Active Substance: Pazopanib (as HCl).
Overview
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This medicine contains an important and useful components, as it consists of
Pazopanib (as HCl)is available in the market in concentration
Pazopanib Hydrochloride
Hepatic Toxicity and Hepatic Impairment, QT Prolongation, Cardiac Dysfunction, Hemorrhagic Events, Thromboembolic Events, Gastrointestinal Perforation and Fistula, Hypertension, Hypothyroidism, Pregnancy. Lactation: Unknown whether distributed in breast milk, do not nurse
Renal cell carcinoma, soft tissue sarcoma
Hypersensitivity.
>10% ALT (SGPT) level raised (all grades, 53%; grade 3, 10%; grade 4, 2% ) AST/SGOT level raised (all grades, 53%; grade 3, 7%; grade 4, less than 1% ) Diarrhea (52%),Increased glucose (41%),Hypertension (40%),Hair depigmentation (38%) Leukopenia (all grades, 37%; grade 3, 0%; grade 4, 0% ) Increased bilirubin level (all grades, 36%; grade 3, 3%; grade 4, less than 1% ) Neutropenia (all grades, 34%; grade 3, 1%; grade 4, less than 1% ) Phosphorous decreased (34%) Thrombocytopenia (all grades, 32%; grade 3, less than 1%; grade 4, less than 1% ) Lymphocytopenia (all grades, 31%; grade 3, 4%; grade 4, less than 1% ) Sodium decreased (31%),Magnesemium decreased (26%),Nausea (26%),Weakness (22%),Vomiting (21%),Anorexia (22%),Fatigue (19%),Bradycardia (19%) Hemorrhage (all grades, 13% to 16%; grade 3 to 5, 2%) Myocardial dysfunction (ie, >15% decline in LVEF from baseline or ?10% with baseline below normal) (11-13%) Abdominal pain (11%) 1-10% (select) Headache (10%),Proteinuria (9%),Weight loss (9%),Alopecia (8%),Dysgeusia (8%),Rash (8%),Hypothyroidism (4% to 7% ),Palmar-plantar erythrodysesthesia (6%),Chest pain (5%),Dyspepsia (5%),Skin depigmentation (3%),Prolonged QT interval (<2%),Hepatotoxicity (1%-2%),Facial edema (1%),Rectal hemorrhage (1%),Transient ischemic attack (1%),Hemorrhagic death (0.9%-1%) <1% Cardiac dysfunction (eg, decreased LVEF, CHF) (0.6%) Congestive heart failure (0.5%),Torsades de pointes,Cerebrovascular accident,Pancreatitis Frequency Not Defined Myocardial infarction,Gastrointestinal fistula,Gastrointestinal perforation
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Multikinase inhibitor (including VEGF & PDGF receptor tyrosine kinases) some of which are implicated in tumor growth, angiogenesis, & metastasis
Co-administration w/ CYP3A4 (eg, itraconazole, clarithromycin, atazanavir, idinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole, grapefruit juice), P-gp & BCRP inhibitors, high-/low-fat food increases exposure & conc of pazopanib. Co-administration w/ CYP3A4 (eg, rifampicin) inducers may decrease plasma pazopanib conc. P-gp & BCRP inducers may alter exposure & distribution of pazopanib. Pazopanib may alter exposure &/or distribution of CYP3A4 substrates (eg, midazolam), CYP2C8 substrates (eg, paclitaxel) & UGT1A1 substrates (eg, irinotecan & its active metabolite SN-38). Pazopanib may increase the ratio of dextrometrophan to dextrophan conc after administration of dextrometrophan. Proton-pump inhibitors (eg, esomeprazole) & other agents that increase gastric pH may decrease bioavailability of pazopanib. Concomitant use w/ simvastatin & other statins may lead to ALT elevations.
Information not available