Rofolin^®

Generic Name: Calcium Folinate

Dosage Form: Scored tablet containing 15 mg of calcium folinate

Drug Class: Antidote, Chemotherapy Enhancer

Indications: This medication is primarily used to reduce the toxicity resulting from excessive intake of methotrexate, pyrimethamine, and trimethoprim.

Rofolin^®

Rofolin^® (calcium folinate or leucovorin) is one of the active forms of folic acid, used as an antidote to poisoning by various agents (including methotrexate) and as an enhancer for the effects of certain chemotherapy drugs (such as 5-fluorouracil).

Rofolin^® competes with methotrexate for intracellular transport sites, displacing it from intracellular binding sites. It also supplies active folate forms needed for DNA and RNA synthesis.

Indications for Rofolin^®

·       Reducing toxicity due to excessive intake of folic acid antagonists (such as methotrexate, trimethoprim, and pyrimethamine)

·       Treatment of megaloblastic anemia due to folic acid deficiency

·       Prevention of blood toxicity due to pyrimethamine in AIDS patients

·       Prevention of graft-versus-host disease (GVHD)

·       Therapy regimens for various cancers, including bladder cancer

 

Dosage form of Rofolin^®

Scored tablet containing 15 mg of calcium folinate

Administration of Rofolin^®

Take Rofolin^® as directed by your doctor and avoid changing the dosage or duration of treatment without consulting your doctor to ensure optimal therapeutic response.

Be sure to take Rofolin^® with a glass of water. Drink more fluids during treatment with this medication. If stomach upset occurs, take the medication with food.
If nausea or vomiting occurs, avoid taking this tablet.

Missed dose of Rofolin^®

If you miss a dose, take it as soon as you remember. If it's near the time for your next dose, skip the missed dose. Do not take two doses at once or an extra dose.

Overdose of Rofolin^®

If you take more than the recommended amount, contact your doctor immediately.

Monitoring required while using Rofolin^®

·       Serum methotrexate levels

·       Electrolyte levels

·       Blood cell counts with platelet measurement

·       Liver enzymes

 

Contraindications for Rofolin^®

·       Allergy to calcium folinate or other formula ingredients

·       Pernicious anemia and other vitamin B12 deficiency anemias

·       Intrathecal administration

 

Warnings and Precautions for using Rofolin^®

·       Take Rofolin^® with methotrexate or 5-fluorouracil under the direct supervision of a specialist doctor.

·       Treatment with Rofolin^® should be started as soon as possible after excessive intake of a folic acid antagonist.

·       High doses over 25 mg are not absorbed more by mouth and are not recommended.

·       Use with caution in patients with a history of seizures or epilepsy, particularly children, a history of allergies to other drugs, severe kidney problems, and vitamin B12 deficiency.

Use of Rofolin^® during Pregnancy and Lactation

Use of this medication during pregnancy should be based on doctor's prescription, considering the benefits for the mother against potential risks for the fetus.

Rofolin^® should be used during breastfeeding with doctor's knowledge due to potential medication excretion into milk and risk of adverse effects in the infant.

Side effects of Rofolin^®

In addition to desired therapeutic effects, any drug may cause some unwanted side effects, although not everyone may experience them. More common potential side effects of this drug include:

·       Allergic reactions (symptoms include skin rash, joint pain, fever, breathing and swallowing

·       difficulties, swelling of lips, throat, and tongue, etc.)

·       Fatigue, weakness, and lethargy

·       Seizures

·       Loss of appetite, nausea, vomiting, and diarrhea

·       Alopecia and dermatitis

 

Drug Interactions for Rofolin^®

Consult your doctor or pharmacist about using Rufolin® with other drugs or supplements.

Packaging of Rofolin^®

·       Each package contains 15 tablets (1 blister of 15 tablets) or 30 tablets (2 blisters of 15 tablets).

·       Storage conditions for Rofolin^®

·       Store the drug at temperatures below 30°C, away from light and moisture.

·       The drug can be used until the end of the month mentioned on the packaging expiration date.

·       Avoid using and storing expired drugs.

·       Keep the drug out of the reach of children.

·       Do not remove from original packaging until ready to use.

 

 

References:

1.      Leucovorin: Drug information, UpToDate 2025

2.     http://www.medicines.org.uk/emc/product /6343/smpc