Votrient Dosage/Direction for Use

Votrient treatment should only be initiated by a physician experienced in the administration of anti-cancer medicinal products.
Adults: The recommended dose of pazopanib for the treatment of RCC or STS is 800 mg once daily.
Dose modifications: Dose modification (decrease or increase) should be in 200 mg decrements or increments in a stepwise fashion based on individual tolerability in order to manage adverse reactions. The dose of pazopanib should not exceed 800 mg.
Paediatric population: Pazopanib should not be used in children younger than 2 years of age because of safety concerns with regard to organ growth and maturation (see Pharmacology: Toxicology: Preclinical safety data under Actions and Precautions).
The safety and efficacy of pazopanib in children aged 2 to 18 years of age have not yet been established.
Currently available data are described in sections Adverse Reactions, and Pharmacology: Pharmacodynamics and Pharmacokinetics under Actions but no recommendation on a posology can be made.
Elderly: There are limited data of the use of pazopanib in patients aged 65 years and older. In the RCC studies of pazopanib, overall no clinically significant differences in safety of pazopanib were observed between subjects aged at least 65 years and younger subjects. Clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
Renal impairment: Renal impairment is unlikely to have a clinically relevant effect on pazopanib pharmacokinetics given the low renal excretion of pazopanib and metabolites (see Pharmacology: Pharmacokinetics under Actions). Therefore, no dose adjustment is required in patients with creatinine clearance above 30 mL/min. Caution is advised in patients with creatinine clearance below 30 mL/min as there is no experience of pazopanib in this patient population.
Hepatic impairment: Dosing recommendations in hepatically impaired patients are based on pharmacokinetic studies of pazopanib in patients with varying degrees of hepatic dysfunction (see Pharmacology: Pharmacokinetics under Actions). All patients should have liver function tests to determine whether they have hepatic impairment before starting and during pazopanib therapy (see Precautions). Administration of pazopanib to patients with mild or moderate hepatic impairment should be undertaken with caution and close monitoring of tolerability. 800 mg pazopanib once daily is the recommended dose in patients with mild abnormalities in serum liver tests [defined either as normal bilirubin and any degree of alanine aminotransferase (ALT) elevation or as an elevation of bilirubin (>35% direct) up to 1.5 x upper limit of normal (ULN) regardless of the ALT value]. A reduced pazopanib dose of 200 mg once daily is recommended in patients with moderate hepatic impairment (defined as an elevation of bilirubin >1.5 to 3 x ULN regardless of the ALT value) (see Pharmacology: Pharmacokinetics under Actions).
Pazopanib is not recommended in patients with severe hepatic impairment (defined as total bilirubin >3 x ULN regardless of the ALT value).
See Precautions for liver monitoring and dose modification for patient with drug-induced hepatotoxicity.
Method of administration: Pazopanib is for oral use. It should be taken without food, at least one hour before or two hours after a meal (see Pharmacology: Pharmacokinetics under Actions). The film-coated tablets should be taken whole with water and not broken or crushed (see Pharmacology: Pharmacokinetics under Actions).