Finished product reference
Tegafur / Gimeracil / Oteracil
Capsule · Oral · 20 mg/5.8 mg/15.8 mg
- List code
- 52013
- Pharmacologic class
- Antineoplastic; oral fluoropyrimidine combination (tegafur with DPD inhibitor and OPRT inhibitor, S-1)
What it is and how it works
Tegafur is a prodrug of fluorouracil, which inhibits thymidylate synthase and is incorporated into RNA and DNA. Gimeracil reversibly inhibits dihydropyrimidine dehydrogenase (DPD), the main enzyme degrading fluorouracil, maintaining higher plasma levels; oteracil inhibits orotate phosphoribosyltransferase in the gut mucosa, reducing local activation of fluorouracil and gastrointestinal toxicity.
Indications
Advanced gastric cancer in adults when given with cisplatin; in the EU also metastatic colorectal cancer in patients for whom other fluoropyrimidines cannot be continued because of hand–foot syndrome or cardiovascular toxicity.
Dosage and administration (summary)
Oral, dosed by body surface area according to the oncology regimen; with cisplatin in gastric cancer typically tegafur 25 mg/m² twice daily for 21 days followed by 7 days’ rest, with dose adjustment for renal function and toxicity.
Contraindications
Known complete DPD deficiency, concomitant or recent (within 4 weeks) treatment with brivudine or sorivudine, treatment with other fluoropyrimidines, severe bone marrow suppression, severe renal impairment requiring dialysis, pregnancy and breastfeeding.
Warnings and precautions
Testing for DPD deficiency is recommended before treatment because partial deficiency increases the risk of severe toxicity. Myelosuppression, diarrhoea, mucositis, dehydration, renal impairment, hepatotoxicity and ocular disorders may occur; it interacts with warfarin and phenytoin (monitor INR and phenytoin levels).
Pregnancy
Contraindicated in pregnancy; effective contraception is required during and after treatment.
Storage and supply
Store below 30 °C in the original package.
Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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