Pazopanib/Pazopanib Instructions

1. Indications and Usage

Pazopanib is a kinase inhibitor used to treat the following diseases in adults:

Advanced renal cell carcinoma (RCC).

Patients with advanced soft tissue sarcoma who have received prior chemotherapy.

Restrictions on Use:The efficacy of pazopanib tablets in the treatment of patients with adipocytic soft tissue sarcoma or gastrointestinal stromal tumors has not been proven.

2. Dosage and usage

Recommended dosage:800mg once daily without food (at least 1 hour before meal or 2 hour after meal).

Moderate liver impairment: Oral administration once daily200 mg.

Three. Dosage form and strength

Tablet: 200mg

Four. Contraindications

No.

Five. Warnings and Precautions

1.Hepatotoxicity:Severe and fatal hepatotoxicity has occurred. Monitor liver tests at baseline, during treatment, and periodically as clinically indicated. Discontinue pazopanib tablets and continue weekly monitoring at dose reduction for 8 weeks, or permanently discontinue weekly monitoring until resolution of hepatotoxicity based on severity.

2.QTprolongation and torsade de pointes:Monitor patients who are at significant risk for QT prolongation. Monitor baseline ECG as clinically indicated (ECG) and electrolytes. Correct hypokalemia, hypomagnesemia, and hypocalcemia before initiating pazopanib tablets and during treatment.

3.Heart dysfunction:Heart dysfunction has developed, including reduced left ventricular ejection fraction (LVEF) and congestive heart failure. Monitor blood pressure and manage as appropriate. Monitor for clinical signs or symptoms of congestive heart failure. Perform baseline and periodic assessments of LVEFin patients at risk for cardiac dysfunction. Withhold or permanently discontinue pazopanib based on severity of cardiac dysfunction.

4.Bleeding Event:A fatal bleeding event has occurred. Pazopanib tablets have not been studied in patients with a history of hemoptysis, intracerebral hemorrhage, or clinically significant gastrointestinal bleeding within the past 6 months. Depending on the severity of the bleeding event, discontinue pazopanib and reduce the dose or permanently discontinue the drug.

5.Arterial Thromboembolic Events:Arterial thromboembolic events have been observed and may be fatal. Pazopanib tablets have not been studied in patients who have had an arterial thromboembolic event within the previous 6 months. If an arterial thromboembolic event occurs, permanently discontinue pazopanib tablets.

6.Venous thromboembolic events:Venous thromboembolic events (VTEs), including fatal pulmonary embolism (PE), have been observed. Monitor for signs and symptoms of VTE and PE. Depending on the severity of VTE, discontinue Pazopanib and then resume the same dose or permanently discontinue.

7.Thrombotic microangiopathy:Thrombotic microangiopathies (TMA), including thrombotic thrombocytopenic purpura (TTP) and hemolytic uremic syndrome (HUS), have been observed. If TMA occurs, permanently discontinue pazopanib tablets.

8.Gastrointestinal perforation and fistula:Fatal perforations have occurred. Monitor for signs and symptoms of gastrointestinal perforation or fistula. If grade 2 or grade 3 gastrointestinal fistula occurs, pazopanib tablets should be discontinued and the medication should be resumed based on medical judgment. If gastrointestinal perforation or grade 4 gastrointestinal fistula occurs, permanently discontinue pazopanib.

9.Interstitial lung disease/Pneumonia:Can be fatal. Monitor patients for pulmonary symptoms. Pazopanib tablets should be permanently discontinued in patients with interstitial lung disease (ILD) or pneumonia.

10.Posterior reversible encephalopathy syndrome:Can be fatal. Pazopanib tablets should be permanently discontinued in patients with posterior reversible encephalopathy syndrome (PRES).

11.Hypertension:Hypertension, including hypertensive crisis, has been observed. Do not start pazopanib tablets in patients with uncontrolled hypertension. Optimize your blood pressure before starting pazopanib tablets. Monitor blood pressure as clinically indicated and initiate and adjust antihypertensive therapy as appropriate. Depending on the severity of hypertension, discontinue pazopanib tablets and then reduce the dose or permanently discontinue the drug.

12.Risk of poor wound healing:Discontinue Pazopanib tablets for at least 1 weeks before elective surgery. Do not administer this medication for at least 2 weeks after major surgery until the wound has completely healed. The safety of resuming pazopanib after resolution of wound healing complications has not been established.

13.Hypothyroidism:Monitor thyroid examinations at baseline, during treatment, and when clinically indicated, and manage hypothyroidism as appropriate.

14.Embryo-Fetal Toxicity:Can cause fetal harm. Inform women of the potential reproductive risks to the fetus and patient and to use effective contraception.

6. Adverse reactions

The most common adverse reactions in patients with RCC (≥ 20%) are diarrhea, hypertension, hair color changes (depigmentation), nausea, anorexia, and vomiting.

The most common adverse reactions in patients with STS (≥ 20%) are fatigue, diarrhea, nausea, weight loss, hypertension, decreased appetite, vomiting, tumor pain, hair color changes, musculoskeletal pain, headache, dysgeusia, dyspnea, and skin hypopigmentation.

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7. Drug interactions

StrongCYP3A4Inhibitors:Avoid pazopanib tablets with strongCYP3A4Combined use of inhibitors. If coadministration cannot be avoided, reduce the dose of pazopanib tablets.

StrongCYP3A4Inducers:Consider alternative concomitant medications with no or minimal enzyme induction potential. Pazopanib tablets are not recommended if long-term use of strong CYP3A4 inducers cannot be avoided.

CYPSubstrates:It is not recommended to co-administer pazopanib tablets with drugs with narrow therapeutic windows metabolized by CYP3A4, CYP2D6 or CYP2C8.

Combined use with simvastatin:Combined use of pazopanib tablets with simvastatin may increase the risk of alanine aminotransferase (ALT) elevation. Increase weekly liver function monitoring as recommended. Depending on the severity of hepatotoxicity, discontinue pazopanib and continue at a reduced dose or permanently discontinue.

Combined use with gastric acid reducers:Avoid coadministration of Pazopanib tablets with gastric acid reducers. Consider using short-acting antacids instead of proton pump inhibitors (PPis) and H2 receptor antagonists. Separate the administration of antacids and pazopanib by several hours.

8. Use among specific groups of people

Lactation:It is recommended not to breastfeed.

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