Votrient (pazopanib)
Generic name: pazopanib (pazopanib hydrochloride) · Brand names: Votrient
Quick facts
Drug class
Value
kinase inhibitor
Source text (exact source wording)
Pazopanib tablets are a kinase inhibitor indicated for the treatment of adults with:
Rx or otc
Value
Rx (prescription)
Source
Label has a Medication Guide and is a prescription oncology drug; label text itself does not state 'Rx only' in the portions captured. Mark as medium confidence.
Confidence
medium
Forms and strengths
- Tablets: 400 mg (generic, Torrent label, section 3)
- Tablets: 200 mg (brand Votrient label, section 3)
Generic available
Yes. See generic_available field.
Common use one line
Treats adults with advanced renal cell carcinoma (RCC) and adults with advanced soft tissue sarcoma (STS) who have received prior chemotherapy.
What it is used for
Pazopanib is a kinase inhibitor used in adults with advanced renal cell carcinoma (RCC) and in adults with advanced soft tissue sarcoma (STS) who have already had chemotherapy. The label says it has not been shown to work for adipocytic STS or gastrointestinal stromal tumors.
Source
Torrent pazopanib tablets label (DailyMed set ID 7235fad0-eb5b-4fdf-a362-c8c65c9bfe1d)
Section
1 INDICATIONS AND USAGE (1.1, 1.2)
Confidence
high
Medlineplus source
https://medlineplus.gov/druginfo/meds/a610013.html
Source text (exact source wording)
Pazopanib tablets are indicated for the treatment of adults with advanced renal cell carcinoma (RCC). 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.
Medlineplus source text (exact source wording)
Pazopanib is used to treat advanced renal cell carcinoma (RCC, a type of cancer that begins in the cells of the kidneys) in adults. Pazopanib is in a class of medications called kinase inhibitors. It works by slowing or stopping the spread of cancer cells.
How it works
Pazopanib blocks several enzymes called tyrosine kinases, including receptors for VEGF and PDGF. In lab and animal studies it blocked signals linked to blood vessel growth and slowed the growth of some tumors in mice.
Source
Torrent pazopanib tablets label (DailyMed set ID 7235fad0-eb5b-4fdf-a362-c8c65c9bfe1d)
Section
12.1 Mechanism of Action
Confidence
high
Source text (exact source wording)
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)-α 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. In vivo, pazopanib inhibited VEGF-induced VEGFR-2 phosphorylation in mouse lungs, angiogenesis in a mouse model, and the growth of some human tumor xenografts in mice.
Dosage: adults
The usual dose is 800 mg (two 400 mg tablets) by mouth once a day, at least 1 hour before or 2 hours after a meal, until the cancer gets worse or side effects become unacceptable. Swallow the tablets whole and do not crush them. The dose may need to change for liver problems or for certain other medicines.
Source
Torrent pazopanib tablets label (DailyMed set ID 7235fad0-eb5b-4fdf-a362-c8c65c9bfe1d)
Section
2.1 Recommended Dosage
Confidence
high
Source text (exact source wording)
The recommended dosage of pazopanib tablets are 800 mg (two 400 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)].
Dose reductions source text (exact source wording)
Table 1. Recommended Dose Reductions of Pazopanib Tablets for Adverse Reactions: First: For renal cell carcinoma 400 mg orally once daily; for soft tissue sarcoma 600 mg orally once daily. Second: For renal cell carcinoma 200 mg orally once daily; for soft tissue sarcoma 400 mg orally once daily. Permanently discontinue pazopanib tablets in patients unable to tolerate the second dose reduction.
Dosage: children
Pazopanib is not approved for children. Its safety and effectiveness in children have not been established, and the label says it may have severe effects on organ growth and maturation early in life.
Source
Torrent pazopanib tablets label (DailyMed set ID 7235fad0-eb5b-4fdf-a362-c8c65c9bfe1d)
Section
8.4 Pediatric Use (first paragraphs) and 5.18
Confidence
high
Source text (exact source wording)
The safety and effectiveness of pazopanib tablets in pediatric patients have not been established. Pazopanib tablets are not indicated for use in pediatric patients [see Warnings and Precautions (5.18)]. Based on its mechanism of action, pazopanib may have severe effects on organ growth and maturation during early postnatal development.
Dosage adjustments
Drug interaction caps
Doctors should avoid strong CYP3A4 inhibitors with pazopanib. If one must be used, the pazopanib dose is reduced to 400 mg. Strong CYP3A4 inducers should be avoided and are not recommended if they cannot be avoided. Acid-reducing medicines should be avoided; if needed, a short-acting antacid is considered instead of PPIs and H2-receptor antagonists, taken several hours apart from pazopanib.
Source
Torrent pazopanib tablets label (DailyMed set ID 7235fad0-eb5b-4fdf-a362-c8c65c9bfe1d)
Section
2.4 Dosage Modifications for Drug Interactions
Confidence
high
Source text (exact source wording)
Strong CYP3A4 Inhibitors Avoid concomitant use of strong CYP3A4 inhibitors by use of an alternate concomitant medication with no or minimal potential to inhibit CYP3A4. If coadministration of a strong CYP3A4 inhibitor is warranted, reduce the dose of pazopanib tablets to 400 mg [see Drug Interactions (7.1)]. Strong CYP3A4 Inducers Avoid concomitant use of strong CYP3A4 inducers by use of an alternate concomitant medication with no or minimal enzyme induction potential. Pazopanib tablets are not recommended in patients who cannot avoid chronic use of strong CYP3A4 inducers [see Drug Interactions (7.1)]. Gastric Acid-Reducing Agents Avoid concomitant use of gastric acid-reducing agents. If concomitant use of a gastric acid-reducing agent cannot be avoided, consider short-acting antacid in place of proton pump inhibitors (PPIs) and H2-receptor antagonists. Separate short-acting antacid and pazopanib tablets dosing by several hours [see Drug Interactions (7.4), Clinical Pharmacology (12.3)].
