HIGHLIGHTS OF PRESCRIBING INFORMATION ACTEMRA …

1 1 HIGHLIGHTS OF PRESCRIBING INFORMATION These HIGHLIGHTS do not include all the INFORMATION needed to use ACTEMRA safely and effectively. See full PRESCRIBING INFORMATION for ACTEMRA . ACTEMRA (tocilizumab) injection, for intravenous or subcutaneous use Initial Approval: 2010 WARNING: RISK OF SERIOUS INFECTIONS See full PRESCRIBING INFORMATION for complete boxed warning. Serious infections leading to hospitalization or death including tuberculosis (TB), bacterial, invasive fungal, viral, and other opportunistic infections have occurred in patients receiving ACTEMRA .

2 ( ) If a serious infection develops, interrupt ACTEMRA until the infection is controlled. ( ) Perform test for latent TB (except patients with COVID-19); if positive, start treatment for TB prior to starting ACTEMRA . ( ) Monitor all patients for active TB during treatment, even if initial latent TB test is negative. ( ) --------------------------- RECENT MAJOR CHANGES --------------------------- Indications and Usage ( ) 12/2022 Dosage and Administration ( , , , ) 02/2022 Dosage and Administration ( , , ) 12/2022 Warnings and Precautions ( , , ) 12/2022 --------------------------- INDICATIONS AND USAGE ---------------------------- ACTEMRA (tocilizumab) is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of.

3 Rheumatoid Arthritis (RA) ( ) Adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs). Giant Cell Arteritis (GCA) ( ) Adult patients with giant cell arteritis. Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD) ( ) Slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD) Polyarticular Juvenile Idiopathic Arthritis (PJIA) ( ) Patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis.

4 Systemic Juvenile Idiopathic Arthritis (SJIA) ( ) Patients 2 years of age and older with active systemic juvenile idiopathic arthritis. Cytokine Release Syndrome (CRS) ( ) Adults and pediatric patients 2 years of age and older with chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome. Coronavirus Disease 2019 (COVID-19) ( ) Hospitalized adult patients with coronavirus disease 2019 (COVID-19) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

5 ----------------------- DOSAGE AND ADMINISTRATION ----------------------- For RA, pJIA and sJIA, ACTEMRA may be used alone or in combination with methotrexate: and in RA, other DMARDs may be used. (2) General Administration and Dosing INFORMATION ( ) RA, GCA, SSc-ILD, PJIA and SJIA It is recommended that ACTEMRA not be initiated in patients with an absolute neutrophil count (ANC) below 2000 per mm3, platelet count below 100,000 per mm3, or ALT or AST above times the upper limit of normal (ULN)( , ).

6 COVID-19 It is recommended that ACTEMRA not be initiated in patients with an absolute neutrophil count (ANC) below 1000 per mm3, platelet count below 50,000 mm3, or ALT or AST above 10 times ULN ( , ). In RA, CRS or COVID-19 patients, ACTEMRA doses exceeding 800 mg per infusion are not recommended. (2. 2, , ) In GCA patients, ACTEMRA doses exceeding 600 mg per infusion are not recommended. ( , ) Rheumatoid Arthritis (2. 2) Recommended Adult Intravenous Dosage: When used in combination with DMARDs or as monotherapy the recommended starting dose is 4 mg per kg every 4 weeks followed by an increase to 8 mg per kg every 4 weeks based on clinical response.

7 Recommended Adult Subcutaneous Dosage: Patients less than 100 kg weight 162 mg administered subcutaneously every other week, followed by an increase to every week based on clinical response Patients at or above 100 kg weight 162 mg administered subcutaneously every week Giant Cell Arteritis ( ) Recommended Adult Intravenous Dosage: The recommended dose is 6 mg per kg every 4 weeks in combination with a tapering course of glucocorticoids. ACTEMRA can be used alone following discontinuation of glucocorticoids.

8 Recommended Adult Subcutaneous Dosage: The recommended dose is 162 mg given once every week as a subcutaneous injection, in combination with a tapering course of glucocorticoids. A dose of 162 mg given once every other week as a subcutaneous injection, in combination with a tapering course of glucocorticoids, may be prescribed based on clinical considerations. ACTEMRA can be used alone following discontinuation of glucocorticoids. Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD) ( ) Recommended Adult Subcutaneous Dosage: The recommended dose of ACTEMRA for adult patients with SSc-ILD is 162 mg given once every week as a subcutaneous injection.

9 Polyarticular Juvenile Idiopathic Arthritis ( ) Recommended Intravenous PJIA Dosage Every 4 Weeks Patients less than 30 kg weight 10 mg per kg Patients at or above 30 kg weight 8 mg per kg Recommended Subcutaneous PJIA Dosage Patients less than 30 kg weight 162 mg once every three weeks Patients at or above 30 kg weight 162 mg once every two weeks Systemic Juvenile Idiopathic Arthritis ( ) Recommended Intravenous SJIA Dosage Every 2 Weeks Patients less than 30 kg weight 12 mg per kg Patients at or above 30 kg weight 8 mg per kg Recommended Subcutaneous SJIA Dosage Patients less than 30 kg weight 162 mg every two weeks Patients at or above 30 kg weight 162 mg every week Cytokine Release Syndrome ( ) Recommended Intravenous CRS Dosage Patients less than 30 kg weight 12 mg per kg Patients at or above 30 kg weight 8 mg per kg Alone or in combination with corticosteroids.

10 Coronavirus Disease 2019 ( ) The recommended dosage of ACTEMRA for adult patients with COVID-19 is 8 mg per kg administered by a 60-minute intravenous infusion. Administration of Intravenous formulation ( ) For patients with RA, GCA, COVID-19, CRS, PJIA, and SJIA patients at or above 30 kg, dilute to 100 mL in or Sodium Chloride Injection, USP for intravenous infusion using aseptic technique. For PJIA, SJIA and CRS patients less than 30 kg, dilute to 50 mL in or Sodium Chloride Injection, USP for intravenous infusion using aseptic technique.