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:4/28/2016)... 28, 2016 Dr. Vivek Ahuja ... and Ste phen Schmidt ... leading provider of cloud-based software solutions for life sciences, today announced ... bring a wealth of insight to a growing business.  This will ... George Phillips joined ArisGlobal in the position of ...
(Date:4/28/2016)... Florida , April 28, 2016 ... the development of innovative peptide and gene-based immunotherapeutics and vaccines ... it will be presenting at the 3rd Annual Growth ... - 5 th , 2016 at Caesars Palace in Las Vegas, ... 8.00 am on Wednesday, May 4 th by Dr. ...
(Date:4/27/2016)... 27 Avril 2016   ... de +5% sur le trimestre, soutenu par une ... Croissance de +16% des ventes aux ... Mauna Kea Technologies (Euronext : MKEA, FR0010609263 ; OTCQX : MKEAY), ... annonce aujourd,hui son chiffre d,affaires pour le premier ...
Breaking Medicine Technology:
(Date:4/29/2016)... ... April 29, 2016 , ... Intellitec Solutions ... use of Microsoft Dynamics GP for one their long-term care clients. Working together ... Dynamics GP with key clinical management systems, and delivered a fully integrated accounting ...
(Date:4/29/2016)... CA (PRWEB) , ... April 29, 2016 , ... Pro3rd ... X. Utilize Pixel Film Studios’ lower thirds to introduce people, characters, and locations without ... that include boxes, lines, accents, textures and many more design components. Simply select a ...
(Date:4/29/2016)... (PRWEB) , ... April 29, 2016 , ... In its ... 1Heart Caregiver Services continues its successful franchise development and expansion as it welcomes Ferdie ... extensive managerial and administrative experience in his 32 years of working in various industries. ...
(Date:4/28/2016)... ... April 29, 2016 , ... Sublime Beauty® is offering a special deal on its webstore. , ... The discount is applied to the product with lesser value. In addition, a free ... $250 or more in products. , "So many women (men, too) love our products and ...
(Date:4/28/2016)... ... April 28, 2016 , ... ProText Layouts is a set ... Pro X . With ProText Layouts, video editors can create an energetic typography ... length and scale of texts. Creating text-based videos have never been easier. , ...
Breaking Medicine News(10 mins):