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Teysuno is a brand name for Tegafur. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Teysuno is indicated in adults: - for the treatment of advanced gastric cancer when given in combination with cisplatin (see section 5.1). - as monotherapy or in combination with oxaliplatin or irinotecan, with or without bevacizumab, for the treatment of patients with metastatic colorectal cancer for whom it is not…
Verbatim from this product's EMA label. Tap a section to expand.
Teysuno should only be prescribed by a qualified physician experienced in treating cancer patients with anti-neoplastic medicinal products. Patients should be provided with outpatient prescriptions for anti-emetic and anti-diarrhoeal medicinal products.
The patient's BSA must be recalculated and the Teysuno dose adjusted accordingly if a patient’s weight increases or decreases by ≥10% from the one used for the previous calculation of BSA and the change is clearly not related to fluid retention.
Posology Advanced gastric cancer when given in combination with cisplatin The recommended standard dose of Teysuno when administered in combination with cisplatin is 25 mg/m2 (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. The standard and reduced Teysuno and cisplatin doses and calculations according to body surface area (BSA) for doses of Teysuno given in combination with cisplatin are provided in Table 1 and Table 2, respectively.
3 The recommended dose of cisplatin with this regimen is 75 mg/m2 by intravenous infusion administered once every 4 weeks. Cisplatin should be discontinued after 6 cycles without withdrawal of Teysuno. If cisplatin is discontinued before 6 cycles, Teysuno treatment alone can be resumed when the criteria for restarting it are met.
Patients treated with Teysuno in combination with cisplatin should be closely monitored and laboratory tests, including haematology, liver function, renal function, and serum electrolytes, should be performed frequently. Treatment should be discontinued if progressive disease or intolerable toxicity is observed.
Refer to the cisplatin summary of product characteristics (SmPC) for pretreatment hyperhydration.
Teysuno doses in advanced gastric cancer Table 1:
Standard dose and dose reductions allowed for Teysuno and/or for cisplatin in advanced gastric cancer Medicinal product Standard dose (mg/m2) Dose reduction 1 (mg/m2) Dose reduction 2 (mg/m2) Teysuno 25a → 20a → 15a and/or Cisplatin 75 → 60 → 45 a Expressed as tegafur content.
29 m2 15 30 1 0 Calculate BSA to 2 decimal places. a Expressed as tegafur content. d. 5 mg/kg on day 1). d. d1-14 followed by one-week pause is recommended.
Summary of safety profile The overall safety profile of Teysuno in combination with cisplatin is based primarily on clinical study data from 593 patients with advanced gastric cancer treated with this regimen. In addition, there is post-marketing experience in over 866,000 Asian (mainly Japanese) patients.
Among 593 patients treated with Teysuno in combination with cisplatin, the most common severe adverse reactions (Grade 3 or higher with frequency of at least 10%) were neutropaenia, anaemia, and fatigue. Tabulated list of adverse reactions 15 The following headings are used to rank the adverse reactions by frequency: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), and not known (cannot be estimated from the available data).
The frequencies of very common, common, and uncommon adverse reactions are from 593 patients treated with Teysuno in combination with cisplatin in clinical trials. The frequencies of medically relevant rare and very rare adverse reactions are estimated from post-marketing surveillance of 866,000 patients in Asia (mostly Japanese) treated with Teysuno-based therapy.
Each term is presented in its most common category only and within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Table 9:
Adverse reactions reported by decreasing seriousness in each frequency grouping System Organ Classa Very common Common Uncommon Rare / Very rare Infections and infestations Neutropenic sepsis, septic shock, sepsis, infection, pneumonia, bacteremia, respiratory tract infection, upper respiratory tract infection, pyelonephritis acute, urinary tract infection, pharyngitis, nasopharyngitis, rhinitis, tooth infection, candidiasis, oral herpes, paronychia, furuncle Hepatitis B reactivation Neoplasms benign, malignant and unspecified (Incl.
Dose limiting toxicities include diarrhoea and dehydration. Most adverse reactions are reversible and can be managed by symptomatic therapy, dose interruptions and dose reductions. Bone marrow suppression Treatment-related bone marrow suppression, including neutropaenia, leukopaenia, thrombocytopaenia, anaemia, and pancytopaenia, has been reported among patients treated with Teysuno in combination with cisplatin.
, with antibiotics, granulocyte-colony stimulating factor [G-CSF]). Patients with low platelet counts are at increased risk for bleeding and should be monitored carefully. 2. Hepatitis B reactivation Administration of Teysuno in hepatitis B virus carriers, HBc antigen negative and HBc antibody positive patients, or HBs antigen negative and HBs antibody positive patients may result in reactivation of hepatitis B.
Patients should be tested for HBV infection before initiating treatment with Teysuno. Experts in liver disease and in the treatment of hepatitis B should be consulted before treatment is initiated in patients with positive hepatitis B serology (including those with active disease) and for patients who test positive for HBV infection during treatment.
Carriers of HBV who require treatment with Teysuno should be closely monitored for signs and symptoms of active HBV infection throughout therapy, and follow-up monitoring for hepatic function tests or viral markers are recommended.
Diarrhoea Patients with diarrhoea should be carefully monitored and given fluid and electrolyte replacement if they become dehydrated. Prophylactic treatment for diarrhoea should be administered as indicated. , loperamide) and intravenous fluids/electrolytes should be initiated early when diarrhoea develops.
Dose suspension/adjustment should be implemented with the occurrence of Grade 2 or higher diarrhoea if symptoms persist despite adequate treatment. Dehydration Dehydration and any associated electrolyte disturbances should be prevented or corrected at onset.
1. • History of severe and unexpected reactions to fluoropyrimidine therapy. 4). • Pregnancy and breast-feeding. 2, Table 7). • End stage renal disease patients requiring dialysis. • Co-administration of other fluoropyrimidines with Teysuno.
5 for drug-drug interaction). • Contraindications for cisplatin; oxaliplatin, irinotecan and bevacizumab refer to the corresponding SmPCs. 9
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Teysuno doses in Metastatic colorectal cancer Table 3a:
Standard dose and dose reductions allowed for Teysuno monotherapy in metastatic colorectal cancer Medicinal product Standard dose (mg/m2) Dose reduction 1 (mg/m2) Dose reduction 2 (mg/m2) Teysuno 30a → 25a → 20a a Expressed as tegafur content.
Table 3b:
Standard dose and dose reductions allowed for Teysuno combination therapy in metastatic colorectal cancer Medicinal product Standard dose (mg/m2) Dose reduction 1 (mg/m2) Teysuno 25a → 20a,e And/or Oxaliplatinb,c,d 130 → 100e Irinotecanc,d 150-225f → g a Expressed as tegafur content.
b Chung KY, Saito K, Zergebel C, Hollywood E, Segal M, Saltz LB. Phase I study of two schedules of oral S-1 in combination with fixed doses of oxaliplatin and bevacizumab in patients with advanced solid tumors. Oncology. 2011;81(2):65-72.
c Winther SB, Zubcevic K, Qvortrup C, et al. Experience with S-1 in older Caucasian patients with metastatic colorectal cancer (mCRC): Findings from an observational chart review. Acta Oncol. 2016;55(7):881-885. d Österlund P, Kinos S, Pfeiffer P, et al.
Continuation of fluoropyrimidine treatment with S-1 after cardiotoxicity on capecitabine- or 5-fluorouracil-based therapy in patients with solid tumours: a multi-centre retrospective observational cohort study. Manuscript Submitted 2021.
e Winther SB, Liposits G, Skuladottir H, et al. Reduced-dose combination chemotherapy (S-1 plus oxaliplatin) versus full-dose monotherapy (S-1) in older vulnerable patients with metastatic colorectal cancer (NORDIC9): a randomised, open-label phase 2 trial.
Lancet Gastroenterol Hepatol. 2019;4(5):376-388. 50 […]
cysts and polyps) Tumour haemorrhage, cancer pain Blood and lymphatic system disorders Neutropenia, leukopenia, anaemia, thrombo- cytopenia Febrile neutropenia, lymphopenia Pancytopenia, prothrombin time prolonged, international normalised ratio increased, hypoprothrombinaemia, prothrombin time shortened, granulocytosis, leukocytosis, eosinophilia, lymphocytosis, monocyte count decreased, monocyte count increased, thrombocythaemia Disseminated intravascular coagulation Immune system disorders Hypersensitivity Endocrine disorders Adrenal haemorrhage Metabolism and nutrition disorders Anorexia Dehydration, hypokalaemia, hyponatraemia, hypocalcaemia, hypomagnesaemia, hypoalbuminaemia, hyperkalaemia Hyperglycaemia, blood alkaline phosphatase increased, blood lactate dehydrogenase increased, hypophosphatameia, hypermagnesaemia, gout, hypoproteinaemia, hyperglobulinaemia, hyperlipidaemia, oral intake reduced Hyperammonaemia Psychiatric disorders Insomnia Confusional state, restlessness, personality disorder, hallucination, depression, anxiety, libido decreased, sexual inhibition 16 System Organ Classa Very common Common Uncommon Rare / Very rare Nervous system disorders Peripheral neuropathy Dizziness, headache, dysgeusia Cerebrovascular accident, cerebellar infarction, cerebrovascular disorder, convulsion, ischaemic stroke, syncope, hemiparesis, aphasia, ataxia, metabolic encephalopathy, loss of consciousness, acoustic neuritis, memory impairment, balance disorder, somnolence, tremor, ageusia, parosmia, burning sensation, formication Leukoenceph- alopathy, anosmia Eye disorders Vision disorder, lacrimal disorder, conjunctivitis, corneal disorder b Eye allergy, eyelid ptosis, erythema of eyelid Ear and labyrinth disorders Hearing impairment, deafness Vertigo, ear congestion, ear discomfort Cardiac disorders Cardiac failure, acute myocardial infarction, pericardial effusion, atrial fibrillation, angina pectoris, cardiac fibrillation, tachycardia, palpitations Vascular disorders Hypotension, deep vein thrombosis, hypertension Iliac artery thrombosis, hypovolaemic shock, arterial limb thrombosis, thrombosis, flushing, pelvic venous thrombosis, thrombophlebitis, phlebitis, phlebitis superficial, orthostatic hypotension, haematoma, hyperaemia, hot flush Respiratory, thoracic and mediastinal disorders Dyspnoea, epistaxis, hiccups, cough Pulmonary embolism, respiratory tract haemorrhage, exertional dyspnoea, pharyngolaryngeal pain, rhinorrhoea, pharyngeal erythema, rhinitis allergic, dysphonia, productive cough, nasal congestion Interstitial lung disease Gastrointestinal disorders Diarrhoea, vomiting, nausea, constipation Gastrointestinal haemorrhage, stomatitis, gastrointestinal inflammation, flatulence, abdominal pain, dysphagia, abdominal discomfort, dyspepsia, dry mouth Gastrointestinal perforation, oesophagitis, gastrointestinal infection, ileus, gastrointestinal obstruction, ascites, lip oedema, oesophageal spasm, gastric ulcer, gastroesophageal reflux disease, reflux gastritis, retroperitoneal fibrosis, gastrointestinal disorder, anal haemorrhage, haemorrhoids, salivary hypersecretion, retching, salivary gland disorder, cheilitis, aerophagia, eructation, glossodynia, oral pain, teeth brittle Acute pancreatitis , terminal ileitis Hepatobiliary disorders Hyperbilirubin-aem ia, alanine aminotransferase increased, aspartate aminotransferase increased Liver function test abnormal, gamma glutamyltransferase increased Acute hepatic failure Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome, rash, skin hyperpigmentation, dry skin, pruritus, alopecia, Exfoliative rash, skin exfoliation, necrolytic migratory erythema, blood blister, dermatitis allergic, skin reaction, dermatitis acneiform, erythema, increased tendency to bruise, purpura, hyperhidrosis, night sweats, nail atrophy, pigmentation disorder, skin discoloration, hypertrichosis Toxic epidermal necrolysis, Stevens-Johnson syndrome, photosensitivity reaction, nail disorder Musculoskeleta l and connective tissue disorders Musculoskeletal pain Muscle […]
Patients with anorexia, asthenia, nausea, vomiting, diarrhoea, stomatitis, and gastrointestinal obstruction should be monitored closely for signs of dehydration. Dehydration should be managed aggressively with rehydration and other appropriate measures.
If Grade 2 (or higher) dehydration occurs, treatment should be immediately suspended and the dehydration corrected. Treatment should not be resumed until dehydration and its underlying causes are corrected or adequately controlled. 2).
, dehydration, electrolyte imbalance, etc). 8). , serum creatinine, CrCl). 2). 10 Dehydration and diarrhoea may increase the risk of renal toxicity for cisplatin. Hyperhydration (forced diuresis) should be administered according to the cisplatin SmPC to reduce the risk of renal toxicity associated with cisplatin therapy.
Gimeracil increases 5-fluorouracil (5-FU) exposure by inhibiting DPD, the primary enzyme for metabolizing 5-FU. 2); so, in patients with renal insufficiency gimeracil renal clearance is decreased and 5-FU exposure thus increased. 2).
2). 8). Most ocular reactions will resolve or improve with suspension of medicinal product and proper treatment (instillation of artificial tears, antibiotic eye drops, implantation of glass or silicone tubes in lacrimal punctas or canaliculi, and/or use of spectacles rather than contact lenses).
Efforts should be made to ensure early detection of ocular reactions, including an early ophthalmologic consultation in the event of any persistent or vision-reducing ocular symptoms such as lacrimation or corneal symptoms. Refer to the cisplatin SmPC for eye disorders observed with cisplatin therapy.
Hyperammonaemia Hyperammonaemia has been observed with Teysuno. In patients who develop unexplained neurologic symptoms (like ataxia, lethargy or changes in mental status), ammonia levels should be measured and appropriate clinical management should be initiated.
If hyperammonaemia neurologic symptoms worsen to hyperammonaemic encephalopathy, discontinuation of Teysuno should be considered. […]