Pazopanib

Pazopanib is a multi-tyrosine kinase inhibitor of vascular endothelial growth factor receptor (VEGFR)-1, VEGFR-2, VEGFR-3, platelet-derived growth factor receptor (PDGFR)-ɑ and -β, fibroblast growth factor receptor (FGFR)-1 and -3, cytokine receptor (Kit), interleukin-2 receptor-inducible T-cell kinase (Itk), lymphocyte-specific protein tyrosine kinase (Lck), and transmembrane glycoprotein receptor tyrosine kinase (c­-Fms). In vitro, pazopanib inhibited ligand-induced autophosphorylation of VEGFR-2, Kit, and PDGFR-β receptors.

• Pazopanib tablets are a kinase inhibitor indicated for the treatment of adults with: advanced renal cell carcinoma (RCC). ( 1.1 ) advanced soft tissue sarcoma (STS) who have received prior chemotherapy.

• None. None.contraindicated

Recommended Dosage: 800 mg orally once daily without food (at least 1 hour before or 2 hours after a meal). ( 2.1 ) Moderate Hepatic Impairment: 200 mg orally once daily. ( 2.2 ) 2.1 Recommended Dosage The recommended dosage of pazopanib tablets is 800 mg (four 200 mg tablets) orally once daily without food (at least 1 hour before or 2 hours after a meal) until disease progression or unacceptable toxicity [see Clinical Pharmacology ( 12.3 )]. The dosage should be modified for hepatic impairment and in patients taking certain concomitant drugs [see Dosage and Administration ( 2.3 , 2.4 )]. Swallow tablets whole. Do not crush tablets due to the potential for increased rate of absorption, which may affect systemic exposure [see Clinical Pharmacology ( 12.3 )]. If a dose is missed, it should not be taken if it is <12 hours until the next dose. 2.2 Dosage Modifications for Adverse Reactions Table 1 summarizes the recommended dose reductions. Table 1. Recommended Dose Reductions of Pazopanib tablets for Adverse Reactions Dose Reduction For Renal Cell Carcinoma For Soft Tissue Sarcoma First 400 mg orally once daily 600 mg orally once daily Second 200 mg orally once daily 400 mg orally once daily Permanently discontinue pazopanib tablets in patients unable to tolerate the second dose reduction. Table 2 summarizes the recommended dosage modifications for adverse reactions. Table 2.

Hepatic Toxicity: Severe and fatal hepatotoxicity has occurred. Monitor liver tests at baseline, regularly during treatment and as clinically indicated. Withhold pazopanib tablets and resume at reduced dose with continued weekly monitoring for 8 weeks, or permanently discontinue with weekly monitoring until resolution based on severity of hepatotoxicity. ( 2.2 , 5.1 ) QT Prolongation and Torsades de Pointes: Monitor patients who are at significant risk of developing QT interval prolongation. Monitor electrocardiograms (ECGs) and electrolytes at baseline and as clinically indicated. Correct hypokalemia, hypomagnesemia, and hypocalcemia prior to initiating pazopanib tablets and during treatment. ( 5.2 , 12.2 ) Cardiac Dysfunction: Cardiac dysfunction, including decreased left ventricular ejection fraction (LVEF) and congestive heart failure, have occurred. Monitor blood pressure and manage as appropriate. Monitor for clinical signs or symptoms of congestive heart failure. Conduct baseline and periodic evaluation of LVEF in patients at risk of cardiac dysfunction. Withhold or permanently discontinue pazopanib tablets based on severity of cardiac dysfunction. ( 2.2 , 5.3 ) Hemorrhagic Events: Fatal hemorrhagic events have occurred. Pazopanib tablets have not been studied in patients who have a history of hemoptysis, cerebral hemorrhage, or clinically significant gastrointestinal hemorrhage in the past 6 months. Withhold pazopanib tablets and resume at reduced dose or permanently discontinue based on severity of hemorrhagic events.

