Drug Action
Tivozanib is a tyrosine kinase inhibitor.
PDF page 1080
Loading InternPractice…
Drug reference
Tivozanib is a tyrosine kinase inhibitor.
PDF page 1080
Advanced renal cell carcinoma (specialist use only) ▶BY MOUTH ▶Adult: 1340 micrograms once daily for 21 consecutive days of repeated 28 day cycles, for dose adjustments due to side effects—consult product literature
PDF page 1080
History of arterial thromboembolic events. history of bleeding disorders. history of posterior reversible encephalopathy syndrome following tivozanib treatment. history of QT-interval prolongation. history of venous thromboembolic events. major surgical procedures—interrupt treatment. patients aged over 65 years—increased risk of adverse effects. pre-existing cardiac disease. risk factors for arterial thromboembolic events. risk factors for gastro-intestinal fistula. risk factors for gastro-intestinal perforation. risk factors for venous thromboembolic events. risk of bleeding
PDF pages 1080, 1081
NICE decisions ▶Tivozanib for treating advanced renal cell carcinoma (March 2018) NICE TA512 Tivozanib is recommended as an option for treating advanced renal cell carcinoma in adults, only if: . they have had no previous treatment, and . the manufacturer provides tivozanib with the discount agreed in the patient access scheme. Patients whose treatment was started within the NHS before this guidance was published should have the option to continue treatment, without change to their funding Immune system and malignant disease arrangements, until they and their NHS clinician consider it appropriate to stop. www.nice.org.uk/guidance/ta512 Scottish Medicines Consortium (SMC) decisions SMC No. 1335/18 The Scottish Medicines Consortium has advised (July 2018) that tivozanib (Fotivda ®) is accepted for restricted use within NHS Scotland for the first line treatment of adults with advanced renal cell carcinoma. This advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland or a list price that is equivalent or lower.
PDF page 1081
RISKS OF INCORRECT DOSING OF ORAL ANTI-CANCER MEDICINES See Cytotoxic drugs p. 938.
PDF page 1080
→Appendix 1: tivozanib
PDF page 1081
▶Common or very common Alopecia. anaemia. angina pectoris. appetite decreased. arrhythmias. arthralgia. asthenia. cancer pain. cerebrovascular insufficiency. chest pain. chills. constipation. cough. diarrhoea. dizziness. dry mouth. dysphonia. dyspnoea. embolism and thrombosis. fever. gastrointestinal discomfort. gastrointestinal disorders. haemorrhage. headache. hypertension. hypothermia. hypothyroidism. increased risk of infection. insomnia. ischaemia. myalgia. myocardial infarction. nasal complaints. nausea. nerve disorders. oral disorders. oropharyngeal pain. pain. pancreatitis. peripheral oedema. proteinuria. sensation abnormal. skin reactions. swallowing difficulty. taste altered. tinnitus. vasodilation. vertigo. vision disorders. vomiting. weight decreased ▶Uncommon Coronary artery insufficiency. ear congestion. excessive tearing. goitre. hyperhidrosis. hyperthyroidism . memory loss. mucositis. muscle weakness. pulmonary oedema. QT interval prolongation. thrombocytopenia. toxic nodular goitre ▶Rare or very rare Posterior reversible encephalopathy syndrome (PRES) ▶Frequency not known Heart failure
PDF page 1081
Manufacturer advises effective contraception in men, women of childbearing potential, and their partners during treatment and for at least one month after the last dose; an additional barrier method of contraception should be used in women using hormonal contraceptives. See also Pregnancy and reproductive function in Cytotoxic drugs p. 938.
PDF page 1081
Manufacturer advises avoid—toxicity in animal studies. See also Pregnancy and reproductive function in Cytotoxic drugs p. 938.
PDF page 1081
Manufacturer advises avoid—no information available.
PDF page 1081
Manufacturer advises caution in mild-to-moderate impairment—monitor patients for tolerability; avoid in severe impairment. Dose adjustments Manufacturer advises reduce dose to 1340 micrograms on alternate days in moderate impairment—increased risk of adverse effects due to increased exposure.
PDF page 1081
Manufacturer advises caution in severe impairment—limited information available.
PDF page 1081
▶Manufacturer advises perform liver function tests (including ALT, AST and AP) before and during treatment; monitor for proteinuria before treatment and periodically thereafter. ▶Manufacturer advises monitor blood pressure before and during treatment; monitor for signs or symptoms of cardiac failure during treatment. ▶Manufacturer advises perform baseline ECG and monitor electrolytes before treatment and as clinically indicated thereafter. ▶Manufacturer advises monitor thyroid function before treatment and periodically thereafter. ▶Manufacturer advises monitor for symptoms of gastro- intestinal perforation or fistula.
PDF page 1081
There can be variation in the licensing of different medicines containing the same drug. Capsule CAUTIONARY AND ADVISORY LABELS 25 ▶Fotivda (EUSA Pharma Ltd) A Tivozanib (as Tivozanib hydrochloride monohydrate).89 mg Fotivda 890microgram capsules | 21 capsule P £2,052.00 (Hospital only) Tivozanib (as Tivozanib hydrochloride monohydrate) 1.34 mg Fotivda 1340microgram capsules | 21 capsule P £2,052.00 (Hospital only)
PDF page 1081
1340 micrograms once daily for 21 consecutive
First-line fragment. Read the complete Indications and Dose section above.
PDF page 1080