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TRIFLURIDINE/TIPIRACIL SERVIER is a brand name for Tipiracil. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Colorectal cancer Trifluridine/ Tipiracil is indicated in combination with bevacizumab for the treatment of adult patients with metastatic colorectal cancer (CRC) who have received two prior anticancer treatment regimens including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents,…
Verbatim from this product's MHRA label. Tap a section to expand.
Trifluridine/ Tipiracil should be prescribed by physicians experienced in the administration of anticancer therapy. 4). When Trifluridine/ Tipiracil is used in combination with bevacizumab for the treatment of metastatic CRC, the dose of bevacizumab is 5 mg/kg of body weight given once every 2 weeks.
Please refer to the full product information for bevacizumab. The dose is calculated according to body surface area (BSA) (see Table 1). The dose must not exceed 80 mg/dose. If doses were missed or held, the patient must not make up for missed doses.
30 80 0 4 160 Recommended dose adjustments Dosing adjustments may be required based on individual safety and tolerability. A maximum of 3 dose reductions are permitted to a minimum dose of 20 mg/m2 twice daily. Dose escalation is not permitted after it has been reduced.
In the event of haematological and/or non-haematological toxicities patients should follow the dose interruption, resumption and reduction criteria stated in Table 2, Table 3 and Table 4. 5 109/L Platelets < 50 109/L 75 109/L a Resumption criterion applied to the start of the next cycle for all patients regardless of whether or not the interruption criteria were met.
5 x 109/L) or thrombocytopenia (< 25 109/L) that results in more than 1 week’s delay in start of next cycle • CTCAE* non-haematologic Grade 3 or Grade 4 adverse reaction; except for Grade 3 nausea and/or vomiting controlled by antiemetic therapy or diarrhoea responsive to antidiarrhoeal medicinal products • Interrupt dosing until toxicity resolves to Grade 1 or baseline.
• When resuming dosing, decrease the dose level by 5 mg/m2/dose from the previous dose level (Table 4). • Dose reductions are permitted to a minimum dose of 20 mg/m2/dose twice daily (or 15 mg/m2/dose twice daily in severe renal impairment).
• Do not increase dose after it has been reduced. 14 mg tablets in the evening. 2). 2). One dose reduction to a minimum dose of 15 mg/m2 twice daily is permitted based on individual safety and tolerability (see Table 5). Dose escalation is not permitted after it has been reduced.
In the event of haematological and/or non-haematological toxicities patients should follow the dose interruption, resumption and reduction criteria stated in Table 2, Table 3 and Table 5. 14 mg tablets in the evening. 4). 2). Moderate or severe hepatic impairment Administration is not […]
4). Trifluridine/ Tipiracil as monotherapy The safety profile of trifluridine/ tipiracil as monotherapy is based on the pooled data from 1114 patients with metastatic colorectal or gastric cancer in controlled phase III clinical studies.
The most common adverse reactions (≥ 30%) are neutropenia (53% [34% ≥ Grade 3]), nausea (31 % [1% ≥ Grade 3]), fatigue (31% [4% ≥ Grade 3]), and anaemia (30 % [11% ≥ Grade 3]). The most common adverse reactions (≥ 2%) that resulted in treatment discontinuation, dose reduction, dose delay, or dose interruption were neutropenia, anaemia, fatigue, leukopenia, thrombocytopenia, diarrhoea, and nausea.
Trifluridine/ Tipiracil in combination with bevacizumab The safety profile of trifluridine/ tipiracil in combination with bevacizumab is based on the data from 246 patients with metastatic colorectal cancer in the controlled phase III clinical study (SUNLIGHT).
The most common adverse reactions (≥ 30%) are neutropenia (69% [48% ≥ Grade 3]), fatigue (35% [3% ≥ Grade 3]), and nausea (33% [1% ≥ Grade 3]). The most common adverse reactions (≥ 2%) that resulted in treatment discontinuation, dose reduction, dose delay, or dose interruption of trifluridine/ tipiracil when used in combination with bevacizumab were neutropenia, fatigue, thrombocytopenia, nausea and anaemia.
When trifluridine/ tipiracil is used in combination with bevacizumab, the frequency of the following adverse reactions was increased compared to trifluridine/ tipiracil as monotherapy: neutropenia (69% vs 53%), severe neutropenia (48% vs 34%), thrombocytopenia (24% vs 16%), stomatitis (11% vs 6%).
The adverse reactions observed from the 533 treated patients with metastatic colorectal cancer in the placebo-controlled Phase III (RECOURSE) clinical study, the 335 treated patients with metastatic gastric cancer in the placebo- controlled Phase III (TAGS) clinical study, the 246 patients treated with trifluridine/ tipiracil in monotherapy and the 246 patients treated with trifluridine/ tipiracil in combination with bevacizumab for metastatic colorectal cancer in the controlled Phase III (SUNLIGHT) clinical study are shown in Table 6.
Bone marrow suppression Trifluridine/ Tipiracil caused an increase in the incidence of myelosuppression including anaemia, neutropenia, leukopenia, and thrombocytopenia. Complete blood cell counts must be obtained prior to initiation of therapy and as needed to monitor toxicity, but at a minimum, prior to each treatment cycle.
5 109/L, if the platelet counts are < 75 109/L, or if the patient has an unresolved Grade 3 or 4 non- haematological clinically relevant toxicity from prior therapies. 8). Given that the majority were reported in the context of bone marrow suppression, the patient’s condition should be monitored closely, and appropriate measures, such as antimicrobial agents and granulocyte-colony stimulating factor (G-CSF), should be administered as clinically indicated.
