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

    0

    GOOD

    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:11/23/2009)...AMI,Nov.23/PRNewswire/--Dr.Siegal,sDirectNutrition...T®productsandoperatorofwebsiteCookieDiet.com(...vorsofDr.SanfordSiegal,sever-popularhunger-satisfy...al-Mart,smembershipdiscountclub,Sam,sClub. ,, "...an900retailersthatcarryDr.Siegal,sCookieDietproduc...
    (Date:11/23/2009)... The Institute of Women,s Health of...IV Testing services at its affiliated campuses in ... this webpage: FREE HIV TESTING SITE or call 1-8... (Vocus) November 23, 2009 --...deficiency Virus (HIV) epidemic and yet, with all ...
    (Date:11/23/2009)... When Ryan Bailey, a leader in his ...me to the leader in Refractive Surgery, Dr. Rajesh...ussion regarding his competitive lifestyle, time s...pecific eye parameters. Dr. Khanna then performed ...) November 23, 2009 -- Ryan Bailey won a silver me...
    (Date:11/22/2009)... study, the amount of television viewed by many yo...evious estimates of early childhood screen time, w...antly more on average than those in center-based d...n time in child care settings in more than 20 year...d care programs in four states, and was guided by ...
    (Date:11/22/2009)...kin,s surface, bacteria are abundant, diverse and ...ch at the University of California, San Diego Scho...living on the skin surface trigger a pathway that ..."These germs are actually good for us," said Richa...diatrics, chief of UCSD,s Division of Dermatology ...
    Breaking Medicine News(10 mins):Health News:Dr. Siegal's COOKIE DIET(R) Cookies Available at Samsclub.com 2Health News:,The Institute of Women's Health of North America Increases its Outreach by Offering Free and Confidential HIV Testing in Florida, 2Health News:,The Institute of Women's Health of North America Increases its Outreach by Offering Free and Confidential HIV Testing in Florida, 3Health News:,The Institute of Women's Health of North America Increases its Outreach by Offering Free and Confidential HIV Testing in Florida, 4Health News:Olympic Silver Medalist, Men's Water Polo Star Ryan Bailey Strikes Gold 2Health News:Daycare may double TV time for young children, study finds 2Health News:Daycare may double TV time for young children, study finds 3Health News:Daycare may double TV time for young children, study finds 4Health News:Surface bacteria maintain skin's healthy balance 2
    ...ctress Alicia Cole, a,Screen Actors Guild member f...octors and nurses, including roles on General Hosp... ago, Cole switched from playing a doctor to,becom...o survive. This also lead Cole to fight to bring a...
    ... and advanced life support monitor/defibrillator...DOVER, Mass., April 18 Royal Philips,Electronics ...s the sole,provider of automated external defibril...yment of Philips HeartStart,AEDs and ALS monitor/d...
    ...iCure, Inc.,(Nasdaq: ATRC ), a medical device com...ducts, will release its financial results for the ... 6, 2008., AtriCure will host a conference call a...e investor relations page,of AtriCure,s corporate ...
    ...The Life Sciences Discovery Fund (LSDF) has today ...on State-based life sciences organizations and the...iatives focus on the areas of medical genetics, au...awardees are: Gail Jarvik, University of Washingto...
    ...study finds female African American patients tend ...ndicating that current estimates of screening base.... , Researchers from the Societys Behavioral Rese...red their recollection to the screening history do...
    ...rnment Investigation -, SOMERSET, N.J., April 18 ...ider of healthcare, logistics and,administrative s...l,shareholder meeting, preliminary financial resul...uing operations of,approximately $0.1 million, wit...