The following clinically significant adverse reactions are elsewhere in the labeling: Hepatic Toxicity [see Warnings and Precautions ( 5.1 )] QT Prolongation and Torsades de Pointes [see Warnings and Precautions ( 5.2 )] Cardiac Dysfunction [see Warnings and Precautions ( 5.3 )] Hemorrhagic Events [see Warnings and Precautions ( 5.4 )] Arterial Thromboembolic Events [see Warnings and Precautions ( 5.5 )] Venous Thromboembolic Events [see Warnings and Precautions ( 5.6 )] Thrombotic Microangiopathy (TMA) [see Warnings and Precautions ( 5.7 )] Gastrointestinal Perforation and Fistula [see Warnings and Precautions ( 5.8 )] Interstitial Lung Disease (ILD)/Pneumonitis [see Warnings and Precautions ( 5.9 )] Posterior Reversible Encephalopathy Syndrome (PRES) [see Warnings and Precautions ( 5.10 )] Hypertension [see Warnings and Precautions ( 5.11 )] Hypothyroidism [see Warnings and Precautions ( 5.13 )] Proteinuria [see Warnings and Precautions ( 5.14 )] Tumor Lysis Syndrome [see Warnings and Precautions ( 5.15 )] Infection [see Warnings and Precautions ( 5.16 )] The most common adverse reactions in patients with RCC (≥ 20%) are diarrhea, hypertension, hair color changes (depigmentation), nausea, anorexia, and vomiting. ( 6.1 ) The most common adverse reactions in patients with STS (≥ 20%) are fatigue, diarrhea, nausea, decreased weight, hypertension, decreased appetite, vomiting, tumor pain, hair color changes, musculoskeletal pain, headache, dysgeusia, dyspnea, and skin hypopigmentation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Apotex Corp.

Lactation : Advise not to breastfeed. ( 8.2 ) 8.1 Pregnancy Risk Summary Based on animal reproduction studies and its mechanism of action [see Clinical Pharmacology ( 12.1 )], pazopanib tablets can cause fetal harm when administered to a pregnant woman. There are no available data on pazopanib tablets use in pregnant women to evaluate for a drug-associated risk. In animal developmental and reproductive toxicology studies, oral administration of pazopanib to pregnant rats and rabbits throughout organogenesis resulted in teratogenicity, and abortion at systemic exposures lower than that observed at the MRHD of 800 mg/day (based on AUC) (see Data). Advise pregnant women of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects in clinically recognized pregnancies and miscarriage is 2% to 4% and 15% to 20%, respectively.

Metabolism

The recommended dosage of 800 mg once daily results in mean AUC of 1,037 mcg•h/mL and C max of 58.1 mcg/mL. There was no consistent increase in AUC or C max at pazopanib doses above 800 mg.

Dose-limiting toxicity (Grade 3 fatigue) and Grade 3 hypertension were each observed in 1 of 3 patients dosed at 2,000 mg daily (2.5 times the recommended dose) and 1,000 mg daily (1.25 times the recommended dose), respectively. Provide general supportive measures to manage an overdose. Hemodialysis is not expected to enhance the elimination of pazopanib tablets because pazopanib is not significantly renally excreted and is highly bound to plasma proteins.

• Oct 19, 2009NDANDA022465Novartis
• Oct 19, 2023ANDAANDA217713Apotex
• Oct 19, 2023ANDAANDA217517Teva Pharms Inc
• Oct 19, 2023ANDAANDA215837Sun Pharm
• Apr 23, 2024ANDAANDA218231Novugen
• Dec 4, 2024ANDAANDA219034Eugia Pharma
• Sep 4, 2025ANDAANDA219922Torrent

1. 1Death4,57517%
2. 2Diarrhoea3,59613%
3. 3Fatigue2,4849.3%
4. 4Nausea2,4189.0%
5. 5Malignant Neoplasm Progression1,6566.2%
6. 6Drug Ineffective1,4695.5%
7. 7Decreased Appetite1,4365.4%
8. 8Vomiting1,4035.2%
9. 9Hypertension1,2534.7%
10. 10Disease Progression1,0073.8%
11. 11Asthenia9313.5%
12. 12Malaise9003.4%
13. 13Weight Decreased8823.3%
14. 14Dyspnoea8423.1%
15. 15Hair Colour Changes8313.1%

