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Treatment Name: Trifluridine and Tipiracil (Lonsurf®)

Trifluridine and Tipiracil (Lonsurf®) is a Chemotherapy Regimen for Colon Cancer

How does trifluridine and tipiracil (Lonsurf®) work?
Trifluridine is designed to kill or slow the growth of colong cancer cells. Tipiracil slows down the body’s ability to break down trifluridine, which allows it to stay in the body longer and affect more colon cancer cells.

Goals of therapy:
Trifluridine and tipiracil is taken to shrink colon tumors or decrease symptoms of colon cancer and is not commonly given with the goal of cure.

Schedule

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  • Usual starting dose: three to four oral tablets by mouth twice daily on Days 1, 2, 3, 4, 5 and then on Days 8, 9, 10, 11, and 12
    • Take each dose within one hour after a meal (breakfast and dinner)
    • You may have to take two different strength tablets to get your correct dose. Be sure to check that you are taking the correct amount of tablets of each strength before taking each dose

Each trifluridine and tipiracil cycle is repeated every 28 days. Treatment is taken until it no longer works or until unacceptable side effects occur.

Trifluridine and tipiracil must be dispensed by a specialty pharmacy and is taken at home.

Side Effects

In clinical studies, the most commonly reported trifluridine and tipiracil (Lonsurf®) side effects are shown here:

  • Low red blood cells [Anemia] (77%)
  • Low white blood cells [Neutropenia] (67%)
  • Nausea (48%)
  • Low platelets [Thrombocytopenia] (42%)
  • Decreased appetite (39%)
  • Increased bilirubin in the blood [sign of liver injury] (36%)
  • Fatigue (35%)
  • Diarrhea (32%)
  • Increase in liver enzymes in blood [sign of liver injury] (24-30%)
  • Vomiting (28%)
  • Abdominal pain (21%)
  • Fever (19%)
  • Weakness (18%)
  • Increase creatinine in blood [sign of kidney injury] (13%)
  • Mouth sores (8%)
  • Neutropenic fever (4%)
  • Redness, blisters, and skin peeling on palms of hands and soles of feet (2%)

On average, 4% of patients discontinue Lonsurf treatment due to unacceptable side effects.

Side effect videos Side Effect Videos
AnemiaAnemiaNausea and VomitingNausea and VomitingFatigue Fatigue DiarrheaDiarrheaPainPainNeutropenic FeverNeutropenic Fever

Monitoring

How often is monitoring needed?
Labs (blood tests) may be checked before starting each Lonsurf cycle and on Day 15 of each cycle. Labs often include: Complete Blood Count (CBC), Comprehensive Metabolic Panel (CMP), plus any others your doctor may order.

How often is imaging needed?
Imaging may be checked before Lonsurf treatment then approximately every 8 weeks. Imaging may include: X-rays, magnetic resonance imaging (MRI), computerized tomography (CT) scans, or positron emission tomography (PET) scans.

How might blood test results/imaging affect treatment?
Depending upon the results, your doctor may advise to continue trifluridine and tipiracil as planned, reduce the dose of future treatments, delay the next dose until the side effect goes away, or switch to an alternative therapy.

ChemoExperts Tips

  • Your dose is calculated based on your weight and you may have to take two different strength tablets to get your total Lonsurf dose. Read the labeling carefully to be sure that you are taking the correct amount of Lonsurf tablets of each strength
  • Patients who are 65 years of age or older may experience low red blood cells, white blood cells, and platelets more often compared to patients younger than 65 years
  • A pharmacist should ALWAYS review your medication list to ensure that drug interactions are prevented or managed appropriately
  • Clinical trials may exist for colon cancer. Ask your doctor if any studies are currently enrolling in your area. If not, go to clinicaltrials.gov to search for other centers offering study medications

Patient Assistance & Co-payment Coverage

Patients under the age of 65 years, or those with private insurance plans:
If you have insurance and are looking for patient assistance or copay assistance for Trifluridine and Tipiracil (Lonsurf®), we have provided links that may help.

Visit our Patient Assistance page and click the links to various patient assistance programs for help paying for Trifluridine and Tipiracil (Lonsurf®). Depending upon your income, they may be able to help cover the cost of:

  • Trifluridine and Tipiracil

For Branded medications (may be available for generic medications too), check with the manufacturer to determine if a co-pay card is offered and if it could reduce your monthly copay.

  • If you are uninsured, check with the manufacturer to determine if you are eligible to receive medication at no cost.

Medicare and Medicaid patients (Patients 65 years or older):
The clinic providing treatment will likely pre-authorize medications and immune therapies such as Trifluridine and Tipiracil (Lonsurf®) and are the best source to help you understand drug cost.

  • Ask to speak with a patient assistance technician or financial counselor at the clinic or hospital administering this therapy.

Emotional Wellness

What is Emotional Wellness?
Emotional wellness is having a positive outlook balanced with a realistic understanding of current life events. This requires both an awareness and acceptance of your emotions. It is with this knowledge that you can develop a plan to take the necessary actions to positively impact your life.

Emotional wellness uses an ongoing process to continually reflect on the stressors of life in a constructive manner to move forward and create happiness.

Because emotional wellness is deeply connected with physical, social, and spiritual wellness, pursuing it often becomes particularly difficult in times of major illness. Despite this difficulty, working toward emotional wellness has been connected to improved treatment outcomes and a higher likelihood of achieving goals of therapy.