5% of patients in the trifluridine/ tipiracil group respectively received G-CSF mainly for therapeutic use. 3% for therapeutic use. Gastrointestinal toxicity Trifluridine/ Tipiracil caused an increase in the incidence of gastrointestinal toxicities including nausea, vomiting and diarrhoea.
Patients with nausea, vomiting, diarrhoea and other gastrointestinal toxicities should be carefully monitored, and anti-emetic, anti-diarrhoeal and other measures, such as fluid/electrolyte replacement therapy, should be administered as clinically indicated.
2). 2). The global incidence of adverse events (AEs) is similar in normal renal function (CrCl ≥ 90 mL/min), mild (CrCl = 60 to 89 mL/min) or moderate (CrCl = 30 to 59 mL/min) renal impairment subgroups. However, the incidence of serious, severe AEs and AEs leading to dose modification tends to increase with advancing levels of renal impairment.
2). Patients with severe renal impairment (CrCl = 15 to 29 mL/min) and adjusted starting dose of 20 mg/m2 twice daily had a safety profile consistent with the safety profile of trifluridine/ tipiracil in patients with normal renal function or mild renal impairment.
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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They are classified according to System Organ Class (SOC) and the appropriate Medical Dictionary for Regulatory (MedDRA) term is used to describe a certain drug reaction and its synonyms and related conditions. Adverse reactions known to occur with trifluridine/ tipiracil given alone or with bevacizumab may occur during treatment with these medicinal products in combination, even if these reactions were not reported in clinical trials with combination therapy.
Adverse reactions are grouped according to their frequencies. Frequency groups are defined by the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥1/1,000 to < 1/100); and rare (≥ 1/10 000 to < 1/1 000).
Within each frequency group, adverse drug reactions are presented in order of decreasing seriousness. Table 6 – Adverse reactions reported in clinical studies in patients treated with Trifluridine/ Tipiracil System Organ Class (MedDRA)a Adverse reactions Frequency Monotherapy Combination with bevacizumab Infections and infestations Lower respiratory tract Common - infection Neutropenic sepsis Uncommon - Biliary tract infection Uncommon - Infection Uncommon Common Urinary tract infection Uncommon Uncommon Bacterial infection Uncommon - Candida infection Uncommon - Conjunctivitis Uncommon - Herpes zoster Uncommon - Influenza Uncommon - Upper respiratory tract Uncommon - infection Enteritis infectious Rare - Septic shockb Rare - Gingivitis Rare Uncommon Tinea pedis Rare - Neoplasms benign, malignant Cancer pain and unspecified (incl cysts and polyps) Uncommon - Blood and lymphatic system Anaemia Very common Very common disorders Neutropenia Very common Very common Leukopenia Very common Common Thrombocytopenia Very common Very common Febrile neutropenia Common Uncommon Lymphopenia Common Common Pancytopenia Uncommon Uncommon Erythropenia Uncommon - Leukocytosis Uncommon - Monocytopenia Uncommon - Monocytosis Uncommon - Granulocytopenia Rare - Metabolism and nutrition disorders Hypoalbuminaemia Very common Very common Dehydration Common Uncommon Hyperglycaemia Uncommon - Hyperkalaemia Uncommon Uncommon Hypocalcaemia Uncommon - Hypokalaemia Uncommon - Hyponatraemia Uncommon - Hypophosphataemia Uncommon - Gout Uncommon - Hypernatraemia Rare - Psychiatric disorders Anxiety Uncommon - Insomnia Uncommon - Nervous system disorders Dysgeusia Common Common Dizziness Uncommon Common Headache Uncommon Common Neuropathy peripheral Uncommon Uncommon Paraesthesia Uncommon Uncommon Lethargy Uncommon - Neurotoxicity Uncommon - Burning sensation Rare - Dysaesthesia Rare - Hyperaesthesia Rare - Hypoaesthesia Rare - Syncope Rare - Eye disorders Cataract Rare - Diplopia Rare - Dry eye Rare - Vision blurred Rare - Visual acuity reduced Rare - Ear and labyrinth disorders Vertigo Uncommon - Ear discomfort Rare - Cardiac disorders Angina pectoris Uncommon - Arrhythmia Uncommon - Palpitations Uncommon - Vascular disorders Hypertension Uncommon Common Flushing Uncommon - Hypotension Uncommon - Embolism Rare - Respiratory, thoracic and Dyspnoea Common Common mediastinal disorders Pulmonary embolismb Uncommon - Dysphonia Uncommon Uncommon Cough Uncommon - Epistaxis Uncommon - Rhinorrhoea Rare Uncommon Oropharyngeal pain Rare - Pleural effusion Rare - Gastrointestinal disorders Diarrhoea Very common Very common Vomiting Very common Very common Nausea Very common Very common Abdominal pain Common Common Stomatitis Common Very common Constipation Common Common Ileus Uncommon - Gastrointestinal haemorrhage Uncommon - Colitis Uncommon Uncommon Mouth ulceration Uncommon Common Oral disorder Uncommon Common Abdominal distension Uncommon […]
2). Patients with renal impairment should be monitored closely when being treated with trifluridine/ tipiracil; patients with moderate or severe renal impairment should be more frequently monitored for haematological toxicities. 2). 8).
Lactose intolerance Trifluridine/ Tipiracil contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.