Trifluridine-Tipiracil

Trifluridine-Tipiracil is a combination medication used for the treatment of metastatic colorectal or gastric cancer.

• Trifluridine-Tipiracil is available under various brand names: Lonsurf

Common side effects of Trifluridine-Tipiracil include:

• anemia,
• low levels of white blood cells (neutropenia),
• weakness,
• fatigue,
• nausea,
• low levels of platelets (thrombocytopenia),
• decreased appetite,
• diarrhea,
• vomiting,
• abdominal pain,
• fever,
• changes in the sense of taste,
• hair loss,
• runny or stuffy nose, and
• urinary tract infections.

Serious side effects of Trifluridine-Tipiracil include:

• blood clots in the lungs (pulmonary emboli).

Rare side effects of Trifluridine-Tipiracil include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Tablet

• 15 mg/6.14 mg
• 20 mg/8.19 mg

Metastatic Colorectal Cancer

Adult dosage

• 35 mg/m² orally twice daily on Days 1-5 and Days 8-12 of each 28-day cycle; not to exceed 80 mg/dose

Metastatic Gastric Cancer or Gastroesophageal Junction Adenocarcinoma

Adult dosage

• 35 mg/m² orally twice daily on Days 1-5 and Days 8-12 of each 28-day cycle; not to exceed 80 mg/dose

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Trifluridine-Tipiracil has no noted severe interactions with any other drugs.
• Trifluridine-Tipiracil has no noted serious interactions with any other drugs.
• Trifluridine-Tipiracil has no noted moderate interactions with any other drugs.
• Trifluridine-Tipiracil has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Trifluridine-Tipiracil?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Trifluridine-Tipiracil?”

Cautions

• Severe and life-threatening myelosuppression reported, including anemia, neutropenia, thrombocytopenia, and febrile neutropenia; obtain CBC count before and on Day 15 of each cycle, or more frequently as indicated
• Stomatitis may occur
• Associated with a moderate emetic potential; antiemetics to prevent nausea and vomiting are recommended; the patient should report severe gastrointestinal toxicity to a healthcare professional
• Grade 3 or 4 bilirubin elevations were reported in patients with hepatic impairment
• Based on animal studies and its mechanism of action, trifluridine-Tipiracil can cause fetal harm when administered to pregnant women (see Pregnancy)

Pregnancy & Lactation

• Based on animal data and its mechanism of action, the drug can cause fetal harm
• Embryo-fetal lethality and embryo-fetal toxicity occurred in pregnant rats when given during gestation at doses resulting in exposures lower than or similar to human exposures at the recommended clinical dose
• There is no available data used on pregnant women
• Verify pregnancy status in females of reproductive potential before initiating treatment
• Contraception
  • Females of reproductive potential: Use effective contraception during treatment and for more than 6 months after the final dose
  • Males with female partners of reproductive potential: Use condoms during treatment and for more than 3 months after the final dose.
• Lactation
  • There are no data on the presence of trifluridine, tipiracil, or its metabolites in human milk or its effects on the breastfed child or milk production
  • In nursing rats, trifluridine and tipiracil or their metabolites were present in breast milk
  • Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment and for 1 day following the final dose