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TRIFLURIDINE AND TIPIRACIL HCl · by SERVIER

ANTINEOPLASTICS Antineoplastic/Antimetabolites SERVIER

Composition

Tab 15mg/6.14mg: Trifluridine 15 mg and Tipiracil HCl 6.14 mg, Tab 20mg/8.19mg: Trifluridine 20 mg and Tipiracil HCl 8.19 mg

Indications & Dosage

Metastatic gastric cancer, Metastatic colorectal cancer (specialist use only): Adult: Initially 35 mg/m2 twice daily (max. per dose 80 mg), given on days 1 to 5 and days 8 to 12 of each 28-day cycle, consult product literature.

Contraindications

Last stage of renal disease, patients undergoing dialysis, severe hepatic impairment.

Precautions

Avoid in moderate hepatic impairment, caution in moderate to severe renal impairment; monitor haematological toxicities, dose reduction in severe impairment (consult product literature). Use effective contraception in women of child-bearing potential, during treatment and for 6 months after stopping treatment. Check baseline blood cell counts before and during treatment; monitor closely for myelosuppression. Monitor for proteinuria before and during treatment.

Pregnancy

Avoid unless essential

Lactation

Avoid

Side Effects

Alopecia, thrombocytopenia, anaemia, headache, malaise, asthenia, appetite decreased, constipation, diarrhoea, decreased leucocytes, hypoalbuminaemia, dyspnoea, fever, IG disorders, hyperbilirubinaemia, increased risk of infection, mucositis, nausea, neutropenia, oedema, peripheral neuropathy, skin reactions, taste altered, urine abnormalities, vomiting, pain, weight decreased, angina pectoris, anxiety, arrhythmia, ascites, bile duct disorders, cataract, conjunctivitis, cough, cystitis, dizziness, dysphonia, electrolyte imbalance, embolism, erythropenia, flushing, gout, haemorrhage, hepatotoxicity, hyperglycaemia, hyperhidrosis, hypertension, hypotension, increased leucocytes, insomnia, joint disorders, lethargy, menstrual disorder, muscle complaints, muscle weakness, neurotoxicity, neutropenic sepsis, palpitations, pancreatitis acute, pancytopenia, photosensitivity reaction, pulmonary embolism, QT interval prolongation, renal failure, respiratory disorders, rhinorrhoea, septic shock, syncope, urinary disorder, vertigo, vision disorders.