Zytiga

Abiraterone acetate

In combination w/ prednisone or prednisolone for the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men in combination w/ androgen deprivation therapy; metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated; mCRPC in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.

1,000 mg as single daily dose. mHSPC Given w/ 5 mg prednisone or prednisolone daily. mCRPC Given w/ 10 mg prednisone or prednisolone daily.

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

Hypersensitivity. Combination w/ Ra-223. Severe hepatic impairment. Women who are or may potentially be pregnant.

HTN, hypokalemia & fluid retention; marked increases in liver enzymes; decreased bone density (in men w/ metastatic advanced prostate cancer); increased hyperglycemia; anemia & sexual dysfunction (in men w/ mCRPC); myopathy/rhabdmyolysis. Lower response rate w/ prior use of ketoconazole in prostate cancer. Patients w/ history of CV disease; active or symptomatic viral hepatitis. Patients on prednisone or prednisolone who are subjected to unusual stress. Measure serum transaminase & bilirubin levels prior to treatment, every 2 wk for the 1st 3 mth of treatment & mthly thereafter. Monitor for adrenocortical insufficiency & symptoms of mineralocorticoid excess if patients are w/drawn from prednisone or prednisolone. Monitor blood sugar in patients w/ diabetes. Not to initiate treatment w/ Ra-223 for at least 5 days after last administration of Zytiga in combination w/ prednisone/prednisolone. Avoid use w/ strong CYP3A4 inducers. Concomitant use w/ cytotoxic chemotherapy. Not to be taken by patients w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Discontinue if severe hepatotoxicity develops. Moderate hepatic impairment; to be used in severe hepatic impairment. Use condom along another effective contraception if patient is engaged in sexual activity. Not for use in women.

UTI; hypokalemia; HTN; diarrhea; increased ALT/AST; peripheral edema. Sepsis; hypertriglyceridemia; cardiac failure, angina pectoris, atrial fibrillation, tachycardia; dyspepsia; rash; hematuria; fractures.

Decreased mean plasma AUC_∞ w/ rifampicin. Avoid use w/ strong CYP3A4 inducers eg, phenytoin, carbamazepine, rifabutin, rifapentine, phenobarb, St. John's wort. Increased systemic exposure of dextromethorphan. Co-administration w/ CYP2D6-activated/metabolized medicinal products eg, metoprolol, propranolol, desipramine, venlafaxine, haloperidol, risperidone, propafenone, flecainide, codeine, oxycodone & tramadol; CYP2C8-metabolized medicinal products eg, repaglinide. Increased AUC of pioglitazone. May prolong QT intervals or induce Torsades de pointes w/ class IA (eg, quinidine, disopyramide) or class III (eg, amiodarone, sotalol, dofetilide, ibutilide) antiarrhythmic medicinal products, methadone, moxifloxacin, antipsychotics. May increase PSA levels w/ spironolactone.

Cancer Hormone Therapy

L02BX03 - abiraterone ; Belongs to the class of other hormone antagonists and related agents. Used in the treatment of metastatic castration-resistant prostate cancer.

Rx