<p>Ruxience is a medicine used to treat the following blood cancers and inflammatory conditions:</p><p>• follicular lymphoma and diffuse large B cell non-Hodgkin’s lymphoma (two types of non-Hodgkin’s lymphoma, a blood cancer);</p><p>• chronic lymphocytic leukaemia (CLL, another blood cancer affecting white blood cells);</p><p>• severe rheumatoid arthritis (an inflammatory condition of the joints);</p><p>• granulomatosis with polyangiitis (GPA or Wegener’s granulomatosis) and microscopic polyangiitis (MPA), which are inflammatory conditions of the blood vessels;</p><p>• pemphigus vulgaris, a serious condition involving widespread blistering of the skin and lining of the mouth, nose, throat and genitals.</p><p>Depending on the condition it is used to treat, Ruxience may be given on its own, or with chemotherapy (cancer medicines) or medicines used for inflammatory disorders (methotrexate or a corticosteroid).</p><p>Ruxience contains the active substance rituximab.</p><p>Ruxience is a ‘biosimilar medicine’. This means that Ruxience is highly similar to another biological medicine (the ‘reference medicine’) that is already authorised in the EU. The reference medicine for Ruxience is MabThera. For more information on biosimilar medicines, see <a href="/en/biosimilar-medicines-overview" data-entity-type="node" data-entity-uuid="7a36e97f-a35c-4984-8565-7324e60db02b" data-entity-substitution="canonical"><span style='font-family:"Verdana",sans-serif;font-size:14px;line-height:115%;' lang="EN-US">here</span></a>.</p>
Therapeutic Indication
<div class="subsection mt-3-5"> <h3>Therapeutic indication</h3><p>Ruxience is indicated in adults for the following indications:</p> <p><strong>Non?Hodgkin’s lymphoma (NHL)</strong></p> <p>Ruxience is indicated for the treatment of previously untreated patients with stage III?IV follicular lymphoma in combination with chemotherapy.</p> <p>Ruxience maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy.</p> <p>Ruxience monotherapy is indicated for treatment of patients with stage III?IV follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy.</p> <p>Ruxience is indicated for the treatment of patients with CD20 positive diffuse large B cell non?Hodgkin’s lymphoma in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy.</p> <p><strong>Chronic lymphocytic leukaemia (CLL)</strong></p> <p>Ruxience in combination with chemotherapy is indicated for the treatment of patients with previously untreated and relapsed/refractory CLL. Only limited data are available on efficacy and safety for patients previously treated with monoclonal antibodies including rituximab or patients refractory to previous rituximab plus chemotherapy.</p> <p><strong>Rheumatoid arthritis</strong></p> <p>Ruxience in combination with methotrexate is indicated for the treatment of adult patients with severe active rheumatoid arthritis who have had an inadequate response or intolerance to other disease?modifying anti?rheumatic drugs (DMARD) including one or more tumour necrosis factor (TNF) inhibitor therapies.</p> <p>Ruxience 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 methotrexate.</p> <p>Granulomatosis with polyangiitis and microscopic polyangiitis</p> <p>Ruxience, in combination with glucocorticoids, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (Wegener’s) (GPA) and microscopic polyangiitis (MPA).</p> <p><strong>Pemphigus vulgaris</strong></p> <p>Ruxience is indicated for the treatment of patients with moderate to severe pemphigus vulgaris (PV).</p> </div>
Therapeutic Area (MeSH)
ATC Code
L01XC02
ATC Item
N/A
Pharmacotherapeutic Group
Antineoplastic agents
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| rituximab | N/A | rituximab |
EMA Name
Ruxience
Medicine Name
Ruxience
Aliases
N/ANo risk management plan link.
