Trifluridine and tipiracil are used in combination to treat colorectal cancer in adult patients whose cancer condition has spread to other body parts or who cannot tolerate other cancer treatments.
The combination is recommended for use in patients who showed treatment failure or loss of response with other cancer treating medications.
Trifluridine works by stopping the growth of cancer cells and tipiracil increases the exposure of trifluridine by slowing its breakdown in the body.
Trifluridine and tipiracil should not be used in patients-
• If there is an allergy to trifluridine and tipiracil
• Pregnancy and breastfeeding
• Children (due to lack of safety and effectiveness data)
• Severe or end-stage kidney disease
• Liver damage
The dose of trifluridine and tipiracil combination is calculated based on the body surface area of the individual patient.
The recommended initial dose of trifluridine and tipiracil is 35 mg/m2 given from days 1 to 5 and from days 8 to 12 of each 28-day treatment cycle.
The maximum dose should not exceed 80 mg per dose. The treatment with trifluridine and tipiracil combination can be taken as long as the patient benefits from it or until the treatment with the drug does not result in intolerable toxicity.
Dose adjustments can be considered if any side effects occur. A maximum of up to 3 dose reductions can be considered and the dose once reduced should not be increased.
The minimum dose of trifluridine and tipiracil is 20 mg/m2.
If a dose of trifluridine and tipiracil is missed do not take the missed dose but continue with the next dose.
Never take another dose of trifluridine and tipiracil tablets to make up for the missed dose which can be harmful.
Trifluridine and tipiracil combination is available in a tablet form which should be taken by mouth twice daily.
The tablets of trifluridine and tipiracil should be swallowed with a sufficient quantity of water within 1 hour after taking the morning and evening meals.
Take the tablets of trifluridine and tipiracil around the same time every day.
Trifluridine and tipiracil combination is a cytotoxic agent which affects healthy cells. So, patients must be advised to wash with clean water thoroughly if the tablet contents comes into contact with the skin or eyes.
• Blood cell count should be regularly checked before initiating the treatment cycle and on day 15 of each treatment cycle.
• Patients should be advised to consult the doctor immediately if any symptoms and signs of infection or severe myelosuppression occur during the treatment with trifluridine and tipiracil.
• Monitor patients for the presence of protein in the urine by performing a dipstick urinalysis before initiating and during the treatment with trifluridine and tipiracil.
Stomach upset can occur during the treatment, and therefore patients must be treated appropriately for loose stools, vomiting, and nausea or stomach pain.
• Women of reproductive potential should use an effective contraception to avoid unwanted pregnancy during the treatment as trifluridine and tipiracil may affect the unborn baby.
• Breastfeeding is not advised during the treatment and for at least one day after taking the last dose of trifluridine and tipiracil.
• Male patients living with active female partners should use a condom to prevent pregnancy during the treatment and should continue to use a condom for three months after the last dose of trifluridine and tipiracil.
• Gastrointestinal: Nausea, vomiting, stomach pain, diarrhea, stomatitis, loss of appetite
• Nervous system: Headache, dizziness, taste disturbances, abnormal weakness, peripheral neuropathy, inability to sleep
• Cardiovascular: Abnormal heart rhythm, heart attack, fluctuations in blood pressure
• Respiratory: Chest pain, cough, breathing difficulty, a blood clot in the lungs
• Skin: Rashes, hair loss, dry skin, itching
• Lab abnormalities: Low levels of red blood cells, neutrophils, and platelets, increased levels of liver enzymes, urea, and creatinine
There is no specific antidote for trifluridine and tipiracil overdose. So, patients must be treated accordingly for the symptoms and signs of an overdose under medical supervision in a multispeciality hospital.
However, before prescribing trifluridine and tipiracil, the doctor should be informed if the patient is taking or has a plan to take prescription or Over-The-Counter drugs, or herbal supplements to avoid dangerous side effects.
Store the trifluridine and tipiracil tablets at room temperature between 20°C and 25°C.
Keep the trifluridine and tipiracil tablets in their original container.
Protect from direct sunlight and moisture.
If trifluridine and tipiracil tablets are stored outside the original container, they must be used within 30 days.
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