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Tegafur with gimeracil and oteracil oral

Updated 2 Feb 2023 | Antimetabolites


Oral formulations containing tegafur, gimeracil and oteracil.

Drugs List

  • tegafur 15mg and gimeracil 4.35mg and oteracil 11.8mg capsules
  • tegafur 20mg and gimeracil 5.8mg and oteracil 15.8mg capsules
  • TEYSUNO 15mg+4.35mg+11.8mg capsules
  • TEYSUNO 20mg+5.8mg+15.8mg capsules
  • Therapeutic Indications


    Advanced gastric carcinoma in combination with platinum-based regimen


    Whilst the doses stated below are those recommended by the manufacturer, local cancer network protocols for the relevant indication should be consulted.


    The recommended dose is 25mg/metre squared of body surface area (BSA) (expressed as tegafur content) twice daily, morning and evening, for 21 consecutive days followed by 7 days rest (1 treatment cycle). This treatment cycle is repeated every 4 weeks.

    Patients with Renal Impairment

    Creatinine clearance below 30ml/minute: Not recommended unless the potential benefits outweighs the risks

    Creatinine clearance 30 to 50ml/minute: 20mg/metre squared BSA (expressed as tegafur content).

    Additional Dosage Information

    To manage toxicity the following reductions should be followed:
    First dose reduction: 20mg/metre squared BSA (expressed as tegafur content).
    Second dose reduction: 15mg/metre squared BSA (expressed as tegafur content).
    Third dose reduction: Discontinue treatment.

    Non-haematological toxicities (excluding renal toxicities)
    CTC Grade 1: No dose adjustment.
    CTC Grade 2: Suspend treatment until CTC returns to at least grade 1 and resume at original dose.
    CTC Grade 3 first or second occurrence: Suspend treatment until CTC returns to at least grade 1 and reduce next dose by 1 dose level.
    CTC Grade 3 third occurrence: Permanently discontinue treatment.

    Renal toxicities - Creatinine clearance should be determined before the start of treatment for every cycle.
    Creatinine clearance equal to or greater than 50ml/minute: No dose adjustment.
    Creatinine clearance 30 to 49ml/minute: Start treatment at first reduced dose level.
    Creatinine clearance less than 30ml/minute: Suspend treatment until creatinine clearance recovers to 30ml/minute or above then restart treatment at 1 reduced dose level.

    Haematologic toxicities
    Neutrophils less than 0.5 x 10 to the power of 9 per litre: Suspend treatment until recovery to 1.5 x 10 to the power of 9 per litre or above - next dose reduce by 1 dose level.
    Platelets less than 25 x 10 to the power of 9 per litre: Suspend treatment until recovery to 100 x 10 to the power of 9 per litre or above - next dose reduce by 1 dose level.
    Haemoglobin 6.5g/dl: Suspend treatment until recovery to 10g/dl and reduce next dose by 1 dose level.

    Doses omitted due to toxicity should not be replaced.
    Once the dose has been reduced it should not be increased again.
    If a patients vomits after taking a dose, the dose must not be replaced.


    Children under 18 years
    Haemoglobin concentration below 10g/dL
    Neutrophil count below 1.5 x 10 to the power of 9 / L
    Platelet count below 100 x 10 to the power of 9/ L
    Complete dihydropyrimidine dehydrogenase deficiency
    Long QT syndrome
    Renal impairment - creatinine clearance below 30 ml/minute
    Torsade de pointes

    Precautions and Warnings

    Family history of long QT syndrome
    Electrolyte imbalance
    Glucose-galactose malabsorption syndrome
    Hepatitis B
    History of hepatitis B
    History of torsade de pointes
    Lactose intolerance
    Partial dihydropyrimidine dehydrogenase deficiency
    Renal impairment - creatinine clearance 30-50ml/minute

    Correct electrolyte disorders before treatment
    Advise ability to drive/operate machinery may be affected by side effects
    Anti-diarrhoeals may be required during treatment
    Anti-emetics may be required during therapy
    Before initiating screen all patients for hepatitis B infection
    DPD deficiency phenotype/genotype testing is recommended prior to treatment
    Hepatitis B: Refer prior to initiation to liver disease specialist
    Recalculate BSA and adjust dose if weight changes by 10% or more
    Treatment to be prescribed under the supervision of a specialist
    Contains lactose
    Consult local policy on the safe use of oral anti-cancer drugs
    Staff: Not to be handled by pregnant staff
    Reduce dose if creatinine clearance is < 50ml/min at start of cycle
    Consider monitoring ECG in patients at risk of QT prolongation
    Consider the use of fluid and electrolyte replacement
    If visual disturbances occur, perform ophthalmic evaluation
    Monitor creatinine clearance before day 1 of each treatment cycle
    Monitor haematological parameters regularly throughout treatment
    Monitor hepatic function regularly
    Monitor patients who develop severe diarrhoea
    Monitor prothrombin times closely in patients on anticoagulant therapy
    Monitor renal function regularly
    Monitor serum electrolytes
    Advise patient to report signs of neuropathy
    Reactivation of hepatitis B may occur in chronic carriers
    Discontinue if severe and persistent diarrhoea develops
    If dehydration occurs, discontinue treatment until patient has recovered
    Suspend therapy if haemoglobin levels fall below 6.5 g/dl
    Suspend therapy if neutrophils fall below 0.5 x 10 to the power of 9 / L
    Suspend therapy if platelets fall below 25 x10 to the power of 9 / L
    Male & female: Contraception required during & for 6 months after treatment
    Advise patient of possible side effects and the need to report them

