Votrient Tablets / Film-coated
Pazopanib Hydrochloride
400mg
GLAXO WELLCOME SA
| Pack size | 30's HDPE Bottle |
|---|---|
| Dispensing mode | POM |
| Source | SPAIN |
| Agent | AL BAKER TRADING EST. |
| Retail Price | 7667.00 AED |
Available as:
Indications
Votrient Tablets / Film-coated is used for:
Renal cell carcinoma, soft tissue sarcoma
Adult Dose
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
Child Dose
Safety and efficacy not established; not indicated for use in pediatric patients
Renal Dose
Renal impairment: No dosage adjustment required
Administration
Should be taken on an empty stomach: Take at least 1 hr before or 2 hr after meals. Swallow whole, do not break/crush.
Contra Indications
Hypersensitivity.
Precautions
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
Pregnancy-Lactation
Pregnancy
Based on animal reproduction studies and mechanism of action, it can cause fetal harm when administered to pregnant woman; there are no available data in pregnant women to inform drug-associated risk; in animal developmental and reproductive toxicology studies, oral administration of pazopanib to pregnant rats and rabbits throughout organogenesis resulted in teratogenicity, and abortion at systemic exposures lower than that observed at maximum recommended human dose of 800 mg (based on AUC); advise pregnant women or women of childbearing potential of potential risk to fetus
Lactation
There is no information regarding presence of drug or its metabolites in human milk, or effects on breastfed infant, or on milk production; because of potential for serious adverse reactions in breast- fed infants, advise a lactating woman not to breastfeed during treatment and for 2 weeks after final dose
Interactions
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.
Adverse Effects
Side effects of Pazopanib Hydrochloride :
>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
Mechanism of Action
Multikinase inhibitor (including VEGF & PDGF receptor tyrosine kinases) some of which are implicated in tumor growth, angiogenesis, & metastasis
Note
Votrient 400mg Tablets / Film-coated manufactured by GLAXO WELLCOME SA. Its generic name is Pazopanib Hydrochloride. Votrient is availble in United Arab Emirates.
Farmaco UAE drug index information on Votrient Tablets / Film-coated is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.