Posts Tagged ‘Invasiveness of surgical procedures’
Protected: MRI Methods and Devices: Range of Potential Applications
Posted in Medical Imaging Technology, Image Processing/Computing, MRI, CT, Nuclear Medicine, Ultra Sound, tagged Ablation, Atrial fibrillation, Invasiveness of surgical procedures, Magnetic resonance imaging, Mitral regurgitation on November 15, 2013|
Ablation Devices Market to 2023 – Global Market Forecast and Trends Analysis by Technology, Devices & Applications
Posted in Bio Instrumentation in Experimental Life Sciences Research, Cardiac & Vascular Repair Tools Subsegment, Ecosystems & Industrial Concentration in the Medical Device Sector, Frontiers in Cardiology and Cardiovascular Disorders, Medical Devices R&D and Inventions, tagged Galil Medical, High-intensity focused ultrasound, Invasiveness of surgical procedures, Medtronic, Olympus Corporation, Radiation therapy, ultrasound, Varian Medical Systems on December 23, 2012| 5 Comments »
Ablation Devices Market to 2023 – Global Market Forecast and Trends Analysis by Technology, Devices & Applications
Reporter: Aviva Lev-Ari, PhD, RN
UPDATED on 7/31/2018
Ablation devices are at present utilized as a part of shifted medicinal services ranges, for example, gynecology, dermatology, cardiology, orthopedic, neurology and a few others. Worldwide development in inclination for negligibly intrusive methodology is driving the interest for Ablation devices. Rising awareness in patient populace about accessibility and advantages from ablation treatments and defeating the cost limitations of regular medications are additionally expected to bolster the development of this market. Where regular radiation treatments have been successful and been received because of high awareness levels, developing advances, for example, hydro-mechanical removal, microwave and aqueous are expanding trusts among patients and healthcare specialist organizations.
How Big is the Global Ablation Devices Market?
The Global Ablation Devices Market is expected to exceed more than US$ 20.99 Billion by 2023 at a CAGR of 9% in the given forecast period.
The major driving factors of Global Ablation Devices Market are as follows:
- Increasing aging population
- Increasing incidence of cancer and cardiovascular diseases
- Rising adoption of minimally invasive procedures
- Development repayment scenario in established markets
- Expansion of next-generation ablation products and technologies
- Growing number of ablation procedures
- Expanding funding for the development of novel ablation device
The restraining factors of Global Ablation Devices Market are as follows:
- Healthcare cost control measures
- Strict regulatory approvals
- Challenges in therapeutic procedure
SOURCE
https://www.marketresearchengine.com/ablation-devices-market
Ablation Devices Market to 2016 – Global Market Forecast and Trends Analysis by Technology, Devices & Applications
http://www.marketsandmarkets.com/Market-Reports/ablation-devices-market-791.html
- Radiofrequency
- Cryoablation
- Microwave
- Ultrasound
- Hydrothermal
- Radiation
- Cardiac
- Cancer
- Gynecology
Ablation procedure refers to a minimally invasive surgical procedure which involves either destruction or removal of diseased or unnecessary tissue to cure the disease. It provides successful form of surgical option that has gradually become a popular alternative over invasive procedure amongst physicians and patients. The principal advantage of these procedures over surgery is short recovery time, short length scars, low risk of infection, less blood loss, and shorter hospital stays.
The global ablation devices market was valued at $7.5 billion in 2011 and is poised to grow at a CAGR of 10.5% to reach $12.4 billion by 2016. The ablation market is broadly segmented into two classes, namely, thermal and non-thermal technologies. Thermal segment consists of technologies such as electrical, radiation, light, radiofrequency, ultrasound, microwave, and hydrothermal and non-thermal segment includes cryoablation and hydromechanical. Ablation devices have applications in myriad clinical areas such as cancer / tumor, cardiac, ophthalmology, urology, gynecology and orthopedics.
Ablation procedures have witnessed significant growth in the recent years, which are attributable to factors such as growing healthcare expenditure, favorable demographics and cost effectiveness over tradition surgical procedures. Moreover, increasing applications in cancer and cardiac segment are fueling the market growth.
