Navigation Links
Astellas Confirms Interim Analysis in PREVAIL Study of XTANDI will Occur within Calendar Year 2013
Date:8/1/2013

TOKYO, Aug. 1, 2013 /PRNewswire/ -- Today, Astellas Pharma Inc. (TSE: 4503) became aware of an error in the English translation of the FY2013 1Q earnings call citing incorrect timing of the PREVAIL interim analysis.

The company's guidance has not changed and Astellas confirms that the interim analysis of the XTANDI PREVAIL study will occur within calendar year 2013.

Important Safety Information

Contraindications- XTANDI can cause fetal harm when administered to a pregnant woman based on its mechanism of action. XTANDI is not indicated for use in women. XTANDI is contraindicated in women who are or may become pregnant.

Warnings and Precautions- In the randomized clinical trial, seizure occurred in 0.9% of patients on XTANDI. No patients on the placebo arm experienced seizure. Patients experiencing a seizure were permanently discontinued from therapy. All seizures resolved. Patients with a history of seizure, taking medications known to decrease the seizure threshold, or with other risk factors for seizure were excluded from the clinical trial. Because of the risk of seizure associated with XTANDI use, patients should be advised of the risk of engaging in any activity where sudden loss of consciousness could cause serious harm to themselves or others.

Adverse Reactions- The most common adverse drug reactions (≥ 5%) reported in patients receiving XTANDI in the randomized clinical trial were asthenia/fatigue, back pain, diarrhea, arthralgia, hot flush, peripheral edema, musculoskeletal pain, headache, upper respiratory infection, muscular weakness, dizziness, insomnia, lower respiratory infection, spinal cord compression and cauda equina syndrome, hematuria, paresthesia, anxiety, and hypertension. Grade 1-4 neutropenia occurred in 15% of XTANDI patients (1% Grade 3-4) and in 6% on placebo (no Grade 3-4). Grade 1-4 elevations in bilirubin occurred in 3% of XTANDI patients and 2% on placebo. One percent of XTANDI patients compared to 0.3% on placebo died from infections or sepsis. Falls or injuries related to falls occurred in 4.6% of XTANDI patients vs 1.3% on placebo. Falls were not associated with loss of consciousness or seizure. Fall-related injuries were more severe in XTANDI patients and included non-pathologic fractures, joint injuries, and hematomas. Grade 1 or 2 hallucinations occurred in 1.6% of XTANDI patients and 0.3% on placebo, with the majority on opioid-containing medications at the time of the event.

Drug Interactions- Effect of Other Drugs on XTANDI: Administration of strong CYP2C8 inhibitors can increase the plasma exposure to XTANDI. Co-administration of XTANDI with strong CYP2C8 inhibitors should be avoided if possible. If co-administration of XTANDI cannot be avoided, reduce the dose of XTANDI. Co-administration of XTANDI with strong or moderate CYP3A4 and CYP2C8 inducers can alter the plasma exposure of XTANDI and should be avoided if possible.

Effect of XTANDI on Other Drugs: XTANDI is a strong CYP3A4 inducer and a moderate CYP2C9 and CYP2C19 inducer in humans. Avoid CYP3A4, CYP2C9 and CYP2C19 substrates with a narrow therapeutic index, as XTANDI may decrease the plasma exposures of these drugs. If XTANDI is co-administered with warfarin (CYP2C9 substrate), conduct additional INR monitoring.

For Full Prescribing Information, please visit www.XtandiHCP.com.


'/>"/>
SOURCE Astellas Pharma Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Astellas Appoints New Senior Vice President of Global Oncology Development
2. Dr. Helen Fisher to Speak at Astellas Presents Executive Womens Day at the Constellation SENIOR PLAYERS Championship
3. Molly Fletcher to Speak at Astellas Presents Executive Womens Day at the AT&T National
4. Astellas Signs Distribution Agreement With Tecnofarma For Enzalutamide In Latin America
5. Molly Fletcher to Speak at Astellas Presents Executive Womens Day at the FedEx St. Jude Classic
6. Amgen And Astellas Announce Japan Alliance
7. Astellas ontvangt handelsvergunning voor VESOMNITM van Nederlandse College ter Beoordeling van Geneesmiddelen
8. Astellas Joins the National Pharmaceutical Council
9. Astellas and Gift of Hope Organ & Tissue Donor Network Join Forces to Raise Awareness of Need for More Organ Donors in Illinois
10. Astellas and Gift of Hope Organ & Tissue Donor Network Join Forces to Raise Awareness of Need for More Organ Donors in Chicago
11. Astellas Pharma Inc.: New Hire Reinforces Global Compliance Structure
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/8/2016)... 2016 Australia Ophthalmic Lasers Market Outlook to ... Lasers Market Outlook to 2022", provides key market data ... value, in millions of US dollars, volume (in units) ... Lasers, Femtosecond Lasers and YAG Lasers. The report ... each of these market segements, and global corporate-level profiles ...
(Date:12/8/2016)... , Dec. 8, 2016 KEY FINDINGS ... poised to grow in 2017-2023. Various reasons for growth ... obese population, higher incidences of chronic diseases, high recovery ... mobility aid services. Medical lifting sling refers to ... with limited mobility. These slings connect to the lift ...
(Date:12/8/2016)... 8, 2016 Research and Markets has announced the addition ... their offering. ... This report analyzes the worldwide markets for Endodontic Supplies in US$ ... , Japan , Europe , ... World. Annual estimates and forecasts are provided for the period 2015 ...
Breaking Medicine Technology:
(Date:12/9/2016)... ... ... Cellairis is a worldwide mobile device and computer repair franchise that is ... and Samsung Galaxy devices with premium parts and accessories. Cellairis has recently set-up for ... for customers. While customers do their shopping, Cellairis can accomplish a number of mobile ...
(Date:12/9/2016)... (PRWEB) , ... December 09, 2016 , ... The ... Drug Dependence, Inc. (NCADD) is recommending the film Whispering Spirits and ... the District of Columbia as an education tool in the war against teen drug ...
(Date:12/9/2016)... , ... December 09, 2016 , ... Mediaplanet today announces ... organ transplantation while encouraging readers to sign up as an organ donor for the ... transplant. , An organ donor can save up to 8 saves through organ ...
(Date:12/9/2016)... ... December 09, 2016 , ... "I had a terrible ... from Winchester, Va. "I thought that if the nebulizer had a more child-friendly design, ... fearing them." , He developed the patent-pending NEBY to avoid the need to deliver ...
(Date:12/8/2016)... Tampa, FL (PRWEB) , ... December 08, 2016 ... ... been awarded accreditation with distinction by the Undersea and Hyperbaric Medical Society (UHMS), ... patients with advanced care and patient safety. Only a few hospitals and facilities ...
Breaking Medicine News(10 mins):