    Prophylactic anti-diarrhoeal or anti-emetic treatment should be provided. If CTC grade 2 or higher diarrhoea occurs dose suspension/adjustment should be implemented if symptoms persist despite adequate treatment. Patients with diarrhoea should be carefully monitored and given fluid and electrolyte replacement if they become dehydrated.

    Dehydration and related electrolyte disturbances should be corrected prior to or during treatment. Dehydration should be treated aggressively with rehydration and other appropriate measures. If CTC grade 2 or higher dehydration occurs, treatment should be suspended until the dehydration and its underlying cause has been corrected or adequately controlled.

    If persistent or vision-reducing ocular symptoms such as lacrimation or corneal symptoms occur, an ophthalmic consultation should be sought.

    Carriers of Hepatitis B virus (HBV) should be closely monitored for signs of active disease. Ongoing monitoring of liver function and viral markers is recommended.

    Pregnancy and Lactation


    Tegafur with gimeracil and oteracil is contraindicated in pregnancy.

    There have been reports of foetal abnormalities in human pregnancy. Discontinue tegafur with gimeracil and oteracil if pregnancy occurs during treatment. Discuss the potential risk to the foetus and consider genetic counselling.

    Animal studies have shown reproductive toxicity both embryolethality and teratogenicity.

    The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( ) or if this is unavailable at the backup site ( ).


    Tegafur with gimeracil and oteracil is contraindicated in breastfeeding

    It is not known if tegafur with gimeracil and oteracil or its metabolites are excreted in human milk. Animal studies have shown excretion into milk therefore a risk to infants cannot be excluded and breastfeeding should be discontinued during treatment.

    Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
    Specialist advice is available from the UK Drugs in Lactation Advisory Service at


    Advise patient if they vomit after taking a dose that they must not replace that dose.

    Advise patients of both sexes to use adequate contraception during and for 6 months after treatment has ended.

    Advise patient to report any symptoms of moderate to severe toxicity promptly.

    Advise patient that their ability to drive or operate machinery may be affected by side effects such as fatigue, dizziness, blurred vision and nausea.

    Side Effects

    Abnormal INR
    Adrenal haemorrhage
    Altered consciousness
    Altered prothrombin concentration
    Altered serum creatinine values
    Angina pectoris
    Atrial fibrillation
    Blood pressure changes
    Blood urea increased
    Cardiac disorders
    Cardiac failure
    Cerebellar dysfunction
    Cerebrovascular accident
    CNS disturbances
    Corneal disorders
    Deep vein thrombosis (DVT)
    Electrolyte disturbances
    Eye disorder
    Febrile neutropenia
    Gamma glutamyl transferase (GGT) increased
    Gastrointestinal disorder
    Hearing disturbances
    Hepatic failure
    Hypersensitivity reactions
    Impaired memory
    Increase in alkaline phosphatase
    Increase in lactate dehydrogenase
    Increase in serum ALT/AST
    Interstitial lung disease
    Intravascular coagulation (disseminated)
    Loss of balance
    Multiorgan failure
    Musculoskeletal disturbances
    Myocardial infarction
    Neutropenic sepsis
    Oral herpes
    Palmar-Plantar Erythrodysaesthesia syndrome
    Pericardial effusion
    Personality disorder
    Pulmonary embolism
    Reactivation of hepatitis B
    Reduced libido
    Renal failure
    Renal toxicity
    Septic shock
    Skin disorder
    Stevens-Johnson syndrome
    Toxic epidermal necrolysis
    Tumour haemorrhage
    Tumour pain
    Visual disturbances


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: July 2015

    Reference Sources

    HPRA Safety Notice - 5-Fluorouracil (i.v.), capecitabine and tegafur containing products: Pre-treatment testing to identify DPD-deficient patients at increased risk of severe toxicity Available at:
    Last accessed: 26 October 2020

    Joint Formulary Committee. British National Formulary(online) London: BMJ Group and Pharmaceutical Press. Accessed on 3 July 2015.

    Martindale: The Complete Drug Reference (online) London: Brayfield A (ed). Pharmaceutical Press. Accessed on 3 July 2015.

    Summary of Product Characteristics: Teysuno 15mg/4.35mg/11.8mg hard capsules. Nordic Pharma Ltd. November 2017.

    Summary of Product Characteristics: Teysuno 20mg/5.8mg/15.8mg hard capsules. Nordic Pharma Ltd. November 2017.

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    Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content

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