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Orencia (Abatacept) - Summary



ORENCIA (abatacept) is a soluble fusion protein that consists of the extracellular domain of human cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) linked to the modified Fc (hinge, CH2, and CH3 domains) portion of human immunoglobulin G1 (IgG1). Abatacept is produced by recombinant DNA technology in a mammalian cell expression system. The apparent molecular weight of abatacept is 92 kilodaltons. ORENCIA is supplied as a sterile, white, preservative-free, lyophilized powder for parenteral administration. Following reconstitution with 10 mL of Sterile Water for Injection, USP, the solution of ORENCIA is clear, colorless to pale yellow, with a pH range of 7.0 to 8.0. Each single-use vial of ORENCIA provides 250 mg abatacept, 500 mg maltose, 17.2 mg monobasic sodium phosphate, and 14.6 mg sodium chloride for administration.

ORENCIA is indicated for reducing signs and symptoms, inducing major clinical response, slowing the progression of structural damage, and improving physical function in adult patients 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. ORENCIA is not recommended for use concomitantly with anakinra.

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Media Articles Related to Orencia (Abatacept)

Salty Foods May Double Smokers' Risk of Rheumatoid Arthritis
Source: MedicineNet Rheumatoid Arthritis Specialty [2014.09.15]
Title: Salty Foods May Double Smokers' Risk of Rheumatoid Arthritis
Category: Health News
Created: 9/12/2014 12:36:00 PM
Last Editorial Review: 9/15/2014 12:00:00 AM

Deactivating a cell protein may halt progress of rheumatoid arthritis
Source: Arthritis / Rheumatology News From Medical News Today [2014.09.11]
Activation of the cell receptor TLR5 is all it takes to trigger inflammation and bone erosion in rheumatoid arthritis, and targeting it with drugs could stop it, says new study.

RoActemra (tocilizumab) receives EU approval for use in patients with early rheumatoid arthritis
Source: Arthritis / Rheumatology News From Medical News Today [2014.09.11]
Roche has announced that RoActemra® (tocilizumab) has received approval from the European Commission for use in patients with severe, active and progressive RA who previously have not been...

Smokers with a high sodium diet are at 'double the risk' of rheumatoid arthritis
Source: Arthritis / Rheumatology News From Medical News Today [2014.09.11]
A new study finds that although having a diet high in sodium itself may not increase risk for rheumatoid arthritis, in people who smoke, this combination causes the risk to double.

Many Rheumatoid Arthritis Patients May Skip Meds: Study
Source: MedicineNet Rheumatoid Arthritis Specialty [2014.09.04]
Title: Many Rheumatoid Arthritis Patients May Skip Meds: Study
Category: Health News
Created: 9/3/2014 5:35:00 PM
Last Editorial Review: 9/4/2014 12:00:00 AM

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Published Studies Related to Orencia (Abatacept)

Evaluation of abatacept administered subcutaneously in adults with active rheumatoid arthritis: impact of withdrawal and reintroduction on immunogenicity, efficacy and safety (phase Iiib ALLOW study). [2012]
rheumatoid arthritis despite methotrexate in a phase III trial... CONCLUSIONS: Overall immunogenicity to SC abatacept is low, consistent with

Model-based determination of abatacept exposure in support of the recommended dose for Japanese rheumatoid arthritis patients. [2011.12]
The objective of this study was to provide support for a body weight-tiered dosing regimen by characterizing abatacept pharmacokinetics (PK) and the relationship between exposure and the ACR20 (American College of Rheumatology criteria for 20% improvement) response in Japanese patients with rheumatoid arthritis (RA)...

Long-term safety, efficacy and inhibition of radiographic progression with abatacept treatment in patients with rheumatoid arthritis and an inadequate response to methotrexate: 3-year results from the AIM trial. [2011.10]
OBJECTIVE: To evaluate abatacept treatment over 3 years in patients with rheumatoid arthritis (RA) refractory to methotrexate (MTX)... CONCLUSION: In MTX-inadequate responders with RA, abatacept provided consistent safety and sustained efficacy over 3 years. The data suggest an increasing inhibitory disease-modifying effect on radiographic progression.

