Indications

• Calcium Folinate is used to reduce the toxicity of Methotrexate and to offset the effects of poor Methotrexate elimination.
• To treat Megaloblastic anemia caused by a lack of folate, similar to sprue, a nutritional deficit.
• Megaloblastic anemia in pregnancy and infancy is treated with this drug.

Pharmacology

Calcium Folinate is a calcium salt of Folinic acid (citrovorum factor), which is a combination of diastereoisomers of Tetrahydrofolic acid's 5-formyl derivative. It's a Folic acid metabolite and a necessary co-enzyme for nucleic acid synthesis that's utilized in cytotoxic treatment.

Dosage & Administration

Oral-

• Reduction of harmful effects of folic acid antagonists: The dose is usually one 5-15 mg tablet every 6 hours for 2 to 3 days.
• Megaloblastic anemia: In the treatment of Megaloblastic anemia, the dose is one 5-15 mg tablet daily.

Intravenous-

• Advanced Colorectal Cancer: Folinic Acid is administered at 200 mg/m2 by slow intravenous injection followed by 5-fluorouracil at 370 mg/m2 by intravenous injection. Or 20 mg/m  2 by slow intravenous injection followed by 5-fluorouracil at 425 mg/m2 by intravenous injection. Treatment is repeated daily for 5 days. This 5 day treatment course may be repeated at 4 weeks interval, for 2 courses and then may repeated at 4-5 weekly intervals if the patient has recovered completely from the toxic effects of the prior treatment course.
• Folinic acid rescue after high dose Methotrexate Therapy: Calcium Folinate starts 24 hours after the beginning of the methotrexate infusion at dose of 15mg (10 mg/m2 ) every 6 hours for 10 doses.

Intramuscular-

• Folate deficient megaloboastic anaemia: Up to 1 mg/day. Or, as directed by the registered physician.

Interactions

When calcium folinate is used with a folic acid antagonist (e.g., cotrimoxazole, pyrimethamine), the folic acid antagonist's effectiveness may be decreased or neutralized altogether.

Calcium folinate may reduce the effect of anti-epileptic drugs such as phenobarbital, primidone, phenytoin, and succinimides, as well as increase the frequency of seizures (a decrease in plasma levels of enzymatic inductor anticonvulsant drugs may be observed due to increased hepatic metabolism, as folates are one of the cofactors) (see also sections 4.4 and 4.8). The effectiveness and toxicity of 5-fluorouracil have been demonstrated to improve when calcium folinate is given at the same time.

Contraindications

Calcium Folinate treatment is not recommended if you have any of the following conditions:

• Hypersensitivity to Calcium Folinate or any of the product's ingredients is known.
• Vitamin B12 deficiency in Pernicious anemia or other Megaloblastic anemia.

Side-Effects

• Allergic reaction: itching rash (hives), swelling of the hands, feet, ankles, face, lips, mouth, or neck may occur (which may cause difficulty in swallowing or breathing).
• Fits and fainting are common.

Pregnancy & Lactation

In pregnant or nursing women, there are no appropriate and well-controlled clinical trials. This medication is not known to be excreted in human milk. Because many medicines are excreted in human milk, when Calcium Folinate is given to a nursing mother, caution should be used.

Precautions & Warnings

Pernicious anemia and other Megaloblastic anemia caused by Vitamin B12 deficiency may be disguised by calcium folate therapy.

Calcium Folinate should only be used in conjunction with 5-fluorouracil or Methotrexate if a doctor with experience with cancer chemotherapeutic drugs is present.

Many cytotoxic medicines cause macrocytosis, whether they are direct or indirect DNA synthesis inhibitors (hydroxycarbamide, cytarabine, mercaptopurine, thioguanine). Folinic acid should not be used to treat such macrocytosis. There is a risk of increased seizure frequency in epileptic patients treated with Phenobarbital, Phenytoin, Primidone, and Succinimides due to a drop in plasma anti-epileptic medication concentrations.

Therapeutic Class

Supportive Care Therapy

Storage Conditions

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

Pharmaceutical Name

Incepta Pharmaceuticals Ltd

Generic

Calcium Folinate [Folinic Acid]

Related Products

• Folita 5 Tablet
• Folix 5 Tab