Trifluxen 15 mg/6.14 mg Tablet

Generic Name: Trifluridine 15 mg + Tipiracil 6.14 mg
Brand Name: Trifluxen
Form: Oral Tablet
Pack Size: Commonly 20 or 60 tablets per box (varies)
Manufacturer: Everest Pharmaceuticals
Distributed by: NP Molecule

Indications:

Trifluxen is indicated for the treatment of:

• Metastatic colorectal cancer (mCRC) in patients who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, anti-VEGF biological therapy, and, if RAS wild-type, an anti-EGFR therapy

• Metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma, after at least two prior therapies

Pharmacology:

Trifluxen is a combination of:

• Trifluridine: a nucleoside analog that incorporates into DNA and interferes with DNA synthesis

• Tipiracil: a thymidine phosphorylase inhibitor that prevents the breakdown of trifluridine, increasing its bioavailability

Together, they exert cytotoxic effects on tumor cells by disrupting their DNA and slowing cell division.

Dosage & Administration:

• Administered orally twice daily on days 1–5 and 8–12 of each 28-day cycle

• Should be taken within 1 hour after eating the morning and evening meals

• Dosage based on body surface area (BSA), typically calculated by the physician

• Tablets must be swallowed whole—do not crush or chew

Drug Interactions:

• No major CYP-mediated interactions, but caution advised when used with other myelosuppressive drugs

• Avoid use with agents that may exacerbate neutropenia or anemia

Contraindications:

• Known hypersensitivity to trifluridine, tipiracil, or any components

• Severe bone marrow suppression

Side Effects:

• Common: Neutropenia, anemia, fatigue, nausea, vomiting, diarrhea, loss of appetite

• Serious: Severe myelosuppression, febrile neutropenia, infections

Pregnancy & Lactation:

• Contraindicated during pregnancy due to fetal toxicity

• Breastfeeding should be avoided during treatment and for 1 day after the last dose

Precautions & Warnings:

• Frequent monitoring of complete blood counts (CBC) is essential

• Delay or reduce dose if bone marrow suppression occurs

• Supportive care for GI symptoms recommended

Overdose Effects:

• Can result in profound bone marrow suppression or GI toxicity

• Provide immediate supportive treatment

Therapeutic Class:

• Antimetabolite / Oral Chemotherapy Agent

Storage Conditions:

• Store below 30°C

• Protect from moisture and light

• Keep out of reach of children