Rofolin® Injectables for Cancer

Rofolin inj^®

Generic name: Calcium Folinate

Pharmaceutical form: Lyophilized powder containing 100 mg and 200 mg calcium folinate for preparation of an injectable solution

Therapeutic class: Antidote; chemotherapy modulating agent

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

Rofolin^®is the active form of folic acid. It acts as an antidote in poisoning caused by various agents, including methanol and methotrexate, and is also used as a biochemical modulator to enhance the efficacy of certain chemotherapeutic agents.

Toxicity due to folic acid antagonists (e.g., methotrexate and pyrimethamine)
Enhancement of the therapeutic effect of 5-fluorouracil in cancer treatment
Megaloblastic anemia due to folate deficiency
Adjunct treatment in methanol poisoning
Various malignancies, including cancers of the bladder, biliary tract, esophagus, stomach, pancreas, colon, rectum, and leukemia
Prevention of graft-versus-host disease (GVHD)
Tubal ectopic pregnancy
Gestational trophoblastic neoplasia

Lyophilized powder containing 100 mg and 200 mg calcium folinate for preparation of an injectable solution

To prepare the solution, add 10 mL of sterile water for injection to the vial containing the lyophilized powder and gently swirl until complete dissolution. The resulting solution is clear to slightly yellow and contains 10 mg folinic acid per mL.

For intravenous infusion, Rofolin^®may be diluted with the following solutions:

10% dextrose in 0.9% sodium chloride
10% dextrose
5% dextrose
Ringer’s solution
Lactated Ringer’s solution
0.9% sodium chloride

Rofolin^®may be administered via intramuscular injection, intravenous injection, or intravenous infusion. It must not be administered intrathecally.

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

Plasma methotrexate levels during methotrexate toxicity management

Differential complete blood count, including platelet count

Liver enzyme levels

Renal function

Electrolyte levels during 5-fluorouracil therapy

Serum hCG levels in tubal ectopic pregnancy

Hypersensitivity to calcium folinate or any of the excipients
Pernicious anemia and other anemias caused by vitamin B12 deficiency
Intrathecal administration is contraindicated

If signs of hypersensitivity reactions occur—such as redness, swelling, skin rash, blisters, urticaria, pruritus, wheezing, chest or throat tightness, difficulty breathing, swallowing or speaking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat—seek immediate medical attention.

Concomitant use with 5-fluorouracil in elderly patients may increase toxicity. Patients experiencing severe intestinal disorders, diarrhea, or dehydration should contact their physician.

Use during pregnancy should be based on a physician’s judgment, weighing the potential benefits to the mother against possible risks to the fetus.

Use during breastfeeding should be carried out under medical supervision.

Like all medications, calcium folinate may cause adverse effects, although not everyone experiences them. Common adverse effects include:

Fatigue and drowsiness
Gastrointestinal disturbances such as loss of appetite, nausea, vomiting, diarrhea, and constipation
Hair loss (alopecia)
Skin inflammation (dermatitis)
Inflammation of the oral mucosa, including the lips and mouth

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

Each pack contains one vial of Rofolin^®.