Pazotab 200 mg (Tablet)

Indications

• Treatment of advanced renal cell carcinoma (RCC)
• Treatment of advanced soft tissue sarcoma (STS)
• Effectiveness not demonstrated for adipocytic STS or gastrointestinal stromal tumors

Pharmacology

• Multi-tyrosine kinase inhibitor targeting VEGFR, PDGFR, FGFR, cytokine receptors, and more
• Oral absorption with median time to peak concentrations of 2 to 4 hours
• Binding to human plasma proteins greater than 99%
• Metabolized primarily by CYP3A4
• Mean half-life of 30.9 hours after 800 mg dose
• Elimination primarily via feces with less than 4% renal elimination

Dosage & Administration

• 800 mg orally once daily without food
• Tablets should not be crushed
• Missed dose should not be taken if less than 12 hours to next dose

Interaction

• Metabolism affected by inhibitors and inducers of CYP3A4
• Dose adjustment with strong CYP3A4 inhibitors or inducers
• Substrate of P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP)
• Weak inhibitor of CYP3A4, CYP2C8, and CYP2D6
• Concomitant use with certain drugs may increase incidence of ALT elevations

Contraindications

• Known hypersensitivity to Pazopanib or any other components

Side Effects

• Hepatic Toxicity and Hepatic Impairment
• QT Prolongation and Torsades de Pointes
• Cardiac Dysfunction
• Hemorrhagic Events
• Thrombotic Events
• Gastrointestinal Perforation
• Interstitial Lung Disease
• Hypertension
• Hypothyroidism
• Proteinuria
• Tumor Lysis Syndrome
• Infection
• Increased Toxicity with Other Cancer Therapy

Pregnancy & Lactation

• Potential fetal harm
• No data on presence in human milk or effects on breastfed infants
• Advisory against breastfeeding during treatment and for 2 weeks after final dose

Precautions & Warnings

• Hepatotoxicity, especially in patients over 65 years
• QT interval monitoring and electrolyte maintenance recommended
• Use with caution in patients with relevant pre-existing cardiac disease

Use in Special Populations

• Females advised to use effective contraception during treatment
• Males advised to use condoms during treatment to avoid potential drug exposure to partners
• Safety and effectiveness not established in pediatric patients

Overdose Effects

• Dose-limiting toxicities observed at high doses
• Treatment consists of general supportive measures
• No specific antidote, and hemodialysis not expected to enhance elimination

Storage Conditions

• Store below 30°C in a cool, dry place away from sunlight
• Keep out of reach of children

Related Brands

• Votrient 200 mg (Tablet) - novartis-bangladesh-ltd