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Pazopanib Package Insert

pazopanib package insert

Description

Votrient (pazopanib) is indicated for the treatment of patients with advanced renal cell carcinoma (RCC) and it is indicated for the treatment of patients with advanced soft tissue sarcoma (STS) who have received prior chemotherapy. The efficacy of Votrient (pazopanib) for the treatment of patients with adipocytic STS or gastrointestinal stromal tumors (GIST) has not been demonstrated.

votrient (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), leukocyte-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.

Warnings, Precautions, and other Clinical Information:

For patients with moderate hepatic impairment, reduce initial dose to 200 mg once daily It is not recommended in patients with severe hepatic impairment (Child-Pugh Class C) or total bilirubin>  Interrupt therapy for isolated ALT elevation of > 8x ULN, restart when resolves, if ALT increase > 3x ULN recurs, permanently discontinue Votrient ALT elevation > 3x ULN with bilirubin elevation > 2x ULN, permanently discontinue Votrient Use with caution in patients at risk for developing QT interval prolongation such as those using antiarrhythmic agents, or other drugs that prolong QT interval and in patients with relevant pre-existing cardiac disease.

pazopanib oral tablet

  • Votrient has not been studied in patients who have a history of hemoptysis, cerebral hemorrhage, or
  • clinically significant gastrointestinal hemorrhage in the past 6 months and should not be used in these
  • patients
  • Votrient has not been studied in patients who has had an arterial thromboembolic event within the
  • previous 6 months and should not be used in these patients
  • Votrient can cause thrombotic microangiopathy (TMA) such as thrombotic thrombotcytopenic purpura
  • (TTP) and hemolytic uremic syndrome (HUS), permanently discontinue if TMA occurs
  • Discontinue use in patients who develop interstitial lung disease (ILD) or pneumonitis
  • Permanently discontinue if Reversible Posterior Leukoencephalopathy Syndrome (RPLS) occurs
  • Blood pressure should be well controlled before starting therapy
  • Discontinue if there is evidence of hypertensive crisis or if severe and persistent hypertension occurs
  • despite antihypertensive therapy
  • Interrupt treatment for 24-hour urine protein > 3 grams and discontinue for repeated episodes despite
  • dose reduction
  • Interrupt or discontinue for severe infection with or without neutropenia
  • Votrient is not indicated for use in combination with other cancer therapy agents

How does pazopanib work?

Pazopanib is designed to slow the growth of cancer cells by inhibiting (stopping or slowing) several mechanisms that the cell uses to grow and survive. Pazopanib is in a class of medications called Tyrosine Kinase Inhibitors (TKI's).

Side Effects

In clinical studies, the most commonly reported side effects with pazopanib are shown here. Side effects sometimes have percentage ranges [example: 37 – 43% had low white cells] because they differed between clinical studies:

  • Fatigue (19 - 55%)
  • Diarrhea (52%)
  • Low white blood cells (37 - 43%)
  • Increased bleeding risk [low platelets] (32 - 41%)
  • High blood pressure (40%)
  • Hair color changes (30 - 38%)
  • Anemia [low red blood cells] (26 - 31%)
  • Rash and blistering on soles of hands and feet (6 - 29%)
  • Nausea (26%)
  • Altered sense of taste (26%)
  • Decreased appetite (24%)
  • Vomiting (21%)
  • Rash (18%)
  • Constipation (17%)

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