Navigation Links
FDA Approves PREZISTA®/ritonavir Once-Daily Dosing for HIV-1 Treatment-Experienced Adults With No Darunavir Resistance-Associated Mutations
Date:12/13/2010

olytic hepatitis) has been reported with PREZISTA/ritonavir. During the clinical development program (N=3063), hepatitis has been reported in 0.5% of patients receiving combination therapy with PREZISTA/ritonavir. Patients with preexisting liver dysfunction, including chronic active hepatitis B or C, have an increased risk for liver function abnormalities, including severe hepatic adverse events

Post-marketing cases of liver injury, including some fatalities, have been reported. A causal relationship with PREZISTA/ritonavir therapy has not been establishedAppropriate laboratory testing should be conducted prior to initiating therapy with PREZISTA/ritonavir and patients should be monitored during treatment. Increased AST/ALT monitoring should be considered in patients with underlying chronic hepatitis, cirrhosis, or in patients who have pretreatment elevations of transaminases, especially during the first several months of PREZISTA/ritonavir treatment. Evidence of new or worsening liver dysfunction (including clinically significant elevation of liver enzymes and/or symptoms such as fatigue, anorexia, nausea, jaundice, dark urine, liver tenderness, hepatomegaly) in patients on PREZISTA/ritonavir should prompt consideration of interruption or discontinuation of treatment


  • Severe Skin Reactions:  Severe skin reactions (0.4%), accompanied by fever and/or elevations of transaminases in some cases, Stevens-Johnson Syndrome (<0.1%), and toxic epidermal necrolysis (post-marketing experience) have been reported in patients receiving PREZISTA/ritonavir.  Discontinue PREZISTA/ritonavir immediately if signs or symptoms of severe skin reactions develop (including, but not limited to, severe rash or rash accompanied with fever, general malaise, fatigue, muscle or join aches, blisters, oral lesions, conjunctivitis, hepatitis and/or eosinophilia)  

  • In clinical trials (N=3063), rash (all grades, generally m
    '/>"/>

    SOURCE Tibotec Therapeutics
    Copyright©2010 PR Newswire.
    All rights reserved

    Page: 1 2 3 4 5 6

    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:3/27/2015)... 2015  RXi Pharmaceuticals Corporation (NASDAQ: ... announced that they have entered into an ... proprietary sd-rxRNA® technology for use in developing ... the potential to result in novel, more ... could be a significant step toward personalized ...
    (Date:3/27/2015)... 27, 2015  Delcath Systems, Inc. (NASDAQ: ... company focused on oncology with an emphasis on ... announces the reporting of data from a single ... Injection with the Delcath Hepatic Delivery System (Melphalan/HDS) ... the Society of Surgical Oncology (SSO) Annual Meeting ...
    (Date:3/26/2015)... 2015  The Burzynski Research Institute, Inc. (BRI) announced ... by the Department of Surgery at Kurume University ... have been published. The study, a randomized non-blinded ... as post-operative adjuvant therapy with and without Antineoplastons ... A total of 65 patients, ...
    Breaking Medicine Technology:RXi Pharmaceuticals and MirImmune LLC Enter into an Exclusive Licensing Agreement for RXi's Self-Delivering RNAi (sd-rxRNA) Technology to Develop Cell-based Immunotherapies to Treat Cancer 2RXi Pharmaceuticals and MirImmune LLC Enter into an Exclusive Licensing Agreement for RXi's Self-Delivering RNAi (sd-rxRNA) Technology to Develop Cell-based Immunotherapies to Treat Cancer 3RXi Pharmaceuticals and MirImmune LLC Enter into an Exclusive Licensing Agreement for RXi's Self-Delivering RNAi (sd-rxRNA) Technology to Develop Cell-based Immunotherapies to Treat Cancer 4RXi Pharmaceuticals and MirImmune LLC Enter into an Exclusive Licensing Agreement for RXi's Self-Delivering RNAi (sd-rxRNA) Technology to Develop Cell-based Immunotherapies to Treat Cancer 5Data Highlighting Delcath's Melphalan/HDS Presented At The Society Of Surgical Oncology Annual Meeting 2Data Highlighting Delcath's Melphalan/HDS Presented At The Society Of Surgical Oncology Annual Meeting 3Data Highlighting Delcath's Melphalan/HDS Presented At The Society Of Surgical Oncology Annual Meeting 4Data Highlighting Delcath's Melphalan/HDS Presented At The Society Of Surgical Oncology Annual Meeting 5
    ... Reportlinker.com announces that a new ... its catalogue: Pharmaceutical ... Infrastructure Overview: Pharma innovates, diversifies and ... profits http://www.reportlinker.com/p0484917/Pharmaceutical-Key-Trends-2011----Pharmaceutical-Industry-Infrastructure-Overview-Pharma-innovates-diversifies-and-contains-cost-in-order-to-grow-profits.html ...
    ... Simcere Pharmaceutical Group (NYSE: SCR ), a ... marketing of branded generic and proprietary pharmaceuticals in China, ... results for the first quarter ended March 31, 2011 ... in the United States. Simcere,s management will host an ...
    Cached Medicine Technology:Reportlinker Adds Pharmaceutical Key Trends 2011 - Pharmaceutical Industry Infrastructure Overview: Pharma innovates, diversifies and contains cost in order to grow profits 2Reportlinker Adds Pharmaceutical Key Trends 2011 - Pharmaceutical Industry Infrastructure Overview: Pharma innovates, diversifies and contains cost in order to grow profits 3Reportlinker Adds Pharmaceutical Key Trends 2011 - Pharmaceutical Industry Infrastructure Overview: Pharma innovates, diversifies and contains cost in order to grow profits 4Simcere Pharmaceutical Group to Announce First Quarter 2011 Financial Results on Tuesday, May 10, 2011 2
    (Date:3/28/2015)... March 28, 2015 Genomic medicine experts ... mesothelioma, revealing, for the first time, key information for ... to read the newly posted story on the ... University of British Columbia, the British Columbia Cancer Agency, ... to reveal underlying molecular alterations and mutations that can ...
    (Date:3/28/2015)... Lately the student-athlete experience has ... proposals around the NCAA. In a March episode of ... across a spectrum of universities and sports shed light ... special panel consists of athletes who have competed for ... track and field, baseball, and volleyball. They discuss the ...
    (Date:3/28/2015)... Mirada, CA (PRWEB) March 28, 2015 ... ear, nose and throat disorders, are now ... is a common issue which is characterized by the ... Affecting 1 in 5 people, tinnitus is a prevalent ... disorder and while it is non-fatal, tinnitus can impede ...
    (Date:3/28/2015)... March 28, 2015 Designers and Professionals ... overlay entitled Scratches 5K from Pixel Film Studios. , ... to any media inside Final Cut Pro X” Said ... saves time and is an effective tool for any ... Overlay Scratches 5K's intuitive grunge overlays. Simply drag title ...
    (Date:3/28/2015)... NY (PRWEB) March 28, 2015 ... of dietary supplements announces the release of their ... was shown in two randomized, double-blind, placebo-controlled clinical ... and waist and hip size. MuffinStop™ is a ... indicus and Garcinia mangostana, fused together to create ...
    Breaking Medicine News(10 mins):Health News:New Genomics Research May Help Doctors Tailor Mesothelioma Treatment, According to Surviving Mesothelioma 2Health News:SCI TV Panel of Former College Athletes Discusses Student Athlete Experience 2Health News:SCI TV Panel of Former College Athletes Discusses Student Athlete Experience 3Health News:Healthpointe now Offering Tinnitus Treatments in Clinics throughout Southern California 2Health News:Pixel Film Studios Unveiled Scratches 5k for Final Cut Pro X Editors 2Health News:Purity Products Releases Revolutionary New Weight Loss Product, MuffinStop™ 2
    ... WASHINGTON, D.C., October 5, 2011 The Merck ... than $4 million in funding to implement the ... Symptoms (CHAMPS) partnership in five non-profit, Federally Qualified ... (CHC) is designed to demonstrate how asthma management ...
    ... (October 4, 2011)In a new study led by Fox ... have found that Gleason scores determined by pathologists at ... of recurrence than Gleason scores from referring institutions. ... Meeting of the American Society for Radiation Oncology on ...
    ... new study from the University of Adelaide shows the parents of ... some form of cardiovascular disease. PCOS is a hormonal disorder ... one of the most common endocrine disorders in women and a ... with PCOS are more likely to have any form of cardiovascular ...
    ... HealthDay Reporter , TUESDAY, Oct. 4 (HealthDay News) -- Heart ... just as well if they are released the same day as ... research shows. "[Discharging patients the same day] wasn,t associated ... lead author of a study appearing in the Oct. 5 issue ...
    ... Oct. 5 (HealthDay News) -- Three hours of vigorous exercise ... 22 percent, a new study suggests. The Harvard School ... of that decreased risk was due to the beneficial effects ... (HDL) cholesterol. The findings were published Oct. 4 the ...
    ... (HealthDay News) -- ,A common structural variation in the brain ... details of past events and to distinguish real events from ... report. The study included 53 healthy adults who underwent ... a fold at the front of the brain called the ...
    Cached Medicine News:Health News:Childhood asthma non-profit invests millions in health centers to help children better manage asthma 2Health News:Childhood asthma non-profit invests millions in health centers to help children better manage asthma 3Health News:Fox Chase Gleason scores better predict prostate cancer's recurrence after radiation 2Health News:Fox Chase Gleason scores better predict prostate cancer's recurrence after radiation 3Health News:Overnight Stay May Not Be Necessary for Stenting: Study 2Health News:Overnight Stay May Not Be Necessary for Stenting: Study 3Health News:MRI Study Unfolds Clues to Memory 2