Navigation Links
Soliris(R) Improved Fatigue Independent of Changes in Anemia in Patients with PNH by Controlling Hemolysis
Date:6/14/2008

,16) In patients with thrombosis of unknown origin, PNH may be an underlying cause. (3,12)

Prior to approval of Soliris, there were no therapies specifically available for the treatment of PNH. PNH treatment was limited to symptom management through periodic blood transfusions, non-specific immunosuppressive therapy and, infrequently, bone marrow transplantations -- a procedure that carries considerable mortality risk. (4,17)

About Soliris

Soliris was approved in March 2007 by the U.S. Food and Drug Administration (FDA) as the first treatment for PNH, a rare, debilitating and life-threatening blood disorder defined by hemolysis, or the destruction of red blood cells. In June 2007, the European Commission (EC) also approved the use of Soliris for the treatment of patients with PNH. Soliris is the first therapy approved in Europe for the treatment of PNH and was the first medicinal product to receive EC approval under the EMEA Accelerated Assessment Procedure.

Important Safety Information

Soliris is generally well tolerated. The most frequent adverse events observed in clinical studies were headache, nasopharyngitis (a runny nose), back pain and nausea. Treatment with Soliris should not alter anticoagulant management because the effect of withdrawal of anticoagulant therapy during Soliris treatment has not been established.

The U.S. product label for Soliris also includes a boxed warning: "Soliris increases the risk of meningococcal infections. Vaccinate patients with a meningococcal vaccine at least two weeks prior to receiving the first dose of Soliris; revaccinate according to current medical guidelines for vaccine use. Monitor patients for early signs of meningococcal infections, evaluate immediately if infection is suspected, and treat with antibiotics if necessary." During clinical studies, two out of 196 vaccinated PNH patients treated with Soliris experienced a serious meningococcal infection.

Prior to beginning
'/>"/>

SOURCE Alexion Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6 7 8 9

Related medicine technology :

1. Alexion Completes Enrollment in AEGIS Registration Study of Soliris(R) (eculizumab) in Patients with PNH in Japan
2. Alexion Commences Dosing in AEGIS Registration Study of Soliris(R) (eculizumab) in Patients with PNH in Japan
3. PNH Patients With Lower Levels of Hemolysis, Mild Anemia and Minimal Transfusion Support Have Significant Disease Burden; Soliris(R) Therapy Provided Clinical Improvements in PNH Patients Regardless of Disease Severity
4. Long-Term Soliris(R) Therapy Improved or Stabilized Kidney Function in Patients With PNH
5. Soliris(R) Demonstrates Reductions in Hemolysis and Improvements in Fatigue, Overall Quality of Life and Anemia in a Broad Population of PNH Patients
6. Data From Two Phase 3 Studies Show Anti-TNF Golimumab Significantly Improved Signs and Symptoms of Rheumatoid Arthritis
7. Ambien CR(R) (zolpidem tartrate extended-release) CIV Tablets Improved Insomnia and Daily Functioning in Patients with Co-Morbid Major Depressive Disorder
8. Monotherapy BYETTA(R) (exenatide) Injection Study Results Presented at ADA 2008 Showed Adults with Type 2 Diabetes Experienced Improved Glycemic Control and Weight Loss
9. Final Results of the CellCept(R) Spare the Nephron (STN) Study Show Maintenance Therapy is Associated with Improved Renal Function
10. Data Published at ASCO Find Correlation Between ChemoFx(R) Assay and Significantly Improved Overall Survival in Patients With Ovarian Cancer
11. New Study Suggests Tapentadol IR for Acute Pain Is Associated With Improved Gastrointestinal Tolerability Compared to Oxycodone IR
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/15/2014)... , Jan. 15, 2014 The Cadence Fitness & ... Center by the Medical Fitness Association, a non-profit organization ... their full potential. The Cadence Fitness & Health Center ... suburbs and second in the Chicagoland area. ...
(Date:1/15/2014)... NEW YORK , Jan. 15, 2014 ... research report is available in its catalogue: ... - India Drug Forecast and Market Analysis ... PharmaPoint: Atopic Dermatitis - India ...
(Date:1/15/2014)... , Jan. 15, 2014 Reportlinker.com ... report is available in its catalogue: ... and Technologies for Advanced Drug Delivery ... Administration http://www.reportlinker.com/p01941928/Global-Markets-and-Technologies-for-Advanced-Drug-Delivery-Systems----Focus-on-Routes-of-Administration.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Drug_Delivery_Technology ...
Breaking Medicine Technology:Cadence Fitness & Health Center Certified as Medical Fitness Facility 2Cadence Fitness & Health Center Certified as Medical Fitness Facility 3PharmaPoint: Atopic Dermatitis - India Drug Forecast and Market Analysis to 2022 2PharmaPoint: Atopic Dermatitis - India Drug Forecast and Market Analysis to 2022 3PharmaPoint: Atopic Dermatitis - India Drug Forecast and Market Analysis to 2022 4PharmaPoint: Atopic Dermatitis - India Drug Forecast and Market Analysis to 2022 5Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 2Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 3Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 4Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 5Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 6Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 7Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 8Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 9Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 10Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 11Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 12Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 13Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 14Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 15Global Markets and Technologies for Advanced Drug Delivery Systems -- Focus on Routes of Administration 16
... 28, 2011 Burg Simpson Eldredge Hersh & Jardine, P.C., ... delighted to announce that shareholder, Seth. A. Katz, has been ... a member of the Plaintiffs, Steering Committee in the multidistrict litigation ... ASR XL Acetabular Hip System. In August 2010, ...
... 28, 2011 Awarepoint Corporation, a privately held ... with 91 hospital sites contracted consisting of 45,062,013 ... network coverage in U.S. hospitals and 135,265 healthcare ... enterprise-wide U.S. hospital client base for RTLS in ...
Cached Medicine Technology:Burg Simpson Leads National Litigation Against DePuy Orthopaedics, Inc. 2Awarepoint Announces RTLS in Healthcare Leadership with 2010 Results 2Awarepoint Announces RTLS in Healthcare Leadership with 2010 Results 3Awarepoint Announces RTLS in Healthcare Leadership with 2010 Results 4
(Date:4/17/2014)... the April issue of Experimental Biology and ... Drs. Rex Gaskins and Paul Kenis in the ... of the University of Illinois Urbana-Champaign describe their ... reactions underlie a variety of cell functions including ... these crucial roles in regulating normal cellular behavior, ...
(Date:4/17/2014)... Pediatrician-in-Chief Jon McCullers, MD, was recently invited to ... Nature Reviews Microbiology , one of the ... world-renowned infectious disease specialist, and chair of the ... Health Science Center, analyzed the epidemiology and microbiology ... pandemics, as well as more recent 2009 novel ...
(Date:4/17/2014)... older Americans suffer from depression, often brought on by ... a project that followed the lives of thousands ... that Internet use among the elderly can reduce the ... "That,s a very strong effect," said Shelia Cotten, a ... media who led the project. "And it all has ...
(Date:4/17/2014)... School of Medicine (BUSM) have discovered that the ... experimental model. The findings, reported in the ... may lead to more effective treatments for alcoholism. ... the leading causes of illness and death in ... by limiting the productivity of workers and necessitating ...
(Date:4/17/2014)... Cesar A. Arias, M.D., Ph.D., at The University of ... a new superbug that caused a bloodstream infection in ... 17 issue of The New England Journal of ... a class of highly-resistant bacteria known as methicillin-resistant ... cause of hospital and community-associated infections. The superbug has ...
Breaking Medicine News(10 mins):Health News:Live cell imaging reveals distinct alterations of subcellular glutathione potentials 2Health News:Internet use can help ward off depression among elderly 2Health News:BUSM researchers find anti-seizure drug may reduce alcohol consumption 2Health News:New MRSA superbug emerges in Brazil 2
... Scientists working at the Medical Research Council have identified ... pre-cancerous cells in the esophagus, a condition called Barrett,s ... these cells before they develop into esophageal cancer. These ... have important implications for patients and may help to ...
... News) -- Soccer players need to use the correct ... or redirect the ball -- to prevent possible brain injury, ... link between the sport and brain damage, Dr. Alejandro Spiotta ... are moving at high speeds when they come into contact ...
... -- A study about how wearing contact lenses affects ... Loyola University Chicago Stritch School of Medicine,s annual St. ... study is Marie Brenner, a fourth-year student at Stritch ... effects of contact lens wear on retinal nerve fiber ...
... an accepted way to simplify a complex array of symptoms ... an independent disease in itself. However, the truth is not ... at work explaining the symptoms. This is also one of ... not bring the hoped result," says Kari Tikkinen, MD, PhD, ...
... The University of Kentucky will be the first site ... the entire country participating in the first stages of a ... human adult stem cell product, on patients with acute ischemic ... stroke protocol B01-02, was recently approved by UK,s institutional review ...
... By Alan Mozes HealthDay Reporter , ... smartphone may not actually be that smart, British researchers ... study that finds an association between the increasingly popular ... levels. The reason: a relentless need to immediately ...
Cached Medicine News:Health News:Researchers use sugar to halt esophageal cancer in its tracks 2Health News:Heading Soccer Balls Could Injure Brain 2Health News:The concept of 'overactive bladder' serves better commercial rather than patient interests 2Health News:Your Smartphone May Be Stressing You Out 2Health News:Your Smartphone May Be Stressing You Out 3
For use with catalog #0540, 0887....
For use with catalog #0454....
Lupus Anticoagulant-Sensitive APTT Reagent.Cephalin with particulate activator (silica), freeze-dried....
Antigenic Free Protein S, ELISA Method...
Medicine Products: