Pazopanib
Generic: PAZOPANIB
Basic Information
Manufacturer
Golden State Medical Supply, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
115eb5bb-1403-fb3d-e063-6394a90ad320
Indications & Usage
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.
Limitations of Use : The efficacy of pazopanib tablets for the treatment of patients with adipocytic STS or gastrointestinal stromal tumors has not been demonstrated.
( 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.
Limitations of Use : The efficacy of pazopanib tablets for the treatment of patients with adipocytic STS or gastrointestinal stromal tumors has not been demonstrated.
Adverse Reactions
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 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.
at 1-800-706-5575 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical 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 tablets 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 tablets 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 tablets 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 tablets.
Forty-two percent of patients on pazopanib tablets 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 Tablets in VEG105192 Adverse Reactions Pazopanib Tablets (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.
a National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.
Other adverse reactions observed more commonly in patients treated with pazopanib tablets 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 Tablets with a Difference Between Arms of ≥ 5% Compared to Placebo in VEG105192 Parameters Pazopanib Tablets (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.
a National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.
Additional adverse reactions from other clinical trials in patients with RCC who received pazopanib tablets include arthralgia and muscle spasms.
Soft Tissue Sarcoma The safety of pazopanib tablets 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 tablets.
Fifty-eight percent of patients on pazopanib tablets required a dose interruption and 38% required a dose reduction.
Seventeen percent of patients who received pazopanib tablets 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 Tablets in VEG110727 Adverse Reactions Pazopanib Tablets (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 disorder b 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.
a National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.
b 27 of the 28 cases of skin disorder were palmar-plantar erythrodysesthesia.
Other adverse reactions observed more commonly in patients treated with pazopanib tablets 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 Tablets with a Difference Between Arms of ≥ 5% Compared to Placebo in VEG110727 Parameters Pazopanib Tablets (N = 240) Placebo (N = 123) All Grades a Grade 3 Grade 4 All Grades a Grade 3 Grade 4 % % % % % % Chemistry AST increased 51 5 3 22 2 0 ALT increased 46 8 2 18 2 1 Glucose increased 45 < 1 0 35 2 0 Albumin decreased 34 1 0 21 0 0 Alkaline phosphataseincreased 32 3 0 23 1 0 Sodium decreased 31 4 0 20 3 0 Total bilirubin increased 29 1 0 7 2 0 Potassium increased 16 1 0 11 0 0 Hematologic Leukopenia 44 1 0 15 0 0 Lymphocytopenia 43 10 0 36 9 2 Thrombocytopenia 36 3 1 6 0 0 Neutropenia 33 4 0 7 0 0 Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; STS, soft tissue sarcoma.
a National Cancer Institute Common Terminology Criteria for Adverse Events, version 3 Other Clinically Relevant Adverse Reactions Lipase Elevations In a single-arm RCC trial (VEG102616), elevated lipase was observed for 27% of 181 patients with available laboratory data.
Elevated lipase as an adverse reaction was reported for 4% of 225 patients, including 2.7% (6/225) with Grade 3 and 0.4% (1/225) with Grade 4.
In the RCC trials, clinical pancreatitis was observed in < 1% of 586 patients.
Pneumothorax Two of 290 patients (0.7%) treated with pazopanib tablets in the randomized RCC trial (VEG105192) and 8 of 240 patients (3.3%) treated with pazopanib tablets in the randomized STS trial (VEG110727) developed a pneumothorax.
Bradycardia In the randomized RCC trial (VEG105192), bradycardia based on vital signs (< 60 beats per minute) was observed in 19% of 280 patients treated with pazopanib tablets.
Bradycardia was reported as an adverse reaction in 2% of 290 patients.
In the randomized STS trial (VEG110727), bradycardia based on vital signs (< 60 beats per minute) was observed in 19% of 238 patients treated with pazopanib tablets.
Bradycardia was reported as an adverse reaction in 2% of 240 patients.
Adverse Reactions in East Asian Patients In an analysis of pooled clinical trial data (N = 1,938) with pazopanib tablets, Grade 3 and Grade 4 neutropenia (12% versus 2%), thrombocytopenia (6% versus < 1%) and palmar-plantar erythrodysesthesia (6% versus 2%) were observed more frequently in patients of East Asian descent than in patients of non-East Asian descent.
6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of pazopanib tablets.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure.
