Pazopanib tablets are 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.
1.1Renal Cell Carcinoma
Pazopanib tablets are indicated for the treatment of adults with advanced renal cell carcinoma (RCC).
1.2Soft Tissue Sarcoma
Pazopanib tablets are indicated for the treatment of adults with advanced soft tissue sarcoma (STS) who have received prior chemotherapy. Limitations of Use : The efficacy of pazopanib tablets for the treatment of patients with adipocytic STS or gastrointestinal stromal tumors has not been demonstrated.
Contraindications
None. None. (4)
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. (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 based on severity of cardiac dysfunction. (2.2, 5.3)
Hemorrhagic Events : Fatal hemorrhagic events have occurred. Pazopanib has 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 and resume at reduced dose or permanently discontinue based on severity of hemorrhagic events. (2.2, 5.4 )
Arterial Thromboembolic Events : Arterial thromboembolic events have been observed and can be fatal. pazopanib has not been studied in patients who have had an arterial thromboembolic event within the previous 6 months. Permanently discontinue pazopanib in case of an arterial thromboembolic event. (2.2, 5.5)
Venous Thromboembolic Events : Venous thromboembolic events (VTEs) have been observed, including fatal pulmonary emboli (PE). Monitor for signs and symptoms of VTE and PE. Withhold pazopanib and then resume at same dose or permanently discontinue based on severity of VTE. (2.2, 5.6)
Thrombotic Microangiopathy : Thrombotic microangiopathy (TMA), including thrombotic thrombocytopenic purpura (TTP) and hemolytic uremic syndrome (HUS), has been observed. Permanently discontinue pazopanib if TMA occurs. (2.2, 5.7)
Gastrointestinal Perforation and Fistula : Fatal perforation events have occurred. Monitor for signs and symptoms of gastrointestinal perforation or fistula. Withhold pazopanib in case of Grade 2 or 3 gastrointestinal fistula and resume based on medical judgement. Permanently discontinue pazopanib in case of gastrointestinal perforation or Grade 4 gastrointestinal fistula. (2.2, 5.8)
Interstitial Lung Disease/Pneumonitis : Can be fatal. Monitor patients for pulmonary symptoms. Permanently discontinue pazopanib in patients who develop interstitial lung disease (ILD) or pneumonitis. (2.2, 5.9)
Posterior Reversible Encephalopathy Syndrome : Can be fatal. Permanently discontinue pazopanib in patients who develop posterior reversible encephalopathy syndrome (PRES). (2.2, 5.10)
Hypertension : Hypertension, including hypertensive crisis, has been observed. Do not initiate pazopanib in patients with uncontrolled hypertension. Optimize blood pressure prior to initiating pazopanib. Monitor blood pressure as clinically indicated and initiate and adjust antihypertensive therapy as appropriate. Withhold and then dose reduce pazopanib or permanently discontinue based on severity of hypertension. (2.2, 5.11)
Risk of Impaired Wound Healing : Withhold pazopanib for at least 1 week prior to elective surgery. Do not administer for at least 2 weeks following major surgery and until adequate wound healing. The safety of resumption of pazopanib after resolution of wound healing complications has not been established. (5.12 )
Hypothyroidism : Monitor thyroid tests at baseline, during treatment and as clinically indicated and manage hypothyroidism as appropriate. (5.13)
Proteinuria : Perform baseline and periodic urinalysis during treatment with follow up measurement of 24-hour urine protein as clinically indicated. Withhold pazopanib then resume at a reduced dose or permanently discontinue based on severity of proteinuria. Permanently discontinue in patients with nephrotic syndrome. (2.2, 5.14)
Tumor Lysis Syndrome : Cases of tumor lysis syndrome (TLS) (some fatal) have been reported in patients with RCC and STS. Closely monitor patients at risk and treat as clinically indicated. (5.15)
Infection : Serious infections (with or without neutropenia), some with fatal outcome, have been reported. Monitor for signs and symptoms of infection. Institute appropriate anti-infective therapy promptly. Consider interruption or discontinuation of pazopanib. (5.16)
Embryo-Fetal Toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and patients to use effective contraception. (5.19, 8.1, 8.3)
5.1Hepatic Toxicity
Hepatotoxicity, manifested as increases in ALT, aspartate aminotransferase (AST) and bilirubin, occurred in patients who received pazopanib. This hepatotoxicity can be severe and fatal. Patients older than 65 years are at greater risk for hepatotoxicity [see Use in Specific Populations (8.5)] . Transaminase elevations occur early in the course of treatment; 92% of all transaminase elevations of any grade occurred in the first 18 weeks.
