Included In This Lesson
Outline
What is the Generic Name
ABATACEPT
What is the Trade Name for ABATACEPT
ORENCIA
What is the Indication for ABATACEPT
- 1 INDICATIONS AND USAGE ORENCIA is a selective T cell costimulation modulator indicated for: • the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA). (1.1) • the treatment of patients 2 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis (pJIA). (1.2) • the treatment of adult patients with active psoriatic arthritis (PsA). (1.3) • the prophylaxis of acute graft versus host disease (aGVHD), in combination with a calcineurin inhibitor and methotrexate, in adults and pediatric patients 2 years of age and older undergoing hematopoietic stem cell transplantation (HSCT) from a matched or 1 allele-mismatched unrelated donor. (1.4) Limitations of Use: Concomitant use of ORENCIA with other immunosuppressives [e.g., biologic disease-modifying antirheumatic drugs (bDMARDS), Janus kinase (JAK) inhibitors] is not recommended ( 1.5 , 5.1) . 1.1 Adult Rheumatoid Arthritis ORENCIA ® is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis. 1.2 Polyarticular Juvenile Idiopathic Arthritis ORENCIA is indicated for the treatment of patients 2 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis. 1.3 Adult Psoriatic Arthritis ORENCIA is indicated for the treatment of adult patients with active psoriatic arthritis (PsA). 1.4 Prophylaxis for Acute Graft versus Host Disease ORENCIA is indicated for the prophylaxis of acute graft versus host disease (aGVHD), in combination with a calcineurin inhibitor and methotrexate, in adults and pediatric patients 2 years of age and older undergoing hematopoietic stem cell transplantation (HSCT) from a matched or 1 allele-mismatched unrelated-donor. 1.5 Limitations of Use The concomitant use of ORENCIA with other potent immunosuppressants [e.g., biologic disease-modifying antirheumatic drugs (bDMARDS), Janus kinase (JAK) inhibitors] is not recommended.
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References: https://open.fda.gov/