Kidney
The label does not recommend a dose change for kidney problems. It has not been studied in severe kidney impairment or in people on peritoneal dialysis or hemodialysis.
Source
Torrent pazopanib tablets label (DailyMed set ID 7235fad0-eb5b-4fdf-a362-c8c65c9bfe1d)
Section
8.6 Renal Impairment
Confidence
high
Source text (exact source wording)
No dose adjustment is recommended for patients with renal impairment. Pazopanib tablets have not been studied in patients with severe renal impairment or in patients undergoing peritoneal dialysis or hemodialysis.
Liver
With moderate liver impairment the label says to consider other treatments, and if pazopanib is used the dose is 200 mg once daily. It is not recommended in severe liver impairment. No dose change is needed for mild liver impairment.
Source
Torrent pazopanib tablets label (DailyMed set ID 7235fad0-eb5b-4fdf-a362-c8c65c9bfe1d)
Section
2.3 Dosage Modifications for Hepatic Impairment and 8.7 Hepatic Impairment
Confidence
high
Source text (exact source wording)
In patients with moderate hepatic impairment [total bilirubin >1.5 to 3 × upper limit of normal (ULN) and any alanine aminotransferase (ALT) value], consider alternatives to pazopanib tablets. If pazopanib tablets are used in patients with moderate hepatic impairment, reduce the pazopanib tablets dose to 200 mg orally once daily. Pazopanib tablets are not recommended in patients with severe hepatic impairment (total bilirubin >3 × ULN and any ALT value) [see Use in Specific Populations (8.7)]. No dose adjustment is required in patients with mild hepatic impairment (either total bilirubin ≤ ULN and ALT > ULN or bilirubin > 1 to 1.5 × ULN and any ALT value).
Elderly
In pooled trials, 30% of 2,080 patients were 65 or older. More of those patients had ALT liver-test elevations above 3 × ULN than younger patients (23% versus 18%).
Source
Torrent pazopanib tablets label (DailyMed set ID 7235fad0-eb5b-4fdf-a362-c8c65c9bfe1d)
Section
8.5 Geriatric Use (first paragraph) and 5.1
Confidence
high
Source text (exact source wording)
In pooled clinical trials with pazopanib tablets, 30% of 2,080 patients were aged ≥ 65 years. More patients ≥ 65 years had ALT elevations > 3 × ULN compared to patients < 65 years (23% versus 18%) [see Warnings and Precautions (5.1)].
Missed dose
Do not take a missed dose if it is less than 12 hours until the next dose.
Source
Torrent pazopanib tablets label (DailyMed set ID 7235fad0-eb5b-4fdf-a362-c8c65c9bfe1d)
Section
2.1 Recommended Dosage (last sentence); MedlinePlus given separately
Confidence
high
Medlineplus source
https://medlineplus.gov/druginfo/meds/a610013.html
Source text (exact source wording)
If a dose is missed, it should not be taken if it is < 12 hours until the next dose.
Medlineplus source text (exact source wording)
Take the missed dose as soon as you remember it. However, if it is within 12 hours of your next scheduled dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
Overdose
In studies, serious fatigue and high blood pressure were seen at 2,000 mg daily and 1,000 mg daily. Treatment is general supportive care, and dialysis is not expected to help. In case of overdose call poison control at 1-800-222-1222.
Source
Torrent pazopanib tablets label (DailyMed set ID 7235fad0-eb5b-4fdf-a362-c8c65c9bfe1d)
Section
10 OVERDOSAGE
Confidence
high
Medlineplus source
https://medlineplus.gov/druginfo/meds/a610013.html
Source text (exact source wording)
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.
Medlineplus source text (exact source wording)
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911. Symptoms of overdose may include: extreme tiredness
Storage
Store at 20°C to 25°C (68°F to 77°F). Short trips between 15°C and 30°C (59°F and 86°F) are allowed. Storage details are from the Torrent label and may differ for other makers.
Source
Torrent pazopanib tablets label (DailyMed set ID 7235fad0-eb5b-4fdf-a362-c8c65c9bfe1d)
Section
16 HOW SUPPLIED/STORAGE AND HANDLING (Torrent labeler-specific)
Confidence
high
Source text (exact source wording)
Pazopanib 400 mg tablets are supplied as white, capsule-shaped, film coated tablet with ‘A77’ debossed on one side and plain on other side and are available in: Bottles of 30 tablets: NDC 13668-735-30; Bottles of 60 tablets: NDC 13668-735-60; Bottles of 90 tablets: NDC 13668-735-90. Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].
Medlineplus source text (exact source wording)
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).
Boxed warning
Pazopanib can cause severe liver damage that can be fatal. Liver function must be monitored, and the dose may be paused, lowered, or stopped.
Source
Torrent pazopanib tablets label (DailyMed set ID 7235fad0-eb5b-4fdf-a362-c8c65c9bfe1d)
Section
WARNING: HEPATOTOXICITY (full prescribing information boxed warning)
Confidence
high
Source text (exact source wording)
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)].
Contraindications
The label lists no contraindications.
Source
Torrent pazopanib tablets label (DailyMed set ID 7235fad0-eb5b-4fdf-a362-c8c65c9bfe1d)
Section
4 CONTRAINDICATIONS
Confidence
high
Source text (exact source wording)
None.
Warnings and precautions
Pazopanib can raise liver tests and cause severe or fatal liver injury, and people older than 65 years are at greater risk. Most liver-test rises happen early (92% in the first 18 weeks). Liver tests are checked at baseline, at Weeks 3, 5, 7, and 9, at Month 3 and Month 4, and then as needed. Taking simvastatin at the same time raises the risk of ALT elevations.
Heading
5.1 Hepatic Toxicity
Source
Torrent pazopanib tablets label (DailyMed set ID 7235fad0-eb5b-4fdf-a362-c8c65c9bfe1d)
Section
5.1 Hepatic Toxicity
Confidence
high
Source text (exact source wording)
Hepatotoxicity, manifested as increases in ALT, aspartate aminotransferase (AST) and bilirubin, occurred in patients who received pazopanib tablets. 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. 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. Concomitant use of pazopanib tablets and simvastatin increases the risk of ALT elevations [see Drug Interactions (7.3)].
Pazopanib can affect the heart rhythm (QT prolongation). People at risk have ECG and electrolyte checks, and low potassium, magnesium, or calcium is corrected before and during treatment.
Heading
5.2 QT Prolongation and Torsades de Pointes
Source
Torrent pazopanib tablets label (DailyMed set ID 7235fad0-eb5b-4fdf-a362-c8c65c9bfe1d)
Section
5.2 QT Prolongation and Torsades de Pointes
Confidence
high
Source text (exact source wording)
Monitor patients who are at significant risk of developing QTc prolongation, including patients with a history of QT interval prolongation, in patients taking antiarrhythmics or other medications that may prolong QT interval, and those with relevant preexisting cardiac disease [see Drug Interactions (7.5)]. Monitor ECG and electrolytes (e.g., calcium, magnesium, potassium) at baseline and as clinically indicated. Correct hypokalemia, hypomagnesemia, and hypocalcemia prior to initiating pazopanib tablets and during treatment.
Pazopanib can weaken the heart's pumping and cause heart failure. Blood pressure and heart failure signs are monitored, and heart function is checked at baseline and periodically in people at risk.
Heading
5.3 Cardiac Dysfunction
Source
Torrent pazopanib tablets label (DailyMed set ID 7235fad0-eb5b-4fdf-a362-c8c65c9bfe1d)
Section
5.3 Cardiac Dysfunction
Confidence
high
Source text (exact source wording)
Cardiac dysfunction, including decreased left ventricular ejection fraction (LVEF) and congestive heart failure, occurred in patients who received pazopanib tablets. Monitor blood pressure and manage as appropriate [see Warnings and Precautions (5.11)]. Monitor for clinical signs or symptoms of congestive heart failure. Conduct baseline and periodic evaluation of LVEF in patients at risk of cardiac dysfunction, including previous anthracycline exposure. Withhold or permanently discontinue pazopanib tablets based on severity of cardiac dysfunction [see Dosage and Administration (2.2)].
Serious bleeding, including fatal bleeding, has happened (fatal hemorrhage in 0.9% of 586 patients in RCC trials). It has not been studied in people with a history of coughing up blood, brain bleeding, or significant stomach or bowel bleeding in the past 6 months.
Heading
5.4 Hemorrhagic Events
Source
Torrent pazopanib tablets label (DailyMed set ID 7235fad0-eb5b-4fdf-a362-c8c65c9bfe1d)
Section
5.4 Hemorrhagic Events
Confidence
high
Source text (exact source wording)
In the RCC trials, fatal hemorrhage occurred in 0.9% of 586 patients, and cerebral/intracranial hemorrhage was observed in <1% (2/586) of patients treated with pazopanib tablets. 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 [see Dosage and Administration (2.2)].
Blood clots in arteries (such as heart attack or stroke) can happen and can be fatal. Treatment is permanently stopped if one occurs.
Heading
5.5 Arterial Thromboembolic Events
Source
Torrent pazopanib tablets label (DailyMed set ID 7235fad0-eb5b-4fdf-a362-c8c65c9bfe1d)
Section
5.5 Arterial Thromboembolic Events
Confidence
high
Source text (exact source wording)
In the RCC trials, fatal arterial thromboembolic events occurred in 0.3% of 586 patients. Pazopanib tablets have not been studied in patients who have had an arterial thromboembolic event within the previous 6 months. Permanently discontinue pazopanib tablets in case of an arterial thromboembolic event [see Dosage and Administration (2.2)].
Blood clots in veins, including clots in the lungs that can be fatal, have occurred. Signs are monitored and treatment is paused or stopped depending on severity.
Heading
5.6 Venous Thromboembolic Events
Source
Torrent pazopanib tablets label (DailyMed set ID 7235fad0-eb5b-4fdf-a362-c8c65c9bfe1d)
Section
5.6 Venous Thromboembolic Events
Confidence
high
Source text (exact source wording)
Venous thromboembolic events (VTEs), including venous thrombosis and fatal pulmonary embolus (PE), occurred in patients who received pazopanib tablets. Monitor for signs and symptoms of VTE and PE. Withhold pazopanib tablets and then resume at same dose or permanently discontinue based on severity of VTE [see Dosage and Administration (2.2)].
A blood-vessel and blood-cell disorder called TMA (including TTP and HUS) has happened. Treatment is permanently stopped if it occurs.
Heading
5.7 Thrombotic Microangiopathy
Source
Torrent pazopanib tablets label (DailyMed set ID 7235fad0-eb5b-4fdf-a362-c8c65c9bfe1d)
Section
5.7 Thrombotic Microangiopathy
Confidence
high
Source text (exact source wording)
Thrombotic microangiopathy (TMA), including thrombotic thrombocytopenic purpura (TTP) and hemolytic uremic syndrome (HUS), occurred in clinical trials of pazopanib tablets as monotherapy, in combination with bevacizumab, and in combination with topotecan. Pazopanib tablets are not indicated for use in combination with other agents. Monitor for signs and symptoms of TMA. Permanently discontinue pazopanib tablets in patients developing TMA. Manage as clinically indicated.
