Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Roche Products Ltd. Please contact Roche Drug Safety Centre by emailing firstname.lastname@example.org or calling +44 (0)1707 367554.
Rheumatoid Arthritis (RA)
RoACTEMRA, in combination with methotrexate (MTX), is indicated for:
- the treatment of severe, active and progressive rheumatoid arthritis (RA) in adults not previously treated with MTX.
- the treatment of moderate to severe active RA in adult patients who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists.
In these patients, RoACTEMRA can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.
RoACTEMRA has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function when given in combination with MTX.
Giant Cell Arteritis (GCA)
RoActemra is indicated for the treatment of Giant Cell Arteritis (GCA) in adult patients.
Please refer to the SmPC for further information
Systemic juvenile idiopathic arthritis (sJIA)
RoACTEMRA is indicated for the treatment of active sJIA in patients 1 year of age* and older, who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids. RoActemra can be given as monotherapy (in case of intolerance to MTX or where treatment with MTX is inappropriate) or in combination with MTX.
Juvenile idiopathic polyarthritis (pJIA)
RoACTEMRA in combination with methotrexate (MTX) is indicated for the treatment of juvenile idiopathic polyarthritis (pJIA; rheumatoid factor positive or negative and extended oligoarthritis) in patients 2 years of age and older*, who have responded inadequately to previous therapy with MTX. RoActemra can be given as monotherapy in case of intolerance to MTX or where continued treatment with MTX is inappropriate.
* The ages shown above for sJIA and pJIA relates to SPC for RoACTEMRA pre-filled syringe. Please refer to the SPC for RoACTEMRA IV or pre-filled pen for age recommendations for these alternative formulations
- RoACTEMRA Summary of Product Characteristics.
Date of preparation: September 2021