Brand Name
Votrient
Generic Name
Pazopanib
View Brand Information FDA approval date: July 12, 2016
Classification: Kinase Inhibitor
Form: Tablet
What is Votrient (Pazopanib)?
Pazopanib tablets are kinase inhibitor indicated for the treatment of adults with: advanced renal cell carcinoma .
Approved To Treat
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Brand Information
VOTRIENT (pazopanib hydrochloride)
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)].
1DOSAGE FORMS AND STRENGTHS
Tablets: 200 mg, modified capsule-shaped, gray or pink, film-coated with ‘GS JT’ debossed on one side.
2CONTRAINDICATIONS
None.
3ADVERSE REACTIONS
The following clinically significant adverse reactions are elsewhere in the labeling:
- Hepatic Toxicity
- QT Prolongation and Torsades de Pointes
- Cardiac Dysfunction
- Hemorrhagic Events
- Arterial Thromboembolic Events
- Venous Thromboembolic Events
- Thrombotic Microangiopathy (TMA)
- Gastrointestinal Perforation and Fistula
- Interstitial Lung Disease (ILD)/Pneumonitis
- Posterior Reversible Encephalopathy Syndrome (PRES)
- Hypertension
- Hypothyroidism
- Proteinuria
- Tumor Lysis Syndrome
- Infection
3.1Clinical 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 VOTRIENT as a single agent, including 586 VOTRIENT-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 VOTRIENT 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 VOTRIENT was evaluated in 290 patients with RCC who participated in VEG105192, a randomized, double-blind, placebo-controlled trial
Forty-two percent of patients on VOTRIENT required a dose interruption and 36% required a dose reduction.
Table 3 presents adverse reactions in VEG105192.
Other adverse reactions observed more commonly in patients treated with VOTRIENT 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.
Additional adverse reactions from other clinical trials in patients with RCC who received VOTRIENT include arthralgia and muscle spasms.
Soft Tissue Sarcoma
The safety of VOTRIENT was evaluated in 240 patients who participated in VEG110727, a randomized, double-blind, placebo-controlled trial
Fifty-eight percent of patients on VOTRIENT required a dose interruption and 38% required a dose reduction. Seventeen percent of patients who received VOTRIENT discontinued therapy due to adverse reactions.
Table 5 presents the adverse reactions in VEG110727.
Other adverse reactions observed more commonly in patients treated with VOTRIENT 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.
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 VOTRIENT in the randomized RCC trial (VEG105192) and 8 of 240 patients (3.3%) treated with VOTRIENT 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 VOTRIENT. 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 VOTRIENT. 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 = 1938) with VOTRIENT, 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.
3.2Postmarketing Experience
The following adverse reactions have been identified during post-approval use of VOTRIENT. 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)
4OVERDOSAGE
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 VOTRIENT because pazopanib is not significantly renally excreted and is highly bound to plasma proteins.
5DESCRIPTION
Pazopanib is a kinase inhibitor. Pazopanib is presented as the hydrochloride salt, with the chemical name 5-[[4-[(2,3-dimethyl-2H-indazol-6-yl)methylamino]-2-pyrimidinyl]amino]-2-methylbenzenesulfonamide monohydrochloride. It has the molecular formula C
Pazopanib hydrochloride is a white to slightly yellow solid. It is very slightly soluble at pH 1 and practically insoluble above pH 4 in aqueous media.
VOTRIENT tablets are for oral use. Each 200-mg tablet of VOTRIENT contains 200 mg of pazopanib equivalent to 216.7 mg of pazopanib hydrochloride. The inactive ingredients of VOTRIENT are:
6HOW SUPPLIED/STORAGE AND HANDLING
VOTRIENT 200 mg tablets are supplied as modified capsule-shaped, gray or pink, film-coated with ‘GS JT’ debossed on one side and are available in:
- Bottles of 120 tablets: NDC 0078-0670-66 (gray tablets), NDC 0078-1077-66 (pink tablets)
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].
7PATIENT COUNSELING INFORMATION
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)].
- QT Prolongation and Torsades de Pointes: Inform patients that ECG monitoring may be performed. Advise patients to inform their physicians of concomitant medications [see Warnings and Precautions (5.2)].
