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Pazotri® (Pazopanib)

Pazotri® (Pazopanib)

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200, 400 mg film coated tablets

 

 

 




INDICATIONS

PAZOTRI® is a kinase inhibitor indicated for the treatment of patients with:

· Advanced renal cell carcinoma (RCC).

· Advanced soft tissue sarcoma (STS) who have received prior chemotherapy.

  • Limitations of Use: The efficacy of PAZOTRI® for the treatment of patients with adipocytic soft tissue sarcoma or gastrointestinal stromal tumors has not been demonstrated.

 

DOSAGE AND ADMINISTRATION

• 800 mg orally once daily without food (at least 1 hour before or 2 hours after a meal).

• Baseline moderate hepatic impairment – 200 mg orally once daily.

  • Not recommended in patients with severe hepatic impairment.
WARNINGS AND PRECAUTIONS
  • Hepatic Toxicity and Hepatic Impairment
  • QT Prolongation and Torsades de Pointes
  • Cardiac Dysfunction
  • Hemorrhagic Events
  • Arterial Thromboembolic Event
  • Venous Thromboembolic Events
  • Thrombotic Microangiopathy
  • Gastrointestinal Perforation and Fistula
  • Interstitial Lung Disease/Pneumonitis
  • Reversible Posterior Leukoencephalopathy Syndrome
  • Hypertension
  • Wound Healing
  • Hypothyroidism
  • Proteinuria
  • Tumor Lysis Syndrome
  • Infection
  • Increased Toxicity with Other Cancer Therapy
  • Increased Toxicity in Developing Organs
Embryo-Fetal Toxicity
DRUG INTERACTIONS
  • Strong CYP3A4 Inhibitors: Coadministration of PAZOTRI® with strong inhibitors of CYP3A4 (e.g., ketoconazole, ritonavir, clarithromycin, grapefruit) increases PAZOTRI® concentrations and should be avoided. If coadministration of a strong CYP3A4 inhibitor is warranted, reduce the dose of PAZOTRI® to 400 mg.
  • Strong CYP3A4 Inducers: CYP3A4 inducers such as rifampin may decrease plasma PAZOTRI® concentrations. PAZOTRI® should not be used if chronic use of strong CYP3A4 inducers cannot be avoided.
  • CYP Substrates: Concomitant use of PAZOTRI® with agents with narrow therapeutic windows that are metabolized by CYP3A4, CYP2D6, or CYP2C8 is not recommended. Coadministration may result in inhibition of the metabolism of these products and create the potential for serious adverse events.
  • Concomitant Use with Simvastatin: Concomitant use of PAZOTRI® and simvastatin increases the incidence of ALT elevations.
  • Concomitant Use with Gastric Acid-Reducing Agents: Concomitant administration of PAZOTRI® with esomeprazole, a proton pump inhibitor (PPI), decreased the exposure of PAZOTRI®. If such drugs are needed, short-acting antacids should be considered in place of PPIs and H2-receptor antagonists. Separate antacid and PAZOTRI® dosing by several hours to avoid a reduction in PAZOTRI® exposure.
Pazopanib

Pazopanib




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Headquarter: Unit 4, No.8, Hamedan St., North Kargar St., Tehran. Iran.

Postal Code: 1418693911

Fax: 66437014-103

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Phone :

+98 21 66437014

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