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)
Clinical Notes: FDA Broadens Use for JIA Drug
Source: MedPage Today Rheumatology [2013.05.05]
(MedPage Today) -- The arthritis drug tocilizumab was approved to treat polyarticular juvenile idiopathic arthritis (JIA) in children as young as 2. Also this week: more SARS-like virus infections strike in Saudi Arabia.
In The Most Severe Form Of Rheumatoid Arthritis, Enzyme-Activating Antibodies Identified As A Marker
Source: Health News from Medical News Today [2013.05.25]
In a series of lab experiments designed to unravel the workings of a key enzyme widely considered a possible trigger of rheumatoid arthritis, researchers at Johns Hopkins have found that in the most severe cases of the disease, the immune system makes a unique subset of antibodies that have a disease-promoting role. Reporting in the journal Science Translational Medicine online, the Johns Hopkins team describes how it found the novel antibodies to peptidylarginine deiminase 4, or PAD4, in blood samples from people with aggressive inflammation and connective tissue damage...
Fat Triggers Rheumatoid Arthritis: Discovery Paves Way For New Gene Therapies, Treatments
Source: Arthritis / Rheumatology News From Medical News Today [2013.05.13]
Scientists have discovered that fat cells in the knee secrete a protein linked to arthritis, a finding that paves the way for new gene therapies that could offer relief and mobility to millions worldwide. ar "We found that fat in the knee joints secretes a protein called pro-factor D which gives rise to another protein known as factor D that is linked to arthritis," said Nirmal Banda, Ph.D...
Women Who Smoke May Have Higher Risk for Rheumatoid Arthritis
Source: MedicineNet Rheumatoid Arthritis Specialty [2013.04.29]
Title: Women Who Smoke May Have Higher Risk for Rheumatoid Arthritis
Category: Health News
Created: 4/26/2013 12:35:00 PM
Last Editorial Review: 4/29/2013 12:00:00 AM
Risk For Rheumatoid Arthritis Increased By Smoking
Source: Arthritis / Rheumatology News From Medical News Today [2013.04.23]
Number of cigarettes smoked a day and the number of years a person has smoked both increase the risk of rheumatoid arthritis (RA), finds research in BioMed Central's open access journal Arthritis Research & Therapy. The risk decreases after giving up smoking but, compared to people who have never smoked, this risk is still elevated 15 years after giving up...
Published Studies Related to Actemra (Tocilizumab)
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.
IL-6 receptor inhibition positively modulates bone balance in rheumatoid
arthritis patients with an inadequate response to anti-tumor necrosis factor
therapy: biochemical marker analysis of bone metabolism in the tocilizumab
RADIATE study (NCT00106522). [2012]
rheumatoid arthritis (RA)... CONCLUSIONS: In anti-tumor necrosis factor-refractory patients, tocilizumab
Efficacy of tocilizumab in patients with moderate to severe active rheumatoid
arthritis and a previous inadequate response to disease-modifying antirheumatic
drugs: the ROSE study. [2012]
analysed... CONCLUSIONS: This study demonstrated the efficacy of tocilizumab in improving
Tocilizumab monotherapy reduces arterial stiffness as effectively as etanercept or adalimumab monotherapy in rheumatoid arthritis: an open-label randomized controlled trial. [2011.10]
OBJECTIVE: To compare the respective effects of tocilizumab (TCZ) monotherapy, etanercept (ETN) monotherapy, and adalimumab (ADA) monotherapy on arterial stiffness in patients with rheumatoid arthritis (RA) in an open-label, randomized controlled trial... CONCLUSION: The 3 types of monotherapy limited arterial stiffness in patients with RA to a similar extent.
Disease-drug-drug interaction involving tocilizumab and simvastatin in patients with rheumatoid arthritis. [2011.05]
In rheumatoid arthritis (RA), interleukin-6 (IL-6) concentration is elevated, which may cause reduced cytochrome P450 (CYP) activity and increased exposure (peak plasma concentration and area under the plasma concentration-vs.-time curve (AUC)) to certain drugs... The study findings suggest that caution should be exercised when starting tocilizumab in RA patients who are taking simvastatin.
Clinical Trials Related to Actemra (Tocilizumab)
A Study of Administration of RoActemra/Actemra (Tocilizumab) by Auto-injector Vs. Pre-filled Syringe in Healthy Volunteers [Recruiting]
This open-label, multi-center study will compare the bioavailability of RoActemra/Actemra
(tocilizumab) administration by auto-injector versus pre-filled syringe in healthy
volunteers. Healthy volunteers will receive a single dose of RoActemra/Actemra
(tocilizumab). The anticipated time of study duration is 28 days.
A Study of RoActemra/Actemra (Tociliumab) in Patients With Ankylosing Spondylitis Who Have Had an Inadequate Response to Previous TNF Antagonist Therapy [Not yet recruiting]
This randomized, double-blind, placebo-controlled study will evaluate the safety and
efficacy of RoActemra/Actemra (tocilizumab) in patients with ankylosing spondylitis who have
had an inadequate response to previous TNF antagonist therapy. Patients will be randomized
to receive RoActemra/Actemra at a dose of either 8 mg/kg or 4mg/kg intravenously (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 104 for all
patients. Anticipated time on study treatment is 104 weeks.
A Study of RoActemra/Actemra (Tociliumab) in Patients With Ankylosing Spondylitis Who Have Failed Treatment [Not yet recruiting]
This randomized, double-blind, placebo-controlled study will evaluate the safety and
efficacy of RoActemra/Actemra (tociliumab) in patients with ankylosing spondylitis who have
failed treatment with non-steroidal anti-inflammatory drugs and are naïve to 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.
A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Disease-Modifying Antirheumatic Drugs (DMARDs) (ALABASTER) [Recruiting]
This open-label, single arm study will assess the safety and efficacy of RoActemra/Actemra
(tocilizumab) in combination with methotrexate in patients with active moderate to severe
rheumatoid arthritis who have an inadequate response to disease-modifying antirheumatic
drugs (DMARDs). Patients will receive RoActemra/Actemra at a dose of 8 mg/kg (maximum 800
mg) intravenously every 4 weeks for a total of 6 infusions. Methotrexate will be continued
at a stable dose. Anticipated time on study treatment is 24 weeks.
A Study of RoActemra/Actemra (Tocilizumab) Given Subcutaneously in Combination With Traditional DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis [Recruiting]
This randomized, parallel-group, placebo-controlled, multicenter study will evaluate the
reduction in disease activity and the safety of RoActemra/Actemra (tocilizumab) in
combination with traditional disease-modifying antirheumatic drugs (DMARDs) in patients with
active moderate to severe rheumatoid arthritis. In the double-blind part of the study,
patients will be randomized to receive either 162 mg RoActemra/Actemra or placebo
subcutaneously every 2 weeks for 24 weeks using a pre-filled syringe. In the open-label part
of the study, patients will be randomized to receive 162 mg RoActemra/Actemra subcutaneously
every 2 weeks from Week 24 to Week 96 using a pre-filled syringe or an autoinjector.
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: 2013-05-25
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