- Interstitial Lung Disease/Pneumonitis: Advise patients to report pulmonary signs or symptoms indicative of interstitial lung disease (ILD) or pneumonitis [see Warnings and Precautions (5.9)].
- Cardiac Dysfunction: Advise patients to report hypertension or signs and symptoms of congestive heart failure [see Warnings and Precautions (5.3)].
- Hemorrhagic Events: Advise patients to report unusual bleeding [see Warnings and Precautions (5.4)].
- Arterial Thromboembolic Events: Advise patients to report signs or symptoms of an arterial thrombosis [see Warnings and Precautions (5.5)].
- Pneumothorax and Venous Thromboembolic Events: Advise patients to report new onset of dyspnea, chest pain, or localized limb edema [see Warnings and Precautions (5.6), Adverse Reactions (6.1)].
- Posterior Reversible Encephalopathy Syndrome: Advise patients to inform their doctor if they have worsening of neurological function consistent with PRES (headache, seizure, lethargy, confusion, blindness, and other visual and neurologic disturbances) [see Warnings and Precautions (5.10)].
- Hypertension: Advise patients to monitor blood pressure early in the course of therapy and frequently thereafter and report increases of blood pressure or symptoms, such as blurred vision, confusion, severe headache, or nausea and vomiting [see Warnings and Precautions (5.11)].
- Gastrointestinal Perforation and Fistula: Advise patients to report signs and symptoms of a GI perforation or fistula [see Warnings and Precautions (5.8)].
- Risk of Impaired Wound Healing: Advise patients that VOTRIENT may impair wound healing. Advise patients to inform their healthcare provider of any scheduled surgical procedure [see Warnings and Precautions (5.12)].
- Hypothyroidism and Proteinuria: Inform patients that thyroid function testing and urinalysis will be performed during treatment [see Warnings and Precautions (5.13, 5.14)].
- Tumor Lysis Syndrome: Advise patients to contact their healthcare provider promptly to report any signs and symptoms of TLS, such as abnormal heart rhythm, seizure, confusion, muscle cramps or spasms, or a decrease in urine output [see Warnings and Precautions (5.15)].
- Infection: Advise patients to promptly report any signs or symptoms of infection [see Warnings and Precautions (5.16)].
- Embryo-Fetal Toxicity: Advise female patients to inform their healthcare provider of a known or suspected pregnancy during treatment with VOTRIENT. Inform female patients of the risk to a fetus and the potential loss of the pregnancy [see Warnings and Precautions (5.19), Use in Specific Populations (8.1)].
Advise females of reproductive potential to use effective contraception during treatment and for at least 2 weeks after the last dose of VOTRIENT. Advise male patients with female partners of reproductive potential to use condoms during treatment with VOTRIENT and for at least 2 weeks after the last dose [see Warnings and Precautions (5.19), Use in Specific Populations (8.3)]. - Lactation: Advise women not to breastfeed during treatment with VOTRIENT and for 2 weeks after the last dose [see Use in Specific Populations (8.2)].
- Infertility: Advise males and females of reproductive potential that VOTRIENT may impair fertility [see Use in Specific Populations (8.3)].
- Gastrointestinal Adverse Reactions: Advise patients on how to manage nausea, vomiting, and diarrhea and to notify their healthcare provider if moderate-to-severe vomiting or diarrhea occurs or if there is a decrease in oral intake [see Adverse Reactions (6.1)].
- Depigmentation: Advise patients that depigmentation of the hair or skin may occur during treatment with VOTRIENT [see Adverse Reactions (6.1)].
- Drug Interactions: Advise patients to inform their healthcare providers of all concomitant medications, vitamins, or dietary and herbal supplements [see Drug Interactions (7)].
- Dosage and Administration: Advise patients to take VOTRIENT without food (at least 1 hour before or 2 hours after a meal) [see Dosage and Administration (2.1)].
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© Novartis
T2024-07
8PRINCIPAL DISPLAY PANEL
NDC 0078-1077-66
Votrient
(pazopanib)
Tablets
200 mg
120 Tablets
R
Each tablet contains 216.7 mg of
Dispense with Medication Guide
NOVARTIS