Factors such as advancements in technology, increasing demand for minimally invasive surgical procedures, growing baby boomers population (especially in U.S., Japan and Western European countries) are driving the market. The incidence cases of chronic diseases is expected to rise continuously in the coming years, because with increasing age, the risk of developing chronic diseases such as cancer, cardiovascular disorders, gynaecological, and orthopaedic problems increases. The ablation devices market for treating these diseases would show significant growth in the forecast period. The principal advantage of ablation procedures over surgery is short recovery time, short surgical timelines, low risk of infection, minimal damage to the healthy tissue, less blood loss, and shorter hospital stays.
Radiation therapy accounted for the largest share of 41% of the total ablation technologies market in 2011. The major driver of radiation therapy is the fact that it is applicable to any form of cancer ranging from soft tissue such as liver, lungs to bone metastases. Compared to most other techniques, radiation therapy is considered to be effective in all cancer scenarios, thus it is a single treatment for control of cancer used by most radiologists. It is expected that, radiation therapy devices will continue to enjoy the majority share in the ablation devices market for at least another decade owing to its broad scope of use, different methods of application, stable acceptance in population, and high level of awareness as compared to newly introduced ablation techniques such as hydrothermal, microwave and hydromechanical ablation.
Americas is the biggest market for ablation devices, followed by Europe. However, Asian countries represent the fastest growing markets and factors such as high patient pool, growing preferences to MIS, geographical expansion of market players, increased government investment in healthcare facilities especially in rural areas, westernization in life style and dietary habits, increasing healthcare expenditure & improving medical insurance plans are driving the ablation devices market.
Report includes company profiles of major players such as Accuray (U.S.), Alcon Laboratories Inc. (U.S.), AngioDynamics Inc. (U.S.), Arthrocare Corporation (U.S.), Atricure Inc. (U.S.), Biosense Webster (U.S.), Boston Scientific (U.S.), BSD Medical Corporation (U.S.), C.R. Bard Inc. (U.S.), ConMed Corporation (U.S.), Covidien (Ireland), Elekta AB ( Sweden), Galil Medical Ltd. (Israel), Medtronic Inc. (U.S.), Misonix Inc. (U.S.), nContact Surgical Inc. (U.S.), Olympus Corporation (Japan), Smith & Nephew (U.K.), St. Jude Medical (U.S.), Urologix Inc. (U.S.) and Varian Medical Systems Inc. (U.S.).
Scope of the Report
This research report categorizes the market for ablation devices into the following segments:
Global ablation devices market, by technology
- Thermal
- Electrical
- Radiation
- Light
- Radiofrequency
- Ultrasound
- Microwave
- Hydrothermal
- Non-thermal
- Cryoablation
- Hydromechanical
Global ablation devices market, by products
- Electrical – Electrical ablators and electronic brachytherapy
- Radiation – Brachytherapy, Intensity modulated radiation therapy, Image guided radiotherapy, Stereotactic Radiotherapy (SRT), Stereotactic body radiation therapy, Nano-radiation therapy and Proton beam therapy
- Light – Cold lasers, Excimer lasers and ultraviolet B lasers
- Radiofrequency – Temperature controlled devices, fluid cooled device and robotic navigation–catheter manipulation systems
- Ultrasound – High intensity focused ultrasound, Magnetic Resonance Imaging-Guided Focused Ultrasound (MRI-FUS), Ultrasound surgical systems and shock wave therapy
- Microwave – Microwave thermotherapy
- Hydrothermal – Endometrial hydrothermal balloon ablation devices
- Cryoablation – Tissue contact probe, cryogen spray probe and epidermal and subcutaneous cryoablation devices
Global ablation devices market, by applications
-
- Cancer
- Cardiac
- Ophthalmology
- Gynecology
- Urology
- Orthopedics
TABLE OF CONTENTS
1 INTRODUCTION
1.1 KEY TAKE AWAYS
1.2 REPORT DESCRIPTION
1.3 MARKETS COVERED
1.4 STAKEHOLDERS
1.5 RESEARCH METHODOLOGY
1.5.1 MARKET SIZE
1.5.2 MARKET SHARE
1.5.3 KEY DATA POINTS FROM SECONDARY SOURCES
1.5.4 KEY DATA POINTS FROM PRIMARY SOURCES
1.5.5 ASSUMPTIONS
2 EXECUTIVE SUMMARY
3 MARKET OVERVIEW
3.1 INTRODUCTION
3.2 ABLATION TECHNOLOGIES MARKET
3.3 ABLATION APPLICATION MARKET
3.4 MARKET DYNAMICS
3.4.1 DRIVERS
3.4.1.1 Technological advancements
3.4.1.2 Increasing procedures through minimal invasive surgery
3.4.1.3 Increasing aging population with higher risk of chronic diseases
3.4.2 RESTRAINTS
3.4.2.1 Pricing and reimbursement issues
3.4.2.2 Increasing regulatory agencies pressures
3.4.3 OPPORTUNITIES & CHALLENGES
3.4.3.1 Emerging markets
3.4.3.2 Technical and educational challenges
3.5 BURNING ISSUES
3.5.1 INCREASING RESEARCH IN CARDIAC ABLATION
3.6 MARKET SHARE ANALYSIS
4 ABLATION MARKET, BY TECHNOLOGY
4.1 INTRODUCTION
4.2 THERMAL
4.2.1 ELECTRICAL
4.2.2 RADIATION
4.2.3 RADIOFREQUENCY
4.2.4 LIGHT
4.2.5 ULTRASOUND
4.2.6 MICROWAVE
4.2.7 HYDROTHERMAL
4.3 NON-THERMAL
4.3.1 CRYOTHERAPY
4.3.2 HYDROMECHANICAL
5 ABLATION TECHNOLOGY MARKET, BY PRODUCTS
5.1 ELECTRICAL
5.1.1 ELECTRICAL ABLATORS
5.1.1.1 Argon Plasma/Beam coagulators
5.1.1.2 Irreversible electroporation
5.1.2 ELECTRONIC BRACHYTHERAPY
5.2 RADIATION
5.2.1 BRACHYTHERAPY
5.2.1.1 High-Dose-Rate (HDR) brachytherapy
5.2.1.2 Pulsed-Dose-Rate brachytherapy
5.2.1.3 Permanent seed brachytherapy or Low-Dose-Rate (LDR) brachytherapy
5.2.2 STEREOTACTIC RADIOSURGERY & STEREOTACTIC RADIOTHERAPY
5.2.3 IMAGE GUIDED RADIATION THERAPY (IGRT)
5.2.4 INTENSITY-MODULATED RADIATION THERAPY (IMRT)
5.2.5 STEREOTACTIC BODY RADIATION THERAPY (SBRT)
5.2.6 PROTON BEAM THERAPY
5.3 RADIOFREQUENCY
5.3.1 TEMPERATURE CONTROLLED RADIOFREQUENCY ABLATION DEVICES
5.3.2 FLUID COOLED RF ABLATION
5.3.3 THE ROBOTIC CATHETER MANIPULATION SYSTEM
5.4 LIGHT/LASER
5.4.1 COLD LASERS
5.4.2 EXCIMER LASERS
5.5 ULTRASOUND
5.5.1 HIGH INTENSITY FOCUSED ULTRASOUND (HIFU)
5.5.2 MAGNETIC RESONANCE GUIDED ULTRASOUND MRGFUS
5.5.3 ULTRASONIC SURGICAL SYSTEMS
5.5.4 EXTRACORPOREAL SHOCKWAVE LITHOTRIPSY
5.6 MICROWAVE ABLATION
5.6.1 MICROWAVE THERMOTHERAPY
5.7 HYDROTHERMAL ABLATION
5.7.1 ENDOMETRIAL HYDROTHERMAL BALLOON ABLATION DEVICES
5.8 CRYOABLATION
5.8.1 TISSUE CONTACT PROBE
5.8.2 TISSUE SPRAY PROBE
5.8.3 EPIDERMAL AND SUBCUTANEOUS CRYOABLATION DEVICES
6 ABLATION TECHNOLOGY MARKET, BY APPLICATIONS
