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trifluridine and tipiracil (Oral route)

trye-FLURE-i-deen, tye-PIR-a-sil

Commonly used brand name(s)

In the U.S.

  • Lonsurf

Available Dosage Forms:

  • Tablet

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Viral DNA Thymidylate Synthetase Inhibitor

Chemical Class: Pyrimidine Nucleoside Analog

Uses For trifluridine and tipiracil

Trifluridine and tipiracil combination is used to treat metastatic colorectal cancer (cancer of the colon or rectum that has spread to other parts of the body) in patients who have received other cancer medicines (eg, fluoropyrimidine, oxaliplatin, irinotecan).

trifluridine and tipiracil is available only with your doctor's prescription.

Before Using trifluridine and tipiracil

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For trifluridine and tipiracil, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to trifluridine and tipiracil or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of Lonsurf® in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Lonsurf® in the elderly.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking trifluridine and tipiracil, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using trifluridine and tipiracil with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Measles Virus Vaccine, Live
  • Mumps Virus Vaccine, Live
  • Rubella Virus Vaccine, Live
  • Varicella Virus Vaccine

Using trifluridine and tipiracil with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Adenovirus Vaccine
  • Bacillus of Calmette and Guerin Vaccine, Live
  • Cholera Vaccine, Live
  • Influenza Virus Vaccine, Live
  • Poliovirus Vaccine, Live
  • Smallpox Vaccine
  • Typhoid Vaccine
  • Yellow Fever Vaccine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of trifluridine and tipiracil. Make sure you tell your doctor if you have any other medical problems, especially:

  • Kidney disease, moderate—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of trifluridine and tipiracil

Medicines used to treat cancer are very strong and can have many side effects. Before using trifluridine and tipiracil, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

Take trifluridine and tipiracil exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

trifluridine and tipiracil should come with patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Take trifluridine and tipiracil within 1 hour after morning and evening meals.

Wear gloves when handling trifluridine and tipiracil. Wash your hands after handling the tablets.

Dosing

The dose of trifluridine and tipiracil will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of trifluridine and tipiracil. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For metastatic colorectal cancer:
      • Adults—Dose is based on body size and must be determined by your doctor. At first, 35 milligrams (mg) per square meter (m(2)) of body size two times a day, taken on Days 1 to 5, and Days 8 to 12 of every 28-day cycle. Your doctor may adjust your dose if needed. However, the dose is usually not more than 80 mg two times a day.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of trifluridine and tipiracil, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

If you store the tablets outside the original bottle, throw away any unused tablets after 30 days.

Precautions While Using trifluridine and tipiracil

It is very important that your doctor check your progress at regular visits to make sure that trifluridine and tipiracil is working properly. Blood tests will be needed to check for unwanted effects.

Using trifluridine and tipiracil while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. Male patients should use condoms as forms of birth control during sexual intercourse while taking Lonsurf® and for 3 months after the last dose of trifluridine and tipiracil. Tell your doctor right away if you think you have become pregnant.

Lonsurf® can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

  • If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
  • Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
  • Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
  • Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
  • Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
  • Avoid contact sports or other situations where bruising or injury could occur.

Tell your doctor right away if you have severe or persistent diarrhea, nausea, or vomiting while taking trifluridine and tipiracil.

trifluridine and tipiracil Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common
  • Black, tarry stools
  • bleeding gums
  • blood in the urine or stools
  • cough or hoarseness
  • fever or chills
  • lower back or side pain
  • painful or difficult urination
  • pale skin
  • pinpoint red spots on the skin
  • sore throat
  • troubled breathing with exertion
  • ulcers, sores, or white spots in the mouth
  • unusual bleeding or bruising
  • unusual tiredness or weakness
Less common
  • Bladder pain
  • bloody or cloudy urine
  • frequent urge to urinate
  • headache
  • muscle aches
  • stuffy or runny nose

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Abdominal or stomach pain
  • change in taste
  • decreased appetite
  • diarrhea
  • hair loss or thinning of the hair
  • lack or loss of strength
  • loss of taste
  • nausea
  • swelling or inflammation of the mouth
  • vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

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