Holes (perforations) or abnormal connections (fistulas) in the stomach or bowel can occur and some were fatal. Treatment is permanently stopped for a perforation or a Grade 4 fistula.
Heading
5.8 Gastrointestinal Perforation and Fistula
Source
Torrent pazopanib tablets label (DailyMed set ID 7235fad0-eb5b-4fdf-a362-c8c65c9bfe1d)
Section
5.8 Gastrointestinal Perforation and Fistula
Confidence
high
Source text (exact source wording)
In the RCC and STS trials, gastrointestinal perforation or fistula occurred in 0.9% of 586 patients and 1% of 382 patients who received pazopanib tablets, respectively. Fatal perforations occurred in 0.3% (2/586) of these patients in the RCC trials and in 0.3% (1/382) of these patients in the STS trials. Monitor for signs and symptoms of gastrointestinal perforation or fistula. Permanently discontinue pazopanib tablets in case of gastrointestinal perforation or Grade 4 gastrointestinal fistula [see Dosage and Administration (2.2)].
Lung inflammation (ILD or pneumonitis) can occur, can be fatal, and occurred in 0.1% of patients. Treatment is permanently stopped if it develops.
Heading
5.9 Interstitial Lung Disease/Pneumonitis
Source
Torrent pazopanib tablets label (DailyMed set ID 7235fad0-eb5b-4fdf-a362-c8c65c9bfe1d)
Section
5.9 Interstitial Lung Disease/Pneumonitis
Confidence
high
Source text (exact source wording)
Interstitial lung disease (ILD)/pneumonitis, which can be fatal, has been reported with pazopanib tablets across clinical trials. ILD/pneumonitis occurred in 0.1% of patients treated with pazopanib tablets. Monitor patients for pulmonary symptoms indicative of ILD/pneumonitis. Permanently discontinue pazopanib tablets in patients who develop ILD or pneumonitis [see Dosage and Administration (2.2)].
PRES is a brain condition that can cause headache, seizure, lethargy, confusion, blindness, and other vision and nerve problems, and it may be fatal. Treatment is permanently stopped if it develops.
Heading
5.10 Posterior Reversible Encephalopathy Syndrome
Source
Torrent pazopanib tablets label (DailyMed set ID 7235fad0-eb5b-4fdf-a362-c8c65c9bfe1d)
Section
5.10 Posterior Reversible Encephalopathy Syndrome
Confidence
high
Source text (exact source wording)
Posterior Reversible Encephalopathy Syndrome (PRES) has been reported in patients who received pazopanib tablets and may be fatal. PRES is a neurological disorder which can present with headache, seizure, lethargy, confusion, blindness, and other visual and neurologic disturbances. Mild to severe hypertension may be present. Confirm diagnosis of PRES by magnetic resonance imaging. Permanently discontinue pazopanib tablets in patients who develop PRES.
About 40% of patients had high blood pressure. Treatment should not start in people with uncontrolled high blood pressure, and blood pressure is monitored and treated as needed.
Heading
5.11 Hypertension
Source
Torrent pazopanib tablets label (DailyMed set ID 7235fad0-eb5b-4fdf-a362-c8c65c9bfe1d)
Section
5.11 Hypertension
Confidence
high
Source text (exact source wording)
Hypertension (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg) and hypertensive crisis were observed in patients treated with pazopanib tablets. Approximately 40% of patients who received pazopanib tablets experienced hypertension, with Grade 3 occurring in 4% to 7% of patients [see Adverse Reactions (6.1)]. Do not initiate pazopanib tablets in patients with uncontrolled hypertension. Optimize blood pressure prior to initiating pazopanib tablets. Monitor blood pressure as clinically indicated and initiate and adjust antihypertensive therapy as appropriate.
Pazopanib may slow wound healing. It is held at least 1 week before planned surgery and not given for at least 2 weeks after major surgery and until the wound has healed.
Heading
5.12 Risk of Impaired Wound Healing
Source
Torrent pazopanib tablets label (DailyMed set ID 7235fad0-eb5b-4fdf-a362-c8c65c9bfe1d)
Section
5.12 Risk of Impaired Wound Healing
Confidence
high
Source text (exact source wording)
Withhold pazopanib tablets 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 tablets after resolution of wound healing complications has not been established.
Pazopanib can cause an underactive thyroid, so thyroid tests are monitored.
Heading
5.13 Hypothyroidism
Source
Torrent pazopanib tablets label (DailyMed set ID 7235fad0-eb5b-4fdf-a362-c8c65c9bfe1d)
Section
5.13 Hypothyroidism
Confidence
high
Source text (exact source wording)
Monitor thyroid tests at baseline, during treatment and as clinically indicated and manage hypothyroidism as appropriate.
Protein can leak into the urine. Urine is tested at baseline and periodically, and treatment is changed or stopped based on severity.
Heading
5.14 Proteinuria
Source
Torrent pazopanib tablets label (DailyMed set ID 7235fad0-eb5b-4fdf-a362-c8c65c9bfe1d)
Section
5.14 Proteinuria
Confidence
high
Source text (exact source wording)
Perform baseline and periodic urinalysis during treatment with follow up measurement of 24-hour urine protein as clinically indicated. Withhold pazopanib tablets then resume at a reduced dose or permanently discontinue based on severity of proteinuria. Permanently discontinue in patients with nephrotic syndrome [see Dosage and Administration (2.2)].
Tumor lysis syndrome, including fatal cases, has been reported. People at risk are closely monitored.
Heading
5.15 Tumor Lysis Syndrome
Source
Torrent pazopanib tablets label (DailyMed set ID 7235fad0-eb5b-4fdf-a362-c8c65c9bfe1d)
Section
5.15 Tumor Lysis Syndrome
Confidence
high
Source text (exact source wording)
Cases of tumor lysis syndrome (TLS), including fatal cases, have been reported in RCC and STS patients treated with pazopanib tablets [see Adverse Reactions (6.2)]. Closely monitor patients at risk, consider appropriate prophylaxis, and treat as clinically indicated.
