| Formulary Chapter 8: Malignant disease and immunosuppression - Full Chapter
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| 08.02.03 |
Anti-lymphocyte monoclonal antibodies |
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Rituximab
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Formulary
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NICE have approved rituximab for the following indications:
- First line use in NHL in combination with CHOP.
- Maintenance therapy in follicular NHL that has responded to first line induction therapy with rituximab in combination with chemotherapy.
- Stage III and IV follicular lymphoma in previously untreated people.
- Replased or refractory follicular NHL.
- Post-transplant lymphoproliferative disease.
- First line use in CLL in combination with fludarabine and cyclophosphamide.
- Combination with fludarabine and cyclophosphamide for relapsed or refractory CLL.
- Autoimmune haematological conditions (where conventional treatments have failed)
- Autoimmune haemolytic anaemia (AIHA), Evans syndrome, pure red cell aplasia (PRCA), & thrombocytopenia purpura (TTP).
- Combination with bendamustine for first line use in CLL (Binet stage B or C) in patients for whom fludarabine combination chemotherapy is not appropriate.Vasculitis (including Wegener’s granulomatosis in adults and children) that has not responded adequately to conventional treatment (e.g. corticosteroids, cyclophosphamide) in line with NICE and additional NHS England criteria.
NECDAG have approved rituximab for the following indications:
- Treatment of NLPHL
- Newly diagnosed mantle cell NHL in patients aged
- In combination with bendamustine for patients with CLL not fit for FCR chemotherapy or for patients who relapse within 2 years of FCR chemotherapy and not fit for alemtuzumab.
- Salvage chemotherapy for patients relapsing > 12 months post 1st line therapy with R-CHOP.
- Standard NHL induction regimen in patients who cannot be given an anthracycline. Rituximab with other chemotherapy regimens is an alternative treatment option e.g. DECC, CVP for this group of patients, as part of their first line therapy. Also in addition to the MACOP-B regimen for the small number of young patients with DLBCL, subtype Primary Mediastinal B cell Lymphoma.
- Treatment of Hairy Cell Leukaemia (HCL) or HCL varian (HCL-v) who:
- relapse early after purine analogue therapy (< 2 years post treatment)
- are refractory to purine analogues.
NTAG have approved rituximab for the following indications:
- Treatment of immune (idiopathic) thrombocytopenic purpura (ITP) in adults and children.
NHS England have approved rituximab for the following indications:
- Treatment of immunobullous disease
- Steroid Sensitive Nephrotic Syndrome in Children
- Steroid Resistant Nephrotic Syndrome in Children
- Acquired Haemophilia
- Cytopenia Complicating Primary Immunodeficiency
- Maintenance single agent therapy in FL, mantle cell lymphoma, marginal zone lymphoma and lymphoplasmacytic lymphoma in line with (SSC1434) - 1.4g solution for sc injection.
- Second line treatment for anti-NMDAR auto-immune encephalitis (all ages)
- Treatment of refractory myasthenia gravis in a specialised neuroscience centre
- Treatment of nodal/paranodal antibody positive inflammatory/autoimmune neuropathy in adults and post-pubescent children
- Treatment of IgM paraproteinaemic demyelinating peripheral neuropathy in adults
- Treatment of Thrombotic Thrombocytopenic Purpura (TTP)
- Treatment of Idiopathic Membranous Nephropathy (IMN)
North of Tyne, Gateshead and North Cumbria APC have approved rituxumab for the following indication:
- Autoimmune hepatitis in patients who have failed or who are intolerant of therapies such as azathioprine, mycophenolate mofetil, corticosteroids and tacrolimus.
For musculoskeletal indications see chapter 10
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Key |
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Cytotoxic Drug
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Controlled Drug
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High Cost Medicine
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NHS England |
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Homecare |
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CCG |
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Traffic Light Status Information
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Drugs for hospital use only. The responsibility for initiation and monitoring treatment should rest with an appropriate hospital clinician and the drug should be supplied through the hospital throughout the duration of treatment.
In some very exceptional circumstances (e.g. due to distance from the hospital, storage, supply or mobility/transport problems) it may be appropriate for the GP to be asked to prescribe a Red drug. This should be negotiated on an individual patient basis and should only be done with the GP’s prior informed agreement where the roles of the GP and hospital services are clearly defined and agreed. The GP should not feel under pressure to prescribe in these circumstances.
For all RED drugs automatically added to the formulary in response to a positive NICE TA: Prescribers need to ensure that local Trust new drug governance procedures and pharmacy processes are followed before any prescribing. |
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Drugs initiated by hospital specialist, but where continuing treatment by GPs may be appropriate under a shared care arrangement.
The specialist should send the GP a copy of the shared care agreement to sign. The GP should sign the shared care agreement, or indicate they do not want to be part of such an agreement, and return a copy back to the specialist. Shared care guidelines are available or are being developed for most of the drugs listed as Amber.
If no shared care guideline is available, the hospital specialist should provide the patient’s GP with sufficient information and support to allow treatment to be continued and managed safely in primary care. |
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Drugs normally recommended or initiated by a specialist (hospital or GP with an extended role https://www.rcgp.org.uk/gpwer), but can be safely maintained in primary care with very little or no monitoring required. In some cases there may be a further restriction for use outlined - these will be defined in each case. Provision of additional information, or an information leaflet, may be appropriate in some cases to facilitate continuing treatment by GPs. |
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Drugs where prescribing by GPs is appropriate. Can be initiated and prescribed in all care settings, and if appropriate, discontinued without recourse to secondary care. |
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NOT APPROVED: Drugs that have been considered by NTAG or the NENC ICB Medicines Subcommittee (or other approved body) and are not approved for prescribing within the North East and North Cumbria. |
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UNDER REVIEW: drugs whose current formulary status or RAG status is currently under review. |
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NOT REVIEWED: Drugs that haven not been reviewed yet. This usually means that an application is in progress. These drugs are not normally considered appropriate for prescribing in the North East and North Cumbria until such time that a decision is taken on their formulary status. |
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(Bavencio®)