The 10 most recently updated of 301 ClinicalTrials.gov registrations naming Pazopanib as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• NRSTS2021, A Risk Adapted Study Evaluating Maintenance Pazopanib, Limited Margin, Dose-Escalated Radiation Therapy and Selinexor in Non-Rhabdomyosarcoma Soft Tissue Sarcoma (NRSTS)
  Recruiting · Phase 1 · Phase 2 · Interventional · 139 enrolled · St. Jude Children's Research Hospital
  NCT06239272updated 2026-06-10
• Testing Olaparib and Temozolomide Versus the Usual Treatment for Uterine Leiomyosarcoma After Chemotherapy Has Stopped Working
  Active not recruiting · Phase 2 · Phase 3 · Interventional · 74 enrolled · National Cancer Institute (NCI)
  NCT05432791updated 2026-06-01
• Molecular Profiling and Matched Targeted Therapy for Patients With Unresectable Advanced or Metastatic Melanoma
  Completed · Phase 2 · Interventional · 216 enrolled · Melanoma Institute Australia
  NCT02645149updated 2026-05-29
• Pazopanib Hydrochloride in Treating Patients With Metastatic Kidney Cancer Who Have No Evidence of Disease After Surgery
  Active not recruiting · Phase 3 · Interventional · 129 enrolled · National Cancer Institute (NCI)
  NCT01575548updated 2026-05-29
• Pazopanib Hydrochloride in Treating Patients With Progressive Carcinoid Tumors
  Active not recruiting · Phase 2 · Interventional · 171 enrolled · National Cancer Institute (NCI)
  NCT01841736updated 2026-05-29
• Pembrolizumab (MK-3475) Plus Epacadostat vs Standard of Care in mRCC (KEYNOTE-679/ECHO-302)
  Completed · Phase 3 · Interventional · 129 enrolled · Incyte Corporation
  NCT03260894updated 2026-05-22
• Drug Screening Using Novel IMD in Renal Cell Carcinoma
  Recruiting · Phase 1 · Interventional · 20 enrolled · Oliver Jonas
  NCT05700461updated 2026-05-18
• Phase I/II Study of Pazopanib+ Temozolomide in Patients With Newly Diagnosed Glioblastoma Multiforme
  Active not recruiting · Phase 1 · Phase 2 · Interventional · 51 enrolled · Centre Antoine Lacassagne
  NCT02331498updated 2026-05-06
• Radiation Therapy With or Without Combination Chemotherapy or Pazopanib Before Surgery in Treating Patients With Newly Diagnosed Non-rhabdomyosarcoma Soft Tissue Sarcomas That Can Be Removed by Surgery
  Active not recruiting · Phase 2 · Phase 3 · Interventional · 140 enrolled · National Cancer Institute (NCI)
  NCT02180867updated 2026-05-04
• TDM for Optimized Outcome in Patients With mRCC.
  Recruiting · Observational · 200 enrolled · Niels Fristrup
  NCT04659343updated 2026-05-04

CPIC-curated drug–gene pairs for Pazopanib. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

• HLA-BCPIC B/C (provisional)FDA label: Informative PGx
• UGT1A1CPIC B/C (provisional)ClinPGx 3FDA label: Informative PGx

Frequently asked questions

How does Pazopanib work?

Pazopanib is a multi-tyrosine kinase inhibitor of vascular endothelial growth factor receptor (VEGFR)-1, VEGFR-2, VEGFR-3, platelet-derived growth factor receptor (PDGFR)-ɑ and -β, fibroblast growth factor receptor (FGFR)-1 and -3, cytokine receptor (Kit), interleukin-2 receptor-inducible T-cell kinase (Itk), lymphocyte-specific protein tyrosine kinase (Lck), and transmembrane glycoprotein receptor tyrosine kinase (c­-Fms). In vitro, pazopanib inhibited ligand-induced autophosphorylation of VEGFR-2, Kit, and PDGFR-β receptors.

What is Pazopanib used for?

According to FDA labeling, Pazopanib carries indications including: Pazopanib tablets are a kinase inhibitor indicated for the treatment of adults with: advanced renal cell carcinoma (RCC). ( 1.1 ) advanced soft tissue sarcoma (STS) who have received prior chemotherapy.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Pazopanib?

Pazopanib is classified as Other protein kinase inhibitors, Kinase Inhibitor, Cytochrome P450 2C8 Inhibitors, Cytochrome P450 2D6 Inhibitors, Cytochrome P450 3A4 Inhibitors, Platelet-derived Growth Factor Receptor Inhibitors, Protein Kinase Inhibitors, Vascular Endothelial Growth Factor Receptor Inhibitors, Decreased Endothelial Proliferation, Vascular Growth Decrease.

What are the brand names for Pazopanib?

Pazopanib is marketed under brand names including Votrient.

What are the contraindications for Pazopanib?

Pazopanib labeling lists contraindications including: None. None.. Always consult the full prescribing information and a clinician.