Type:Tablet
Generic Name:Pazopanib Hydrochloride
Manufacturer:Drug International Ltd.
Price:৳0.00
Renal cell carcinoma, soft tissue sarcoma
Should be taken on an empty stomach: Take at least 1 hr before or 2 hr after meals. Swallow whole, do not break/crush.
Advanced Renal Cell Carcinoma 800 mg PO qDay on empty stomach Soft Tissue Sarcomas 800 mg PO qDay on empty stomach Hepatic Impairment Billirubin <1.5 x ULN or ALT >ULN: No dosage adjustment required Billirubin >1.5-3 x ULN: Decreased dose to 200 mg PO qDay Billirubin >3 x ULN: Not recommended
Safety and efficacy not established; not indicated for use in pediatric patients
Renal impairment: No dosage adjustment required
Hypersensitivity.
Multikinase inhibitor (including VEGF & PDGF receptor tyrosine kinases) some of which are implicated in tumor growth, angiogenesis, & metastasis
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
>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
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.