Country: United States
Language: English
Source: NLM (National Library of Medicine)
TOCILIZUMAB (UNII: I031V2H011) (TOCILIZUMAB - UNII:I031V2H011)
Genentech, Inc.
tocilizumab
tocilizumab 20 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
ACTEMRA® (tocilizumab) is indicated for the treatment of 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). ACTEMRA® (tocilizumab) is indicated for the treatment of giant cell arteritis (GCA) in adult patients. ACTEMRA® (tocilizumab) is indicated for slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease. ACTEMRA® (tocilizumab) is indicated for the treatment of active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. ACTEMRA® (tocilizumab) is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older. ACTEMRA® (tocilizumab) is indicated for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome in adults and pediatric patients 2 years of age and older. ACTEMRA® (toci
For Intravenous Infusion ACTEMRA (tocilizumab) injection is a preservative-free, sterile clear, colorless to pale yellow solution. ACTEMRA is supplied as 80 mg/4 mL (NDC 50242-135-01), 200 mg/10 mL (NDC 50242-136-01), and 400 mg/20 mL (NDC 50242-137-01) individually packaged 20 mg/mL single-dose vials for further dilution prior to intravenous infusion. For Subcutaneous Injection ACTEMRA (tocilizumab) injection is supplied as a preservative-free, sterile, clear, colorless to slightly yellowish solution for subcutaneous administration. The following packaging configurations are available: Storage and Handling: Do not use beyond expiration date on the container, package, prefilled syringe, or autoinjector. ACTEMRA must be refrigerated at 36°F to 46°F (2ºC to 8ºC). Do not freeze. Protect the vials, syringes, and autoinjectors from light by storage in the original package until time of use, and keep syringes and autoinjectors dry. Once removed from the refrigerator, the prefilled syringe and autoinjector can be stored up to 2 weeks at or below 86°F (30°C). The prefilled syringe and autoinjector must always be kept in the carton.
Biologic Licensing Application
ACTEMRA- TOCILIZUMAB INJECTION, SOLUTION ACTEMRA ACTPEN- TOCILIZUMAB INJECTION, SOLUTION Genentech, Inc. ---------- Medication Guide has been approved by the U.S. Food and Drug Administration Revised: 12/2022 Medication Guide ACTEMRA® (AC-TEM-RA) (tocilizumab) injection for intravenous use ACTEMRA® (AC-TEM-RA) (tocilizumab) injection for subcutaneous use What is the most important information I should know about ACTEMRA? ACTEMRA can cause serious side effects including: 1. Serious Infections. ACTEMRA is a medicine that affects your immune system. ACTEMRA can lower the ability of your immune system to fight infections. Some people have serious infections while taking ACTEMRA, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections. Your healthcare provider should assess you for TB before starting ACTEMRA (except if you have COVID-19). If you have COVID-19, your healthcare provider should monitor you for signs and symptoms of new infections during and after treatment with ACTEMRA. Your healthcare provider should monitor you closely for signs and symptoms of TB during treatment with ACTEMRA. • You should not start taking ACTEMRA if you have any kind of infection unless your healthcare provider says it is okay. Before starting ACTEMRA, tell your healthcare provider if you: • think you have an infection or have symptoms of an infection, with or without a fever, such as: • sweating or chills • shortness of breath • warm, red, or painful skin or sores on your body • feel very tired • muscle aches • blood in phlegm • diarrhea or stomach pain • cough • weight loss • burning when you urinate or urinating more often than normal • are being treated for an infection. • get a lot of infections or have infections that keep coming back. • have diabetes, HIV, or a weak immune system. People with these conditions have a higher chance for infections. • have TB, or have been in close contact wi Read the complete document
ACTEMRA- TOCILIZUMAB INJECTION, SOLUTION, CONCENTRATE ACTEMRA- TOCILIZUMAB INJECTION, SOLUTION ACTEMRA ACTPEN- TOCILIZUMAB INJECTION, SOLUTION GENENTECH, INC. ---------- 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 U.S. 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. (5.1) IF A SERIOUS INFECTION DEVELOPS, INTERRUPT ACTEMRA UNTIL THE INFECTION IS CONTROLLED. (5.1) PERFORM TEST FOR LATENT TB (EXCEPT PATIENTS WITH COVID-19); IF POSITIVE, START TREATMENT FOR TB PRIOR TO STARTING ACTEMRA. (5.1) MONITOR ALL PATIENTS FOR ACTIVE TB DURING TREATMENT, EVEN IF INITIAL LATENT TB TEST IS NEGATIVE. (5.1) RECENT MAJOR CHANGES Indications and Usage (1.7) 12/2022 Dosage and Administration (2.1, 2.3, 2.9, 2.11) 02/2022 Dosage and Administration (2.1, 2.8, 2.9) 12/2022 Warnings and Precautions (5.1, 5.3, 5.4) 12/2022 INDICATIONS AND USAGE ACTEMRA (tocilizumab) is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of: RHEUMATOID ARTHRITIS (RA) (1.1) 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) (1.2) Adult patients with giant cell arteritis. SYSTEMIC SCLEROSIS-ASSOCIATED INTERSTITIAL LUNG DISEASE (SSC-ILD) (1.3) 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) (1.4) Patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis. SYS Read the complete document