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:6/16/2017)... Corp. is voluntarily performing a worldwide field correction of certain Intra-Aortic Balloon Pumps ... ... CS100i IABP ... 0998-UC-0446HXX; 0998-UC-0479HXX 0998-00-3013-XX;  0998-UC-3013-XX 0998-00-3023-XX;  0998-UC-3023-XX ... This field correction also applies to any System 98 or ...
(Date:6/14/2017)... N.C. , June 14, 2017  In 2016, ... Creative Startups pitch competition and came away ... reality platform is described by Forbes as "entering the ... American Medical Association as teaching "empathy to medical professionals ... the startup was recently named a finalist for the ...
(Date:6/10/2017)... , June 9, 2017  Shane K. Burchfield, DPM, is ... for excellence as a Podiatrist in Alabama . ... at Family First Foot Care. He brings over 20 years of ... pain management and healthcare, to his role. ... Foot Care, PC is pleased to welcome you to ...
Breaking Medicine Technology:
(Date:6/27/2017)... , ... June 27, 2017 , ... ... assistance and personal financial planning services to residents of southern New Hampshire, is ... event that promises to fight hunger and homelessness in the region. , New ...
(Date:6/27/2017)... Ore. (PRWEB) , ... June 27, 2017 , ... ... (CSP), today announced the expansion of Atmosera Managed Azure Services . The ... includes enhancements in support of the company’s growing customer base. Atmosera’s next generation ...
(Date:6/27/2017)... CT (PRWEB) , ... June 27, 2017 , ... Dr. ... the recent renovation of his practice, Advanced Periodontics and Dental Implant Center of Connecticut. ... increased the administrative and waiting areas. The renovations are intended to improve patient comfort ...
(Date:6/27/2017)... ... June 27, 2017 , ... Today, June 27th is ... PTSD. Yet less than 20% will receive adequate care due to lack of effective ... receive any care at all. And left untreated, veterans are at an increased risk ...
(Date:6/27/2017)... ... 2017 , ... East Los Angeles dentist, Ramin Assili DDS , comments ... happens to a woman during pregnancy can have profound effects on a developing fetus, ... on a baby’s long-term health. This study, which was performed at the University of ...
Breaking Medicine News(10 mins):