Blood and Lymphatic System Disorders: Polycythemia Eye Disorders: Retinal detachment/tear Gastrointestinal Disorders: Pancreatitis Metabolic and Nutrition Disorder: Tumor lysis syndrome (including fatal cases) Vascular Disorders: Arterial (including aortic) aneurysms, dissections, and rupture (including fatal cases)
( 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.
at 1-800-706-5575 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical 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 tablets 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 tablets 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 tablets 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 tablets.
Forty-two percent of patients on pazopanib tablets 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 Tablets in VEG105192 Adverse Reactions Pazopanib Tablets (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.
a National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.
Other adverse reactions observed more commonly in patients treated with pazopanib tablets 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 Tablets with a Difference Between Arms of ≥ 5% Compared to Placebo in VEG105192 Parameters Pazopanib Tablets (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.
a National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.
Additional adverse reactions from other clinical trials in patients with RCC who received pazopanib tablets include arthralgia and muscle spasms.
Soft Tissue Sarcoma The safety of pazopanib tablets 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 tablets.
Fifty-eight percent of patients on pazopanib tablets required a dose interruption and 38% required a dose reduction.
Seventeen percent of patients who received pazopanib tablets 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 Tablets in VEG110727 Adverse Reactions Pazopanib Tablets (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 disorder b 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.
a National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.
b 27 of the 28 cases of skin disorder were palmar-plantar erythrodysesthesia.
Other adverse reactions observed more commonly in patients treated with pazopanib tablets 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 Tablets with a Difference Between Arms of ≥ 5% Compared to Placebo in VEG110727 Parameters Pazopanib Tablets (N = 240) Placebo (N = 123) All Grades a Grade 3 Grade 4 All Grades a Grade 3 Grade 4 % % % % % % Chemistry AST increased 51 5 3 22 2 0 ALT increased 46 8 2 18 2 1 Glucose increased 45 < 1 0 35 2 0 Albumin decreased 34 1 0 21 0 0 Alkaline phosphataseincreased 32 3 0 23 1 0 Sodium decreased 31 4 0 20 3 0 Total bilirubin increased 29 1 0 7 2 0 Potassium increased 16 1 0 11 0 0 Hematologic Leukopenia 44 1 0 15 0 0 Lymphocytopenia 43 10 0 36 9 2 Thrombocytopenia 36 3 1 6 0 0 Neutropenia 33 4 0 7 0 0 Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; STS, soft tissue sarcoma.
a National Cancer Institute Common Terminology Criteria for Adverse Events, version 3 Other Clinically Relevant Adverse Reactions Lipase Elevations In a single-arm RCC trial (VEG102616), elevated lipase was observed for 27% of 181 patients with available laboratory data.
Elevated lipase as an adverse reaction was reported for 4% of 225 patients, including 2.7% (6/225) with Grade 3 and 0.4% (1/225) with Grade 4.
In the RCC trials, clinical pancreatitis was observed in < 1% of 586 patients.
Pneumothorax Two of 290 patients (0.7%) treated with pazopanib tablets in the randomized RCC trial (VEG105192) and 8 of 240 patients (3.3%) treated with pazopanib tablets in the randomized STS trial (VEG110727) developed a pneumothorax.
Bradycardia In the randomized RCC trial (VEG105192), bradycardia based on vital signs (< 60 beats per minute) was observed in 19% of 280 patients treated with pazopanib tablets.
Bradycardia was reported as an adverse reaction in 2% of 290 patients.
In the randomized STS trial (VEG110727), bradycardia based on vital signs (< 60 beats per minute) was observed in 19% of 238 patients treated with pazopanib tablets.
Bradycardia was reported as an adverse reaction in 2% of 240 patients.
Adverse Reactions in East Asian Patients In an analysis of pooled clinical trial data (N = 1,938) with pazopanib tablets, Grade 3 and Grade 4 neutropenia (12% versus 2%), thrombocytopenia (6% versus < 1%) and palmar-plantar erythrodysesthesia (6% versus 2%) were observed more frequently in patients of East Asian descent than in patients of non-East Asian descent.
6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of pazopanib tablets.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure.
Blood and Lymphatic System Disorders: Polycythemia Eye Disorders: Retinal detachment/tear Gastrointestinal Disorders: Pancreatitis Metabolic and Nutrition Disorder: Tumor lysis syndrome (including fatal cases) Vascular Disorders: Arterial (including aortic) aneurysms, dissections, and rupture (including fatal cases)