"I love ORENCIA® (abatacept) | Information for Healthcare Professionals"

2022-10-12 11:58:48

For questions about BMS medicines during this time, please call 1-800-721-8909. This site is intended for US-based Health Care Professionals only. Full Prescribing Information Indications Patient Site BMS Resources REQUEST A REP This site is intended for US-based Health Care Professionals only. Full Prescribing Information Indications Request a Rep Clinical & Safety Data Dosing & Administration Intravenous Dosing Subcutaneous Dosing Support & Resources Coverage & Patient Support Billing Codes Autoantibodies & RA Other Indications Moderate to Severe pJIA Active Psoriatic Arthritis aGVHD in HSCT Patients Contact & Patient Site 1-800-ORENCIA Patient Site BMS Resources In moderate to severe RA Don’t Treat RA In The Dark See ORENCIA In A Different Light Empower your dual-seropositive (anti-CCP+ and RF+) patients with a different approach from the start EXPLORE THE DATA Home Clinical & Safety Data Exploratory Biomarker-Driven Study Dosing & Administration Intravenous Dosing Subcutaneous Dosing Support & ResourcesCoverage & Patient SupportBilling Codes About ORENCIA Other Indications Active Psoriatic Arthritis Moderate to Severe pJIA aGVHD in HSCT Patients Dosing & administration SEE DETAILS Access & support solutions RESOURCES Other indications pJIA Moderate to severe polyarticular JIA PsA Active psoriatic arthritis anti-CCP, anti-cyclic citrullinated peptide; JIA, juvenile idiopathic arthritis; RA, rheumatoid arthritis; RF, rheumatoid factor. Important Safety Information for ORENCIA® (abatacept) Increased Risk of Infection with Concomitant Use with TNF Antagonists, Other Biologic RA/PsA Therapy, or JAK Inhibitors: Concurrent therapy with ORENCIA and a TNF antagonist is not recommended. In controlled clinical trials, adult moderate to severe rheumatoid arthritis (RA) patients receiving concomitant intravenous ORENCIA and TNF antagonist therapy experienced more infections (63% vs 43%) and serious infections (4.4% vs 0.8%) compared to patients treated with only TNF antagonists, without an important enhancement of efficacy. Additionally, concomitant use of ORENCIA with other biologic RA/PsA therapy or JAK inhibitors is not recommended. Hypersensitivity: There were 2 cases (5% of patients who received ORENCIA in combination with a calcineurin inhibitor and methotrexate included pyrexia (20%), pneumonia (8%), acute kidney injury (7%), diarrhea (6%), hypoxia (5%), and nausea (5%). Malignancies: The overall frequency of malignancies was similar between adult RA patients treated with ORENCIA or placebo. However, more cases of lung cancer were observed in patients treated with ORENCIA (0.2%) than those on placebo (0%). A higher rate of lymphoma was seen compared to the general population; however, patients with RA, particularly those with highly active disease, are at a higher risk for the development of lymphoma. The potential role of ORENCIA in the development of malignancies in humans is unknown. Most Frequent Adverse Events (≥10%): Headache, upper respiratory tract infection, nasopharyngitis, and nausea were the most commonly reported adverse events in the adult RA clinical studies. Other events reported in ≥5% of pJIA patients were diarrhea, cough, pyrexia, and abdominal pain. In general, the adverse events in pediatric pJIA and adult PsA patients were similar in frequency and type to those seen in adult RA patients. The most frequent adverse reactions of all grades reported in ≥10% of patients with aGVHD who received ORENCIA with a difference of ≥2% for the 7/8 cohort, 8/8 cohort ORENCIA arm, and 8/8 cohort placebo arm, respectively, were anemia (56%, 69%, and 57%), CD4 lymphocytes decreased (14%, 14%, and 9%), hypertension (49%, 43%, and 38%), pyrexia (28%, 19%, and 20%), CMV reactivation/CMV infection (26%, 32%, and 22%), pneumonia (19%, 12%, and 10%), epistaxis (12%, 16%, and 10%), acute kidney injury (9%, 15%, and 10%), and hypermagnesemia (5%, 18%, 10%). Incidence rates of grade 3 or 4 adverse reactions were the same as incidence rates of all grades, with the exception of grade 3 or 4 pyrexia in all arms (9% [7/8 cohort], 10% [8/8 cohort, ORENCIA arm], and 4% [8/8 cohort, placebo arm]), pneumonia in the 8/8 cohort placebo arm (9%) and acute kidney injury in the 7/8 cohort ORENCIA arm (7%). Clinically relevant adverse reactions in