Selective T Cell Costimulation Modulator

Arthritis, Juvenile

Arthritis, Rheumatoid

Arthritis, Psoriatic

<section class="Section" data-sectioncode="34089-3"><a name="s11"></a><a name="section-10"></a><h1>11 DESCRIPTION</h1>Abatacept is a selective T-cell costimulation modulator. 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 (abatacept) for injection is a sterile, white, preservative-free lyophilized powder for reconstitution and dilution prior to intravenous infusion. Following reconstitution of the lyophilized powder with 10 mL of Sterile Water for Injection, USP, the reconstituted solution of ORENCIA is clear, colorless to pale yellow, with a concentration of 25 mg/mL and with a pH range of 7.2 to 7.8. Each single-dose vial of ORENCIA provides 250 mg abatacept, maltose (500 mg), monobasic sodium phosphate (17.2 mg), and sodium chloride (14.6 mg).ORENCIA (abatacept) injection is a sterile, preservative-free, clear to slightly opalescent, colorless to pale-yellow solution with a pH range of 6.8 to 7.4 for subcutaneous administration. ORENCIA injection is supplied as a single-dose prefilled syringe or as a single-dose ClickJect autoinjector (see Table 6).<a name="_RefID0EF5BG"></a><table cellpadding="4.8pt" width="100%"><caption>Table 6:     Contents of ORENCIA Subcutaneous Injection</caption><col width="25%"/><col width="25%"/><col width="50%"/><thead><tr class="First Last"><th align="center" class="Botrule Rrule Toprule" valign="top">Presentation</th><th align="center" class="Botrule Lrule Rrule Toprule" valign="top">Active Ingredient Quantity and Volume</th><th align="center" class="Botrule Lrule Toprule" valign="top">Inactive Ingredient Content</th></tr></thead><tbody><tr class="First"><td class="Botrule Rrule Toprule" valign="top">ORENCIA injection 50 mg/0.4 mL prefilled syringe</td><td class="Botrule Lrule Rrule Toprule" valign="top">50 mg of abatacept in 0.4 mL of solution</td><td class="Botrule Lrule Toprule" valign="top">dibasic sodium phosphate anhydrous (0.335 mg)monobasic sodium phosphate monohydrate (0.114 mg)poloxamer 188 (3.2 mg)sucrose (68 mg)qs to 0.4 mL Water for Injection, USP</td></tr><tr><td class="Botrule Rrule" valign="top">ORENCIA injection 87.5 mg/0.7 mL prefilled syringe</td><td class="Botrule Lrule Rrule" valign="top">87.5 mg of abatacept in 0.7 mL of solution</td><td class="Botrule Lrule" valign="top">dibasic sodium phosphate anhydrous (0.587 mg)monobasic sodium phosphate monohydrate (0.200 mg)poloxamer 188 (5.6 mg)sucrose (119 mg)qs to 0.7 mL Water for Injection, USP</td></tr><tr class="Last"><td class="Botrule Rrule" valign="top">ORENCIA injection 125 mg/mL prefilled syringe and ClickJect autoinjector</td><td class="Botrule Lrule Rrule" valign="top">125 mg of abatacept in 1 mL of solution</td><td class="Botrule Lrule" valign="top">dibasic sodium phosphate anhydrous (0.838 mg)monobasic sodium phosphate monohydrate (0.286 mg)poloxamer 188 (8 mg)sucrose (170 mg)qs to 1 mL Water for Injection, USP</td></tr></tbody></table>Unlike the lyophilized formulation for intravenous use, the ORENCIA solutions for subcutaneous administration contain no maltose.</section>

ORENCIA

1 ML abatacept 125 MG/ML Prefilled Syringe

1 ML abatacept 125 MG/ML Prefilled Syringe [Orencia]

1 ML abatacept 125 MG/ML Auto-Injector

1 ML abatacept 125 MG/ML Auto-Injector [Orencia]

0.4 ML abatacept 125 MG/ML Prefilled Syringe

0.4 ML abatacept 125 MG/ML Prefilled Syringe [Orencia]

0.7 ML abatacept 125 MG/ML Prefilled Syringe

0.7 ML abatacept 125 MG/ML Prefilled Syringe [Orencia]

abatacept

Orencia

abatacept 250 MG Injection

abatacept 250 MG Injection [Orencia]

Psoriasis (PsO)

Psoriatic Arthritis (PsA)

Ankylosing Spondylitis (AS)

Nonradiographic Axial Spondyloarthritis

Taltz

Juvenile Idiopathic Arthritis

Hidradenitis Suppurativa (HS)

Cosentyx

Siliq

Tremfya

Crohn's Disease (CD)

Ulcerative Colitis (UC)

Stelara

Skyrizi

Ilumya

Migraine

Cluster Headache

Migraine Prevention

Emgality

Qulipta

Acute Migraine

Ubrelvy

Nurtec ODT

Vyepti

Aimovig

Ajovy

Breast Cancer: HR+ (HER2-)

Verzenio

Ibrance

Kisqali

Atopic Dermatitis (Eczema)

Cibinqo

Eucrisa

Asthma (injectable)

Asthma OCS Dependent

Nasal Polyposis

Eosinophilic Esophagitis (EoE)

Prurigo Nodularis

Dupixent

Opzelura

Adbry

NSCLC ALK+ OR ROS1+ Disease

Lorbrena

Alecensa

Alunbrig

NSCLC cMET Mutation

Xalkori

Rheumatoid Arthritis (RA)

Xeljanz

Uveitis

Graft Versus Host Disease (GVHD)

COVID-19 Treatment

Alopecia Areata

Olumiant

Multiple Sclerosis (MS)

Secondary Progressive Multiple Sclerosis

Zeposia

Rinvoq

Entyvio

Orencia is a medication used to treat inflammatory conditions like rheumatoid arthritis and psoriatic arthritis. It suppresses the immune system and can be given through an IV infusion every 4 weeks or self-administered through a subcutaneous injection every week. Some of the common side effects include headaches and infections.

Orencia is FDA-approved for the following indications: Rheumatoid Arthritis, Polyarticular Juvenile Idiopathic Arthritis, Psoriatic Arthritis, and acute Graft vs. Host Disease. 