Rheumatoid arthritis (specialist use only)
▶BY INTRAVENOUS INFUSION
▶Adult: 1 g, then 1 g after 2 weeks, consult product
literature for information on retreatment
Non-Hodgkin’s lymphoma (specialist use only) | Chronic
lymphocytic leukaemia (specialist use only) |
Granulomatosis with polyangiitis and microscopic
polyangiitis (specialist use only)
▶BY INTRAVENOUS INFUSION
▶Adult: (consult product literature)
Non-Hodgkin’s lymphoma (specialist use only)
▶BY SUBCUTANEOUS INJECTION
▶Adult: (consult product literature)
Pemphigus vulgaris (specialist use only)
▶BY INTRAVENOUS INFUSION
▶Adult: 1 g, then 1 g after 2 weeks; maintenance 0.5 g, at
months 12 and 18, and then every 6 months thereafter
if needed, consult product literature for the treatment
of relapse
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GENERAL CONTRA-INDICATIONS
Severe infection
SPECIFIC CONTRA-INDICATIONS
▶When used for granulomatosis with polyangiitis and microscopic
polyangiitis, pemphigus vulgaris, or rheumatoid arthritis Severe
heart failure. severe, uncontrolled heart disease
CONTRA-INDICATIONS, FURTHER INFORMATION
For full details on contra-indications, consult product
literature.
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GENERAL CAUTIONS History of cardiovascular disease;
exacerbation of angina, arrhythmia, and heart failure have
been reported. patients receiving cardiotoxic
chemotherapy; exacerbation of angina, arrhythmia, and
heart failure have been reported. pre-medication
recommended to minimise adverse reactions (consult
product literature). predisposition to infection. transient
hypotension occurs frequently during infusion (anti-
hypertensives may need to be withheld for 12 hours before
infusion)
SPECIFIC CAUTIONS
▶When used for granulomatosis with polyangiitis and microscopic
polyangiitis, or pemphigus vulgaris Pneumocystis jirovecii
pneumonia—consult product literature for prophylaxis
requirements
CAUTIONS, FURTHER INFORMATION For full details on
cautions, consult product literature or local treatment
protocol.
▶Hepatitis B infection and reactivation Hepatitis B infection and
reactivation (including fatal cases) have been reported in
patients taking rituximab. Patients with positive hepatitis
B serology should be referred to a liver specialist for
monitoring and initiation of antiviral therapy before
treatment initiation; treatment should not be initiated in
patients with evidence of current hepatitis B infection
until the infection has been adequately treated. Patients
should be closely monitored for clinical and laboratory
signs of active hepatitis B infection during treatment and
for up to a year following the last infusion (consult product
literature).
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NICE decisions
▶Rituximab in combination with glucocorticoids for treating
anti-neutrophil cytoplasmic antibody-associated vasculitis
(March 2014) NICE TA308
▶With intravenous use This NICE guidance was issued for
rituximab by intravenous infusion. Rituximab, in
combination with glucocorticoids, is recommended as an
option for inducing remission in adults with anti-
neutrophil cytoplasmic antibody [ANCA]-associated
vasculitis (severely active granulomatosis with polyangiitis
[Wegener’s] and microscopic polyangiitis), only if:
Immune system and malignant disease
. further cyclophosphamide treatment would exceed the
maximum cumulative cyclophosphamide dose, or
. cyclophosphamide is contra-indicated or not tolerated,
or
. the patient has not completed their family, and
treatment with cyclophosphamide may materially affect
their fertility, or
. the disease has remained active or progressed despite a
course of cyclophosphamide lasting 3–6 months or
. the patient has had uroepithelial malignancy.
www.nice.org.uk/guidance/ta308
▶Adalimumab, etanercept, infliximab, rituximab, and
abatacept for the treatment of rheumatoid arthritis after the
failure of a TNF inhibitor (August 2010) NICE TA195
▶With intravenous use This NICE guidance was issued for
rituximab by intravenous infusion. Rituximab, in
combination with methotrexate, is recommended as an
option for the treatment of severe active rheumatoid
arthritis in adults who have had an inadequate response
to, or are intolerant of, other disease-modifying
antirheumatic drugs (DMARDs), including at least 1
tumour necrosis factor (TNF) inhibitor. Repeat courses of
rituximab should be given no more frequently than every
6 months, and should only be continued if an adequate
response is achieved and maintained.
www.nice.org.uk/guidance/ta195
▶Rituximab for the first-line treatment of stage III-IV follicular
lymphoma (January 2012) NICE TA243
▶With intravenous use This NICE guidance was issued for
rituximab by intravenous infusion. Rituximab, in
combination with:
. cyclophosphamide, vincristine and prednisolone (CVP);
. cyclophosphamide, doxorubicin, vincristine and
prednisolone (CHOP);
. mitoxantrone, chlorambucil and prednisolone (MCP);
. cyclophosphamide, doxorubicin, etoposide,
prednisolone and interferon-alfa (CHVPi); or
. chlorambucil
is recommended as an option for the treatment of
symptomatic stage III and IV follicular lymphoma in
previously untreated patients.
