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Actemra (Tocilizumab) - Summary

 
 



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:

  • 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.
  • Invasive fungal infections, including candidiasis, aspergillosis, and pneumocystis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.
  • 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].

 

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.


See all Actemra indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Actemra (Tocilizumab)

Positive top-line results from Phase 3 trial of baricitinib in moderate to severe rheumatoid arthritis
Source: Arthritis / Rheumatology News From Medical News Today [2014.12.11]
Eli Lilly and Company and Incyte Corporation have announced that the Phase 3 RA-BEACON study of the investigational medicine baricitinib met its primary endpoint of improved ACR20 response compared...

Patient Story: Rheumatoid Arthritis and Pregnancy
Source: MedicineNet Arthritis Specialty [2014.12.09]
Title: Patient Story: Rheumatoid Arthritis and Pregnancy
Category: Doctor's Views
Created: 1/26/2012 12:00:00 AM
Last Editorial Review: 12/9/2014 12:00:00 AM

Rheumatoid Arthritis: Which Patients Do Best?
Source: MedicineNet Rheumatoid Arthritis Specialty [2014.12.09]
Title: Rheumatoid Arthritis: Which Patients Do Best?
Category: Doctor's Views
Created: 1/19/2012 12:00:00 AM
Last Editorial Review: 12/9/2014 12:00:00 AM

5 Potential Complications of Untreated Rheumatoid Arthritis
Source: MedicineNet Anemia Specialty [2014.12.01]
Title: 5 Potential Complications of Untreated Rheumatoid Arthritis
Category: Doctor's Views
Created: 1/24/2012 12:00:00 AM
Last Editorial Review: 12/1/2014 12:00:00 AM

Rheumatoid Arthritis: Questions for Your Doctor
Source: MedicineNet Arthritis Specialty [2014.12.01]
Title: Rheumatoid Arthritis: Questions for Your Doctor
Category: Doctor's Views
Created: 8/6/2001 12:00:00 AM
Last Editorial Review: 12/1/2014 12:00:00 AM

more news >>

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

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.

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

more studies >>

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 na´ve 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.

more trials >>

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 >>


Page last updated: 2014-12-11

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