Subcutaneous abatacept versus intravenous abatacept: a phase IIIb noninferiority study in patients with an inadequate response to methotrexate. [2011.10]
OBJECTIVE: To compare the efficacy and safety of subcutaneous (SC) and intravenous (IV) abatacept... CONCLUSION: SC abatacept provides efficacy and safety comparable with that of IV abatacept, with low immunogenicity and high retention rates, consistent with the established IV abatacept profile. Rates of injection site reactions were low. SC abatacept will provide additional treatment options, such as an alternative route of administration, for patients with RA. Copyright (c) 2011 by the American College of Rheumatology.

Co-stimulation modulation with abatacept in patients with recent-onset type 1 diabetes: a randomised, double-blind, placebo-controlled trial. [2011.07.30]
BACKGROUND: The immunopathogenesis of type 1 diabetes mellitus is associated with T-cell autoimmunity. To be fully active, immune T cells need a co-stimulatory signal in addition to the main antigen-driven signal. Abatacept modulates co-stimulation and prevents full T-cell activation. We evaluated the effect of abatacept in recent-onset type 1 diabetes... INTERPRETATION: Co-stimulation modulation with abatacept slowed reduction in beta-cell function over 2 years. The beneficial effect suggests that T-cell activation still occurs around the time of clinical diagnosis of type 1 diabetes. Yet, despite continued administration of abatacept over 24 months, the decrease in beta-cell function with abatacept was parallel to that with placebo after 6 months of treatment, causing us to speculate that T-cell activation lessens with time. Further observation will establish whether the beneficial effect continues after cessation of abatacept infusions. FUNDING: US National Institutes of Health. Copyright (c) 2011 Elsevier Ltd. All rights reserved.

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Clinical Trials Related to Orencia (Abatacept)

Efficacy, Pharmacokinetics, Safety and Immunogenicity Study of Abatacept Administered Subcutaneously to Treat Rheumatoid Arthritis in Japan [Recruiting]
The purpose of this study is to assess the efficacy of abatacept after subcutaneous administration and intravenous administration in Japanese active rheumatoid arthritis (RA) subjects with inadequate response to methotrexate (MTX), and on background MTX in the short term.

Pharmacokinetic Study to Compare the Blood Levels of Abatacept Manufactured at Lonza Biologics to the Blood Levels of Abatacept Manufactured at the Devens, MA Facility of Bristol-Myers Squibb [Not yet recruiting]
The purpose of this study is to determine whether the blood levels of Abatacept (BMS-188667) drug product manufactured at Lonza Biologics and the Devens, MA facility of Bristol-Myers Squibb are comparable in healthy subjects

Effect on Orencia (Abatacept) on the Apoptosis of T Cells, B Cells and APC Cells in Rheumatoid Arthritis [Not yet recruiting]
This proposal will test the hypothesis that Orencia affects apoptosis and apoptosis related genes/biomarkers in vivo in rheumatoid arthritis (RA) patients.

Efficacy and Safety Study of Abatacept to Treat Lupus Nephritis [Not yet recruiting]
The purpose of this study is to evaluate Orencia (abatacept) for treatment of lupus nephritis when used on a background of Cellcept (mycophenolate) and prednisone (corticosteroids)

Abatacept in the Treatment of Uveitis [Recruiting]

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Reports of Suspected Orencia (Abatacept) Side Effects

Drug Ineffective (115)Headache (87)Fatigue (83)Nausea (62)Pneumonia (59)Dyspnoea (50)Circumstance or Information Capable of Leading TO Medication Error (49)Diarrhoea (49)Incorrect Storage of Drug (47)Interstitial Lung Disease (45)more >>

Page last updated: 2014-09-15

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