VOTRIENT

What it is

VOTRIENT contains pazopanib hydrochloride, supplied as 200 mg and 400 mg film-coated tablets. Pazopanib is an orally administered, potent multi-target tyrosine kinase inhibitor of vascular endothelial growth factor receptors (VEGFR)-1, -2, and -3, platelet-derived growth factor receptor (PDGFR)-α and –β, and stem cell factor receptor (c-KIT).

Approved indications

— Advanced and/or metastatic renal cell carcinoma (RCC). — Advanced (unresectable and/or metastatic) soft tissue sarcoma (STS) in patients who, unless otherwise contraindicated, have received prior chemotherapy including an anthracycline treatment.

Dosing overview

The recommended dose of VOTRIENT for the treatment of RCC or STS is 800 mg orally once daily. Dose modification, either an increase or decrease in dose, should be in 200 mg increments in a stepwise fashion, based on individual tolerability, in order to manage adverse reactions. The daily dose of VOTRIENT should not exceed 800 mg per day. VOTRIENT should be administered orally once daily without food and on an empty stomach (at least one hour before or two hours after a meal). The tablets should be taken whole with water and must not be broken or crushed.

Key safety warnings

Severe and fatal hepatotoxicity have been observed in clinical studies. Monitor hepatic function and interrupt, reduce, or discontinue dosing as recommended. Monitor serum liver tests before initiation of treatment with VOTRIENT, and at weeks 3, 5, 7 and 9. Thereafter monitor at month 3 and at month 4, and as clinically indicated. Periodic monitoring should then continue after month 4. Events of hypertension including hypertensive crisis have occurred in clinical studies with pazopanib. Blood pressure should be well controlled prior to initiating VOTRIENT. Hypertension (systolic blood pressure ≥150 or diastolic blood pressure ≥100 mm Hg) occurs early in the course of VOTRIENT treatment (39% of cases occurred by day 9 and 88% occurred in the first 18 weeks). Posterior reversible encephalopathy syndrome (PRES)/reversible posterior leukoencephalopathy syndrome (RPLS) has been reported in association with VOTRIENT. PRES/RPLS is a neurological disorder which can present with headache, hypertension (mild to severe), seizure, lethargy, confusion, blindness and other visual and neurological disturbances, and can be fatal. Permanently discontinue VOTRIENT in patients developing PRES/RPLS. Interstitial lung disease (ILD), which can be fatal, has been reported in association with VOTRIENT. Venous thromboembolic events including venous thrombosis and fatal pulmonary embolus have occurred. The incidence was higher in the STS population (5%) than in the RCC population (2%).

Contraindications

VOTRIENT is contraindicated in patients with hypersensitivity to the active substance pazopanib hydrochloride or to any of the excipients.

PBS listing

VOTRIENT 400 mg tablets are listed on the PBS with 6 items, streamlined restriction, and an ex-manufacturer price of A$1591.56. VOTRIENT 200 mg tablets are listed on the PBS with 6 items, streamlined restriction, and an ex-manufacturer price of A$1193.67.

Regulatory history

VOTRIENT pazopanib 200 mg and 400 mg tablets were first listed on the ARTG on 30 June 2010. The TGA approved VOTRIENT on 22 June 2010 for the treatment of advanced and/or metastatic renal cell carcinoma.