Classes
DEA Class; Rx
Common Brand Names; Votrient
- Antineoplastics, Tyrosine Kinase Inhibitor;
- Antineoplastics, VEGF Inhibitor
Description
Oral multi-tyrosine kinase inhibitor
For advanced renal cell carcinoma and soft-tissue sarcoma
Severe and fatal hepatotoxicity has been reported
Indications
Indicated for advanced renal cell carcinoma (RCC)
Indicated for advanced soft tissue sarcoma (STS) who have received prior chemotherapy
Adverse Effects
- ALT/AST increased (53%)
- Diarrhea (52%)
- Glucose increased (41%)
- Hypertension (40%)
- Hair color changes (38%)
- Leukopenia (37%)
- Total bilirubin increased (36%)
- Phosphorous decreased (34%)
- Neutropenia (34%)
- Thrombocytopenia (32%)
- Lymphocytopenia (31%)
- Sodium decreased (31%)
- Magnesium decreased (26%)
- Nausea (26%)
- Anorexia (22%)
- Vomiting (21%)
- Fatigue (19%)
- Glucose decreased (17%)
- Asthenia (14%)
- Abdominal pain (11%)
Warnings
Hepatotoxicity, manifested as increases in ALT, AST, and bilirubin, occurred
Mild, indirect (unconjugated) hyperbilirubinemia may occur in patients with Gilbert’s syndrome; manage elevation in ALT >3x ULN per dosing recommendations in such patients
Fatal hemorrhage, fatal arterial thromboembolic events, and cerebral/intracranial hemorrhage have occurred
Has not been studied in patients who have a history of hemoptysis, cerebral hemorrhage, patients who have had an arterial thromboembolic event within the previous 6 months, or clinically significant gastrointestinal hemorrhage in the past 6 months
Venous thromboembolic events (VTEs), including venous thrombosis and fatal pulmonary embolus (PE) reported; monitor for signs and symptoms of VTE and PE
Thrombotic microangiopathy (TMA), including thrombotic thrombocytopenic purpura (TTP) and hemolytic uremic syndrome (HUS), occurred in clinical trials
Gastrointestinal perforation or fistula has been reported; monitor for signs and symptoms of gastrointestinal perforation or fistula; withhold in case of Grade 2 or 3 gastrointestinal fistula and resume based on medical judgement; permanently discontinue in case of gastrointestinal perforation or Grade 4 gastrointestinal fistula
ILD/pneumonitis and PRES, which can be fatal, has been reported
Hypothyroidism has occurred; monitor thyroid tests at baseline, during treatment and as clinically indicated and manage appropriately
Proteinuria has been reported; perform baseline and periodic urinalysis during treatment with follow up measurement of 24-hr urine protein as clinically indicated
Cases of TLS, including fatal cases, have been reported
Can cause fetal harm when administered to a pregnant woman
Pregnancy and Lactation
Based on animal studies and its mechanism of action, fetal harm may occur; advise pregnant women of potential risk to a fetus
No data available on the drug presence or its metabolites in human milk or the effects on the breastfed infant or milk production
Maximum Dosage
800 mg PO/day.
800 mg PO/day.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Pazopanib
tablet
- 200mg
- 400mg