Pregnancy: Contraindicated in pregnancy.
Lactation: Contraindicated or not recommended.
Contraindications: Severe hepatic impairment. Ensure adequate contraception in women of childbearing age. Cerebral or clinically significant haemorrhage or haemoptysis in the past 6 months.
Precautions: Renal impairment (CrCl <30 mL/min). Mild to moderate hepatic impairment. Monitor hepatic function before and at least four weekly for 1st four months of treatment, then monitor periodically. Hypertension; withdraw temporarily if severe and unresponsive to therapy and dose reduction. History of or risk factors for QT prolongation; monitor ECG and electrolytes. Risk factors for MI, ischaemic stroke, GI perforation, fistula. History of haemoptysis, cerebral, or clinically significant GI haemorrhage in previous 6 months; significant risk of haemorrhage. Risk of hypothyroidism; monitor thyroid function before and during treatment. Perform baseline and periodic urinalysis; discontinue if Grade 4 proteinuria. Surgery, heart failure.
Advanced renal cell carcinoma, as first line treatment and following cytokine t
Inducers, inhibitors and substrates of P-glycoprotein, breast cancer resistance protein (BCRP) and CYP3A4. Substrates of UGT1A1 (e.g. irinotecan). Rosuvastatin, grapefruit juice.
Blood dyscrasias, hypothyroidism, decreased appetite, dysgeusia, headache, dizziness, lethargy, paraesthesia hypertension, hot flush, epistaxis, dysphonia, GI upset, abnormal hepatic function, hair colour. Change, skin reactions, myalgia, muscle spasms, proteinuria, fatigue, asthenia, mucosal inflammation, oedema, chest pain, altered LFTs and blood chemistry, weight loss. Cardiac dysfunction, transient ischaemic attack, stroke, myocardial infarction, myocardial ischaemia, bradycardia, haemorrhage, hypertensive crisis, QT-interval prolongation, pulmonary embolism, peripheral neuropathy, menstrual disturbances.