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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.

See all Orencia indications & dosage >>


Media Articles Related to Orencia (Abatacept)

New tool for prognosis and choice of therapy for rheumatoid arthritis
Source: Arthritis / Rheumatology News From Medical News Today [2017.03.24]
In rheumatoid arthritis, antibodies are formed that affect the inflammation in the joints.

Rheumatoid Arthritis Drug May Not Ease Chronic Fatigue Syndrome After All
Source: MedicineNet Chronic Fatigue Syndrome Specialty [2017.03.07]
Title: Rheumatoid Arthritis Drug May Not Ease Chronic Fatigue Syndrome After All
Category: Health News
Created: 3/6/2017 12:00:00 AM
Last Editorial Review: 3/7/2017 12:00:00 AM

Rheumatoid arthritis: New treatment option for difficult-to-treat patients
Source: Arthritis / Rheumatology News From Medical News Today [2017.03.03]
Between 3 and 5% of the population suffer from a form of inflammatory rheumatism. It affects approximately 250,000 - 400,000 people in Austria.

Pitt bioinformatics study provides clues to relationship between schizophrenia and rheumatoid arthritis
Source: Arthritis / Rheumatology News From Medical News Today [2017.02.28]
An in-depth computational analysis of genetic variants implicated in both schizophrenia and rheumatoid arthritis by researchers at the University of Pittsburgh points to eight genes that may...

Remicade for Rheumatoid Arthritis Treatment
Source: MedicineNet infliximab Specialty [2017.02.23]
Title: Remicade for Rheumatoid Arthritis Treatment
Category: eMedicineHealth Doctor's Perspective
Created: 1/6/2001 12:00:00 AM
Last Editorial Review: 2/23/2017 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)

Study to Assess Steady-State Trough Concentrations, Safety, and Immunogenicity of Abatacept After Subcutaneous (SC) Administration to Subjects With Rheumatoid Arthritis (RA) [Completed]
The purpose of this study is to study serum levels of Abatacept after subcutaneous dosing in subjects with RA.

Phase IIIB Subcutaneous Abatacept Monotherapy Study [Completed]
To evaluate safety and immunogenicity of abatacept when used with or without methotrexate in the absence of an IV loading dose of abatacept

Abatacept for the Treatment of Relapsing, Non-Severe, Granulomatosis With Polyangiitis (Wegener's) [Recruiting]
Multi-center, randomized, double-blind, placebo-controlled trial to evaluate the efficacy of abatacept to achieve sustained glucocorticoid-free remission in patients with relapsing non-severe granulomatosis with polyangiitis (Wegener's) (GPA) . Participants will be randomized 1: 1 to receive either abatacept 125 mg or placebo administered by subcutaneous injection once a week. Participants will continue on study treatment for a minimum of 12 months unless they experience a disease relapse or disease flare. Participants who experience a non-severe disease relapse, non-severe disease worsening, or who have not achieved remission by month 6 will have the option of entering an open-label trial period whereby they would receive open-label abatacept.

Study of Abatacept (Orencia) to Treat Primary Biliary Cirrhosis [Recruiting]
The purpose of this study is to determine if abatacept (Orencia) is effective in patients with primary biliary cirrhosis who do not respond adequately to standard treatment with ursodeoxycholic acid (UDCA, Urso, Ursodiol, Actigall).

Abatacept for Patients With Inflammatory Arthritis Associated With Sjögren's Syndrome: an Open-Label Phase II Study [Withdrawn]
The primary purpose of this pilot study is to evaluate the efficacy and safety of Abatacept in subjects with Sjogren's Syndrome (SS). This clinical trial study will enroll and treat 15 subjects with active moderate and severe inflammatory arthritis associated with primary Sjogren's syndrome (pSS) and secondary Sjogren's sybdrine (sSS) with Rheumatoid Arthrits (RA). All subjects will receive Abatacept weekly by Subcutaneous (SC) dosing. Subjects will receive Abatacept by SC injection of 125 mg on day 1 and followed by 125 mg SC weekly thereafter.

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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: 2017-03-24

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