Serious infections, some fatal, have happened. Signs of infection are monitored and treated promptly, and treatment may be paused or stopped.
Heading
5.16 Infection
Source
Torrent pazopanib tablets label (DailyMed set ID 7235fad0-eb5b-4fdf-a362-c8c65c9bfe1d)
Section
5.16 Infection
Confidence
high
Source text (exact source wording)
Serious infections (with or without neutropenia), including some with fatal outcome, have been reported. Monitor patients for signs and symptoms of infection. Institute appropriate anti-infective therapy promptly and consider interruption or discontinuation of pazopanib tablets for serious infections.
Pazopanib is not approved to be combined with other cancer drugs. Trials combining it with pemetrexed and lapatinib were stopped early because of more toxicity and deaths.
Heading
5.17 Increased Toxicity With Other Cancer Therapy
Source
Torrent pazopanib tablets label (DailyMed set ID 7235fad0-eb5b-4fdf-a362-c8c65c9bfe1d)
Section
5.17 Increased Toxicity With Other Cancer Therapy
Confidence
high
Source text (exact source wording)
Pazopanib tablets are not indicated for use in combination with other agents. Clinical trials of pazopanib tablets in combination with pemetrexed and lapatinib were terminated early due to increased toxicity and mortality. The fatal toxicities observed included pulmonary hemorrhage, gastrointestinal hemorrhage, and sudden death. A safe and effective combination dose has not been established with these regimens.
Not for children. It may have severe effects on organ growth in patients younger than 2 years of age.
Heading
5.18 Increased Toxicity in Developing Organs
Source
Torrent pazopanib tablets label (DailyMed set ID 7235fad0-eb5b-4fdf-a362-c8c65c9bfe1d)
Section
5.18 Increased Toxicity in Developing Organs
Confidence
high
Source text (exact source wording)
The safety and effectiveness of pazopanib tablets in pediatric patients have not been established. Pazopanib tablets are not indicated for use in pediatric patients. Based on its mechanism of action, pazopanib may have severe effects on organ growth and maturation in patients younger than 2 years of age [see Use in Specific Populations (8.4)].
Pazopanib can harm an unborn baby. Women who can become pregnant should use effective contraception during treatment and for at least 2 weeks after the last dose. Men with partners who can become pregnant should use condoms during treatment and for at least 2 weeks after the last dose.
Heading
5.19 Embryo-Fetal Toxicity
Source
Torrent pazopanib tablets label (DailyMed set ID 7235fad0-eb5b-4fdf-a362-c8c65c9bfe1d)
Section
5.19 Embryo-Fetal Toxicity
Confidence
high
Source text (exact source wording)
Based on findings from animal studies and its mechanism of action, pazopanib tablets can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with pazopanib tablets and for at least 2 weeks following the final dose. Advise males (including those who have had vasectomies) with female partners of reproductive potential to use condoms during treatment with pazopanib tablets and for at least 2 weeks after the last dose [see Use in Specific Populations (8.1, 8.3)].
Pregnancy and breastfeeding
Pazopanib can cause fetal harm. There are no data in pregnant women. Women should not breastfeed during treatment and for 2 weeks after the final dose. Pregnancy status is verified before starting treatment.
Source
Torrent pazopanib tablets label (DailyMed set ID 7235fad0-eb5b-4fdf-a362-c8c65c9bfe1d)
Section
8.1 Pregnancy (Risk Summary), 8.2 Lactation, 8.3
Confidence
high
Medlineplus source
https://medlineplus.gov/druginfo/meds/a610013.html
Source text (exact source wording)
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 use in pregnant women to evaluate for a drug-associated risk. Advise pregnant women of the potential risk to a fetus. 8.2 Lactation: There is no data on the presence of pazopanib or its metabolites in human milk or their effects on the breastfed infant or milk production. Because of the potential for serious adverse reactions in breastfed infants, advise women not to breastfeed during treatment with pazopanib tablets and for 2 weeks after the final dose. 8.3: Verify pregnancy status of females of reproductive potential prior to starting treatment with pazopanib tablets.
Medlineplus source text (exact source wording)
tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. You should not become pregnant while you are taking pazopanib. If you become pregnant while taking pazopanib, call your doctor. Pazopanib may harm the fetus.
Side effects
Common
In kidney cancer (RCC) patients, the most common side effects (20% or more) were diarrhea, high blood pressure, hair color change, nausea, loss of appetite (anorexia), and vomiting; section 6.1 also lists fatigue. In soft tissue sarcoma (STS) patients the most common were fatigue, diarrhea, nausea, weight loss, high blood pressure, decreased appetite, vomiting, tumor pain, hair color changes, muscle and bone pain, headache, taste change, shortness of breath, and skin lightening.
Source
Torrent pazopanib tablets label (DailyMed set ID 7235fad0-eb5b-4fdf-a362-c8c65c9bfe1d)
Section
Highlights, Adverse Reactions; 6.1 Clinical Trials Experience
Threshold
≥20%
Confidence
high
Note
The label's own Highlights RCC list omits fatigue, while section 6.1 includes fatigue. Both are quoted; not merged.
Source text (exact source wording)
The most common adverse reactions in patients with RCC (≥20%) are diarrhea, hypertension, hair color changes (depigmentation), nausea, anorexia, and vomiting. (Highlights). Section 6.1: the most common adverse reactions (≥ 20%) in these 586 patients were diarrhea, hypertension, hair color change, nausea, fatigue, anorexia, and vomiting. The most common adverse reactions (≥ 20%) in these 382 patients [STS] were fatigue, diarrhea, nausea, decreased weight, hypertension, decreased appetite, vomiting, tumor pain, hair color changes, musculoskeletal pain, headache, dysgeusia, dyspnea, and skin hypopigmentation.
Less common
In the kidney cancer trial, less common reactions (below 20%) included fatigue (19% versus 8% on placebo), weakness (asthenia, 14%), abdominal pain (11%), and headache (10%), plus hair loss (8%), taste change (8%), rash (8%), and weight loss (9%). In the sarcoma trial, reactions below 20% included exfoliative rash (18%), cough (17%), swelling in the arms or legs (14%), mouth sores (mucositis 12%), hair loss (12%), and dizziness (11%). Other reactions were seen in 5% to 9% of patients, such as insomnia (9%) and underactive thyroid (8%).
Source
Torrent pazopanib tablets label (DailyMed set ID 7235fad0-eb5b-4fdf-a362-c8c65c9bfe1d)
Section
6.1, Table 3 (RCC, VEG105192) and Table 5 (STS, VEG110727)
Confidence
high
Note
Table 3 and Table 5 values transcribed in short form from the printed tables; abbreviations as in the label.
Source text (exact source wording)
Table 3 (RCC) pazopanib vs placebo, all grades %: Diarrhea 52 vs 9; Hypertension 40 vs 10; Hair color changes 38 vs 3; Nausea 26 vs 9; Anorexia 22 vs 10; Vomiting 21 vs 8; Fatigue 19 vs 8; Asthenia 14 vs 8; Abdominal pain 11 vs 1; Headache 10 vs 5. 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 5 (STS) below 20%: Exfoliative rash 18 vs 9; Cough 17 vs 12; Peripheral edema 14 vs 9; Mucositis 12 vs 2; Alopecia 12 vs 1; Dizziness 11 vs 4; Skin disorder 11 vs 1; Skin hypopigmentation 11 vs 0; Stomatitis 11 vs 3; Chest pain 10 vs 6. Other STS reactions in ≥ 5% and more than 2% difference from placebo: 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%).
Serious
The label warns of serious problems including liver damage, heart rhythm and heart pumping problems, serious bleeding, blood clots, bowel holes, lung inflammation, brain swelling (PRES), high blood pressure, poor wound healing, thyroid problems, protein in the urine, tumor lysis syndrome, and serious infections. After approval, reports also included polycythemia, retinal detachment/tear, pancreatitis, and aortic aneurysms, dissections, and rupture.
MedlinePlus says to call your doctor right away for fast or irregular heartbeat, chest pain, trouble speaking, weakness or numbness of an arm or leg, wounds that do not heal, stomach pain or swelling, black or bloody stools, bloody vomit, blood in urine, nosebleeds, or coughing up blood. Report side effects to FDA MedWatch at 1-800-FDA-1088.
Label source
Torrent pazopanib tablets label (DailyMed set ID 7235fad0-eb5b-4fdf-a362-c8c65c9bfe1d)
Label section
5 Warnings and Precautions (5.1 to 5.16); 6.2 Postmarketing Experience
Medlineplus source
https://medlineplus.gov/druginfo/meds/a610013.html
Medlineplus section
What side effects can this medication cause? (call your doctor immediately list)
Confidence
high
Label source text (exact source wording)
6.2 Postmarketing Experience: 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). Serious reactions in section 5 include hepatotoxicity, QT prolongation and torsades de pointes, cardiac dysfunction, hemorrhagic events, arterial and venous thromboembolic events, thrombotic microangiopathy, gastrointestinal perforation and fistula, interstitial lung disease/pneumonitis, posterior reversible encephalopathy syndrome, hypertension, impaired wound healing, hypothyroidism, proteinuria, tumor lysis syndrome, and infection.
Medlineplus source text (exact source wording)
Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately: fast or irregular heartbeat; chest pain; pain in the arms, back, neck or jaw; shortness of breath; headache; slow or difficult speech; dizziness or faintness; weakness or numbness of an arm or leg; wounds that do not heal; stomach pain or swelling; black and tarry stools; red blood in stools; bloody vomit; vomit that looks like coffee grounds; blood in urine; nosebleeds; coughing up blood
Led to discontinuation
Source
Torrent pazopanib tablets label (DailyMed set ID 7235fad0-eb5b-4fdf-a362-c8c65c9bfe1d)
Section
6.1 Soft Tissue Sarcoma; 5.11; 5.14
Confidence
medium
Source text (exact source wording)
Seventeen percent of patients who received pazopanib tablets discontinued therapy due to adverse reactions. [STS trial VEG110727] Approximately 1% of patients required permanent discontinuation of pazopanib tablets because of hypertension. In 2 patients, proteinuria led to discontinuation of pazopanib tablets. [RCC trial VEG105192]
Interactions
Drugs
Strong CYP3A4 inhibitors raise pazopanib levels. The label says to avoid them, and to reduce the pazopanib dose if one cannot be avoided.
Name
Strong CYP3A4 inhibitors
Source
Torrent pazopanib tablets label (DailyMed set ID 7235fad0-eb5b-4fdf-a362-c8c65c9bfe1d)
Section
7.1
Source text (exact source wording)
Coadministration of pazopanib with strong inhibitors of CYP3A4 increases pazopanib concentrations [see Clinical Pharmacology (12.3)]. Avoid coadministration of pazopanib tablets 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 tablets [see Dosage and Administration (2.4)].
Strong CYP3A4 inducers may lower pazopanib levels. Pazopanib is not recommended if long-term use of one cannot be avoided.
Name
Strong CYP3A4 inducers
Source
Torrent pazopanib tablets label (DailyMed set ID 7235fad0-eb5b-4fdf-a362-c8c65c9bfe1d)
Section
7.1
Source text (exact source wording)
Coadministration of strong CYP3A4 inducers may decrease plasma pazopanib concentrations. Consider an alternate concomitant medication with no or minimal enzyme induction potential. Pazopanib tablets are not recommended if chronic use of strong CYP3A4 inducers cannot be avoided [see Dosage and Administration (2.4)].
