Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Votrient is indicated in adults for the first-line treatment of advanced renal cell carcinoma (RCC) and for patients who have received prior cytokine therapy for advanced disease.
Votrient is indicated for the treatment of adult patients with selective subtypes of advanced soft-tissue sarcoma (STS) who have received prior chemotherapy for metastatic disease or who have progressed within 12 months after (neo) adjuvant therapy.
Efficacy and safety has only been established in certain STS histological tumour subtypes (see section 5.1).
Votrient treatment should only be initiated by a physician experienced in the administration of anti-cancer medicinal products.
The recommended dose of pazopanib for the treatment of RCC or STS is 800 mg once daily.
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.
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 sections 4.4 and 5.3).
The safety and efficacy of pazopanib in children aged 2 to 18 years of age have not yet been established. No data are available (see section 5.1).
There are limited data on 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 elderly patients cannot be ruled out.
Renal impairment is unlikely to have a clinically relevant effect on pazopanib pharmacokinetics given the low renal excretion of pazopanib and metabolites (see section 5.2). 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.
Dosing recommendations in hepatically impaired patients are based on pharmacokinetic studies of pazopanib in patients with varying degrees of hepatic dysfunction (see section 5.2). All patients should have liver function tests to determine whether they have hepatic impairment before starting and during pazopanib therapy (see section 4.4). 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 section 5.2).
Pazopanib is not recommended in patients with severe hepatic impairment (defined as total bilirubin >3 x ULN regardless of the ALT value).
See section 4.4 for liver monitoring and dose modification for patients with drug-induced hepatotoxicity.
Pazopanib is for oral use. It should be taken without food, at least one hour before or two hours after a meal (see section 5.2). The film-coated tablets should be taken whole with water and not broken or crushed (see section 5.2).
Pazopanib doses up to 2000 mg have been evaluated in clinical studies. Grade 3 fatigue (dose-limiting toxicity) and Grade 3 hypertension were each observed in 1 of 3 patients dosed at 2000 mg and 1000 mg daily, respectively.
There is no specific antidote for overdose with pazopanib and treatment of overdose should consist of general supportive measures.
Shelf life: 2 years.
This medicinal product does not require any special storage conditions.
Votrient 200 mg film-coated tablets: HDPE bottles with polypropylene child resistant closures containing either 30 or 90 tablets.
Votrient 400 mg film-coated tablets: HDPE bottles with polypropylene child resistant closures containing either 30 or 60 tablets.
Not all pack sizes may be marketed.
No special requirements.
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