Votrient

Pazopanib HCl

Advanced &/or metastatic renal cell carcinoma (RCC); advanced soft tissue sarcoma (STS) who have received prior chemotherapy, excluding patients w/ GI stromal tumor (GIST) or adipocytic STS.

800 mg once daily. Dose modification: Increase/decrease by 200 mg increments. Should not exceed 800 mg.

Should be taken on an empty stomach: Take at least 1 hr before or 2 hr after meals. Swallow whole, do not break/crush.

Hypersensitivity.

Monitor liver function; avoid concomitant use w/ simvastatin. Discontinue in case of hypertensive crisis or if HTN is severe & persists. Permanently discontinue in patients developing posterior reversible encephalopathy syndrome (PRES)/reversible posterior leukoencephalopathy syndrome (RPLS). Discontinue in patients developing ILD or pneumonitis. Monitor BP & clinical signs or symptoms of CHF. Baseline & periodic evaluation of LVEF in patients at risk of cardiac dysfunction. Patients w/ history of QT interval prolongation, taking antiarrhythmics or drugs that prolong QT interval, those w/ relevant pre-existing cardiac disease. Baseline & periodic monitoring of ECG & electrolytes. Caution in patients at increased risk of thrombotic events or w/ history of thrombotic events. VTE including venous thrombosis. Permanently discontinue in patients developing thrombotic microangiopathy. Significant risk of hemorrhage. Patients w/ risk factors eg, HTN or history of aneurysm. Patients at risk for GI perforation or fistula. Discontinue in patients w/ wound dehiscence. Monitor of thyroid function. Baseline & periodic urinalysis; monitor for worsening proteinuria. Closely monitor for tumor lysis syndrome. Serious infections (w/ or w/o neutropenia). Not indicated for use in combination w/ other anticancer agents. Use effective contraception in females of reproductive potential during treatment & for at least 2 wk after last dose. Not recommended in patients w/ severe renal impairment or undergoing peritoneal dialysis or hemodialysis. Severe hepatic impairment. may affect ability to drive or operate machinery. May impair fertility. Not recommended during pregnancy & lactation. Not recommended on childn <2 yr.

Tumor pain; decreased appetite; dizziness, dysgeusia, headache; asymptomatic bradycardia; HTN; cough; dyspnea; abdominal pain, diarrhea, nausea, stomatitis, vomiting; alopecia, exfoliative rash, hair color changes, palmar-plantar erythrodysesthesia syndrome, skin depigmentation; musculoskeletal pain, myalgia; chest pain, fatigue, peripheral edema; decreased wt.

Increase mean AUC_(0-24) & C_max w/ CYP3A4 & P-gp (ketoconazole). Increased conc w/ strong CYP3A4 inhibitors eg, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole; drugs primarily eliminated through UGT1A1 & OATP1B1. Increased plasma conc w/ grapefruit juice & lapatinib. Avoid strong CYP3A4 inhibitor; strong P-gp or BCRP inhibitors. May decrease plasma conc w/ CYP3A4 inducers eg, rifampin. Increased mean AUC & C_max of midazolam, dextromethorphan, paclitaxel. 2-fold increase in AUC & C_max w/ high-fat or low-fat meals. Increased incidence of ALT elevations w/ simvastatin. Decreased bioavailability w/ esomeprazole.

Targeted Cancer Therapy

L01EX03 - pazopanib ; Belongs to the class of other protein kinase inhibitors. Used in the treatment of cancer.

Rx