6.1 INTRODUCTION
6.2 CANCER
6.3 CARDIOVASCULAR
6.4 OPHTHALMOLOGY
6.5 GYNECOLOGY
6.6 UROLOGY
6.7 ORTHOPEDICS
6.8 OTHERS
7 GEOGRAPHICAL ANALYSIS
7.1 INTRODUCTION
7.2 AMERICAS
7.3 EUROPE
7.4 ASIA-PACIFIC
7.5 ROW
8 COMPETITIVE LANDSCAPE
8.1 INTRODUCTION
8.2 MERGERS & ACQUISITIONS
8.3 AGREEMENTS, PARTNERSHIPS, COLLABORATIONS, JOINT VENTURES
8.4 NEW PRODUCT LAUNCHES
8.5 PIPELINE DEVELOPMENTS
8.6 OTHER DEVELOPMENTS
9 COMPANY PROFILES
9.1 ACCURAY INC.
9.1.1 OVERVIEW
9.1.2 FINANCIALS
9.1.3 PRODUCTS & SERVICES
9.1.4 STRATEGY
9.1.5 DEVELOPMENTS
9.2 ALCON LABORATORIES INC.
9.2.1 OVERVIEW
9.2.2 FINANCIALS
9.2.3 PRODUCTS & SERVICES
9.2.4 STRATEGY
9.2.5 DEVELOPMENTS
9.3 ANGIODYNAMICS INC.
9.3.1 OVERVIEW
9.3.2 FINANCIALS
9.3.3 PRODUCTS & SERVICES
9.3.4 STRATEGY
9.3.5 DEVELOPMENTS
9.4 ARTHROCARE CORPORATION
9.4.1 OVERVIEW
9.4.2 FINANCIALS
9.4.3 PRODUCTS & SERVICES
9.4.4 STRATEGY
9.4.5 DEVELOPMENTS
9.5 ATRICURE INC.
9.5.1 OVERVIEW
9.5.2 FINANCIALS
9.5.3 PRODUCTS & SERVICES
9.5.4 STRATEGY
9.5.5 DEVELOPMENTS
9.6 BIOSENSE WEBSTER INC.
9.6.1 OVERVIEW
9.6.2 PRODUCTS & SERVICES
9.6.3 STRATEGY
9.6.4 DEVELOPMENTS
9.7 BOSTON SCIENTIFIC CORPORATION
9.7.1 OVERVIEW
9.7.2 FINANCIALS
9.7.3 PRODUCTS & SERVICES
9.7.4 STRATEGY
9.7.5 DEVELOPMENTS
9.8 BSD MEDICAL CORPORATION
9.8.1 OVERVIEW
9.8.2 FINANCIALS
9.8.3 PRODUCTS & SERVICES
9.8.4 STRATEGY
9.8.5 DEVELOPMENTS
9.9 C.R. BARD INC.
9.9.1 OVERVIEW
9.9.2 FINANCIALS
9.9.3 PRODUCTS & SERVICES
9.9.4 STRATEGY
9.9.5 DEVELOPMENTS
9.10 CONMED CORPORATION
9.10.1 OVERVIEW
9.10.2 FINANCIALS
9.10.3 PRODUCTS & SERVICES
9.10.4 STRATEGY
9.10.5 DEVELOPMENTS
9.11 COVIDIEN PLC
9.11.1 OVERVIEW
9.11.2 FINANCIALS
9.11.3 PRODUCTS & SERVICES
9.11.4 STRATEGY
9.11.5 DEVELOPMENTS
9.12 ELEKTA AB
9.12.1 OVERVIEW
9.12.2 FINANCIALS
9.12.3 PRODUCTS & SERVICES
9.12.4 STRATEGY
9.12.5 DEVELOPMENTS
9.13 GALIL MEDICAL LTD.
9.13.1 OVERVIEW
9.13.2 FINANCIALS
9.13.3 PRODUCTS & SERVICES
9.13.4 STRATEGY
9.13.5 DEVELOPMENTS
9.14 MEDTRONIC INC.
9.14.1 OVERVIEW
9.14.2 FINANCIALS
9.14.3 PRODUCTS & SERVICES
9.14.4 STRATEGY
9.14.5 DEVELOPMENTS
9.15 MISONIX INC.
9.15.1 OVERVIEW
9.15.2 FINANCIALS
9.15.3 PRODUCTS & SERVICES
9.15.4 STRATEGY
9.15.5 DEVELOPMENTS
9.16 NCONTACT SURGICAL INC.
9.16.1 OVERVIEW
9.16.2 FINANCIALS
9.16.3 PRODUCTS & SERVICES
9.16.4 STRATEGY
9.16.5 DEVELOPMENTS
9.17 OLYMPUS CORPORATION
9.17.1 OVERVIEW
9.17.2 FINANCIALS
9.17.3 PRODUCTS & SERVICES
9.17.4 STRATEGY
9.17.5 DEVELOPMENTS
9.18 SMITH & NEPHEW
9.18.1 OVERVIEW
9.18.2 FINANCIALS
9.18.3 PRODUCTS & SERVICES
9.18.4 STRATEGY
9.18.5 DEVELOPMENTS
9.19 ST. JUDE MEDICAL INC.
