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OTC
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400 mg/20mL, Injection, solution, concentrate
INN: TOCILIZUMAB
Available in:
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Form
INJECTION, SOLUTION, CONCENTRATE
Dosage
400 mg/20mL
Route
INTRAVENOUS
Storage
—
About This Product
Manufacturer
User Reviews
Reviews reflect personal experiences and are not medical advice. Always consult your doctor.
Genentech, Inc.
ATC Code
L04AC07
Source
OPENFDA_NDC
(
ARTG
)
Rheumatoid Arthritis (IV and SC formulations),ACTEMRA is indicated for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients in combination with methotrexate (MTX) or other non-biological disease-modifying anti-rheumatic drugs (DMARDs) in case of either an inadequate response or intolerance to previous therapy with one or more DMARDs. ACTEMRA is indicated for the treatment of moderate to severe active rheumatoid arthritis in adult patients with poor prognostic factors (see section 5.1 Pharmacodynamic Properties, Clinical Trials) in combination with MTX in those not previously treated with MTX. In the two groups of patients above, ACTEMRA can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate. ACTEMRA has been shown to inhibit the progression of joint damage in adults, as measured by X-ray, when given in combination with methotrexate. Polyarticular Juvenile Idiopathic Arthritis (IV and SC formulations), Actemra is indicated for the treatment of moderate to severe active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older who have had an inadequate response to or intolerance to methotrexate (MTX). Actemra can be given alone or in combination with MTX.,Systemic Juvenile Idiopathic Arthritis (IV and SC formulations), Intravenous formulation, ACTEMRA is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 2 years of age and older. Subcutaneous formulation Actemra is indicated for the treatment of active systemic juvenile idiopathic arthritis in patients 1 year of age and older.Actemra IV and SC can be given alone or in combination with methotrexate (MTX).,Cytokine Release Syndrome (CRS) (IV formulation only), Actemra is indicated for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in adults and paediatric patients 2 years of age and older.Coronavirus disease 2019 (COVID-19) (IV formulation only),Actemra has provisional approval for the treatment of coronavirus disease 2019 (COVID-19) in hospitalised adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation.
Provisional approval has been made on the basis of short-term efficacy and safety data. Continued approval depends on the evidence of longer-term efficacy and safety from ongoing clinical trials and post-market assessment.