www.nice.org.uk/guidance/ta243
▶Rituximab for the treatment of relapsed or refractory stage III
or IV follicular non-Hodgkin’s lymphoma (February 2008)
NICE TA137
▶With intravenous use This NICE guidance was issued for
rituximab by intravenous infusion. Rituximab, in
combination with chemotherapy, is recommended as an
option for the induction of remission in patients with
relapsed stage III or IV follicular non-Hodgkin’s
lymphoma. Rituximab monotherapy, as maintenance
therapy, is recommended as an option for the treatment of
patients with relapsed stage III or IV follicular non-
Hodgkin’s lymphoma in remission induced with
chemotherapy (with or without rituximab). Rituximab
monotherapy is recommended as an option for the
treatment of patients with relapsed or refractory stage III
or IV follicular non-Hodgkin’s lymphoma, when all
alternative treatment options have been exhausted (that
is, if there is resistance to or intolerance of chemotherapy).
www.nice.org.uk/guidance/ta137
▶Rituximab for the treatment of relapsed or refractory chronic
lymphocytic leukaemia (July 2010) NICE TA193
▶With intravenous use This NICE guidance was issued for
rituximab by intravenous infusion. Rituximab in
combination with fludarabine and cyclophosphamide is
recommended as a treatment option for patients 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 it was
in the context of a clinical trial, at a dose lower than the
dose currently licensed for chronic lymphocytic
leukaemia or with chemotherapy other than fludarabine
and cyclophosphamide.
Rituximab in combination with fludarabine and
cyclophosphamide is recommended only in the context of
research for patients with relapsed or refractory chronic
lymphocytic leukaemia that has previously been treated
with rituximab, unless rituximab has been given as
specified above.
www.nice.org.uk/guidance/ta193
▶Rituximab for the first-line maintenance treatment of
follicular non-Hodgkin’s lymphoma (June 2011) NICE TA226
▶With intravenous use This NICE guidance was issued for
rituximab by intravenous infusion. Rituximab
maintenance therapy is recommended as an option for the
treatment of patients with follicular non-Hodgkin’s
lymphoma that has responded to first-line induction
therapy with rituximab in combination with
chemotherapy.
www.nice.org.uk/guidance/ta226
▶Rituximab for the first-line treatment of chronic lymphocytic
leukaemia (July 2009) NICE TA174
▶With intravenous use This NICE guidance was issued for
rituximab by intravenous infusion. Rituximab, in
combination with fludarabine and cyclophosphamide, is
recommended as an option for the first-line treatment of
chronic lymphocytic leukaemia.
www.nice.org.uk/guidance/ta174
▶Idelalisib for treating chronic lymphocytic leukaemia (October
2015) NICE TA359
Rituximab, in combination with idelalisib, is
recommended as an option for treatment in adults:
. who have untreated chronic lymphocytic leukaemia or
. who have chronic lymphocytic leukaemia when the
disease has been treated but has relapsed within
24 months and
. if the manufacturer provides idelalisib with the discount
agreed in the simple discount agreement.
Patients who are already receiving idelalisib should
continue treatment until they or their clinician consider it
appropriate to stop.
www.nice.org.uk/guidance/ta359
▶Venetoclax with rituximab for previously treated chronic
lymphocytic leukaemia (February 2019) NICE TA561
Venetoclax (Venclyxto ®) with rituximab is recommended,
within its marketing authorisation, as an option for
treating chronic lymphocytic leukaemia in adults who
have had at least 1 previous therapy. It is recommended
only if the manufacturer provides it according to the
commercial arrangement.
www.nice.org.uk/guidance/ta561
Scottish Medicines Consortium (SMC) decisions
SMC No. 894/13
▶With intravenous use The Scottish Medicines Consortium has
advised (August 2013) that Rituximab (MabThera ®) is
accepted for restricted use within NHS Scotland, in
combination with glucocorticoids for the induction of
remission in adult patients with severe, active
granulomatosis with polyangiitis (Wegener’s) and
microscopic polyangiitis. It is restricted to use in patients
who have relapsed following treatment with
cyclophosphamide or who are intolerant to or unable to
receive cyclophosphamide.
SMC No. 975/14
▶With subcutaneous use The Scottish Medicines Consortium
has advised (June 2014) that subcutaneous rituximab
(MabThera) ® is accepted for restricted use within NHS
Scotland, in accordance with UK licensing, except in the
maintenance setting, where use is restricted to patients
who have responded to induction therapy with rituximab
plus chemotherapy.
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