9.19.1 OVERVIEW
9.19.2 FINANCIALS
9.19.3 PRODUCTS & SERVICES
9.19.4 STRATEGY
9.19.5 DEVELOPMENTS
9.20 UROLOGIX INC.
9.20.1 OVERVIEW
9.20.2 FINANCIALS
9.20.3 PRODUCTS & SERVICES
9.20.4 STRATEGY
9.20.5 DEVELOPMENTS
9.21 VARIAN MEDICAL SYSTEMS INC.
9.21.1 OVERVIEW
9.21.2 FINANCIALS
9.21.3 PRODUCTS & SERVICES
9.21.4 STRATEGY
9.21.5 DEVELOPMENTS
Please visit http://www.marketsandmarkets.com/knowledge-process-outsourcing-services.asp to specify your custom Research Requirement
SOURCE:
http://www.marketsandmarkets.com/Market-Reports/ablation-devices-market-791.html
Partial Nephrectomy: Similar outcomes for robot-aided vs. conventional surgery
Posted in Bio Instrumentation in Experimental Life Sciences Research, CANCER BIOLOGY & Innovations in Cancer Therapy, Cell Biology, Signaling & Cell Circuits, tagged Invasiveness of surgical procedures, Laparoscopic surgery, Nephrectomy, PSA, UC San Diego School of Medicine, University of Michigan on August 9, 2012| 1 Comment »
Reporter: Aviva Lev-Ari, PhD, RN
A Matched Comparison of Perioperative Outcomes of a Single Laparoscopic Surgeon Versus a Multisurgeon Robot-Assisted Cohort for Partial Nephrectomy
The Journal of Urology
Volume 188, Issue 1 , Pages 45-50, July 2012
Jonathan S. Ellison
- Jeffrey S. Montgomery
- J. Stuart Wolf Jr.
- Khaled S. Hafez
- David C. Miller
- Alon Z. Weizer
,
,
,
,
,
Department of Urology, University of Michigan, Ann Arbor, Michigan
Received 17 October 2011 published online 14 May 2012.
Purpose
Minimally invasive nephron sparing surgery is gaining popularity for small renal masses. Few groups have evaluated robot-assisted partial nephrectomy compared to other approaches using comparable patient populations. We present a matched pair analysis of a heterogeneous group of surgeons who performed robot-assisted partial nephrectomy and a single experienced laparoscopic surgeon who performed conventional laparoscopic partial nephrectomy. Perioperative outcomes and complications were compared.
Materials and Methods
All 249 conventional laparoscopic and robot-assisted partial nephrectomy cases from January 2007 to June 2010 were reviewed from our prospectively maintained institutional database. Groups were matched 1:1 (108 matched pairs) by R.E.N.A.L. (radius, exophytic/endophytic properties, nearness of tumor to collecting system or sinus, anterior/posterior, location relative to polar lines) nephrometry score, transperitoneal vs retroperitoneal approach, patient age and hilar nature of the tumor. Statistical analysis was done to compare operative outcomes and complications.
