Navigation Links
FDA Approves Label Update for PREZISTA® to Include 192-Week Data in HIV-1-Infected Adult Patients Starting Treatment
Date:10/21/2011

ceiving protease inhibitors. Initiation or dose adjustments of insulin or oral hypoglycemic agents may be required. A causal relationship between protease inhibitors and these events has not been established
  • Fat Redistribution: Redistribution and/or accumulation of body fat have been observed in patients receiving ARV therapy. The causal relationship, mechanism, and long-term consequences of these events have not been established
  • Immune Reconstitution Syndrome has been reported in patients treated with ARV therapy
  • Resistance/Cross Resistance: The potential for HIV-1 cross-resistance among protease inhibitors has not been fully explored in PREZISTA/ritonavir-treated patients

  • Use in Specific Populations

  • Hepatic Impairment: PREZISTA/ritonavir is not recommended for use in patients with severe hepatic impairment. There are no pharmacokinetic or safety data available in patients with severe hepatic impairment
  • Pregnancy: PREZISTA should be used during pregnancy only if the potential benefit justifies the potential risk. No adequate and well-controlled studies have been conducted in pregnant women

  • Adverse Reactions

  • In treatment-naive adult patients, the most common adverse drug reactions (greater than or equal to 5%) reported of at least moderate intensity (greater than or equal to Grade 2) in the PREZISTA/ritonavir arm through 192 weeks were diarrhea (9%), headache (7%), abdominal pain (6%), and rash (6%)
  • In treatment-experienced adult patients, the most common adverse drug reactions (greater than or equal to 5%) reported of at least moderate intensity (greater than or equal to Grade 2) in the PREZISTA/ritonavir arm through 96 weeks were diarrhea (14%), nausea (7%), rash (7%), abdominal pain (6%), and vomiting (5%)

  • This is not a complete list of all adverse drug reactions reported with the us
    '/>"/>

    SOURCE Janssen Therapeutics, Division of Janssen Products, LP
    Copyright©2010 PR Newswire.
    All rights reserved

    Page: 1 2 3 4 5 6

    Related medicine technology :

    1. FDA Approves Ferriprox to Treat Patients with Excess Iron in the Body
    2. FDA Approves Combination Therapy Juvisync
    3. FDA Approves Cialis to Treat Benign Prostatic Hyperplasia
    4. FDA Approves Remicade to Treat Ulcerative Colitis in Children Older Than 6 Years
    5. FDA Approves Soliris for Rare Pediatric Blood Disorder
    6. FDA Approves New Indications for Prolia® (Denosumab) for the Treatment of Bone Loss in Patients With Prostate or Breast Cancer Undergoing Hormone Ablation Therapy
    7. FDA Approves Xalkori with Companion Diagnostic for a Type of Late-stage Lung Cancer
    8. FDA Approves Firazyr To Treat Acute Attacks of Hereditary Angioedema
    9. FDA Approves Adcetris to Treat Two Types of Lymphoma
    10. FDA Approves the First Specific Treatment for Scorpion Stings
    11. Cardinal Health Board of Directors Approves Cash Dividend, Elects David P. King as Director
    Post Your Comments:
    *Name:
    *Comment:
    *Email:
    (Date:12/19/2014)... FOREST, Ill. , Dec. 19, 2014   ... world,s leading provider of injectable drugs and infusion technologies, ... J.P. Morgan 33rd Annual Healthcare Conference on Wednesday, Jan. ... The presentation is scheduled to begin at 10:30 a.m. ... be available to all interested parties through a live ...
    (Date:12/19/2014)... SAN DIEGO and CARDIFF-BY-THE-SEA, ... Therapeutics, Inc. (NASDAQ: SRNE ;  Sorrento), ... and associated pain, and Conkwest, Inc., a privately-held ... a Natural Killer (NK) cell-line based therapy, announced ... definitive agreement to jointly develop next generation CAR-TNK™ ...
    (Date:12/19/2014)... , Dec. 18, 2014  Sage Analytics ( ... of equipment for the testing of marijuana potency ... the new Luminary™ Profiler, the industry,s first product ... in a cost-effective, portable unit. Designed ... needs of the cannabis industry, the Luminary™ Profiler ...
    Breaking Medicine Technology:Sorrento and Conkwest Announce Exclusive Global Collaboration 2Sorrento and Conkwest Announce Exclusive Global Collaboration 3Sorrento and Conkwest Announce Exclusive Global Collaboration 4Sorrento and Conkwest Announce Exclusive Global Collaboration 5Sage Analytics Develops Breakthrough System for Potency Testing of Cannabis Products 2
    ... --First of 2 data sets to be released-- ... two randomized, active-controlled clinical trials in patients with blepharospasm and ... limb spasticity trial -- were presented at the Movement Disorder ... studies were sponsored by Merz Pharmaceuticals, which plans to file ...
    ... , , , , , Overview of ... SEATTLE, June 8 Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: ... Phase I and Phase II clinical studies with pixantrone was reviewed ... 4) which is now available on line. The article, "Pixantrone: ...
    Cached Medicine Technology:Merz Pharmaceuticals Announces Results of Clinical Trials with NT-201(Botulinum neurotoxin type A free from complexing proteins) at Annual Movement Disorders Society Meeting 2Merz Pharmaceuticals Announces Results of Clinical Trials with NT-201(Botulinum neurotoxin type A free from complexing proteins) at Annual Movement Disorders Society Meeting 3Merz Pharmaceuticals Announces Results of Clinical Trials with NT-201(Botulinum neurotoxin type A free from complexing proteins) at Annual Movement Disorders Society Meeting 4Pixantrone in Combination with Chemotherapy Regimens Produces Overall Response Rates of 58-74% with Complete Remission Rates of 37-57% in Relapsed/Refractory Aggressive or Indolent NHL 2Pixantrone in Combination with Chemotherapy Regimens Produces Overall Response Rates of 58-74% with Complete Remission Rates of 37-57% in Relapsed/Refractory Aggressive or Indolent NHL 3
    (Date:12/22/2014)... A new vaccine created to fight an illness similar ... livestock and even humans from similar brain infections, researchers ... from becoming infected by the incurable brain disorder known ... the Dec. 21 online edition of the journal ... infectious particles known as prions that go rogue. ...
    (Date:12/22/2014)... (PRWEB) December 22, 2014 Super Saturday, ... Friday this year as the busiest day in the ... retailers, The Grass Station had a steady pre-Christmas stream ... gifts, this past Saturday. , “I definitely intend to ... Robert, a Denver resident who was enjoying The Grass ...
    (Date:12/22/2014)... 2014 Give a loved one the ... of health and vitality. , For a limited time, ... anti-aging formulas in special Holiday Wellness gift packages at ... , Each bottle contains cutting-edge, proven nutritional support for ... as well as we age. , Joint ...
    (Date:12/22/2014)... Pasadena, CA (PRWEB) December 22, 2014 ... is now offering consultations for sleep apnea. Drowsy drivers ... crashes than drivers who are well-rested, and some experts ... on the roads as intoxicated drivers. Unfortunately, millions of ... to the American Academy of Sleep Medicine, about 18 ...
    (Date:12/22/2014)... December 22, 2014 TheHardwareCity.com now stocks ... with many useful features. Customers of the large online ... the new gloves delivered to their home or workplace ... hand tools that incorporate heavy duty magnets, which make ... allows workers to store metal parts on the back ...
    Breaking Medicine News(10 mins):Health News:Vaccine for Deer Against 'Mad Cow'-Like Illness Shows Promise 2Health News:Customers at Colorado’s Grass Station Say They’re Enjoying the Experience of Legally Purchasing Marijuana this Year to Give as Christmas Presents to Friends and Family 2Health News:You Still Have Time to Give the Gift of Health and Vitality to a Mature Loved One 2Health News:Pasadena Dentist, Dr. Marine Martirosyan, Now Offers Consultations for Sleep Apnea 2Health News:MagnoGrip Pro Utility Magnetic Gloves on Sale at TheHardwareCity.com 2
    ... Society of Corporate Compliance and Ethics and Health ... critical time when the public, government leaders and ... bonus reforms, it appears that there is relatively ... according to a recent survey conducted by the ...
    ... 28 /PRNewswire-Asia-FirstCall/ -- China Sky One Medical, Inc. ("China ... CSKI ), a leading fully integrated pharmaceutical company in ... Mr. Hubert Cooleman, Flemish economic representative for the North ... Ren Medical Company ("TDR"), a wholly-owned subsidiary of China ...
    ... Americans Suffer in Silence ... From Constipation(1): From Connecticut ... -NEW YORK, May 28 While it might not ... comfortable talking about constipation, the results of a new ... topic really is: In fact, while more than ...
    ... 28 Air Products (NYSE: APD ) ... John E. McGlade will be presenting at the Goldman ... June 4, 2009, at 8:00 a.m. EDT. An audio ... Products, Investor Relations web site at www.airproducts.com/Invest/PresentationSummary.htm . ...
    ... ESA,s next Earth Explorer, SMOS, has just passed the all-important ... up the mission are in place for launch later this ... to the Plesetsk Cosmodrome in northern Russia. , The Flight ... the mission elements are in order and ready for launch. ...
    ... 28 Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT ... and commercialization of proprietary products that address important therapeutic ... Glenn A. Oclassen, President & Chief Executive Officer, is ... Science Conference in New York City on Wednesday, June ...
    Cached Medicine News:Health News:Survey Data Reveals Little Connection between Executive Compensation, Employee Bonuses and Business Ethics and Compliance 2Health News:Survey Data Reveals Little Connection between Executive Compensation, Employee Bonuses and Business Ethics and Compliance 3Health News:China Sky One Medical, Inc. Welcomes Commercial Counselor from Belgium; Looks for Business Alliance with European Companies 2Health News:China Sky One Medical, Inc. Welcomes Commercial Counselor from Belgium; Looks for Business Alliance with European Companies 3Health News:Guess What Most Americans Don't Want to Talk About (Hint: It's Not Sex!) 2Health News:Guess What Most Americans Don't Want to Talk About (Hint: It's Not Sex!) 3Health News:Guess What Most Americans Don't Want to Talk About (Hint: It's Not Sex!) 4Health News:SMOS ready to ship to launch site 2Health News:Transcept Pharmaceuticals to Present at Needham Life Sciences Conference on June 10, 2009 2Health News:Transcept Pharmaceuticals to Present at Needham Life Sciences Conference on June 10, 2009 3
    ... inserted into the subclavian or jugular vein ... The Cool Line incorporates two proprietary, ... flowing within a closed-loop design, enabling direct ... The Cool Line combines two important patient ...
    ...
    Designed to minimize emblolic debris in SVGs and carotids...
    Our smallest port is available with or without a COOK Peel-Away Introducer Set....
    Medicine Products: