefit justifies the potential risk to the fetus.

Precautions & Warnings

• Should only be used with methotrexate or 5-FU under the direct supervision of a clinician experienced in the use of cancer chemotherapeutic agents.
• Treatment of inadvertent overdosage of a folic acid antagonist, folinate should be administered as soon as possible.
• Flowever, calcium folinate given concurrently with folate antagonists, such as pyrimethamine and trimethoprim does not inhibit their antibacterial activity.
• Measures to ensure the prompt excretion of methotrexate are important as part of Calcium Folinate Rescue Therapy.

Overdose Effects

• Excessive amounts of calcium folinate may nullify the chemotherapeutic effect of folic acid antagonists.
• No specific antidote to calcium folinate overdose.

Therapeutic Class

• Supportive Care Therapy

Storage Conditions

• Do not store above 30°C.
• Keep away from light and out of the reach of children.

Related Brands

• Foly 15 mg (Tablet) - drug-international-ltd
• Folicid 10 mg/ml (IM/IV Injection) - techno-drugs-ltd
• Bendafolin 10 mg/ml (IM/IV Injection) - solupharm-gmbh-germany
• Folcasin 10 mg/ml (IM/IV Injection) - bots-pvt-limited
• Folinex 10 mg/ml (IM/IV Injection) - beacon-pharmaceuticals-plc