Five-Year Data Demonstrate Long-Term Efficacy and Safety with ORENCIA(R) (abatacept) in Adults with Rheumatoid Arthritis Who had an Inadequate Response to Me...(tes for reducing signs andsymptoms induc...),Health

Date:11/9/2007

tes for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adults with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more DMARDs, such as methotrexate or TNF antagonists. ORENCIA may be used as monotherapy or concomitantly with DMARDs other than TNF antagonists. ORENCIA should not be administered concomitantly with TNF antagonists and is not recommended for use concomitantly with anakinra.

Dosing and Administration

ORENCIA is administered by a healthcare professional as a 30-minute intravenous infusion at a fixed dose based on body weight range approximating 10 mg/kg at day 0, 2 weeks, 4 weeks, and every 4 weeks thereafter. Acute infusion-related reactions were experienced in nine percent of people treated with ORENCIA and in six percent of people treated with placebo. According to the full prescribing information, the most frequently reported infusion- related adverse events (1 percent to 2 percent) were dizziness, headache, and hypertension. In pivotal studies, premedications were not required. However, appropriate medical support measures for the treatment of hypersensitivity reactions should be available for immediate use in the event of a reaction.

Important Safety Information about ORENCIA(R) (abatacept)

Before receiving treatment with ORENCIA individuals should tell their doctor if they are taking a TNF blocker (e.g., Enbrel(R), Humira(R), Remicade(R)) to treat rheumatoid arthritis (RA). ORENCIA should not be taken with these medications because of a higher chance of getting a serious infection. Individuals should also tell their doctor if they are taking Kineret(R) to treat RA. ORENCIA should not be taken with Kineret. People taking ORENCIA should notify their doctor if they are taking any other medications including hormones, over-the-counter medicines, vitamins, supplements or herbal prod
'/>"/>

SOURCE Bristol-Myers Squibb Company Copyright©2007 PR Newswire. All rights reserved

0 GOOD

Page: 1 2 3 4 5 6
Related medicine technology :

1. Cypher(R) Sirolimus-Eluting Coronary Stent Demonstrates Sustained Clinical Benefits Compared to Bare Metal Stents in Five-Year Randomized Clinical Trial With No Differences in Long-Term Safety
2. Five-Year Data From Taxus II Clinical Trial Highlights Safety and Efficacy of Taxus(R) Stent Compared to Bare-Metal Stent
3. Positive Xeloda(R) Five-Year Overall Survival Study Data in the Adjuvant Treatment of Colon Cancer Presented at Leading European Cancer Meeting
4. Positive Five-Year Safety Data for TAXUS(R) Stent Reported in Boston Scientific Trial
5. Cytokine Demonstrates Oral Efficacy of Small-Molecule MIF Inhibitors
6. Lpath Demonstrates Strong Safety Profile of Lead Drug Candidate, Sphingomab(TM), in Non-Human Primates
7. ImmuneRegen BioSciences, Inc. Demonstrates Radilex(TM) Increases Disease-Fighting White Blood Cells
8. New Study Presented at WorldSleep 2007 Demonstrates Ramelteon Has Sustained Efficacy Over Six Months in Adults With Chronic Insomnia
9. Nebivolol Lowers Blood Pressure in Mild-to-Moderate Hypertensive Patients as Demonstrated in a Study Published in the Journal of Clinical Hypertension
10. Lpath Demonstrates Preclinical Efficacy of Lpathomab(TM) and Initiates Humanization Process
11. R7128 Demonstrates Safety and Potent Antiviral Activity in HCV-Infected Patients