Navigation Links
Tibotec Submits Application to U.S. Food and Drug Administration Seeking Traditional Approval for INTELENCE(TM) (etravirine)
Date:2/5/2009

ution syndrome has been reported in patients treated with ARV therapy, including INTELENCE.
  • INTELENCE should be used with caution in patients with severe hepatic impairment (Child-Pugh class C) as pharmacokinetics of INTELENCE have not been evaluated in these patients.
  • The most common adverse events (>10 percent) of any intensity that occurred at a higher rate than placebo at 24-weeks were rash (16.9 percent vs. 9.3 percent) and nausea (13.9 percent vs. 11.1 percent).
  • The most common treatment-emergent adverse reactions (Grade 2-4) that occurred in patients receiving an INTELENCE-containing regimen vs. placebo at 24-weeks were rash (9.0 percent vs. 3.1 percent), diarrhea (5.2 percent vs. 9.6 percent), nausea (4.7 percent vs. 3.5 percent), fatigue (3.3 percent vs. 4.0 percent), abdominal pain (3.0 percent vs. 2.5 percent), peripheral neuropathy (2.8 percent vs. 1.8 percent), hypertension (2.8 percent vs. 2.2 percent), headache (2.7 percent vs. 4.1 percent), and vomiting (2.3 percent vs. 2.0 percent).
  • Drug Interactions

    • INTELENCE should not be co-administered with the following ARVs: tipranavir/ritonavir, fosamprenavir/ritonavir, atazanavir/ritonavir, full-dose ritonavir (600 mg bid), protease inhibitors administered without ritonavir, and other NNRTIs.
    • INTELENCE should not be co-administered with carbamazepine, phenobarbital, phenytoin, rifampin, rifapentine, rifabutin (when part of a regimen containing protease inhibitor/ritonavir) or products containing St. John's wort (Hypericum perforatum).
    • INTELENCE and lopinavir/ritonavir should be co-administered with caution.
    • Co-administration of INTELENCE with other agents such as substrates, inhibitors, or inducers of CYP3A4, CYP2C9, and/or CYP2C19 may alter the therapeutic effect or adverse events profile of INTELENCE or the co-administered drug(s). '/>"/>

    SOURCE Tibotec, Inc.
    Copyright©2009 PR Newswire.
    All rights reserved

    Page: 1 2 3 4 5

    Related medicine news :

    1. Tibotec and Emcure Collaborate on Access to Darunavir for India
    2. Tibotec presents interim findings for TMC435, an investigational genotype 1 hepatitis C treatment
    3. Tibotec Pharmaceuticals a Respectful Partner to HIV Community in Pricing of Novel New HIV NNRTI, INTELENCE
    4. Interleukin Genetics Submits Plan to Regain Compliance with Continued Listing Standards
    5. STERIS Corporation Submits New Sterilization System To FDA and Announces Developments on SYSTEM 1 Warning Letter
    6. TriServ Alliance Submits Final Bid for TRICARE South Region Contract
    7. WorldHeart Submits IDE Application for a Pivotal Bridge-to-Transplant Study of the Levacor(TM) VAD
    8. Biopure Submits IND Application for Proposed Clinical Trial in Patients with Acute Myeloid Leukemia
    9. ViroPharma Submits Supplemental Biologics License Application for Cinryze(TM) to Treat Acute Attacks of Hereditary Angioedema
    10. SCOLR Pharma, Inc. Submits Abbreviated New Drug Application for a 12-hour CDT-based Pseudoephedrine Formulation
    11. TriServ Alliance Submits Bid for TRICARE South Region Contract
    Post Your Comments:
    *Name:
    *Comment:
    *Email:
    (Date:8/22/2014)... Japantown Dental is excited to announce that ... Air polishing is a technique used to remove external ... be caused by a number of factors, which are ... External stains include coffee, wine, tea, smoking and chewing ... such as tetracycline, and direct trauma to the tooth. ...
    (Date:8/22/2014)... A Penn Medicine team has found that targeted ... urinary tract infections in hospital patients with urinary ... alert was simplified, the rate of improvement dramatically ... their patients need urinary catheters in the first ... need for catheters that have not been removed ...
    (Date:8/22/2014)... Las Vegas, NV (PRWEB) August 22, 2014 ... developed by Kevin Richardson to restore his own vision from ... of Shane Michaels, prompting an investigative review. , “There ... on glasses or contacts for everyday function, and most people ... they resort to corrective eye surgery that can be pretty ...
    (Date:8/22/2014)... (EGFR) mutations found in the circulating free tumor DNA ... cancer (NSCLC) patients correlates well with the EGFR mutations ... inhibitor (TKI) therapy is approved for EGFR activating mutation ... determining mutation status is with DNA derived directly from ... A more abundant and less invasive source of tumor ...
    (Date:8/22/2014)... New York (PRWEB) August 22, 2014 ... to be filed in U.S. courts on behalf ... due to their use of prescription low testosterone ... documents, a new claim was filed against Pfizer ... who allegedly suffered life-threatening heart issues due to ...
    Breaking Medicine News(10 mins):Health News:Japantown Dental Introduces Air Polishing 2Health News:Penn study: Electronic alerts significantly reduce catheter-associated urinary tract infections 2Health News:Penn study: Electronic alerts significantly reduce catheter-associated urinary tract infections 3Health News:Natural Clear Vision: Review Exposes Kevin Richardson’s Program for Restoring Vision Naturally 2Health News:High concordance between EGFR mutations from circulating-free tumor DNA and tumor tissue in non-small cell lung cancer 2Health News:Testosterone Treatment Lawsuit News: New Filing Alleges Depo-Testosterone Caused Life-Threatening Heart Problems, Bernstein Liebhard LLP reports. 2Health News:Testosterone Treatment Lawsuit News: New Filing Alleges Depo-Testosterone Caused Life-Threatening Heart Problems, Bernstein Liebhard LLP reports. 3Health News:Testosterone Treatment Lawsuit News: New Filing Alleges Depo-Testosterone Caused Life-Threatening Heart Problems, Bernstein Liebhard LLP reports. 4
    ... 2010 (Portland, Ore.) A new study finds that ... up to a year and the program can also save ... most common eating disorder in the country, affecting more than ... few treatment options are available. But a first-of-a-kind study ...
    ... upon estrogens to survive and proliferate in about 70% ... treatment to fight this variety of tumours relies on ... of therapy develops in more than 30% of the ... resistance to tamoxifen is thus essential to develop new ...
    ... ... of Consumers Consider Apples a Value-Based Anytime Food for Both Adults and Children; ,Shoppers ... ... than three-out-of-four Americans, apples and apple beverages fill the dual purpose of being a ...
    ... gastric cancer patients who have had part or all ... post-operative weight loss and improve appetite, according to a ... of the American Gastroenterological Association (AGA) Institute. "It ... the side effects of gastrectomy. Our study provides convincing ...
    ... ... , ... 2010 -- Pat Heyward Canes, a new provider of fashion forward walking canes , ... women ranging from classic to whimsical. Made from performance materials, the canes can withstand ...
    ... ... key management to PCI compliance efforts , ... Salt Lake City, UT (Vocus) March 31, 2010 -- Venafi, ... the security risks they face when encryption keys are not properly monitored and managed., ...
    Cached Medicine News:Health News:Short-term program for binge eaters has long-term benefits 2Health News:Short-term program for binge eaters has long-term benefits 3Health News:How breast cancer cells evade therapeutic attacks 2Health News:Apples Are the New Superfruit 2Health News:Apples Are the New Superfruit 3Health News:Apples Are the New Superfruit 4Health News:Promising hormone may help reduce malnutrition in gastric cancer patients 2Health News:Pat Heyward Canes Unveils New Stylish Walking Cane Collection Just in Time for Mother's Day 2Health News:PCI Compliance and Data Security Requires Private Key Management – New Industry White Paper Explains 2
    (Date:8/22/2014)... , Aug. 22, 2014  Cannabis Science, ... cannabis formulation-based drug development and related consulting, is ... third international medical cannabis conference taking place at ... France , on October 22, 2014.  The ... stakeholders, such as researchers, health professionals, and patients, ...
    (Date:8/22/2014)... -- WaferGen Bio-systems, Inc. (NASDAQ: WGBS) today announced the pricing ... stock and warrants at a price of $10,000 per ... deducting underwriting discounts and commissions and offering expenses payable ... separable and will be issued separately.  The shares of ... NASDAQ Stock Market under the ticker symbol "WGBS" on ...
    (Date:8/21/2014)...  Vermillion, Inc. (NASDAQ: VRML ), a ... health, has appointed Holly B. Bauzon as ... Ms. Bauzon has a proven track record in both ... services companies. She has more than 20 years of ... held the position of Director, Lab Services Sales and ...
    Breaking Medicine Technology:Cannabis Science, Inc. (CBIS) to Sponsor 3rd International Conference on Cannabinoids in Medicine in October 2014 in Strasbourg, France 2Cannabis Science, Inc. (CBIS) to Sponsor 3rd International Conference on Cannabinoids in Medicine in October 2014 in Strasbourg, France 3WaferGen Bio-Systems Announces Pricing of $20 Million Underwritten Offering and Uplisting to NASDAQ 2WaferGen Bio-Systems Announces Pricing of $20 Million Underwritten Offering and Uplisting to NASDAQ 3WaferGen Bio-Systems Announces Pricing of $20 Million Underwritten Offering and Uplisting to NASDAQ 4Vermillion Appoints Holly B. Bauzon as VP of Sales and Managed Markets 2
    ... 22 The American Association of Oral and ... paper on Bisphosphonate-Related Osteonecrosis of the Jaw to ... this condition. BRONJ appears as a non-healing exposed ... patients undergoing intravenous cancer-related bisphosphonate therapy or more ...
    ... a full service and,leading clinical research organization (CRO), today ... S.r.l., a CRO focused on Phase I to,Phase IV ... http://www.newscom.com/cgi-bin/prnh/20080122/335477 ) , The ... have legal and,operating offices in Milan, Italy. The combined ...
    Cached Medicine Technology:AAOMS Updates BRONJ Position Paper 2AAOMS Updates BRONJ Position Paper 3Phidea Srl and Marvin Research Srl Announce Completion of Merger 2Phidea Srl and Marvin Research Srl Announce Completion of Merger 3
    Castroviejo "HM" Micro Needle Holder with Tungsten-Carbide Inserts, with catch. Serrated....
    Barraquer needle holder, curved, delicate....
    Clinical micro clamps by Acland. Black finish. It provides impressive security in use, both against slippage and against leakage due to controlled closing force and working grip surface....
    Clinical micro clamps by Acland. Black finish. It provides impressive security in use, both against slippage and against leakage due to controlled closing force and working grip surface....
    Medicine Products: