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Zytiga (Abiraterone Acetate) - Summary

 
 



ZYTIGA SUMMARY

Abiraterone acetate, the active ingredient of ZYTIGA is the acetyl ester of abiraterone. Abiraterone is an inhibitor of CYP17 (17alpha┬▒-hydroxylase/C17,20-lyase). Each ZYTIGA tablet contains 250 mg of abiraterone acetate.

ZYTIGA in combination with prednisone is indicated for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC) who have received prior chemotherapy containing docetaxel.


See all Zytiga indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Zytiga (Abiraterone)

Abiraterone acetate plus prednisone versus prednisone alone in chemotherapy-naive men with metastatic castration-resistant prostate cancer: patient-reported outcome results of a randomised phase 3 trial. [2013]
pain and functional status in a preplanned interim analysis of a phase 3 trial... INTERPRETATION: Abiraterone plus prednisone delays patient-reported pain

Effect of abiraterone acetate and prednisone compared with placebo and prednisone on pain control and skeletal-related events in patients with metastatic castration-resistant prostate cancer: exploratory analysis of data from the COU-AA-301 randomised trial. [2012]
docetaxel chemotherapy... INTERPRETATION: In patients with metastatic castration-resistant prostate cancer

Effect of abiraterone acetate on fatigue in patients with metastatic castration-resistant prostate cancer after docetaxel chemotherapy. [2013]
validated fatigue-specific instrument... CONCLUSIONS: In patients with mCRPC progressing after docetaxel chemotherapy,

Abiraterone acetate: a novel drug for castration-resistant prostate carcinoma. [2012]
Androgen-deprivation therapy is the mainstay of treatment for the management of advanced prostate carcinoma till transition to castration-resistant prostate carcinoma (CRPC)... Searches of Pubmed, Cochrane database, Medscape, Google and clinicaltrial.org were made for terms like CRPC and abiraterone.

Effect of abiraterone acetate plus prednisone on the QT interval in patients with metastatic castration-resistant prostate cancer. [2012]
to assess the effect of AA and abiraterone on the QT interval... CONCLUSIONS: There is no significant effect of AA plus prednisone on the QT/QTc

more studies >>

Clinical Trials Related to Zytiga (Abiraterone)

A Study to Evaluate the Pharmacokinetics of Abiraterone in Healthy Chinese Male Participants [Completed]
The purpose of this study is to evaluate the pharmacokinetics (how the drug concentrations change over time) of abiraterone acetate after oral administration of abiraterone acetate at different dose levels of 250, 500, and 1000 mg in healthy Chinese male participants under fasted conditions.

A Study to Evaluate the Effect of Rifampicin on the Pharmacokinetics of Abiraterone in Healthy Male Participants [Completed]
The purpose of this study is to assess the effects of repeated daily administration of rifampicin on the pharmacokinetics (what the body does to the medication) of abiraterone following single-dose administration of abiraterone acetate tablets in healthy male participants.

A Comparative Study of Bioavailability of 3 New Abiraterone Acetate Tablets With Current Commercial Tablet [Completed]
The purpose of this study is to evaluate the pharmacokinetics (what the body does to the medication) and relative bioavailability of 3 newly developed abiraterone acetate tablet formulations compared with the current commercial abiraterone acetate tablet formulation in healthy male participants, under fasted conditions, at a single dose of 1000 mg.

A Study of Abiraterone Acetate Plus Low-Dose Prednisone Plus Androgen Deprivation Therapy (ADT) Versus ADT Alone in Newly Diagnosed Participants With High-Risk, Metastatic Hormone-Naive Prostate Cancer (mHNPC) [Active, not recruiting]
The purpose of this study is to determine if newly diagnosed (within previous 3 months) participants with metastatic (spread of cancer cells from one part of the body to another ) hormone-naive prostate cancer (mHNPC) who have high-risk prognostic factors will benefit from the addition of abiraterone acetate and low-dose prednisone to androgen deprivation therapy (ADT; lutenizing hormone releasing hormone [LHRH] agonists or surgical castration).

A Canadian Observational Study in Metastatic Cancer of the Prostate: A Study of ZYTIGA Use in the Community Urology Setting [Recruiting]
The purpose of this study is to temporally evaluate the impact of abiraterone acetate (ZYTIGA) therapy on Patient Reported Outcomes (PROs) and on clinical outcomes in the chemotherapy-naive metastatic castrate-resistant prostate cancer (mCRPC) population. Safety data, levels of health care resource utilization associated with abiraterone acetate (ZYTIGA) therapy will also be prospectively collected and analyzed.

more trials >>

Reports of Suspected Zytiga (Abiraterone) Side Effects

Prostatic Specific Antigen Increased (55)Death (42)Oedema Peripheral (35)Fatigue (32)Pain (26)Drug Ineffective (25)Confusional State (24)Weight Decreased (24)Blood Alkaline Phosphatase Increased (22)Thrombocytopenia (21)more >>


Page last updated: 2014-12-01

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