Strong P-gp or BCRP inhibitors may raise pazopanib levels and should be avoided.
Name
Strong inhibitors of P-gp or BCRP
Source
Torrent pazopanib tablets label (DailyMed set ID 7235fad0-eb5b-4fdf-a362-c8c65c9bfe1d)
Section
7.1
Source text (exact source wording)
Coadministration of strong inhibitors of P-gp or BCRP may increase pazopanib concentrations. Avoid concomitant use of pazopanib tablets 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.
Pazopanib can slow the breakdown of drugs that have narrow safety margins and are broken down by CYP3A4, CYP2D6, or CYP2C8. Using them together is not recommended.
Name
CYP3A4, CYP2D6, or CYP2C8 substrates with narrow therapeutic windows
Source
Torrent pazopanib tablets label (DailyMed set ID 7235fad0-eb5b-4fdf-a362-c8c65c9bfe1d)
Section
7.2
Source text (exact source wording)
Coadministration of pazopanib tablets 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 tablets with agents with narrow therapeutic windows that are metabolized by CYP3A4, CYP2D6, or CYP2C8 is not recommended [see Clinical Pharmacology (12.3)].
Taking simvastatin with pazopanib raises the chance of ALT liver-test elevations (27% with simvastatin versus 14% without a statin). Liver tests are checked weekly if ALT rises. There are not enough data to judge other statins.
Name
Simvastatin
Source
Torrent pazopanib tablets label (DailyMed set ID 7235fad0-eb5b-4fdf-a362-c8c65c9bfe1d)
Section
7.3
Source text (exact source wording)
Concomitant use of pazopanib tablets with simvastatin increases the incidence of ALT elevations. Across clinical trials of pazopanib tablets as a single agent, ALT > 3 × 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 tablets 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 tablets.
Acid-reducing medicines can lower the amount of pazopanib in the body. They should be avoided; if needed, a short-acting antacid is used instead and taken several hours apart from pazopanib.
Name
Gastric acid-reducing agents (PPIs, H2-receptor antagonists)
Source
Torrent pazopanib tablets label (DailyMed set ID 7235fad0-eb5b-4fdf-a362-c8c65c9bfe1d)
Section
7.4
Source text (exact source wording)
Concomitant use of pazopanib tablets with esomeprazole, a PPI, decreased the exposure of pazopanib. Avoid concomitant use of pazopanib tablets 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)].
Pazopanib can lengthen the QT interval, so drugs known to do the same should be avoided.
Name
Drugs that prolong the QT interval
Source
Torrent pazopanib tablets label (DailyMed set ID 7235fad0-eb5b-4fdf-a362-c8c65c9bfe1d)
Section
7.5
Source text (exact source wording)
Pazopanib tablets are associated with QTc interval prolongation [see Warnings and Precautions (5.2), Clinical Pharmacology (12.2)]. Avoid coadministration of pazopanib tablets with drugs known to prolong the QT/QTc interval.
Food and alcohol
Take on an empty stomach, at least 1 hour before or 2 hours after a meal.
Name
Food (timing)
Source
Torrent pazopanib tablets label (DailyMed set ID 7235fad0-eb5b-4fdf-a362-c8c65c9bfe1d)
Section
2.1
Source text (exact source wording)
800 mg (two 400 mg tablets) orally once daily without food (at least 1 hour before or 2 hours after a meal)
MedlinePlus says to avoid grapefruit and grapefruit juice. The generic label sections captured do not mention grapefruit by name.
Name
Grapefruit (MedlinePlus only)
Source
https://medlineplus.gov/druginfo/meds/a610013.html
Section
What special dietary instructions should I follow?
Conflict note
Not a direct conflict (label silent in captured text); flagged for review.
Source text (exact source wording)
Do not eat grapefruit or drink grapefruit juice while taking this medication.
No alcohol statement was found in the sources read.
Name
Alcohol
Other
MedlinePlus lists St. John's wort and heartburn acid reducers as possible interactions.
Name
St. John's wort and acid reducers (patient wording)
Source
https://medlineplus.gov/druginfo/meds/a610013.html
Section
What special precautions should I follow?
Source text (exact source wording)
the following nonprescription or herbal products may interact with pazopanib: St. John's wort; acid-reducing agents for heart burn such as omeprazole (Prilosec), rabeprazole,esomeprazole, ranitidine, famotidine.
Patient tips
Label
Read the Medication Guide. Expect regular lab tests, and tell your healthcare provider right away about signs of liver problems.
Source
Torrent pazopanib tablets label (DailyMed set ID 7235fad0-eb5b-4fdf-a362-c8c65c9bfe1d)
Source text (exact source wording)
Advise the patient to read the FDA-approved patient labeling (Medication Guide). Hepatic Toxicity: Inform patients that periodic laboratory testing will be performed. Advise patients to report signs and symptoms of liver dysfunction to their healthcare provider right away [see Warnings and Precautions (5.1)].
Medlineplus
Take once a day on an empty stomach at about the same time. Swallow whole. Keep taking it even if you feel well and do not stop without talking to your doctor. Call your doctor right away for yellow skin or eyes, dark urine, extreme tiredness, nausea, vomiting, loss of appetite, upper right stomach pain, or unusual bleeding or bruising.
