Lonsurf is an oral combination tablet that contains tipiracil and trifluridine. Tipiracil and trifluridine are anti-cancer medicines that interfere with the growth and spread of cancer cells in the body.

Lonsurf may be used to treat adults with:

• colorectal cancer that has spread to other parts of the body (metastatic), as a single agent or in combination with bevacizumab in patients who have previously been treated with other specific types of chemotherapy
• metastatic gastric or gastroesophageal junction adenocarcinoma that has previously been treated with at least two different specific chemotherapy regimens.

Lonsurf was first FDA-approved on February 23, 2015.

There are no contraindications to the use of Lonsurf.

Lonsurf affects your immune system and can cause serious bone marrow suppression. You may get infections more easily, even serious or fatal infections. Call your doctor if you have a fever, chills, body aches, or unusual bleeding or bruising.

You will need blood tests before and during treatment with Lonsurf, before and on Day 15 of each cycle. Call your doctor at once if you develop signs of infection (fever, chills, body aches). The dosage of Lonsurf may need to be reduced.

Lonsurf should not be given to pregnant women because it can harm an unborn baby. If you are a female of reproductive potential your doctor may ask you to take a pregnancy test before starting Lonsurf. You should use effective contraception while taking it.

Before taking this medicine

To make sure Lonsurf is safe for you, tell your doctor if you have ever had:

• kidney disease, or

• liver disease.

You may need to have a negative pregnancy test before starting this treatment.

The dosage may need to be reduced in severe kidney disease. Do not use Lonsurf in patients with moderate or severe liver disease.

People over the age of 65 years are more likely to develop blood abnormalities and other side effects from Lonsurf.

Tipiracil and trifluridine can harm an unborn baby if the mother or the father is using this medicine.

• If you are a woman, do not use Lonsurf if you are pregnant. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 6 months after your last dose.

• If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 3 months after your last dose.

• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using Lonsurf.

You should not breastfeed while using this medicine, and for at least 24 hours after your last dose.

Take Lonsurf exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Before and during treatment with this medicine, you will need blood tests. The timing of these tests is very important.

Take with food.

Lonsurf is given in a 28-day treatment cycle. You may need to use the medicine only on certain days of each cycle. Your doctor will determine how long to treat you with this medicine.

Swallow the tablet whole and do not crush, chew, or break it.

To get the correct dose, you may need to take 2 or more tablets that are different strengths and colors. Follow your doctor's dosing instructions very carefully.

Wash your hands after handling Lonsurf tablets. Caregivers who touch or handle the tablets should wear rubber gloves.

If you vomit shortly after taking Lonsurf, do not take another dose. Wait until your next scheduled dose time to take the medicine again.

Tipiracil and trifluridine doses are based on body surface area (height and weight). Your dose needs may change if you gain or lose weight.

Store tablets in their original container at room temperature, away from moisture and heat. Throw away any unused tablets after 30 days if you do not store them in the original container.

Ask your pharmacist how to safely dispose of tablets you no longer need.

Take Lonsurf exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Before and during treatment with this medicine, you will need blood tests. The timing of these tests is very important.

The recommended dosage of Lonsurf is based on your body surface area (calculated by using your height and weight). It is usually dosed at 35 mg/m2/dose, given orally (by mouth) twice a day. Your doctor will calculate the right dose for you and your dosage may change if you gain or lose weight.

• To get the correct dose, you may need to take 2 or more tablets that are different strengths and colors. Follow your doctor's dosing instructions very carefully. Lonsurf comes in two strengths.
• Swallow the tablet whole and do not crush, chew, or break it.
• Lonsurf is given in a 28-day treatment cycle. You may need to use the medicine only on certain days of each cycle. Your doctor will determine how long to treat you with this medicine.
• Take Lonsurf with food, within 1 hour of completion of morning and evening meals.
• Wash your hands immediately after handling Lonsurf tablets. Caregivers who touch or handle the tablets should wear rubber gloves.
• Tipiracil and trifluridine doses are based on body surface area (height and weight). Your dose needs may change if you gain or lose weight.

To make sure Lonsurf is safe for you, tell your doctor if you have ever had:

• kidney disease, or

• liver disease.

You may need to have a negative pregnancy test before starting this treatment.

The dosage may need to be reduced in severe kidney disease. Do not use Lonsurf in patients with moderate or severe liver disease.

People over the age of 65 years are more likely to develop blood abnormalities and other side effects from Lonsurf.

Tipiracil and trifluridine can harm an unborn baby if the mother or the father is using this medicine.

• If you are a woman, do not use Lonsurf if you are pregnant. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 6 months after your last dose.

• If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 3 months after your last dose.

• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using Lonsurf.

You should not breastfeed while using this medicine, and for at least 24 hours after your last dose.

Call your doctor for instructions if you miss a dose. Do not take two doses at one time.

If you vomit shortly after taking Lonsurf, do not take another dose. Wait until your next scheduled dose time to take the medicine again.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Tipiracil and trifluridine can pass into body fluids (urine, feces, vomit). Caregivers should wear rubber gloves while cleaning up a patient's body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Get emergency medical help if you have signs of an allergic reaction to Lonsurf: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• low levels of platelets in your blood - easy bruising, unusual bleeding, purple or red spots under your skin;

• low red blood cells (anemia) - pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet; or

• low white blood cell counts - fever, mouth sores, skin sores, sore throat, cough, trouble breathing.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Serious side effects may be more likely in older adults.

Common Lonsurf side effects may include:

• feeling weak or tired
• fever
• nausea, vomiting, or diarrhea
• infections
• stomach pain, loss of appetite
• mouth ulcers
• pain when swallowing
• hair loss
• low blood cell counts.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may interact with tipiracil and trifluridine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.