8.2.4. Other immunomodulating drugs
Restrictions:
Restricted to specialist use only in combination with a rituximab or cyclophosphamide regimen, for the treatment of adult patients with severe, active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA).
Restrictions:
Restricted to specialist use only. Restricted to use by consultant urologists.
Restrictions:
Formulary indications and restrictions on use are detailed in the Prescribing Notes below.
Prescribing Notes:
Muliple myeloma
For regional protocols click here [NHS network access required]
- Use for the third line treatment of multiple myeloma in combination with dexamethasone, or for patients who have received at least one prior therapy, is restricted in accordance with regional protocol.
- Adult patients with previously untreated multiple myeloma who are not eligible for transplant. It is restricted to specialist use in accordance with regional protocol for use in patients unsuitable for thalidomide-containing regimens.
- Use as monotherapy for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation (ASCT) is restricted to use in accordance with regional protocol.
- Use in combination with dexamethasone for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant, and are suitable for thalidomide-containing regimen (off label use as approved by NCMAG).
Lymphoma
- In combination with rituximab (anti-CD20 antibody) for the treatment of adult patients with previously treated follicular lymphoma (Grade 1 to 3a) is restricted to specialist use in accordance with regional protocol click here [NHS network access required].
Transfusion-dependent anaemia
Use for the treatment of patients with transfusion-dependent anaemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate is restricted in accordance with regional protocol [NHS network access required].
Non-formulary indications:
- Treatment of adult patients with relapsed or refractory mantle cell lymphoma is not recommended by SMC and remains non-formulary.
- As combination therapy with bortezomib and dexamethasone for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant.
Restrictions:
The use in combination with other chemotherapy for the treatment of high-grade resectable non-metastatic osteosarcoma after macroscopically complete surgical resection is restricted to use in accordance with regional protocol.
Prescribing Notes:
For relevant SMC advice for osteosarcoma click here
Restrictions:
- Restricted to specialist use in accordance with regional protocols for use in combination with dexamethasone for the treatment of adult patients with multiple myeloma who have received one prior treatment regimen including lenalidomide, and where more effective alternatives are not suitable (as approved by NCMAG, click here for regional protocol, NHS Network access required).
- Restricted to specialist use in accordance with regional protocols when used in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior treatment regimen including lenalidomide (as approved by NCMAG, click here for regional protocol, NHS Network access required).
- Restricted to specialist use in accordance with regional protocols for use in combination with dexamethasone for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy. To access regional protocol please click here [NHS network access required].
Restrictions:
Restricted to specialist use in accordance with regional protocol for:
- Treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior lines of systemic therapies, at least one of them given for unresectable locally advanced or metastatic disease.
Restrictions:
Restricted to specialist use only. Treatment of multiple myeloma is restricted to use in accordance with regional protocol.