Learn more about pursuing emotional wellness while receiving treatment with Trifluridine and Tipiracil (Lonsurf®)

Individual Drug Label Information

Trifluridine and Tipiracil (Lonsurf®)

  • Is an oral tablet available in 15 mg trifluridine/6.14 mg tipiracil and 20 mg trifluridine/8.19 mg tipiracil 
  • Take with food (1 hour after a meal), with a large glass of water at the same times each day
  • Food decreases absorption so it is best to take with food to avoid an increase in side effects
  • If you miss a dose, skip that dose and take the next dose at the original scheduled time. DO NOT double your dose to make up for the missed dose
  • Store at 20°C to 25°C (68°F to 77°F) 
  • Dosage adjustments may be required for low blood counts or other side effects
  • May cause fetal harm if taken while pregnant. Use effective method of contraception during treatment and for at least 3 months after treatment. Do not breastfeed during therapy and for at least one day following the last dose
General side effects from trifluridine and tipiracil (Lonsurf®)
  • Low red blood cells, white blood cells, and platelets
  • Nausea and vomiting
  • Decreased appetite
  • Liver injury
  • Fatigue
  • Diarrhea
  • Abdominal pain
  • Weakness
  • Redness, blisters, and skin peeling on palms of hands and soles of feet
  • Click on the trifluridine and tipiracil (Lonsurf®) package insert below for reported side effects, possible drug interactions, and other trifluridine and tipiracil prescribing information

Side Effect Videos
Nausea and VomitingNausea and VomitingDiarrheaDiarrheaFatigue Fatigue PainPainAnemiaAnemiaNeutropenic FeverNeutropenic Fever

See DailyMed package insert.

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References

1) Mayer RJ,  Van Cutsem E,  Falcone A, et al. Randomized  trial  of  TAS-102 for refractory metastatic colorectal cancer. N Engl J Med. 2015;372:1909-1919.

Created: February 16, 2019 Updated: June 23, 2019

What is Colon Cancer?

A disease of the cells from the large intestine.  Colon cancer is the third most common cancer among both men and women.  Known causes include:  family history, poor diet, sedentary lifestyle, obestity, diabetes, history of colon polyps, smoking, heavy alcohol use, prior radiation treatment to abdomen for other cancers, and old age.  The stage can vary at diagnosis and throughout treatment.  Stages of colon cancer use Tumor, Node, Metastasis (TNM) staging as well as Stage Grouping using Stages I, II, III, or IV.  The effectiveness of the treatment may depend upon the stage at diagnosis.

NOTE: Treatment Options listed below are not all-inclusive. Other treatments may be available. ChemoExperts provides drug information and does not recommend any one treatment over another. Only your Doctor can choose which therapy is appropriate for you.

Common Trifluridine and Tipiracil (Lonsurf®) starting doses

  • Usual starting dose: 35 mg/mby mouth twice daily on Days 1, 2, 3, 4, 5 and then on Days 8, 9, 10, 11, and 12
    • Doses are based on the trifluridine component. Maxiumum dose of 80 mg per dose. Round dose to the nearest 5 mg increment

Note: Individual doses may vary based upon your Doctor's recommendation, or drug availability.

What does Cure mean?

The word “cure” means there are no cancer cells left in the body and cancer will never come back. Depending on the cancer type and stage, this may be the true goal of therapy. However, it is very difficult to prove all cancer cells are gone. Even though images, like X-rays and MRI’s, and blood tests may not show any signs of cancer, there can be a small amount of cancer cells still left in the body. Because of this, the word “remission” is used more often. This means there are no signs or symptoms of cancer. Patients in remission are followed closely for any signs of cancer returning. Sometimes, more chemotherapy may be given while in remission to prevent the cancer from coming back.

Doctors usually do not consider a patient “cured” until the chance of cancer returning is extremely low. If cancer does return, it usually happens within 5 years of having a remission. Because of this, doctors do not consider a patient cured unless the cancer has not come back within 5 years of remission. The five-year cutoff does not apply to all cancers.

What is Specialty Pharmacy?

A pharmacy that manages the handling and services for drugs used by patients with rare or chronic diseases. This has expanded in the last several years to include very expensive drugs used to treat cancer, mainly oral cancer medications or injections that can be taken at home.

What is a CBC?

A Complete Blood Count (CBC) is a frequently ordered blood test that tells clinicians the status of your: 1) White blood cell count, 2) Hemoglobin, and 3) Platelet count at the time the test was taken.

Common uses:
1) White blood cell count (WBC): is used to determine infection risk, or response to chemotherapy. Certain chemotherapy agents may harm our good infection-fighting cells. Sometimes chemotherapy may need to be delayed to allow these cells to recover.

2) Hemoglobin: is used to determine if someone is anemic. Anytime the hemoglobin is below 12 g/dL, the person is said to be anemic. Red blood cell transfusions, and sometimes iron can be given to restore the hemoglobin level, but anemia treatment should always aim at treating the underlying cause or condition.

3) Platelet count: is used to determine if the risk of bleeding is increased or if a platelet transfusion is required to prevent bleeding. Certain medications that increase bleeding risk, such as: aspirin, certain chemotherapy agents, and blood thinners, may need to be stopped temporarily until the platelet count is within a safe range.

What is a CMP?

A Comprehensive Metabolic Panel (CMP) is a frequently ordered blood test that tells clinicians the status of your: 1) Electrolytes & Acid/Base status2) Kidney function, 3) Liver function, 4) Blood sugar, and 5) Calcium at the time the test was taken. It is commonly used to monitor liver and kidney function when beginning new medications such as chemotherapy. A total of 14 tests are run simultaneously and are shown below.

Electrolytes & Acid/Base status:
1) Sodium, 2) Potassium, 3) Carbon dioxide, 4) Chloride

Kidney Function:
5) BUN (blood urea nitrogen), 6) Serum creatinine (Scr)

Liver Function:
7) AST, 8) ALT, 9) Total bilirubin, 10) Alk Phos, 11) Albumin, 12) Total protein

Blood sugar:
13) Serum glucose

Calcium:
14) Serum calcium