Tegafur, gimeracil, and oteracil combination drugs are used along with cisplatin to treat advanced stomach cancer or unresectable cancer (gastric cancer that cannot be removed completely by surgery) in adult patients.
In Japan, the combination of tegafur, gimeracil, and oteracil along with cisplatin has been considered as a first-line treatment for unresectable cancer or cancer that returns after treatment.
The standard therapy of tegafur, gimeracil, and oteracil with cisplatin is used with the intention to provide palliation (care given during terminal illness) and to prolong survival.
Tegafur, gimeracil and oteracil combination should not be used in patients-
If there is an allergy to tegafur, gimeracil and oteracil combination
Allergic to cisplatin or fluoropyrimidine group of drugs (e.g., Capecitabine, Fluorouracil, Doxifluridine)
Pregnancy and breastfeeding
Severe bone marrow suppression
History of dihydropyrimidine dehydrogenase (DPD) deficiency
Undergoing dialysis in end-stage kidney disease
Children below 18 years of age
The dose of tegafur, gimeracil, and oteracil along with cisplatin is calculated based on the individual patients body surface area (BSA) depending on the height and the weight of the patient.
The recommended dose of tegafur, gimeracil, and oteracil is 25 mg/m2 given for 21 consecutive days followed by seven treatment-free days in a 28-day treatment cycle repeated every four weeks.
The dose of cisplatin is 75 mg/m2 given once every four weeks and discontinued after six continuous cycles. If cisplatin therapy is discontinued before 6 cycles, treatment with tegafur, gimeracil, and oteracil alone can be started as per the prescribed schedule.
Dose modification of tegafur, gimeracil, and oteracil or cisplatin can be considered if patients develop toxicity while making sure the dose that is omitted is not replaced.
The dose of tegafur, gimeracil, and oteracil that is reduced due to toxicity reasons should not be increased to the usual dose but can be resumed at one reduced dose level.
If a dose of tegafur, gimeracil, and oteracil is missed do not take the missed dose but continue with the next following dose.
Never take a double dose of tegafur, gimeracil, and oteracil capsules to make up for the missed dose which can be harmful.
Tegafur, gimeracil, and oteracil combination is available in a capsule form which should be taken by mouth twice daily (morning and evening) at least one hour before or one hour after meals.
The capsule should not be broken, opened, crushed or chewed because it may affect the healthy cells when it comes into contact as it is a cytotoxic agent.
Swallow the capsule of tegafur, gimeracil, and oteracil with sufficient quantity of water.
If the patient vomits after taking the dose of tegafur, gimeracil, and oteracil do not repeat the dose but take the next dose on the following day as directed.
Patients should be monitored for any treatment-related bone marrow suppression along with an abnormal count of platelets, neutrophils, red blood cells, and white blood cells.
Patients must be treated with appropriate antibiotics or other medications in case any infections are reported. Low platelet count can cause an increased risk of bleeding; therefore, patients must be observed carefully.
Treatment with tegafur, gimeracil, and oteracil may result in reactivation of hepatitis B virus (HBV) in patients with hepatitis B virus carriers or previous illness of HBV. Monitor the liver function efficiently during the therapy.
Diarrhea and dehydration can occur during the treatment with tegafur, gimeracil, and oteracil. So, patients with such episodes must be treated under proper medical care with fluid and electrolytes followed by standard antidiarrheal therapy if required.
Kidney function should be monitored very closely as treatment with tegafur, gimeracil, and oteracil along with cisplatin may cause kidney damage during treatment.
Eye disorders can occur during the treatment with tegafur, gimeracil, and oteracil in combination with cisplatin. Patients must be advised to consult an eye specialist at an early stage in case of any eye-related problems.
Gastrointestinal: Diarrhea, nausea, vomiting, constipation, dry mouth, bleeding in the stomach, indigestion
Cardiovascular: Fluctuations in blood pressure, an occurrence of a blood clot in the deep vein
Nervous system: Peripheral neuropathy, headache, dizziness, taste disturbances, sleeping difficulty
Respiratory: Nosebleed, cough, breathing difficulty, hiccups
Eye: Increased tear secretion, blurred vision, itching or irritation of the eye, a sensation of a flash of light in the eye (photopsia)
Others: Kidney damage, rashes, hair loss, muscle pain, infections, weakness, dehydration, hearing loss
Women of reproductive potential should be tested for pregnancy and should be treated with tegafur, gimeracil, and oteracil only if the results are negative.
Both male and female patients should follow proper contraceptive measure during the treatment that should continue for at least six months after stopping to take tegafur, gimeracil, and oteracil capsules.
No antidote is available in case of overdose. So, patients with tegafur, gimeracil, and oteracil overdose must be managed medically by supportive therapy and treatment of the symptoms and signs of overdose.
Patients taking anticoagulant medications such as warfarin are at an increased risk of developing stomach or intestinal bleeding, the presence of blood in urine, and anemia. Therefore warfarin should be used with caution in patients taking tegafur, gimeracil, and oteracil.
Co-administration of tegafur, gimeracil, and oteracil can result in additional toxicity and should be avoided with the following drugs-
Store the capsules of tegafur, gimeracil, and oteracil at room temperature between 15°C and 25°C.
Protect the capsules from excess heat and moisture.
Keep the tegafur, gimeracil, and oteracil capsules away from the reach of children.
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