Rofolin^®

Rofolin^® is the active form of folic acid. It is used as an antidote in poisoning caused by various agents (including methotrexate) and as a potentiating agent for certain chemotherapeutic drugs (such as 5-fluorouracil).

Rofolin^® competes with methotrexate for intracellular transport sites and displaces it from intracellular binding sites. It also replenishes active folate stores required for the synthesis of DNA and RNA.

• Reduction of toxicity caused by folic acid antagonists (e.g., methotrexate, trimethoprim, and pyrimethamine) in overdose situations
• Treatment of megaloblastic anemia due to folic acid deficiency
• Prevention of hematologic toxicity induced by pyrimethamine in patients with AIDS
• Prevention of graft-versus-host disease (GVHD)
• Treatment regimens for various cancers, including bladder cancer

Scored tablet containing 15 mg calcium folinate

Rofolin^® should be taken exactly as prescribed by your physician. Do not increase or decrease the dose or duration of treatment without medical advice to achieve optimal therapeutic outcomes.

Swallow Rofolin^® with a full glass of water. Increase fluid intake during treatment. If gastric discomfort occurs, the medication may be taken with food.

In case of nausea or vomiting, avoid taking the tablet.

If a dose is missed, take it as soon as you remember. If it is almost time for the next dose, skip the missed dose. Do not take a double or extra dose.

In case of taking more than the recommended dose, contact your physician immediately.

• Serum methotrexate levels
• Electrolyte levels
• Complete blood count (CBC), including platelet count
• Liver function tests
• Renal function tests
• Urinalysis

Hypersensitivity to calcium folinate or any component of the formulation

Pernicious anemia and other anemias due to vitamin B12 deficiency

Intrathecal administration

• Calcium folinate, when used in combination with methotrexate or 5-fluorouracil, should be administered under the direct supervision of a specialist physician.
• Following overdose of a folic acid antagonist, calcium folinate therapy should be initiated as soon as possible.
• Oral doses above 25 mg are not absorbed effectively and are not recommended.
• Use with caution in patients with a history of seizures or epilepsy (especially in children), hypersensitivity to other medications, severe renal impairment, and vitamin B12 deficiency.

During pregnancy, calcium folinate should only be used when prescribed by a physician, after careful assessment of the potential benefits for the mother versus possible risks to the fetus.

Because of the potential excretion into breast milk and possible adverse effects in the infant, use during breastfeeding should only be undertaken under medical supervision.

Like all medications, calcium folinate may cause adverse effects, although not everyone experiences them. The most commonly reported side effects include:

• Hypersensitivity reactions (symptoms may include skin rash, joint pain, fever, difficulty breathing or swallowing, swelling of the lips, throat, or tongue, etc.)
• Fatigue, weakness, and malaise
• Seizures
• Loss of appetite, nausea, vomiting, and diarrhea
• Alopecia and dermatitis

Consult your physician or pharmacist regarding the concomitant use of calcium folinate with other medications or supplements.

Each package contains 30 tablets.

• Store below 30°C, protected from light and moisture.
• The product may be used until the expiry date indicated on the packaging. Do not use expired medication.
• Keep out of reach of children.
• Do not remove tablets from the original packaging until immediately before use.

1. Leucovorin: Drug information, UpToDate 2025
2. http://www.medicines.org.uk/emc/product /6343/smpc