Pazopanib
Generic Name: pazopanib
Brand Names:
Pazopanib
11 DESCRIPTION Pazopanib is a kinase inhibitor. Pazopanib is presented as the hydrochloride salt, with the chemical name 5-[[4-[(2,3-dimethyl-2H-indazol-6-yl)methylamino]-2-pyrimidinyl]amino]-2-methylbenzenesulfonamide hydrochloride. It has the molecular formula C 21 H 23 N 7 O 2 S•HCl and a molecular weight of 473.99 g/mol. Pazopanib hydrochloride has the following chemical structure: Pazopanib hydrochloride is a white to slightly yellow solid.
Overview
11 DESCRIPTION Pazopanib is a kinase inhibitor. Pazopanib is presented as the hydrochloride salt, with the chemical name 5-[[4-[(2,3-dimethyl-2H-indazol-6-yl)methylamino]-2-pyrimidinyl]amino]-2-methylbenzenesulfonamide hydrochloride. It has the molecular formula C 21 H 23 N 7 O 2 S•HCl and a molecular weight of 473.99 g/mol. Pazopanib hydrochloride has the following chemical structure: Pazopanib hydrochloride is a white to slightly yellow solid.
Uses
1 INDICATIONS AND USAGE 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. ( 1.2 ) Limitations of Use : The efficacy of pazopanib tablets for the treatment of patients with adipocytic soft tissue sarcoma or gastrointestinal stromal tumors has not been demonstrated. 1.1 Renal Cell Carcinoma Pazopanib tablets are indicated for the treatment of adults with advanced renal cell carcinoma (RCC). 1.2 Soft Tissue Sarcoma Pazopanib tablets are indicated for the treatment of adults with advanced soft tissue sarcoma (STS) who have received prior chemotherapy.
Dosage
2 DOSAGE AND ADMINISTRATION 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.
Side Effects
6 ADVERSE REACTIONS 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...
Interactions
7 DRUG INTERACTIONS Strong CYP3A4 Inhibitors : Avoid coadministration of pazopanib with strong CYP3A4 inhibitors. If coadministration cannot be avoided, reduce the dose of pazopanib. ( 2.4 , 7.1 ) Strong CYP3A4 Inducers : Consider an alternate concomitant medication with no or minimal enzyme induction potential. Pazopanib is not recommended if chronic use of strong CYP3A4 inducers cannot be avoided. ( 2.4 , 7.1 ) CYP Substrates : Coadministration of pazopanib with agents with narrow therapeutic windows that are metabolized by CYP3A4, CYP2D6, or CYP2C8 is not recommended. ( 7.2 ) Concomitant Use with Simvastatin : Concomitant use of pazopanib with simvastatin increases the risk of alanine aminotransferase (ALT) elevations. Increase to weekly monitoring of liver function as recommended.
Warnings
WARNING: HEPATOTOXICITY Severe and fatal hepatotoxicity has been observed in clinical trials. Monitor hepatic function and interrupt, reduce, or discontinue dosing as recommended [see Warnings and Precautions ( 5.1 )] . WARNING: HEPATOTOXICITY See full prescribing information for complete boxed warning. Severe and fatal hepatotoxicity has been observed in clinical trials. Monitor hepatic function and interrupt, reduce, or discontinue dosing as recommended. (5.1) 5 WARNINGS AND PRECAUTIONS Hepatic Toxicity : Severe and fatal hepatotoxicity has occurred. Monitor liver tests at baseline, regularly during treatment and as clinically indicated. Withhold pazopanib 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 and during treatment. 4 CONTRAINDICATIONS None. None. ( 4 )
Pregnancy
8.1 Pregnancy Risk Summary Based on animal reproduction studies and its mechanism of action [see Clinical Pharmacology ( 12.1 )] , pazopanib can cause fetal harm when administered to a pregnant woman. There are no available data on pazopanib 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) .
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Pazopanib 200 mg tablets are supplied as grey, biconvex, capsule shaped, film-coated tablets, marked with “T” on one side and “4184” on the other side and are available in: Bottles of 120 tablets (NDC 42291-939-12) Store at 20º to 25ºC (68º to 77ºF), excursions permitted between 15º and 30ºC (59º and 86ºF) [see USP Controlled Room Temperature].
Frequently Asked Questions
What is Pazopanib used for?▼
1 INDICATIONS AND USAGE 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. ( 1.2 ) Limitations of Use : The efficacy of pazopanib tablets for the treatment of patients with adipocytic soft tissue sarcoma or gastrointestinal stromal tumors has not been demonstrated. 1.1 Renal Cell Carcinoma Pazopanib tablets are indicated for the treatment of adults with advanced renal cell carcinoma (RCC). 1.2 Soft Tissue Sarcoma Pazopanib tablets are indicated for the treatment of adults with advanced soft tissue sarcoma (STS) who have received prior chemotherapy.
What are the side effects of Pazopanib?▼
6 ADVERSE REACTIONS 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...
Can I take Pazopanib during pregnancy?▼
8.1 Pregnancy Risk Summary Based on animal reproduction studies and its mechanism of action [see Clinical Pharmacology ( 12.1 )] , pazopanib can cause fetal harm when administered to a pregnant woman. There are no available data on pazopanib 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) .
What are the important warnings for Pazopanib?▼
WARNING: HEPATOTOXICITY Severe and fatal hepatotoxicity has been observed in clinical trials. Monitor hepatic function and interrupt, reduce, or discontinue dosing as recommended [see Warnings and Precautions ( 5.1 )] . WARNING: HEPATOTOXICITY See full prescribing information for complete boxed warning. Severe and fatal hepatotoxicity has been observed in clinical trials. Monitor hepatic function and interrupt, reduce, or discontinue dosing as recommended. (5.1) 5 WARNINGS AND PRECAUTIONS Hepatic Toxicity : Severe and fatal hepatotoxicity has occurred. Monitor liver tests at baseline, regularly during treatment and as clinically indicated. Withhold pazopanib 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 and during treatment. 4 CONTRAINDICATIONS None. None. ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.