Rofolin inj^®

Generic Name: Calcium Folinate

Dosage Form:

· Lyophilized powder containing 100 mg of calcium folinate for preparing injectable solution

· 20 ml injectable solution of calcium folinate (10 mg per ml)

Drug Category: Antidote, Chemotherapy Modulating agent

Indications: This medication is primarily used in the treatment of methotrexate, pyrimethamine, and methanol overdose or poisoning.

Rofolin^®

Rofolin^® (calcium folinate or leucovorin) is one of the active forms of folic acid used as an antidote in poisoning by various agents, including methanol and methotrexate, and also as an enhancing agent for the effects of some chemotherapy drugs.

Rofolin^® Indications

· Poisoning with folic acid antagonist drugs (such as methotrexate and pyrimethamine)

· Increasing the efficacy of the anticancer drug 5-fluorouracil

· Megaloblastic anemia dependent on folic acid deficiency

· Methanol poisoning

· Various cancers, including bladder cancer, bile ducts, esophagus, stomach, pancreas, intestine, rectum, and leukemia

· Prevention of graft-versus-host disease

· Tubal ectopic pregnancy

· Trophoblastic neoplasia of pregnancy

Rofolin^® Dosage Form

· Lyophilized powder containing 100 mg of calcium folinate for preparing injectable solution

· 20 ml injectable solution of calcium folinate (10 mg per ml)

Rofolin^® Preparation

Add 10 ml of injectable distilled water to the Rofolin^® vial containing the lyophilized powder, and gently shake the vial until the powder is completely dissolved. The resulting solution is clear and slightly yellowish, containing 10 mg of folinic acid per ml.

Rofolin^® solution with a concentration of 10 mg per ml does not require preparation in injectable sterile water.

If the drug is prescribed as an intravenous infusion, Rofolin^® can be diluted with the following solutions:

· Dextrose 10% in 0.9% sodium chloride

· Dextrose 10%

· Dextrose 5%

· Ringer's

· Ringer's lactate

· 0.9% sodium chloride

Rofolin^® Administration and Dosage

Rofolin^® can be administered as intramuscular injection, intravenous injection, or intravenous infusion and should not be used intrathecally.

Due to its calcium content, Rofolin^® can be administered intravenously at a maximum infusion rate of 160 mg per minute.

Monitoring Requirements During Rofolin^® Use

· Plasma methotrexate levels in poisoning treatment with methotrexate

· Differential blood cell counts including platelet counts

· Liver enzyme levels

· Kidney function

· Electrolyte levels in fluorouracil treatment

· hCG level in tubal ectopic pregnancy

Contraindications for Rofolin^®

· Allergy to calcium folinate or other formulation components

· Pernicious anemia and other anemias caused by vitamin B12 deficiency

· Intrathecal administration of this drug is prohibited.

Warnings and Precautions for Rofolin^® Use

· Seek immediate medical attention if you observe symptoms of allergic reactions, including redness, swelling, rash, blisters, hives, itching, wheezing, feeling tightness in the chest or throat, trouble breathing, swallowing or speaking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.

· Using this drug in combination with 5-fluorouracil in elderly patients may increase its toxicity. Contact your doctor if you experience severe intestinal problems, diarrhea, and dehydration.

Rofolin^® Use During Pregnancy and Lactation

The use of calcium folinate during pregnancy should be based on a physician's prescription with consideration of the benefits for the mother against potential harm to the fetus.

This drug should be used under medical supervision during lactation.

Rofolin^® Side Effects

Along with its desired therapeutic effects, this drug may cause some unwanted side effects, although not everyone may experience them. Some of the more common potential side effects of this drug include:

· Fatigue and drowsiness

· Gastrointestinal side effects including loss of appetite, nausea, vomiting, diarrhea, and constipation

· Hair loss

· Skin inflammation

· Inflammation of the mouth and lips

Rofolin^® Drug Interactions

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

Rofolin^® Packaging

Each package contains 1 vial of Rofolin^®.

Rofolin^® Storage Conditions

· Store lyophilized powder at a temperature below 30°C and the injectable solution in refrigerated conditions (2 to 8°C).

· Protect the drug from light, moisture, and freezing.

· Avoid using and storing expired medication.

· Keep the drug out of the sight and reach of children.

Sources

1. Leucovorin: Drug information, UpToDate, 2025

2. https://www.medicines.org.uk/emc/product/1572/smpc