In the randomized RCC trial (VEG105192), ALT > 3 times ULN occurred in 18% and ALT > 10 times ULN occurred in 4% of the 290 patients who received pazopanib. Concurrent elevation in ALT > 3 times ULN and bilirubin > 2 times ULN in the absence of significant alkaline phosphatase > 3 times ULN occurred in 2%. In the monotherapy trials, 2 patients died with disease progression and hepatic failure. In the randomized STS trial (VEG110727), ALT > 3 times ULN occurred in 18% and ALT > 8 times ULN occurred in 5% of the 240 patients who received pazopanib.
Concurrent elevation in ALT > 3 times ULN and bilirubin > 2 times ULN in the absence of significant alkaline phosphatase > 3 times ULN occurred in 2%. One patient died of hepatic failure. Monitor liver tests at baseline; at Weeks 3, 5, 7, and 9; at Month 3 and Month 4; and then periodically as clinically indicated. Increase to weekly monitoring for patients with elevated ALT until ALT returns to Grade 1 or baseline. 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 [see Dosage and Administration (2.2)] .
Gilbert’s Syndrome Pazopanib is a uridine diphosphate (UDP)-glucuronosyl transferase 1A1 (UGT1A1) inhibitor. Mild, indirect (unconjugated) hyperbilirubinemia may occur in patients with Gilbert’s syndrome [see Clinical Pharmacology (12.5)] . In patients with only a mild indirect hyperbilirubinemia known as Gilbert’s syndrome, manage elevation in ALT > 3 times ULN per the recommendations outlined for isolated ALT elevations [see Dosage and Administration (2.2)] .
Concomitant Use of Simvastatin Concomitant use of pazopanib and simvastatin increases the risk of ALT elevations [see Drug Interactions (7.3)]. Insufficient data are available to assess the risk of concomitant administration of alternative statins and pazopanib.
5.2 QT Prolongation and Torsades de Pointes In the RCC trials, 558/586 patients were subject to routine electrocardiogram (ECG) monitoring and QT prolongation ≥ 500 msec was identified in 2% of these 558 patients. In monotherapy trials, torsades de pointes occurred in < 1% of 977 patients who received pazopanib. In the randomized RCC (VEG105192) and STS (VEG110727) trials, 1% (3/290) and 0.4% (1/240) of patients, respectively, who received pazopanib had post-baseline values between 500 to 549 msec.
Post-baseline QT data were only collect
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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. Withhold pazopanib and resume at reduced dose, or permanently discontinue based on severity of hepatotoxicity. (7.3) Concomitant Use With Gastric Acid-Reducing Agents : Avoid concomitant use of pazopanib with gastric acid-reducing agents.
Consider short-acting antacids in place of proton pump inhibitors (PPIs) and H2-receptor antagonists. Separate antacid and pazopanib dosing by several hours. (2.4, 7.4)
7.1Effect of Other Drugs on Pazopanib Strong CYP3A4 Inhibitors Coadministration
of pazopanib with strong inhibitors of CYP3A4 increases pazopanib concentrations [see Clinical Pharmacology (12.3)] . Avoid coadministration of pazopanib with strong CYP3A4 inhibitors and consider an alternate concomitant medication with no or minimal enzyme inhibition potential. If coadministration of a strong CYP3A4 inhibitor cannot be avoided, reduce the dose of pazopanib [see Dosage and Administration (2.4)] . Strong CYP3A4 Inducers Coadministration of strong CYP3A4 inducers may decrease plasma pazopanib concentrations.