Source
https://medlineplus.gov/druginfo/meds/a610013.html
Section
How should this medicine be used? / IMPORTANT WARNING
Source text (exact source wording)
Pazopanib comes as a tablet to take by mouth. It is usually taken on an empty stomach once a day, at least 1 hour before or 2 hours after a meal. Take pazopanib at around the same time every day. Swallow the tablets whole; do not split, chew, or crush them. Continue to take pazopanib even if you feel well. Do not stop taking pazopanib without talking to your doctor. If you experience any of the following symptoms, call your doctor immediately: yellowing of the skin or eyes; dark urine; extreme tiredness; nausea; vomiting; loss of appetite; pain in the upper right part of the stomach; or unusual bleeding or bruising.
Alternatives
Class source
Torrent pazopanib tablets label (DailyMed set ID 7235fad0-eb5b-4fdf-a362-c8c65c9bfe1d) Highlights: kinase inhibitor; MedlinePlus: 'a class of medications called kinase inhibitors'
Indication source
Label section 1
Recommendation
none
Frequently asked questions
Question
What is pazopanib used for?
Answer
Pazopanib is used in adults with advanced renal cell carcinoma (RCC) and in adults with advanced soft tissue sarcoma (STS) who have already had chemotherapy. MedlinePlus describes only the kidney cancer use.
Source section
1 INDICATIONS AND USAGE
Source
Torrent pazopanib tablets label (DailyMed set ID 7235fad0-eb5b-4fdf-a362-c8c65c9bfe1d)
Question
How and when do I take it?
Answer
The usual dose is 800 mg (two 400 mg tablets) once a day, at least 1 hour before or 2 hours after a meal. Swallow the tablets whole and do not crush them.
Source section
2.1 Recommended Dosage
Source
Torrent pazopanib tablets label (DailyMed set ID 7235fad0-eb5b-4fdf-a362-c8c65c9bfe1d)
Question
What if I miss a dose?
Answer
Do not take the missed dose if it is less than 12 hours until your next dose. Do not take a double dose.
Source section
2.1; MedlinePlus missed dose
Source
Torrent pazopanib tablets label (DailyMed set ID 7235fad0-eb5b-4fdf-a362-c8c65c9bfe1d) ; https://medlineplus.gov/druginfo/meds/a610013.html
Question
What are the most common side effects?
Answer
In kidney cancer patients, the most common side effects (20% or more) were diarrhea, high blood pressure, hair color change, nausea, loss of appetite, and vomiting. Section 6.1 also lists fatigue.
Source section
6.1
Source
Torrent pazopanib tablets label (DailyMed set ID 7235fad0-eb5b-4fdf-a362-c8c65c9bfe1d)
Question
Can pazopanib harm my liver?
Answer
Yes. The boxed warning says severe and fatal liver toxicity has been seen. Liver tests are checked at baseline, at Weeks 3, 5, 7, and 9, at Month 3 and Month 4, and then as needed.
Source section
Boxed warning; 5.1
Source
Torrent pazopanib tablets label (DailyMed set ID 7235fad0-eb5b-4fdf-a362-c8c65c9bfe1d)
Question
Can I take it with acid reducers or simvastatin?
Answer
The label says to avoid acid-reducing medicines, and to use a short-acting antacid several hours apart if one is needed. Simvastatin raises the risk of ALT elevations, so liver tests are checked weekly if ALT rises.
Source section
7.3, 7.4
Source
Torrent pazopanib tablets label (DailyMed set ID 7235fad0-eb5b-4fdf-a362-c8c65c9bfe1d)
Question
Is it safe in pregnancy or while breastfeeding?
Answer
Pazopanib can cause fetal harm. Use effective contraception during treatment and for at least 2 weeks after the last dose. Women should not breastfeed during treatment and for 2 weeks after the final dose.
Source section
5.19, 8.2
Source
Torrent pazopanib tablets label (DailyMed set ID 7235fad0-eb5b-4fdf-a362-c8c65c9bfe1d)
Question
Should I stop taking it if I feel well?
Answer
MedlinePlus says to keep taking it even if you feel well and not to stop without talking to your doctor.
Source section
How should this medicine be used?
Source
https://medlineplus.gov/druginfo/meds/a610013.html
Sources
- Torrent pazopanib tablets (primary generic label)
Set id: 7235fad0-eb5b-4fdf-a362-c8c65c9bfe1d · Label effective or revised date: Revised: 2/2026 · Dailymed version date: May 13, 2026 (DailyMed publish date) · Fetched at: 2026-11-02 · Sections used: Highlights, Boxed warning, 1, 2, 3, 4, 5, 6, 7, 8.1-8.7, 10, 12.1, 16, 17 (first lines) - Votrient brand label (Novartis)
Set id: eeaaaf38-fb86-4d9f-a19d-0f61daac2fd7 · Label effective or revised date: Revised: 1/2024 · Dailymed version date: Dec 17, 2025 · Fetched at: 2026-11-02 · Sections used: revised date and section 3 only - Sun Pharmaceutical pazopanib (alternate 1)
Set id: d3e8dd09-d7d2-43da-8f63-bdf0ea0fcdf5 · Label effective or revised date: Revised: 2/2024 (read in an earlier WebFetch summary, not re-read in Chrome) · Dailymed version date: May 28, 2026 · Fetched at: 2026-11-02 · Sections used: revised date only - MedlinePlus Pazopanib
Set id: n/a · Label effective or revised date: Last Revised - 10/15/2016 · Fetched at: 2026-11-02 · Sections used: all patient sections - DailyMed SPL list (pazopanib)
Fetched at: 2026-11-02 · Sections used: set IDs and publish dates - openFDA label API (pharmacologic class)
Fetched at: 2026-11-02 · Sections used: queried; returned no result (NOT FOUND) - Drugs@FDA
Fetched at: 2026-11-02 · Sections used: not searched: NOT FOUND
Information is taken from the cited sources and is for general reference only. It is not medical advice. Report side effects to FDA MedWatch at 1-800-FDA-1088. For a poison emergency call 1-800-222-1222. See prices for this drug