ORENCIA U.S. Prescribing Information - BMS

1 HIGHLIGHTS OF Prescribing Information Subcutaneous Administration for Adult PsA ( ). These highlights do not include all the Information needed to use ORENCIA safely Administer by subcutaneous injection once weekly without the need of an and effectively. See full Prescribing Information for ORENCIA . intravenous loading dose. ORENCIA (abatacept) for injection, for intravenous use Patients transitioning from ORENCIA (abatacept) intravenous therapy to ORENCIA (abatacept) injection, for subcutaneous use subcutaneous administration should administer the first subcutaneous dose instead Initial Approval: 2005 of the next scheduled intravenous dose.

2 ----------------------------- RECENT MAJOR CHANGES------------------------------ General Dosing Information for intravenous Administration ( and ). Indications and Usage, Juvenile Idiopathic Arthritis ( ) 3/2017 Administer as a 30-minute intravenous infusion ( , ). Indications and Usage, Adult Psoriatic Arthritis (PsA) ( ) 6/2017 Following initial dose, give at 2 and 4 weeks, then every 4 weeks ( ). Dosage and Administration, Juvenile Idiopathic Arthritis ( ) 3/2017. Prepare ORENCIA using only the silicone-free disposable syringe ( ).

3 Dosage and Administration, Adult Psoriatic Arthritis (PsA) ( ) 6/2017. Use only Sterile Water for Injection, USP to reconstitute the powder ( ). ------------------------------INDICATION S AND USAGE------------------------------ ORENCIA is a selective T cell costimulation modulator indicated for: The reconstituted and diluted product must be administered using a filter ( ). Adult Rheumatoid Arthritis (RA) ( ) ------------------------- DOSAGE FORMS AND STRENGTHS-------------------------- moderately to severely active RA in adults.

4 ORENCIA may be used as monotherapy intravenous Infusion or concomitantly with DMARDs other than TNF antagonists ( ). For Injection: 250 mg lyophilized powder in a single-use vial for reconstitution and Juvenile Idiopathic Arthritis ( ) dilution prior to intravenous infusion (3). moderately to severely active polyarticular juvenile idiopathic arthritis in patients Subcutaneous Injection 2 years of age and older. ORENCIA may be used as monotherapy or concomitantly Injection: 50 mL, mL, 125 mg/mL solution in single-dose with methotrexate ( ).

5 Prefilled syringes for subcutaneous use (3). Adult Psoriatic Arthritis (PsA) ( ) Injection: 125 mg/mL solution in a single-dose prefilled ClickJect autoinjector for active PsA in adults. ( ) subcutaneous use (3). Important Limitations of Use ( ) -------------------------------- CONTRAINDICATIONS----------------------- --------- should not be given concomitantly with TNF antagonists ( , ). None (4). ---------------------------DOSAGE AND ADMINISTRATION-------------------------- - --------------------------- WARNINGS AND PRECAUTIONS--------------------------- intravenous Administration for Adult RA ( ) and Adult PsA ( ) Concomitant use with a TNF antagonist can increase the risk of infections and Body Weight of Patient Dose Number of Vials serious infections ( ).

6 Less than 60 kg 500 mg 2 Hypersensitivity, anaphylaxis, and anaphylactoid reactions ( ). 60 to 100 kg 750 mg 3 Patients with a history of recurrent infections or underlying conditions predisposing to infections may experience more infections ( , ). More than 100 kg 1000 mg 4. Discontinue if a serious infection develops ( ). Subcutaneous Administration for Adult RA ( ) Screen for latent TB infection prior to initiating therapy. Patients testing positive Administer by subcutaneous injection once weekly with or without an intravenous should be treated prior to initiating ORENCIA ( ).

7 Loading dose. For patients initiating therapy with an intravenous loading dose, Live vaccines should not be given concurrently or within 3 months of discontinuation administer a single intravenous infusion (as per body weight categories above), ( ). followed by the first 125 mg subcutaneous injection given within a day of the Patients with juvenile idiopathic arthritis should be brought up to date with all intravenous infusion. immunizations prior to ORENCIA therapy ( ). Patients transitioning from ORENCIA intravenous therapy to subcutaneous Based on its mechanism of action, ORENCIA may blunt the effectiveness of some administration should administer the first subcutaneous dose instead of the next immunizations ( ).

8 Scheduled intravenous dose. COPD patients may develop more frequent respiratory adverse events ( ). intravenous Administration for Juvenile Idiopathic Arthritis ( ) --------------------------------ADVERSE REACTIONS------------------------------- - Pediatric patients weighing less than 75 kg receive 10 mg/kg intravenously based Most common adverse events ( 10%) are headache, upper respiratory tract infection, on the patient's body weight. Pediatric patients weighing 75 kg or more should nasopharyngitis, and nausea ( ).

9 Be administered ORENCIA following the adult intravenous dosing regimen, not to exceed a maximum dose of 1000 mg. intravenous dosing has not been studied in To report SUSPECTED ADVERSE REACTIONS, contact Bristol-Myers Squibb at patients younger than 6 years of age. ( ) 1-800-721-5072 or FDA at 1-800-FDA-1088 or Subcutaneous Administration for Juvenile Idiopathic Arthritis ( ) ---------------------------USE IN SPECIFIC POPULATIONS--------------------------- Pregnancy: Registry available. The data with ORENCIA use in pregnant women are Body Weight of Patient Dose (once weekly) insufficient to inform on drug-associated risk ( ).

10 10 to less than 25 kg 50 mg 25 to less than 50 kg mg See 17 for PATIENT COUNSELING Information and FDA-approved patient labeling. 50 kg or more 125 mg Revised: 6/2017. FULL Prescribing Information : CONTENTS *. 6 ADVERSE REACTIONS. 1 INDICATIONS AND USAGE Clinical Studies Experience in Adult RA Patients Treated with Adult Rheumatoid Arthritis (RA) intravenous ORENCIA . Juvenile Idiopathic Arthritis Clinical Studies Experience in Adult RA Patients Treated with Adult Psoriatic Arthritis (PsA) Subcutaneous ORENCIA . Important Limitations of Use Clinical Studies Experience in Juvenile Idiopathic Arthritis Patients 2 DOSAGE AND ADMINISTRATION Treated with intravenous ORENCIA .