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 [see Dosage and Administration (2.4)] . Transporters Coadministration of strong inhibitors of P-gp or BCRP may increase pazopanib concentrations. Avoid concomitant use of pazopanib with strong inhibitors of P-gp or BCRP. Consider selection of alternative concomitant medicinal products with no or minimal potential to inhibit P-gp or BCRP.
7.2Effects of Pazopanib on Other Drugs CYP Substrates Coadministration
of pazopanib with agents with narrow therapeutic windows that are metabolized by CYP3A4, CYP2D6, or CYP2C8 may result in inhibition of the metabolism of these products and create the potential for serious adverse reactions. The concomitant use of pazopanib with agents with narrow therapeutic windows that are metabolized by CYP3A4, CYP2D6, or CYP2C8 is not recommended [see Clinical Pharmacology (12.3)] .
7.3Concomitant Use With Simvastatin
Concomitant use of pazopanib with simvastatin increases the incidence of ALT elevations. Across clinical trials of pazopanib as a single agent, ALT > 3 times ULN was reported in 126/895 (14%) of patients who did not use statins compared with 11/41 (27%) of patients who had concomitant use of simvastatin. If a patient receiving concomitant simvastatin develops ALT elevations, increase to weekly monitoring of liver function as recommended.
Withhold pazopanib and resume at reduced dose, or permanently discontinue based on severity of hepatotoxicity [see Dosage and Administration (2.2), Warnings and Precautions (5.1)] . Insufficient data are available to assess the risk of concomitant administration of alternative statins and pazopanib.
7.4Concomitant Use With Gastric Acid-Reducing Agents
Concomitant use of pazopanib with esomeprazole, a PPI, decreased the exposure of pazopanib. Avoid concomitant use of pazopanib with gastric acid-reducing agents. If concomitant administration with a gastric acid-reducing agent cannot be avoided, consider short-acting antacids in place of PPIs and H2-receptor antagonists. Separate short-acting antacid and pazopanib dosing by several hours to avoid a reduction in pazopanib exposure [see Dosage and Administration (2.4), Clinical Pharmacology (12.3)] .
7.5Drugs That Prolong the QT Interval
Pazopanib is associated with QTc interval prolongation [see Warnings and Precautions (5.2), Clinical Pharmacology (12.2)] . Avoid coadministration of pazopanib with drugs known to prolong the QT/QTc interval.
Pregnancy and breastfeeding
8.1Pregnancy 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 ).
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.
Data Animal Data In a female fertility and early embryonic development study, female rats were administered oral pazopanib at least 15 days prior to mating and for 6 days after mating, which resulted in increased pre-implantation loss and early resorptions at dosages greater than or equal to 30 mg/kg/day (approximately 0.4-fold the AUC at the MRHD of 800 mg/day). Total litter resorption was seen at 300 mg/kg/day (approximately 0.8-fold the AUC at the MRHD of 800 mg/day).
Postimplantation loss, embryolethality, and decreased fetal body weights were noted in females administered doses greater than or equal to 10 mg/kg/day (approximately 0.3-fold the AUC at the MRHD of 800 mg/day). In embryo-fetal developmental toxicity studies in rats and rabbits, oral pazopanib was administered to pregnant animals during organogenesis. In rats, dose levels of greater than or equal to 3 mg/kg/day (approximately 0.1‑fold the AUC at the MRHD of 800 mg/day) resulted in teratogenic effects, including cardiovascular malformations (retroesophageal subclavian artery, missing innominate artery, changes in the aortic arch), incomplete or absent ossification, increases in postimplantation loss, embryolethality and reduced fetal body weight.
