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RoActemra (tocilizumab) - patient safety update

RoActemra, for Rheumatoid arthritis, Juvenile idiopathic arthritis and Giant cell arteritis from Roche Products Limited

The Medicines and Healthcare products Regulatory Agency (MHRA) have issued a warning that there is a rare risk of serious liver injury including cases requiring transplantation in patients taking tocilizumab, brand name RoActemra.

RoActemra is used to treat rheumatoid arthritis, giant cell arteritis and juvenile idiopathic arthritis.

The advice to clinicians is that the levels of the enzymes (chemicals produced by the body that speed up reactions) alanine aminotransferase (ALT) and aspartate aminotransferase (AST) should be measured before starting treatment with tocilizumab. These enzymes should be monitored every 4–8 weeks for the first 6 months of treatment followed by every 12 weeks thereafter. Serious liver injury has been reported on treatment with tocilizumab from 2 weeks to more than 5 years after initiation.

You can follow developments on RoActemra by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

About RoActemra (source EMA)
RoActemra is a medicine used to treat:
  • adults with severe rheumatoid arthritis that is getting worse in patients who have not been previously treated with a medicine called methotrexate;
  • adults with moderate to severe active rheumatoid arthritis whose previous treatments with disease modifying antirheumatic drugs (DMARDs), such as methotrexate or medicines known as tumour necrosis factor (TNF) blockers, have not worked well or were not tolerated;
  • children from 1 year of age with active systemic juvenile idiopathic arthritis in whom other treatments (with anti-inflammatory medicines called NSAIDs and corticosteroids) have not worked well enough;
  • children from 2 years of age with juvenile idiopathic polyarthritis in whom treatment with methotrexate has not worked well enough.
RoActemra is used in combination with methotrexate for these conditions but it can be used on its own in patients for whom methotrexate is inappropriate.

RoActemra is also used to treat adults with giant cell arteritis, a disease in which arteries, usually of the head, are swollen.

RoActemra can also be used in adults and children from 2 years of age for the treatment of severe or life-threatening cytokine release syndrome (CRS, a condition that can cause nausea, vomiting, pain and low blood pressure). CRS is a side effect of certain cancer treatments and RoActemra is used for CRS caused by chimeric antigen receptors (CAR) T-cell medicines.

RoActemra contains the active substance tocilizumab.

The active substance in RoActemra, tocilizumab, is a monoclonal antibody, a type of protein that has been designed to recognise and attach to a specific target (called an antigen) in the body. Tocilizumab attaches to the receptor for a messenger molecule or ‘cytokine’ called interleukin‑6. This messenger is involved with inflammation and is found at high levels in patients with rheumatoid arthritis, systemic juvenile idiopathic arthritis, juvenile idiopathic polyarthritis, giant cell arteritis and CRS. By preventing interleukin‑6 attaching to its receptors, tocilizumab reduces the inflammation and other symptoms of these diseases.

RoActemra was first made available in the EU in 2009. It is manufactured by Roche.

Sources
European Medicines Agency website page for RoActemra
Accessed 19/07/19
Links available in full article

MHRA warning on RoActemra

Reporting of suspected adverse reactions

Reporting suspected adverse reactions (side effects) after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals or patients are asked to report any suspected adverse reactions via the Yellow Card Scheme at yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store.


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