Results
Matched analysis revealed that nephrometry score, age, gender, tumor side and American Society of Anesthesia physical status classification were similar. Operative time favored conventional laparoscopic partial nephrectomy. During the study period robot-assisted partial nephrectomy showed significant improvements in estimated blood loss and warm ischemia time compared to those of the experienced conventional laparoscopic group. Postoperative complication rates, and complication distributions by Clavien classification and type were similar for conventional laparoscopic and robot-assisted partial nephrectomy (41.7% and 35.0%, respectively).
Conclusions
Robot-assisted partial nephrectomy has a noticeable but rapid learning curve. After it is overcome the robotic procedure results in perioperative outcomes similar to those achieved with conventional laparoscopic partial nephrectomy done by an experienced surgeon. Robot-assisted partial nephrectomy likely improves surgeon and patient accessibility to minimally invasive nephron sparing surgery.
Key Words: kidney , kidney neoplasms , nephrectomy , laparoscopy , robotics
Abbreviations and Acronyms: CLPN, conventional laparoscopic partial nephrectomy, EBL, estimated blood loss, eGFR,estimated glomerular filtration rate, ICU, intensive care unit, LOS, length of stay, RAPN, robot-assisted partial nephrectomy,SRM, small renal mass, WIT, warm ischemia time
Similar outcomes for robot-aided, conventional nephrectomy June 22, 2012 in Other Robot-assisted and conventional laparoscopic partial nephrectomies have similar outcomes and complication rates, according to a study published in the July issue of The Journal of Urology. (HealthDay) — Robot-assisted and conventional laparoscopic partial nephrectomies have similar outcomes and complication rates, according to a study published in the July issue of The Journal of Urology. Ads by Google Prostate Cancer Treatment – Expert Prostate Cancer Treatment & Care – View Video to Learn More! – http://www.TuftsMedicalCenter.tv Prostate Cancer Treatment – Learn about Watchful Waiting. Get a Second Opinion at BIDMC. – http://www.BIDMC.org Jonathan S. Ellison, M.D., from the University of Michigan in Ann Arbor, and colleagues compared perioperative outcomes and complications from conventional laparoscopic and robot-assisted partial nephrectomy cases from January 2007 to June 2010. Robot-assisted partial nephrectomies were performed by a heterogeneous group of surgeons, while a single experienced laparoscopic surgeon performed the conventional procedures. One hundred eight pairs of patients were matched by age, hilar nature of the tumor, approach, and R.E.N.A.L. (radius, exophytic/endophytic properties, nearness of tumor to collecting system or sinus, anterior/posterior, location relative to polar lines) nephrometry score. The researchers found that nephrometry score, age, gender, tumor side, and American Society of Anesthesia physical status classification were similar between the groups. Conventional laparoscopic partial nephrectomy had better operative time. Robot-assisted partial nephrectomy showed significant improvements in estimated blood loss and warm ischemia time compared to the conventional laparoscopic group. The postoperative complication rates and complication distributions by Clavien classification and type were similar for both groups (41.7 percent for the conventional group and 35.0 percent for the robot-assisted group). “Robot-assisted partial nephrectomy has a noticeable but rapid learning curve,” write the authors. “After it is overcome the robotic procedure results in perioperative outcomes similar to those achieved with conventional laparoscopic partial nephrectomy done by an experienced surgeon.” More information: Abstract Full Text (subscription or payment may be required) Journal reference: Journal of Urology
http://medicalxpress.com/news/2012-06-similar-outcomes-robot-aided-conventional-nephrectomy.html
What does your PSA score, level, reading, test mean?
Unfortunately there is no failsafe test or methods at this time that can differentiate between a high PSA level caused by inflammation of the prostate or infection of the prostate or prostate cancer. At best doctors use a statistical model, which seeks to predict your chances of having prostate cancer. But that is purely a statistical construct and does not actually predict your specific and personal situation at all.
Nonetheless, an elevated PSA reading should not be ignored. It is a good indicator, certainly the best we have, and you should take precautionary action.
If you have a high PSA reading you need to return your prostate back to good health. You need to make important changes to your diet. You also need to have regular exercise. A third and equally important part of my recommendation is to take appropriate natural supplements.
