Navigation Links
Astellas Confirms Interim Analysis in PREVAIL Study of XTANDI will Occur within Calendar Year 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

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:
(Date:11/25/2015)... THOUSAND OAKS, Calif. , Nov. 25, 2015 /PRNewswire/ ... of a Biologics License Application (BLA) with ... Administration (FDA) for ABP 501, a biosimilar candidate to ... the first adalimumab biosimilar application submitted to the FDA ... biosimilar pathway. Sean E. Harper , M.D., ...
(Date:11/25/2015)... On Tuesday, November 24, 2015, the ... Wright Medical Technology, Inc. for product liability and ... implant device, awarded $11 million in favor of ... and three days of deliberations, the jury found ... designed and unreasonably dangerous, and that Wright Medical ...
(Date:11/25/2015)... -- Allergan plc (NYSE: AGN ) today announced that ... York State Attorney General,s Office to end the ... statutes with the Attorney General over the decision of Forest ... selling the now generic version of memantine immediate release tablets.  ... released its counterclaims against New York , ...
Breaking Medicine Technology:
(Date:11/27/2015)... ... 2015 , ... The men and women on this list ... the country. They have overseen financial turnarounds, shown commitment to their community through ... as a whole through their advocacy and professional efforts. , Becker's Hospital Review ...
(Date:11/27/2015)... San Francisco, California (PRWEB) , ... November 27, 2015 , ... ... 1969 Janis Joplin Ann Arbor Michigan boxing style concert posters. This is one of ... 1969 at the Canterbury House at the University of Michigan in Ann Arbor. The ...
(Date:11/26/2015)... ... November 26, 2015 , ... Patients at Serenity Point Recovery, ... together on Thanksgiving Day to share the things that they are most grateful ... Point YouTube channel, patients displayed what they wrote on index cards, describing the ...
(Date:11/26/2015)... ON and Cambridge, ON (PRWEB) , ... November ... ... today the availability of a real-time eReferral system for diagnostic imaging in the ... ultrasounds, X-rays, mammography, BMD and Nuclear Medicine tests directly from their electronic medical ...
(Date:11/26/2015)... ... November 26, 2015 , ... The Catalent Applied Drug Delivery ... to integrate dose form selection in early phase drug development. The first of ... and bringing together the UK’s emerging life sciences companies, corporate partners, and investors, ...
Breaking Medicine News(10 mins):