Navigation Links
FDA Approves an Expanded Indication for Peginterferon-Based Combination Therapy for Patients With Chronic Hepatitis C
Date:3/11/2009

ence of Adverse Events

Most common adverse reactions (more than 40%) in adult patients receiving either PEGINTRON or PEGINTRON/REBETOL are injection site inflammation/reaction, fatigue/asthenia, headache, rigors, fevers, nausea, myalgia, and anxiety/emotional lability/irritability. Most common adverse reactions (more than 25%) in pediatric patients receiving PEGINTRON/REBETOL are pyrexia, headache, neutropenia, fatigue, anorexia, injection site erythema and vomiting.

In a study with PEGINTRON/REBETOL (weight-based) combination therapy in adult patients, anemia with weight-based dosing was 29%; however, the majority of these cases were mild and responded to dose reductions. The incidence of serious adverse reactions reported for the weight-based REBETOL group was 12%. In many but not all cases, adverse reactions resolved after dose reduction or discontinuation of therapy. Some patients experienced ongoing or new serious adverse reactions during the 6-month follow-up period. Discontinuations for adverse events were 15% and were related to known interferon effects of psychiatric, systemic (e.g., fatigue, headache), or gastrointestinal adverse reactions. Dose modifications due to adverse reactions occurred in 29% of patients.

Most common adverse reactions with PEGINTRON/REBETOL (weight-based) combination therapy were psychiatric which occurred among 68-69% of patients. These psychiatric adverse reactions included most commonly depression, irritability, and insomnia, each reported by approximately 30-40% of subjects in all treatment groups. Suicidal behavior (ideation, attempts and suicides) occurred in 2% of all patients during treatment or during follow-up after treatment cessation. PEGINTRON induced fatigue or headache in approximately two-thirds of patients, with fever or rigors in approximately half of the patients. The severity of some of these systemic symptoms (e.g., fever and headache) tends to decrease as tr
'/>"/>

SOURCE Schering-Plough Corporation
Copyright©2009 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2 3 4 5 6 7 8 9

Related medicine technology :

1. FDA Approves Lillys Osteoporosis Drug EVISTA(R) (raloxifene HCl) to Reduce The Risk of Invasive Breast Cancer in Two Populations of Postmenopausal Women
2. Health Canada Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for HIV
3. FDA Approves Cymbalta(R) for Maintenance Treatment of Major Depressive Disorder
4. European Commission Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for Virologically Suppressed Adults With HIV-1 Infection
5. FDA Approves MiddleBrooks Amoxicillin PULSYS for Pharyngitis/Tonsillitis in Adolescents and Adults
6. FDA Approves XYZAL(R) (levocetirizine dihydrochloride) Oral Solution for the Relief of Seasonal and Year Round Allergies and Chronic Idiopathic Urticaria
7. UM Maryland Industrial Partnerships Program Approves 18 Collaborative Research Projects, Worth $4.4 Million, Between University Faculty, State Technology Companies
8. U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) for the Acute Treatment of Manic and Mixed Episodes Associated With Bipolar I Disorder in Pediatric Patients (10 to 17 Years of Age)
9. U.S. Food and Drug Administration Approves ORENCIA(R) (abatacept) for the Treatment of Moderate-to-Severe Polyarticular Juvenile Idiopathic Arthritis (JIA) in Patients Six Years and Older
10. FDA Approves HIFU Clinical Trial for Recurrent Prostate Cancer
11. EPA Approves XDS-CALUX(R) as Alternate Dioxin Test Method 4435
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/16/2009)... 16 EuroPharma, Inc. signs exclusive ... use of super absorbency BCM-95® curcumin and ... The exclusive distribution territory for these ... store channel and professional channel, which includes ... BCM-95® is a highly absorbable curcumin. ...
(Date:12/16/2009)... Dec. 16 Verathon®, maker of ... announce that portable bladder volume ultrasound is ... guidelines for the Prevention of Catheter-Associated Urinary ... guidelines, introduced in early November 2009, replace ... 1981. The guidelines are located on ...
(Date:12/16/2009)... -- Biovista Inc.,today announced that it was awarded ... the 2009 New England Venture Summit, held on ... cutting edge private companies,driving the future of innovation, ... other privately held companies that play a leading ... Clean-tech sectors. , "We ...
Breaking Medicine Technology:EuroPharma Exclusive Distributor of BCM-95 and BosPure 2EuroPharma Exclusive Distributor of BCM-95 and BosPure 3New 2009 CDC Guidelines for the Prevention of Catheter-Associated Urinary Tract Infections Include Bladder Volume Ultrasound 2New 2009 CDC Guidelines for the Prevention of Catheter-Associated Urinary Tract Infections Include Bladder Volume Ultrasound 3New 2009 CDC Guidelines for the Prevention of Catheter-Associated Urinary Tract Infections Include Bladder Volume Ultrasound 4New 2009 CDC Guidelines for the Prevention of Catheter-Associated Urinary Tract Infections Include Bladder Volume Ultrasound 5Biovista Inc. Named Top Innovator in Life Sciences 2Revolt Against Career Politicians in the US Congress Begins Today 55619 1Revolt Against Career Politicians in the US Congress Begins Today 55619 2Soluble Fiber But Not Bran Soothes Irritable Bowel 55617 1Soluble Fiber But Not Bran Soothes Irritable Bowel 55617 2New research findings pave the way to more accurate interpretation of brain imaging data 55615 1New research findings pave the way to more accurate interpretation of brain imaging data 55615 2
... MedImmune to Present Preclinical Data From Study of,Oral ... GAITHERSBURG, Md., April 10, 2007 (PRIME,NEWSWIRE) -- Infinity ... that data from a,preclinical study with an oral ... will be presented at the upcoming Annual,Meeting of ...
... 2007--In a study appearing in the March,22 New ... Institutes of Healths National Institute of Arthritis and,Musculoskeletal ... a specific gene and the inflammatory skin,condition vitiligo, ... , Vitiligo is a chronic condition in which ...
Other Medicine Technology:Infinity and MedImmune to Present Preclinical Data From Study of,Oral Formulation of IPI-504 At AACR 2Infinity and MedImmune to Present Preclinical Data From Study of,Oral Formulation of IPI-504 At AACR 3Infinity and MedImmune to Present Preclinical Data From Study of,Oral Formulation of IPI-504 At AACR 4Scientists Implicate Gene in Vitiligo and Other Autoimmune Diseases 2Scientists Implicate Gene in Vitiligo and Other Autoimmune Diseases 3
(Date:12/16/2009)... of Children with Autism and Other Special Needs, ... Levi Join Ben Stiller to Ring in the Holiday ... At its 13th annual Teddy Bear Ball, The Help ... CEO Brian Goldner received the ... philanthropic leadership and commitment to children,s causes; parent ...
(Date:12/16/2009)... WASHINGTON, Dec. 16 Losing has never felt ... knows maintaining his healthy new lifestyle means continuing to ... Drinking fat free milk is one healthy choice that ... a simple step everyone can take. Every glass of ... muscle, potassium to help maintain normal blood pressure, and ...
(Date:12/16/2009)... 16 HealthSciences Institute will sponsor ... professionals, teams and organizations who serve individuals ... diseases in employer, health plan, medical home ... will offer free, noncommercial webinars on topics, ... prevention, management and care improvement. Each webinar ...
(Date:12/16/2009)... an advance that could help ease health and environmental ... development of technology for changing the behavior of nanoparticles ... into the environment. Their study was published in ACS, ... Jarvie from the UK Centre for Ecology and Hydrology ... the production of nanoparticles particles less than 1/1000th ...
(Date:12/16/2009)... In animals, they cut bleeding time in half, but use ... (HealthDay News) -- Hoping to improve on nature, researchers have ... platelets, to be used in trauma or other cases where ... a core, with material that is used in degradable stitches, ... professor of biomedical engineering at Case Western Reserve University, and ...
Breaking Medicine News(10 mins):Health News:The Help Group Honors Brian Goldner, Mary Urquhart and Max Mayer at its Teddy Bear Ball Featuring Ben Stiller and Celebrity Guests 2Health News:The Help Group Honors Brian Goldner, Mary Urquhart and Max Mayer at its Teddy Bear Ball Featuring Ben Stiller and Celebrity Guests 3Health News:The Help Group Honors Brian Goldner, Mary Urquhart and Max Mayer at its Teddy Bear Ball Featuring Ben Stiller and Celebrity Guests 4Health News:The Help Group Honors Brian Goldner, Mary Urquhart and Max Mayer at its Teddy Bear Ball Featuring Ben Stiller and Celebrity Guests 5Health News:New Learning Collaborative to Prepare Clinicians for Better Chronic Care 2Health News:New Learning Collaborative to Prepare Clinicians for Better Chronic Care 3Health News:Behavior modification could ease concerns about nanoparticles 2Health News:Synthetic Platelets Put the Brakes on Blood Loss 2Health News:Synthetic Platelets Put the Brakes on Blood Loss 3
... high blood pressure are less likely than other groups ... lifestyle modifications that can help lower their blood pressure, ... hypertension (high blood pressure) patients who are not taking ... obese are less likely to receive lifestyle modification advice ...
... Instruments, Inc.,developer and manufacturer of Mikro-Tip(R) pressure transducer ... of its MPVS,Ultra(TM) P-V system for both small ... simultaneously and continuously measures high-fidelity,left ventricular pressure and ... in size from transgenic mice to domestic livestock. ...
... Art for Sale and Auction Available Online, PRINCETON, N.J., Nov. ... of Wales, President,William Jefferson Clinton, President Ronald Reagan, Lady Margaret Thatcher,Pope ... American,Red Cross of Central New Jersey is honored to partner with ... ...
... to Cover Medical Devices, ARLINGTON, Va., Nov. 2 ... Capital Markets) today announced that,Christopher Warren has joined FBR ... Analyst within its healthcare group and will,focus on the ... of experience in equity research, and we,value the disciplined, ...
... Meeting, TAMPA, Fla., Nov. 2 Romark ... a,randomized phase II clinical trial showing that 79% ... receiving nitazoxanide plus,the standard of care had a ... 12 weeks following treatment, compared to 43%,of patients ...
... including CPR, assistance, measuring pain medication effectiveness, improving cancer ... ... A novel way to treat cancer,has won the top honor at ... of Fame Foundation. Ian,Cheong of Johns Hopkins University was announced as the ...
Other Medicine News:Health News:Elderly with high blood pressure less likely to get lifestyle modification advice from doctors 2Health News:Millar Instruments Launches Complete Pressure-Volume System for Large and Small Animal Models 2Health News:Distinctive Art Auction Supports American Red Cross of Central New Jersey 2Health News:FBR Capital Markets Hires Senior Healthcare Analyst 2Health News:Phase II Study Shows that Nitazoxanide Significantly Improves Response to Standard of Care in Patients with Chronic Hepatitis C 2Health News:Phase II Study Shows that Nitazoxanide Significantly Improves Response to Standard of Care in Patients with Chronic Hepatitis C 3Health News:Phase II Study Shows that Nitazoxanide Significantly Improves Response to Standard of Care in Patients with Chronic Hepatitis C 4Health News:Collegiate Inventors Competition(R) Announces Winners for 2007 2Health News:Collegiate Inventors Competition(R) Announces Winners for 2007 3Health News:Collegiate Inventors Competition(R) Announces Winners for 2007 4Health News:Collegiate Inventors Competition(R) Announces Winners for 2007 5
... with BD Xstar Blade includes a specially ... blade in prodedure and handling. The ... grind-less process for manufacturing surgical blades. ... consistency. The arch style, single-bevel geometry ...
... Knife with BD Xstar Blade includes a ... the blade in prodedure and handling. ... a grind-less process for manufacturing surgical blades. ... and consistency. The arch style, single-bevel ...
Bio-Rad's Genetic Systems HIV-1/HIV-2 PLUS O EIA is a unique assay that detects the broadest range of HIV....
An advanced microprocessor-controlled unit with superior reliability and reproducible power. Its modern electronics provides the precision and control a surgeon expects....
Medicine Products: