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trifluridine - tipiracil
How does this medication work? What will it do for me?
This combination product contains two medications: trifluridine and tipiracil. Together, these two medications are in the class of medications known as antineoplastics. Trifluridine – tipiracil is used to treat colorectal cancer that has metastasized (spread) when other medications are either not appropriate or have not controlled the cancer. This medication is also used to treat a gastric cancer (a type of stomach cancer) or a type of esophageal cancer called gastroesophageal junction cancer that has spread to other parts of the body.
Trifluridine works by preventing the cancer cells from reproducing, slowing the growth of the tumours. Tipiracil stops trifluridine from breaking down before it has a chance to act.
This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.
Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.
Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.
What form(s) does this medication come in?
The recommended starting dose of this medication is based on body surface area and will be calculated by your doctor. It is taken twice daily, on days 1 to 5 and days 8 to 12 of a 28-day treatment cycle. Trifluridine-tipiracil should be taken be taken with a glass of water. Take it after eating, within 1 hour of your morning and evening meals.
Wash your hands after handling the tablets.
Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.
It is important to take this medication exactly as prescribed by your doctor.
If you miss a dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.
Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.
How should I use this medication?
15 mg/6.14 mg
Each white, biconvex, round, film-coated tablet, with a diameter of 7.1 mm and a thickness of 2.7 mm, imprinted with "15" on one side, and "102" and "15 mg" on the other side, in grey pharmaceutical ink, contains 15 mg trifluridine and 6.14 mg tipiracil (as 7.065 mg tipiracil hydrochloride). Nonmedicinal ingredients: hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, pregelatinized starch, stearic acid, and titanium dioxide; pharmaceutical ink: carnauba wax, FD&C Blue No. 2 Aluminum Lake, ferric oxide red, ferric oxide yellow, shellac, talc, and titanium dioxide.
20 mg/8.19 mg
Each pale red, biconvex, round, film-coated tablet, with a diameter of 7.6 mm and a thickness of 3.2 mm, imprinted with "20" on one side, and "102" and "20 mg" on the other side, in grey pharmaceutical ink, contains 20 mg trifluridine and 8.19 mg tipiracil (as 9.420 mg tipiracil hydrochloride), contains 20 mg trifluridine and 8.19 mg tipiracil (as 9.420 mg tipiracil hydrochloride). Nonmedicinal ingredients: ferric oxide, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, pregelatinized starch, stearic acid, and titanium dioxide; pharmaceutical ink: carnauba wax, FD&C Blue No. 2 Aluminum Lake, ferric oxide red, ferric oxide yellow, shellac, talc, and titanium dioxide.
Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
Who should NOT take this medication?
Do not take this medication if you are allergic to trifluridine-tipiracil or any ingredients of the medication.
What side effects are possible with this medication?
Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.
The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.
The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.
Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.
- abdominal pain
- changed sense of taste
- cold symptoms (e.g., nasal congestion, runny nose, sore throat, headache)
- decreased appetite
- hair loss
Although most of the side effects listed below don’t happen very often, they could lead to serious problems if you do not seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
- signs of anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)
- signs of clotting problems (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don’t stop bleeding)
- signs of dehydration (e.g., decreased urine, dry skin, dry and sticky mouth, sleepiness, dizziness, headache, thirst, confusion)
- signs of infection (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
- skin rash
- swelling of gums, tongue, lips, or mouth
Stop taking the medication and seek immediate medical attention if any of the following occur:
- symptoms of lung inflammation (e.g., sudden worsening of shortness of breath, wheezing, tiredness, cough, fever, painful breathing)
- symptoms of severe lung problems (e.g., shortness of breath, severe chest pain, painful breathing, coughing up blood)
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.
Are there any other precautions or warnings for this medication?
Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
Anemia: Trifluridine – tipiracil may cause low levels of red blood cells. If you experience symptoms of reduced red blood cell count (anemia) such as shortness of breath, feeling unusually tired, or pale skin, contact your doctor as soon as possible.
Your doctor will do blood tests regularly to monitor the number of specific types of blood cells, including red blood cells, in your blood.
Bleeding: This medication may cause a reduced number of platelets in the blood, which can make it difficult to stop cuts from bleeding. If you notice any signs of bleeding, such as frequent nosebleeds, unexplained bruising, or black and tarry stools, notify your doctor as soon as possible. Your doctor will order routine blood tests to make sure potential problems are caught early.
Birth control: There is a risk that exposure to trifluridine – tipiracil before birth may cause birth defects. Women who may become pregnant or men taking this medication who have female partners who may become pregnant, should use a barrier method of birth control while taking trifluridine – tipiracil and for 6 months after the last dose.
Fluid and electrolyte balance: Trifluridine-tipiracil may cause increased nausea, vomiting, and diarrhea, leading to dehydration. If you experience symptoms of dehydration or fluid and electrolyte imbalance such as muscle pains or cramps; dry mouth; numb hands, feet, or lips; or racing heartbeat, contact your doctor as soon as possible. Your doctor will do blood tests regularly to monitor the levels of these electrolytes in your blood while you are taking this medication.
Galactose intolerance/glucose malabsorption: Trifluridine – tipiracil medications are prepared with lactose. If you have lactose or galactose intolerance you should not take these medications.
Infection: As well as killing cancer cells, trifluridine – tipiracil can reduce the number of cells that fight infection in the body (white blood cells). If possible, avoid contact with people with contagious infections. Tell your doctor immediately if you notice signs of an infection, such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness. Your doctor will do blood tests regularly to monitor the number of specific types of blood cells in your blood.
Kidney function: The safety and effectiveness of this medication have not been determined for people with severely decreased kidney function. If you have reduced kidney function or kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Liver function: The safety and effectiveness of this medication have not been determined for people with moderately to severely reduced liver function. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: It is not known if trifluridine – tipiracil passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of using this medication have not been established for children.
Seniors: People over the age of 65 years may be more likely to experience side effects.
What other drugs could interact with this medication?
There may be an interaction between trifluridine – tipiracil and any of the following:
If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:
- stop taking one of the medications,
- change one of the medications to another,
- change how you are taking one or both of the medications, or
- leave everything as is.
An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.
Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.
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