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(abatacept) Lyophilized Powder for Intravenous Infusion
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 lyophilized powder for intravenous infusion is supplied as a sterile, white, preservative-free, lyophilized powder for intravenous administration. Following reconstitution of the lyophilized powder with 10 mL of Sterile Water for Injection, USP, the solution of ORENCIA is clear, colorless to pale yellow, with a pH range of 7.2 to 7.8. Each single-use vial of ORENCIA provides 250 mg abatacept, maltose (500 mg), monobasic sodium phosphate (17.2 mg), and sodium chloride (14.6 mg) for administration.
ORENCIA solution for subcutaneous administration is supplied as a sterile, preservativefree, clear, colorless to pale-yellow solution with a pH of 6.8 to 7.4. Each single dose of subcutaneous injection provides 125 mg abatacept, dibasic sodium phosphate anhydrous (0.838 mg), monobasic sodium phosphate monohydrate (0.286 mg), poloxamer 188 (8 mg), sucrose (170 mg), and quantity sufficient to 1 mL with water for injection. Unlike the intravenous formulation, ORENCIA solution for subcutaneous administration contains no maltose.
What are the possible side effects of abatacept (Orencia)?
Some people receiving an abatacept injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, light-headed, itchy, or have a severe headache or trouble breathing within 1 hour after receiving the injection.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Serious infections may occur during treatment with abatacept. Stop using abatacept and call your doctor right away if you have...
What are the precautions when taking abatacept (Orencia)?
Before using abatacept, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: chronic obstructive pulmonary disease-COPD, current/recent/returning infection (e.g., tuberculosis, hepatitis virus), cut or open sore, cancer, immune system disorder (e.g., HIV infection, bone marrow disorder), diabetes (especially if you are checking your blood sugar level at home).
Before having surgery, tell your doctor or dentist that you are using this medication.
Do not have immunizations/vaccinations while...
Last reviewed on RxList: 3/1/2016
This monograph has been modified to include the generic and brand name in many instances.
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