    Other Medicine News:Health News:Actress Continues Fight Against Hospital Errors & Rise in MRSA Cases 2Health News:Philips Supports the Boston Marathon as the Sole Provider of Life-Saving Medical Devices 2Health News:Philips Supports the Boston Marathon as the Sole Provider of Life-Saving Medical Devices 3Health News:Philips Supports the Boston Marathon as the Sole Provider of Life-Saving Medical Devices 4Health News:AtriCure Announces Web Cast and Conference Call of First Quarter 2008 Financial Results 2Health News:Life Sciences Fund grants awards to launch health research 2Health News:Life Sciences Fund grants awards to launch health research 3Health News:Life Sciences Fund grants awards to launch health research 4Health News:Life Sciences Fund grants awards to launch health research 5Health News:Study finds patients overestimate cancer screening history 2Health News:TeamStaff, Inc. Reports Preliminary Second Quarter 2008 Results 2Health News:TeamStaff, Inc. Reports Preliminary Second Quarter 2008 Results 3Health News:TeamStaff, Inc. Reports Preliminary Second Quarter 2008 Results 4
    (Date:11/20/2009)..., NEW YORK, Nov. 20 Reportlinker.c...available in its catalogue. ,, Medical Adhesiv...://www.reportlinker.com/p0164242/Medical-Adhesives...=prnewswire&utm_medium=pr&utm_campaign=prn...ealants is gaining preeminence in medical devices ...
    (Date:11/20/2009)...NKLIN LAKES, N.J., Nov. 20 /PRNewswire-FirstCall/ ... ) today announced the completion of its acquisiti... company that develops and manufactures molecular ...In May 2009, BD and HandyLab announced an exclusiv...lecular assays on the HandyLab Jaguar(TM) platform...
    (Date:11/19/2009)...N, France, Nov. 19 In response to ...ngerous and illegal medicines, Operation Pangea II...POL and the World Health Organization,s Internatio... (IMPACT) to highlight the dangers of buying medic... resulted in a series of arrests and the seizure o...
    Breaking Medicine Technology:Reportlinker Adds Medical Adhesives and Sealants - A US Market Review 2Reportlinker Adds Medical Adhesives and Sealants - A US Market Review 3Reportlinker Adds Medical Adhesives and Sealants - A US Market Review 4Reportlinker Adds Medical Adhesives and Sealants - A US Market Review 5Reportlinker Adds Medical Adhesives and Sealants - A US Market Review 6BD Completes Acquisition of HandyLab, Inc. 2BD Completes Acquisition of HandyLab, Inc. 3International Operation Combats Online Supply of Counterfeit and Illegal Medicines 2Lung Cancer Alliance Staff and Advocates to Ring Closing Bell of New York Stock Exchange 28TM 29 61028 1Lung Cancer Alliance Staff and Advocates to Ring Closing Bell of New York Stock Exchange 28TM 29 61028 2J W Bill Marriott to Receive Churchill Centre Award For Leadership 61023 1J W Bill Marriott to Receive Churchill Centre Award For Leadership 61023 2Surgical Care Affiliates Announces Investor Conference Call to Discuss 2009 Third Quarter Results 6114 1
    ..., N.J., Feb. 4 Pharmacopeia (Nasdaq:,PCOP), an in...small,molecule therapeutics, today announced that ...e Officer, will deliver a corporate presentation a...erence will be held February,11-13, 2008, at The W...e,s presentation will take place at 2:00 p.m. EST ...
    ..., Mich., Feb. 1 NanoBio Corporation is,presenting...ents for herpes,labialis (cold sores) and onychomy...he American Academy of Dermatology (AAD), being he...being presented indicate that the company,s topica...ve potent antiviral and antifungal,effects without...
    Other Medicine Technology:Pharmacopeia to Present at BIO CEO & Investor Conference 2008 2Pharmacopeia to Present at BIO CEO & Investor Conference 2008 3NanoBio Corporation Presents Preclinical and Interim Clinical Data on Topical Treatments for Herpes Labialis and Onychomycosis at AAD 2008 2NanoBio Corporation Presents Preclinical and Interim Clinical Data on Topical Treatments for Herpes Labialis and Onychomycosis at AAD 2008 3
    ...SAPORT™ RT cannulas are all able to be used ...th the RT system. , ,The VERSAPORT™ RT cann...r systems packaged for use with the RT system. The...PORT™ Plus V2, SURGISPIKE™ (5mm only, ...
    ...SAPORT™ PLUS V2 trocar has a sharp linear bl...to Suture™ VERSAPORT™ PLUS V2 trocar i...mm-12 mm long sizes with a radiolucent sleeve and ...sharp linear blade and a spring-loaded locking shi...
    ...o Suture™ SPRING-GRIP™ single use nonc... 10 mm, 11 mm and 12 mm sizes for use with the SUR...0 mm, 5 mm-11 mm, 5 mm-12 mm and 10 mm-15 mm sizes...de;, PREMIUM SURGIPORT™, SURGIPORT™ II...
    ...plete line of Surgical Access ...unlike any trocar...ocar system is actually four systems in one desig...inically adaptive to all of your needs., ,By offe...ng tip styles, OnePort™ can effectively addr...
    Medicine Products: