Adult Dosing
Metastatic castration-resistant prostate cancer (CRPC)
- 1,000 mg (four 250 mg tablets)PO qd in combination with prednisone 5 mg PO bid
Notes:- Dose should be taken on an empty stomach. Patient should not consume food at least 2 hours before the dose of abiraterone is taken and for at least 1 hour after the dose of abiraterone is taken
- Refer package insert for toxicity-related dose adjustments
- Do not cut/crush/chew the tablet, it should be swallowed wholly
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
[Outline]
Renal Dose Adjustment
- Renal impairment: No dose adjustments
Hepatic Dose Adjustment
- Child-Pugh Class B: 250 mg Daily
- Child-Pugh Class C: Contraindicated
Hepatic impairment during therapy
- ALT/AST >5X or total bilirubin >3X ULN interrupt treatment until liver function tests return to baseline or AST/ALT 2.5 and total bilirubin 1.5 times ULN. Resume at 500 mg Daily. If hepatotoxicity returners discontinue therapy
See Supplemental Patient Information
- Use cautiously in patients with history of CV disease and whose underlying medical conditions might be compromised by increases in blood pressure, hypokalemia or fluid retention, Abiraterone may cause hypertension, hypokalemia, and fluid retention; co-administration of a corticosteroid suppresses adrenocorticotropic hormone leading to reduction in the incidence and severity of these adverse reactions. Closely monitor patients for hypertension, hypokalemia and fluid retention at least once a month. Control hypertension and correct hypokalemia prior to treatment
- Safety of abiraterone in patients with LVEF <50% or NYHA Class III or IV heart failure have not been established
- Patients receiving abiraterone in combination with prednisone have reported adrenocortical insufficiency. Use cautiously and monitor signs and symptoms of adrenocortical insufficiency if patients are withdrawn from prednisone, have prednisone dose reductions, or experience unusual stress. Corticosteroids may be indicated before, during and after stressful situations
- Increases in liver enzymes may lead to drug interruption; evaluate ALT and AST before starting treatment with abiraterone and every 2 weeks for the first 3 months of treatment and monthly thereafter. Consider discontinuation of therapy if at any time AST or ALT rise above five times the ULN, or the bilirubin rises above three times the ULN
- Consume abiraterone on an empty stomach. therapy should be give 2 hrs before or 1 hr after meals. Exposure (area under the curve) of abiraterone increases up to 10 fold when abiraterone acetate is taken with meals
Cautions: Use cautiously in
- Hepatic impairment, Child-Pugh Class B
- Strong inhibitors and inducers of CYP3A4
- Concomitant use with CYP2D6 substrates (i.e. thioridazine)
- History of cardiovascular disease
- Heart failure
- Adrenocortical insufficiency
Supplemental Patient Information
- Inform patients that abiraterone and prednisone are used together and should not interrupt or stop either of these medications without consulting their physician
Pregnancy Category:X
Breastfeeding: Safety unknown. Because of serious adverse reactions in nursing infants decision should be made to either discontinue nursing, or drug taking into account the importance of the drug to the mother.
Pricing data from www.DrugStore.com in U.S.A.
- Zytiga 250 MG TABS [Bottle] (JANSSEN BIOTECH)
30 mg = $1491
90 mg = $4458.15
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
