WARNING: RISK OF SERIOUS INFECTIONS
Patients treated with ACTEMRA are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions, Adverse Reactions]. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.
If a serious infection develops, interrupt ACTEMRA until the infection is controlled.
Reported infections include:
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Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Patients should be tested for latent tuberculosis before ACTEMRA use and during therapy. Treatment for latent infection should be initiated prior to ACTEMRA use.
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Invasive fungal infections, including candidiasis, aspergillosis, and pneumocystis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.
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Bacterial, viral and other infections due to opportunistic pathogens.
The risks and benefits of treatment with ACTEMRA should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.
Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with ACTEMRA, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy [see Warnings and Precautions].
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ACTEMRA SUMMARY
ACTEMRA (tocilizumab) is a recombinant humanized anti-human interleukin 6 (IL-6) receptor monoclonal antibody of the immunoglobulin IgG1k (gamma 1, kappa) subclass with a typical H2L2 polypeptide structure. Each light chain and heavy chain consists of 214 and 448 amino acids, respectively. The four polypeptide chains are linked intra- and inter-molecularly by disulfide bonds. ACTEMRA has a molecular weight of approximately 148 kDa.
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 TNF antagonist therapies.
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NEWS HIGHLIGHTSMedia Articles Related to Actemra (Tocilizumab)
Rheumatoid Arthritis Quiz: What is Rheumatoid Arthritis?
Source: MedicineNet Arthritis Specialty [2017.09.19]
Title: Rheumatoid Arthritis Quiz: What is Rheumatoid Arthritis?
Category: MedicineNet Quiz
Created: 1/31/2011 12:00:00 AM
Last Editorial Review: 9/19/2017 5:21:49 PM
Rheumatoid Arthritis (RA)
Source: MedicineNet Amyloidosis Specialty [2017.08.15]
Title: Rheumatoid Arthritis (RA)
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 8/15/2017 12:00:00 AM
Does Lipitor Help Rheumatoid Arthritis?
Source: MedicineNet Rheumatoid Arthritis Specialty [2017.08.15]
Title: Does Lipitor Help Rheumatoid Arthritis?
Category: Doctor's & Expert's views on Symptoms
Created: 8/15/2017 12:00:00 AM
Last Editorial Review: 8/15/2017 12:00:00 AM
Certain Jobs Linked to Raised Risk of Rheumatoid Arthritis
Source: MedicineNet Asbestos-Related Disorders Specialty [2017.08.11]
Title: Certain Jobs Linked to Raised Risk of Rheumatoid Arthritis
Category: Health News
Created: 8/10/2017 12:00:00 AM
Last Editorial Review: 8/11/2017 12:00:00 AM
15 Early Symptoms and Signs of Rheumatoid Arthritis (RA)
Source: MedicineNet Juvenile Arthritis Specialty [2017.07.07]
Title: 15 Early Symptoms and Signs of Rheumatoid Arthritis (RA)
Category: Diseases and Conditions
Created: 6/24/2013 12:00:00 AM
Last Editorial Review: 7/7/2017 12:00:00 AM
Published Studies Related to Actemra (Tocilizumab)
Phase III study of the efficacy and safety of subcutaneous versus intravenous
tocilizumab monotherapy in patients with rheumatoid arthritis. [2014]
to synthetic and/or biologic disease-modifying antirheumatic drugs (DMARDs)... CONCLUSION: TCZ-SC monotherapy demonstrated comparable efficacy and safety to
Subcutaneous tocilizumab versus placebo in combination with disease-modifying
antirheumatic drugs in patients with rheumatoid arthritis. [2014]
BREVACTA study... CONCLUSION: TCZ-SC every other week had significantly greater efficacy, including
Exposure-response relationship of tocilizumab, an anti-IL-6 receptor monoclonal
antibody, in a large population of patients with rheumatoid arthritis. [2013]
Relationships between tocilizumab exposure and response were evaluated using data
from 4 phase III studies. Increased tocilizumab exposure was associated with
improvements in Disease Activity Score using 28 joints (DAS28) and American
College of Rheumatology (ACR) criteria and with a decrease in inflammation
markers...
Tocilizumab inhibits structural joint damage and improves physical function in
patients with rheumatoid arthritis and inadequate responses to methotrexate:
LITHE study 2-year results. [2013]
tocilizumab-MTX or MTX during Year 2 of a 2-year study... CONCLUSION: Compared with placebo-MTX, tocilizumab-MTX significantly inhibited
Tocilizumab for the treatment of systemic juvenile idiopathic arthritis. [2012]
Juvenile idiopathic arthritis (JIA) is the most common rheumatic disease in
childhood, resulting in short- and long-term disability. It includes a
heterogeneous group of diseases, of which systemic JIA is often resistant to
treatment.In two Phase III
randomized, double-blind controlled studies a rapid and high response rate has
been achieved both regarding systemic features and arthritis activity together
with a tolerable safety profile in children with systemic JIA refractory to
conventional treatment.
