DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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)

EU's CHMP Endorses New Indications for 2 Arthritis Drugs
Source: Medscape Medical News Headlines [2014.07.25]
The committee recommends tocilizumab for severe rheumatoid arthritis in adults not previously treated with methotrexate and adalimumab for active enthesitis-related arthritis.
International Approvals

Rheumatoid arthritis treatment set to change following research on inflammasomes
Source: Arthritis / Rheumatology News From Medical News Today [2014.07.04]
Patients with more or less severe forms of rheumatoid arthritis (RA) may have the same painful symptoms, but does this mean that the cause of their illness is the same?

Research on inflammasomes opens new therapeutic avenues for treatment of rheumatoid arthritis
Source: Arthritis / Rheumatology News From Medical News Today [2014.07.03]
Patients with more or less severe forms of rheumatoid arthritis (RA) may have the same painful symptoms, but does this mean that the cause of their illness is the same?

Rheumatoid Arthritis Early Symptoms
Source: MedicineNet Arthritis Specialty [2014.07.03]
Title: Rheumatoid Arthritis Early Symptoms
Category: Doctor's & Expert's views on Symptoms
Created: 6/24/2013 5:25:00 PM
Last Editorial Review: 7/3/2014 12:00:00 AM

Rheumatoid Arthritis - My Doctor Says I Need Remicade
Source: MedicineNet Rheumatoid Arthritis Specialty [2014.06.25]
Title: Rheumatoid Arthritis - My Doctor Says I Need Remicade
Category: eMedicineHealth Doctor's Perspective
Created: 1/6/2001 12:00:00 AM
Last Editorial Review: 6/25/2014 12:00:00 AM

more news >>

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.

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: 2014-07-25

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2014