In rabbits, maternal toxicity, increased postimplantation loss and abortion were observed at doses greater than or equal to 30 mg/kg/day (approximately 0.007-fold the AUC at the MRHD of 800 mg/day). In addition, severe maternal body weight loss and 100% litter loss were observed at doses greater than or equal to 100 mg/kg/day (0.02-fold the AUC at the MRHD of 800 mg/day), while fetal weight was reduced at doses greater than or equal to 3 mg/kg/day (AUC not calculated).
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 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 Sun Pharmaceutical Industries, Inc. at 1-800-406-7984 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described in the WARNINGS AND PRECAUTIONS section reflect exposure of 977 patients who received pazopanib as a single agent, including 586 pazopanib-treated patients with RCC.
With a median duration of treatment of 7.4 months (range, 0.1 to 27.6) in these 977 patients, the most common adverse reactions (≥ 20%) in these 586 patients were diarrhea, hypertension, hair color change, nausea, fatigue, anorexia, and vomiting. The data described in the WARNINGS AND PRECAUTIONS also reflects exposure of 382 patients with advanced soft tissue sarcoma who received pazopanib as a single agent, with a median duration of treatment of 3.6 months (range, 0 to 53).
The most common adverse reactions (≥ 20%) in these 382 patients were fatigue, diarrhea, nausea, decreased weight, hypertension, decreased appetite, vomiting, tumor pain, hair color changes, musculoskeletal pain, headache, dysgeusia, dyspnea, and skin hypopigmentation. Renal Cell Carcinoma The safety of pazopanib was evaluated in 290 patients with RCC who participated in VEG105192, a randomized, double-blind, placebo-controlled trial [see Clinical Studies (14.1)] .
The median duration of treatment was 7.4 months (range, 0 to 23) for patients who received pazopanib. Forty-two percent of patients on pazopanib required a dose interruption and 36% required a dose reduction. Table 3 presents adverse reactions in VEG105192. Table 3. Adverse Reactions (≥ 10%) in Patients with RCC Who Received Pazopanib in VEG105192 Adverse Reactions Pazopanib (N = 290) Placebo (N = 145) All Grades a Grade 3 Grade 4 All Grades a Grade 3 Grade 4 % % % % % % Diarrhea 52 3 < 1 9 < 1 0 Hypertension 40 4 0 10 < 1 0 Hair color changes 38 < 1 0 3 0 0 Nausea 26 < 1 0 9 0 0 Anorexia 22 2 0 10 < 1 0 Vomiting 21 2 < 1 8 2 0 Fatigue 19 2 0 8 1 1 Asthenia 14 3 0 8 0 0 Abdominal pain 11 2 0 1 0 0 Headache 10 0 0 5 0 0 Abbreviation: RCC, renal cell carcinoma. aNational Cancer Institute Common Terminology Criteria for Adverse Events, version 3.
Other adverse reactions observed more commonly in patients treated with pazopanib than placebo and that occurred in < 10% (any grade) were alopecia (8% versus < 1%), chest pain (5% versus 1%), dysgeusia (8% versus < 1%), dyspepsia (5% versus < 1%), dysphonia (4% versus < 1%), facial edema (1% versus 0%), palmar-plantar erythrodysesthesia (6% versus < 1%), proteinuria (9% versus 0%), rash (8% versus 3%), skin depigmentation (3% versus 0%), and weight decreased (9% versus 3%).
Table 4 presents the laboratory abnormalities in VEG105192. Table 4. Select Laboratory Abnormalities (> 10%) in Patients with RCC Who Received Pazopanib with a Difference Between Arms of ≥ 5% Compared to Placebo in VEG105192 Parameters Pazopanib (N = 290) Placebo (N = 145) All Grades a Grade 3 Grade 4 All Grades a Grade 3 Grade 4 % % % % % % Chemistry ALT increased 53 10 2 22 1 0 AST increased 53 7 < 1 19 < 1 0 Glucose increased 41 < 1 0 33 1 0 Total bilirubin increased 36 3 < 1 10 1 < 1 Phosphorus decreased 34 4 0 11 0 0 Sodium decreased 31 4 1 24 4 0 Magnesium decreased 26 < 1 1 14 0 0 Glucose decreased 17 0 < 1 3 0 0 Hematologic Leukopenia 37 0 0 6 0 0 Neutropenia 34 1 < 1 6 0 0 Thrombocytopenia 32 < 1 < 1 5 0 < 1 Lymphocytopenia 31 4 < 1 24 1 0 Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; RCC, renal cell carcinoma. aNational Cancer Institute Common Terminology Criteria for Adverse Events, version 3.