Clinical Trials Related to Actemra (Tocilizumab)
A Study to Compare Subcutaneous Versus Intravenous Administration of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Active Rheumatoid Arthritis [Completed]
This randomized, double-blind, parallel group study will compare the efficacy and safety of
subcutaneous (sc) versus intravenous (iv) administration of RoActemra/Actemra (tocilizumab)
in patients with moderate to severe active rheumatoid arthritis. Patients will be randomized
to receive either RoActemra/Actemra 162 mg sc weekly plus iv placebo every 4 weeks, or
RoActemra/Actemra 8 mg/kg iv every 4 weeks plus sc placebo weekly during the double-blind
period from baseline to Week 24. The double-blind period will be followed by a 72-week
open-label treatment with some switching of sc and iv administration. No placebo will be
administered in the open-label phase. Patients will continue on their stable dose of
disease-modifying antirheumatic drugs (DMARDs) throughout the study. Anticipated time on
study treatment is 2 years.
A Study of RoActemra/Actemra (Tocilizumab) in Patients With Ankylosing Spondylitis Who Have Failed Treatment With NSAIDs [Terminated]
This randomized, double-blind, placebo-controlled study will evaluate the safety and
efficacy of RoActemra/Actemra (tocilizumab) in patients with ankylosing spondylitis (AS) who
have failed treatment with non-steroidal anti-inflammatory drugs and are naïve to tumor
necrsos factor (TNF) antagonist therapy. In Part 1 of the study, patients will be randomized
to receive either RoActemra/Actemra 8 mg/kg intravenously (IV) or placebo every 4 weeks for
12 weeks. In Part 2, patients will be randomized to receive RoActemra at either 8 mg/kg or 4
mg/kg IV or placebo every 4 weeks for 24 weeks. The double-blind treatment period will be
followed by open-label treatment with RoActemra/Actemra 8 mg/kg iv every 4 weeks until Week
208 for all patients. Anticipated time on study treatment is 208 weeks.
Study of the Safety, Tolerability, and Bioactivity of Tocilizumab On Patients With Non-infectious UVEITIS: The STOP-UVEITIS Study [Not yet recruiting]
In the STOP-UVEITIS study, we propose to evaluate the safety, tolerability, and bioactivity
of two doses of Tocilizumab (4mg/kg and 8mg/kg), administered monthly, in patients with
non-infectious intermediate, posterior, or panuveitis.
A Study of RoActemra/Actemra (Tocilizumab) Versus Adalimumab in Combination With Methotrexate (MTX) in Patients With Moderate to Severe Active Rheumatoid Arthritis And an Inadequate Response to Treatment With Only One Tumor Necrosis Factor (TNF)-Inhibitor [Terminated]
This randomized, parallel-group study will assess the efficacy and safety of
RoActemra/Actemra (tocilizumab) versus adalimumab, both in combination with methotrexate
(MTX) in patients with moderate to severe active rheumatoid arthritis. Patients, already
treated with MTX at stable doses, will be randomized to receive either RoActemra/Actemra 8
mg/kg intravenously (IV) every 4 weeks or adalimumab 40 mg subcutaneous (SC) every 2 weeks.
All patients will receive methotrexate (10-25 mg weekly) and folate (at least 5 mg weekly).
The anticipated time on study treatment is 24 weeks.
A Study in Patients With Moderate to Severe Active Rheumatoid Arthritis Comparing Different Infusion Durations of RoActemra/Actemra (Tocilizumab) Treatment [Completed]
This multi-center, randomized, parallel-group, active-controlled, open-label study will
evaluate the safety and efficacy of a shortened RoActemra/Actemra (tocilizumab) infusion
time compared to the normal infusion time. Patients will be randomized to 8 mg/kg
RoActemra/Actemra infusion of 31 minutes every 4 weeks or to RoActemra/Actemra 8 mg/kg
infusion of 60 minutes every 4 weeks. The anticipated time on study treatment is 24 weeks.
Reports of Suspected Actemra (Tocilizumab) Side Effects
Pneumonia (118),
Death (106),
Arthralgia (95),
Sepsis (71),
Interstitial Lung Disease (67),
Drug Ineffective (63),
Pain (63),
Pyrexia (60),
Fall (57),
Pain in Extremity (56), more >>
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Page last updated: 2017-09-19
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