Biofol 5

Indications:

Calcium Folinate is commonly prescribed for:

• Neutralizing the toxic effects of folic acid antagonists like methotrexate.
• Calcium folinate rescue treatment, reducing the toxicity of folic acid antagonists.
• Treating megaloblastic anemia caused by conditions such as sprue, nutritional deficiencies, pregnancy, liver disease, or malabsorption syndromes.
• Supplementing calcium folinate in conditions like rickets, pregnancy, lactation, and elderly care.

Always follow the advice of a registered healthcare provider.

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 the calcium salt of folinic acid, a crucial metabolite and active form of folic acid. It supports the biosynthesis of nucleic acids by acting as a cofactor for 1-carbon transfer reactions. This compound is vital for preventing DNA damage and is an effective antidote for the hematologic and reticuloendothelial toxic effects of folic acid antagonists like methotrexate, pyrimethamine, and trimethoprim. Folinate’s use in high-dose methotrexate therapy serves to rescue normal cells from the toxic effects of these drugs.

Dosage & Administration:

• Folinic Acid Rescue: Start treatment within 24 hours of methotrexate administration, usually beginning 24 hours after the infusion. A typical regimen involves 15 mg of folinic acid every 6 hours for 10 doses.
• For Hematologic Toxicity: A daily dose of 5 mg to 15 mg of folinic acid can counteract toxicity from folic acid antagonists.
• For Megaloblastic Anemia: 5 mg to 15 mg daily, depending on the severity.

Note: The use of calcium folinate in children and adolescents has not been established.

Interactions:

• High doses of folinate can reduce the effectiveness of antiepileptic medications (phenobarbitone, phenytoin, primidone), potentially increasing seizure frequency.
• Caution is needed when using calcium folinate with fluoropyrimidines due to a risk of seizures and syncope.

Contraindications:

Calcium Folinate should not be used in the following cases:

• Known hypersensitivity to calcium folinate or any other components.
• Pernicious anemia or vitamin B12 deficiency-related megaloblastic anemia.
• Patients with galactose intolerance, lactase deficiency, or glucose-galactose malabsorption.

Side Effects:

Common side effects may include:

• Mucositis, stomatitis, leukopenia, and/or diarrhea, which may be dose-limiting.

Pregnancy & Lactation:

• The safety of calcium folinate during pregnancy has not been well-studied. It should only be used if the benefits outweigh the potential risks to the fetus.
• It is unclear if calcium folinate passes into human milk. Caution should be exercised when administering this drug to nursing mothers.

Precautions & Warnings:

• Calcium folinate should only be used under the supervision of a clinician experienced with chemotherapy agents like methotrexate and 5-FU.
• Ensure that proper measures are taken to promote methotrexate excretion during calcium folinate rescue therapy, including urine alkalinization and adequate hydration.

Overdose Effects:

• Overdose with calcium folinate has not shown significant effects, but excessive amounts may counteract the effects of folic acid antagonists. No specific antidote exists for calcium folinate overdose; supportive care is recommended.

Therapeutic Class:

Supportive Care Therapy

Storage Conditions:

• Store at temperatures below 30°C.
• Keep the product away from light and out of reach of children.