VOPAZZI

*First-line treatment of advanced renal cell carcinoma, Treatment of advanced renal cell carcinoma in patients who have had previous treatment with cytokine therapy:* Adult: 800 mg daily, adjust dose in steps of 200mg according to tolerability; max. 800 mg per day. *Treatment of selective subtypes of advanced soft-tissue sarcoma:* Adult: (consult product literature). Children: Not recommended.

Severe hepatic impairment, Cerebral or clinically significant haemorrhage or haemoptysis in the past 6 months.

Renal impairment, mild to moderate hepatic impairment. Monitor hepatic function before and at least four times weekly for 1st four months of treatment, then periodically, hypertension; withdraw temporarily if severe and unresponsive to therapy and dose reduction required. Cardiac disease, increased risk of thrombotic microangiopathy; permanently discontinue if symptoms develop, risk of thrombotic events, transient ischaemic attack, History of or risk factors for QT prolongation; monitor ECG and electrolytes, risk factors for MI, ischaemic stroke, GI perforation, fistula, 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. Ensure adequate contraception in women of childbearing age.

Inducers, inhibitors and substrates of P-glyco-protein, breast cancer resistance protein (BCRP) and CYP3A4. Substrates of UGT1A1 (e.g. irinotecan). Rosuvastatin, grapefruit juice.

Abdominal distension & pain,anorexia, blood disorders, blurred vision, chest pain, dyspepsia, dyspnea, epistaxis, flushing, GI upset, hepatic dysfunction, hyperalbuminaemia, hyperbilirubinaemia, hypertension, hypothyroidism, increased amylase, malaise, muscle spasm, myalgia, nail disorders, oedema, paraesthesia, pneumothorax, proteinuria (discontinue if grade 4), skin& hair discoloration, thrombocytopenia, venous thromboembolic events, alopecia, bone-marrow suppression, hyperuricaemia, nausea, oral mucositis, thromboembolism, tumourlysis syndrome, vomiting.Rare: arthralgia, bradycardia, cardiac dysfunction, fistula, GI perforation, haemorrhage, hepatic failure, hypertensive crisis, hypomagnesaemia, menstrual disturbances, myocardial infarction, myocardial ischaemia, oropharyngeal pain, pancreatitis, peripheral neuropathy, peritonitis, photosensitivity, pulmonary embolism, QT-interval prolongation, stroke, transient ischaemic attack, thrombotic microangiopathy