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 (ADT); metastatic castration-resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of ADT 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 (2 tab) as a single daily dose taken w/ 5 mg prednisone or prednisolone daily for mHSPC, or 10 mg prednisone or prednisolone daily for mCRPC.

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

Hypersensitivity. Treatment w/ Zytiga & prednisone or prednisolone in combination w/ Ra-223. Severe hepatic impairment (Child-Pugh class C). Women who are or may potentially be pregnant.

Risk of HTN, hypokalaemia, fluid retention & cardiac failure due to mineralocorticoid excess. Monitor BP, serum K, fluid retention (wt gain, peripheral oedema), & other signs & symptoms of CHF during treatment (every 2 wk for 3 mth, then mthly thereafter). Marked increases in liver enzymes. Measure serum transaminase levels prior to starting treatment, every 2 wk for the 1st 3 mth of treatment, & mthly thereafter. Discontinue treatment in case of severe hepatotoxicity anytime while on therapy. Rare post‑marketing reports of acute liver failure & hepatitis fulminant. Monitor for adrenocortical insufficiency in case of w/drawal from prednisone or prednisolone. Monitor for symptoms of mineralocorticoid excess if continuing Zytiga after w/drawing corticosteroids. Caution in patients on prednisone or prednisolone who are subjected to unusual stress. Risk of decreased bone density. Risk of hyperglycaemia or hypoglycaemia w/ glucocorticoids. Monitor blood sugar in patients w/ diabetes. Potential risks of anaemia & sexual dysfunction. Reports of myopathy & rhabdomyolysis. Lower response rates w/ prior use of ketoconazole. Safety & efficacy of concomitant use w/ cytotoxic chemotherapy has not been established. Avoid concomitant use w/ strong CYP3A4 inducers. Do not initiate subsequent treatment w/ Ra-223 for at least 5 days after the last administration of Zytiga in combination w/ prednisone or prednisolone. Contains lactose. Should not be taken by patients w/ rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Contains 27 mg (1.17 mmol) Na per dose of 2 tab. Caution in patients w/ moderate hepatic impairment (Child-Pugh class B) or severe renal impairment. Use effective contraception. Not for use in women. No relevant use in paed population.

UTI; hypokalaemia; HTN; diarrhoea; increased ALT &/or AST; oedema peripheral. Sepsis; hypertriglyceridaemia; cardiac failure, angina pectoris, atrial fibrillation, tachycardia; dyspepsia; rash; haematuria; fractures.

Significantly increased absorption w/ food. Decreased exposure w/ strong CYP3A4 inducers (eg, phenytoin, carbamazepine, rifampicin, rifabutin, rifapentine, phenobarb, St. John's wort). Increased exposure of CYP2D6 substrates (eg, dextromethorphan, metoprolol, propranolol, desipramine, venlafaxine, haloperidol, risperidone, propafenone, flecainide, codeine, oxycodone, tramadol); CYP2C8 substrates (eg, pioglitazone, repaglinide). May increase conc of medicinal products eliminated by OATP1B1. Caution w/ medicinal products known to prolong the QT interval or those able to induce torsades de pointes eg, class IA (eg, quinidine, disopyramide) or III (eg, amiodarone, sotalol, dofetilide, ibutilide) antiarrhythmics, methadone, moxifloxacin, antipsychotics. Spironolactone may increase PSA levels; use w/ Zytiga is not recommended.

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.

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