I provide a roadmap in my guide “All about the Prostate”. Most men who follow my roadmap will see their PSA levels come down. It will return their prostate to good health.
INDICATION
ZYTIGA® (abiraterone acetate) in combination with prednisone is indicated for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) who have received prior chemotherapy containing docetaxel.
IMPORTANT SAFETY INFORMATION
Contraindications – ZYTIGA® (abiraterone acetate) may cause fetal harm (Pregnancy Category X) and is contraindicated in women who are or may become pregnant.
Hypertension, Hypokalemia and Fluid Retention Due to Mineralocorticoid Excess –Use with caution in patients with a history of cardiovascular disease or with medical conditions that might be compromised by increases in hypertension, hypokalemia, and fluid retention. ZYTIGA® may cause hypertension, hypokalemia, and fluid retention as a consequence of increased mineralocorticoid levels resulting from CYP17 inhibition. Safety has not been established in patients with LVEF <50% or New York Heart Association (NYHA) Class III or IV heart failure because these patients were excluded from the randomized clinical trial. Control hypertension and correct hypokalemia before and during treatment. Monitor blood pressure, serum potassium, and symptoms of fluid retention at least monthly.
Adrenocortical Insufficiency (AI) – AI has been reported in clinical trials in patients receiving ZYTIGA® in combination with prednisone, after an interruption of daily steroids and/or with concurrent infection or stress. Use caution and monitor for symptoms and signs of AI if prednisone is stopped or withdrawn, if prednisone dose is reduced, or if the patient experiences unusual stress. Symptoms and signs of AI may be masked by adverse reactions associated with mineralocorticoid excess seen in patients treated with ZYTIGA®. Perform appropriate tests, if indicated, to confirm AI. Increased dosages of corticosteroids may be used before, during, and after stressful situations.
Hepatotoxicity – Increases in liver enzymes have led to drug interruption, dose modification, and/or discontinuation. Monitor liver function and modify, withhold, or discontinue ZYTIGA® dosing as recommended (see Prescribing Information for more information). Measure serum transaminases [alanine aminotransferase (ALT) and aspartate aminotransferase (AST)] and bilirubin levels prior to starting treatment with ZYTIGA®, every two weeks for the first three months of treatment, and monthly thereafter. Promptly measure serum total bilirubin, AST, and ALT if clinical symptoms or signs suggestive of hepatotoxicity develop. Elevations of AST, ALT, or bilirubin from the patient’s baseline should prompt more frequent monitoring. If at any time AST or ALT rise above five times the upper limit of normal (ULN) or the bilirubin rises above three times the ULN, interrupt ZYTIGA® treatment and closely monitor liver function.
Food Effect – ZYTIGA® must be taken on an empty stomach. Exposure of abiraterone increases up to 10-fold when abiraterone acetate is taken with meals. No food should be eaten for at least two hours before the dose of ZYTIGA® is taken and for at least one hour after the dose of ZYTIGA® is taken. Abiraterone Cmax and AUC0-∞ (exposure) were increased up to 17- and 10-fold higher, respectively, when a single dose of abiraterone acetate was administered with a meal compared to a fasted state.
Adverse Reactions – The most common adverse reactions (≥ 5%) are joint swelling or discomfort, hypokalemia, edema, muscle discomfort, hot flush, diarrhea, urinary tract infection, cough, hypertension, arrhythmia, urinary frequency, nocturia, dyspepsia, fractures and upper respiratory tract infection.
Drug Interactions – ZYTIGA® is an inhibitor of the hepatic drug-metabolizing enzyme CYP2D6. Avoid co-administration with CYP2D6 substrates that have a narrow therapeutic index. If an alternative cannot be used, exercise caution and consider a dose reduction of the CYP2D6 substrate. Additionally, abiraterone is a substrate of CYP3A4 in vitro. Strong inhibitors and inducers of CYP3A4 should be avoided or used with caution.
Use in Specific Populations – The safety of ZYTIGA® in patients with baseline severe hepatic impairment has not been studied. These patients should not receive ZYTIGA®.