PAZOPANIB-RZ

What it is

PAZOPANIB-RZ is a medicine containing pazopanib hydrochloride. It is available as film coated tablets in two strengths: 200 mg and 400 mg. 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 (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 PAZOPANIB-RZ for the treatment of RCC or STS is 800 mg orally once daily. Dose modification should be in 200 mg increments, in a stepwise fashion, based on individual tolerability, in order to manage adverse reactions. The daily dose should not exceed 800 mg per day. PAZOPANIB-RZ should be administered orally once daily without food and on an empty stomach (at least one hour before or two hours after a meal).

Key safety warnings

Cases of hepatic failure (including fatalities) have been reported during use of pazopanib, and increases in serum transaminases (ALT, aspartate aminotransferase [AST]) and bilirubin have been observed in clinical trials. Patients over 60 years of age may be at greater risk for ALT >3x ULN, and patients who carry the HLA-B*57:01 allele also have an increased risk of pazopanib-associated ALT elevations. Serum liver tests should be monitored before initiation of treatment, at weeks 3, 5, 7 and 9, then at month 3 and month 4, and as clinically indicated. Events of hypertension including hypertensive crisis have occurred in clinical studies with pazopanib; blood pressure should be well controlled prior to initiating the medicine, and patients should be monitored for hypertension early after starting treatment and frequently thereafter to ensure blood pressure control. PAZOPANIB-RZ should be discontinued if there is evidence of hypertensive crisis or if hypertension is severe and persists despite anti-hypertensive therapy and pazopanib dose reduction. Posterior reversible encephalopathy syndrome (PRES)/Reversible posterior leuko encephalopathy syndrome (RPLS) has been reported in association with pazopanib and can present with headache, hypertension, seizure, lethargy, confusion, blindness and other visual and neurological disturbances, and can be fatal. Interstitial Lung Disease (ILD), which can be fatal, has been reported in association with pazopanib, and patients should be monitored for pulmonary symptoms indicative of ILD/pneumonitis. Venous thromboembolic events including venous thrombosis and fatal pulmonary embolus have occurred in clinical studies, with higher incidence in the STS population (5%) than in the RCC population (2%). Haemorrhagic events have been reported in clinical studies with pazopanib, and fatal haemorrhagic events have occurred.

Contraindications

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

PBS listing

No information regarding PBS listing is provided in the source documents.

Regulatory history

PAZOPANIB-RZ 200 mg and 400 mg film coated tablets were first listed on the Australian Register of Therapeutic Goods on 20 May 2025 under licence category RE (registered medicine).