Additional adverse reactions from other clinical trials in patients with RCC who received pazopanib include arthralgia and muscle spasms. Soft Tissue Sarcoma The safety of pazopanib was evaluated in 240 patients who participated in VEG110727, a randomized, double-blind, placebo-controlled trial [see Clinical Studies (14.2)] . The median duration of treatment was 4.5 months (range, 0 to 24) for patients who received pazopanib.
Fifty-eight percent of patients on pazopanib required a dose interruption and 38% required a dose reduction. Seventeen percent of patients who received pazopanib discontinued therapy due to adverse reactions. Table 5 presents the adverse reactions in VEG110727. Table 5. Adverse Reactions (≥ 10%) in Patients with STS Who Received Pazopanib in VEG110727 Adverse reactions Pazopanib (N = 240) Placebo (N = 123) All Grades a Grade 3 Grade 4 All Grades a Grade 3 Grade 4 % % % % % % Fatigue 65 13 1 48 4 1 Diarrhea 59 5 0 15 1 0 Nausea 56 3 0 22 2 0 Weight decreased 48 4 0 15 0 0 Hypertension 42 7 0 6 0 0 Appetite decreased 40 6 0 19 0 0 Hair color changes 39 0 0 2 0 0 Vomiting 33 3 0 11 1 0 Tumor pain 29 8 0 21 7 2 Dysgeusia 28 0 0 3 0 0 Headache 23 1 0 8 0 0 Musculoskeletal pain 23 2 0 20 2 0 Myalgia 23 2 0 9 0 0 Gastrointestinal pain 23 3 0 9 4 0 Dyspnea 20 5 < 1 17 5 1 Exfoliative rash 18 < 1 0 9 0 0 Cough 17 < 1 0 12 < 1 0 Peripheral edema 14 2 0 9 2 0 Mucositis 12 2 0 2 0 0 Alopecia 12 0 0 1 0 0 Dizziness 11 1 0 4 0 0 Skin disorderb 11 2 0 1 0 0 Skin hypopigmentation 11 0 0 0 0 0 Stomatitis 11 < 1 0 3 0 0 Chest pain 10 2 0 6 0 0 Abbreviation: STS, soft tissue sarcoma. aNational Cancer Institute Common Terminology Criteria for Adverse Events, version 3. b27 of the 28 cases of skin disorder were palmar-plantar erythrodysesthesia.
Other adverse reactions observed more commonly in patients treated with pazopanib that occurred in ≥ 5% of patients and at an incidence of more than 2% difference from placebo included insomnia (9% versus 6%), hypothyroidism (8% versus 0%), dysphonia (8% versus 2%), epistaxis (8% versus 2%), left ventricular dysfunction (8% versus 4%), dyspepsia (7% versus 2%), dry skin (6% versus < 1%), chills (5% versus 1%), vision blurred (5% versus 2%), and nail disorder (5% versus 0%).
Table 6 presents the laboratory abnormalities in VEG110727. Table 6. Select Laboratory Abnormalities (> 10%) in Patients with STS Who Received Pazopanib with a Difference Between Arms of ≥ 5% Compared to Placebo in VEG110727 Parameters Pazopanib (N = 240) Placebo (N = 123) All Grades a Grade 3 Grade 4 All Grades a Grade 3 Grade 4 % % % % % % Chemistry AST increased 51
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Composition
Active ingredients
PAZOPANIB HYDROCHLORIDE EQ 200MG BASE
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
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