Rituximab

Red

Brand Name(s):Mabthera
Truxima
Rixathon

Indication:Chronic lymphocytic leukaemia

Inflammatory Arthritis & Connective Tissue Disease for Adult Services, over 16

Aggressive non-Hodgkin’s lymphoma (symptomatic stage III and IV
follicular lymphoma)

Vasculitis (off-label use)

Systemic lupus erythematosus (SLE).(off-label use)

Pemphigus Vulgaris (PV).

Rationale:1,2,3

Considered:Feb-09

Review Date:Jul-22

Comments:
MHRA Drug Safety Update
Summary
Screen all patients for HBV before starting treatment with rituximab
Patients with active hepatitis B disease should not be treated with rituximab Refer patients with positive hepatitis B serology (but no active disease) to a liver disease expert before starting treatment with rituximab. These patients should be monitored and managed following local medical standards to prevent HBV reactivation.
further information at:http://www.mhra.gov.uk/home/groups/plp/documents/drugsafetymessage/con344535.pdf
Nov 13
…………………………
1.1 Rituximab in combination with fludarabine and cyclophosphamide is recommended as a treatment option for people with relapsed or refractory chronic lymphocytic leukaemia except when the condition:
* is refractory to fludarabine (that is, it has not responded to fludarabine or has relapsed within 6 months of treatment) or
* has previously been treated with rituximab, unless:
in the context of a clinical trial, at a dose lower than the dose currently licensed for chronic lymphocytic leukaemia or
in the context of a clinical trial, in combination with chemotherapy other than fludarabine and cyclophosphamide.

1.2 Rituximab in combination with fludarabine and cyclophosphamide is recommended only in the context of research for people with relapsed or refractory chronic lymphocytic leukaemia that has previously been treated with rituximab, unless rituximab has been given as specified in section 1.1.

1.3 Rituximab in combination with chemotherapy other than fludarabine and cyclophosphamide is recommended only in the context of research for people with relapsed or refractory chronic lymphocytic leukaemia.
1.4 People with chronic lymphocytic leukaemia that is refractory to fludarabine (as defined in section 1.1), who are currently receiving rituximab in combination with fludarabine and cyclophosphamide should have the option to continue treatment until they and their clinicians consider it appropriate to stop.

1.5 People with chronic lymphocytic leukaemia that has previously been treated with rituximab other than as specified in section 1.1, who are currently receiving rituximab in combination with
fludarabine and cyclophosphamide and people who are currently receiving rituximab in combination with other chemotherapy regimens that is not in the context of research, should have the option to continue treatment until they and their clinicians consider it appropriate to stop.

NICE TA 193
Rituximab for the treatment of relapsed or refractory chronic lymphocytic leukaemia July 2010

Rituximab in combination with fludarabine and cyclophosphamide is recommended as an option for the first-line treatment of chronic lymphocytic leukaemia in people for whom fludarabine in combination with cyclophosphamide is considered appropriate.

Rituximab in combination with chemotherapy agents other than fludarabine and cyclophosphamide is not recommended for the first-line treatment of chronic lymphocytic leukaemia.

NICE TA 174
Rituximab for the first-line treatment of chronic lymphocytic leukaemia July 2009