NHS Greater Glasgow & Clyde Area Drug and Therapeutics Committee
Greater Glasgow and Clyde Prescribing
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8 Malignant disease and immunosuppression

8.2 Drugs affecting the immune response

8.2.1 Antiproliferative immunosuppressants

Total Formulary
AZATHIOPRINE

Restrictions: Restricted to specialist initiation. Azathioprine should only be used instead of mycophenolate for renal transplantation if there is a low perceived immunological risk.

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/4779.htm

MYCOPHENOLATE MOFETIL

Restrictions: Restricted to specialist initiation. Mycophenolate mofetil is restricted to specialist use in selected patients who are at high risk of organ transplant rejection. Mycophenolate mofetil injection is restricted to use on specialist advice in exceptional cases e.g. patients who are nil by mouth.

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/38696.htm

MYCOPHENOLIC ACID

Restrictions: Restricted to specialist initiation. Restricted to use by transplant specialists as part of an immunosuppressive regimen.

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/129179.htm

8.2.2 Corticosteroids and other immunosuppressants

Total Formulary
SIROLIMUS

Restrictions: Restricted to specialist use in specific patients with intolerance to calcineurin inhibitors.

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/106034.htm

TACROLIMUS

Restrictions: Restricted to specialist initiation. Tacrolimus preparations should be prescribed and dispensed by brand name to minimise the risk of inadvertent switching between products, which has been associated with previous reports of toxicity and graft rejection.

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/27585.htm

TACROLIMUS (MODIGRAF) (GRANULES)

Restrictions: Restricted to specialist initiation. Restricted to patients who are unable to swallow capsules or small changes in dosing increments.

Prescribing Notes:

Tacrolimus preparations should be prescribed and dispensed by brand name to minimise the risk of inadvertent switching between products, which has been associated with previous reports of toxicity and graft rejection.

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/208985.htm

BASILIXIMAB

Restrictions: Restricted to specialist use only. Restricted to specialist use in selected patients who are at high risk of renal transplant rejection or for kidneys expected to have significant ischaemic damage.

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/72819.htm

CICLOSPORIN

Prescribing Notes:

Formulations should not be substituted in individual patients due to varying bioavailability. Prescribe by brand name.

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/4783.htm

PREDNISOLONE

Restrictions: Excludes 25mg tablets

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/4258.htm

8.2.3 Anti-lymphocyte monoclonal antibodies

Total Formulary
ALEMTUZUMAB

Restrictions: Use for the treatment of B-cell chronic lymphontic leukaemia is restricted to specialist use according to regional protocol. Use for adults with relapsing-remitting multiple sclerosis (RRMS) with active disease is restricted to specialist use only.

Prescribing Notes:

Alemtuzumab for use in CLL is available on a named-patient basis.

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/106036.htm

OBINUTUZUMAB (GAZYVARO) (infusion)

Restrictions:

Restricted to specialist use in accordance with regional protocols for the following indications:

  • In combination with chlorambucil, obinutuzumab for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) and with comorbidities making them unsuitable for full-dose fludarabine based therapy (regional protocol)
  • In combination with bendmustine followed by obinutuzumab maintenance is indicated for the treatment of patients with follicular lymphoma who did not respond or who progressed during or up to six months after treatment with rituximab or a rituximab-containing regimen (in development).

BNF Link: https://www.medicinescomplete.com/mc/bnf/current/PHP34840-obinutuzumab.htm?q=obinutuzumab&t=search&ss=text&p=1#_hit

OFATUMUMAB

Restrictions:

Restricted to specialist use in accordance with regional protocol for the indication below:

  • Use in combination with chlorambucil or bendamustine for the treatment of patients with chronic lymphocytic leukaemia (CLL) who have not received prior therapy and who are not eligible for fludarabine-based therapy is restricted to specialist use in accordance with regional protocol in patients who would not be considered for bendamustine therapy and who would receive chlorambucil-based therapy

Prescribing Notes:

The treatment of adults with relapsed CLL in combination with fludarabine and cyclophosphamide is not recommended by SMC and is non-Formulary.

BNF Link: https://www.medicinescomplete.com/mc/bnf/current/PHP5660-ofatumumab.htm?q=ofatumumab&t=search&ss=text&p=1#_hit

RITUXIMAB

Restrictions: Use in haemato-oncology is restricted to accordance with regional protocols. The maintenance treatment of follicular lymphoma in previously untreated patients responding to induction therapy is restricted in accordance with regional protocol. The treatment of patients with previously untreated and relapsed/ refractory chronic lymphotic leukaemia (CLL) in combination with chemotherapy is restricted to use in accordance with regional protocol. The use in combinatation with glucocorticoids for the induction of remission in adult patients with severe, active granulomatosis with polyangiitis (Wegener’s) (GPA) and microscopic polyangiitis (MPA) is restricted to specialist use in patients who have relapsed following treatment with cyclophosphamide or who are intolerant to or unable to receive cyclophosphamide. The subcutaneous injection formulation is restricted to use only in accordance with regional protocols.

Prescribing Notes:

SMC advice for various indications for rituximab can be found here

Please note: The subcutaneous preparation is not licensed for all the indications that the IV infusion is licensed for.

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/70421.htm

8.2.4 Other immunomodulating drugs

Total Formulary
THALIDOMIDE

Restrictions: Restricted to specialist use only. Treatment of multiple myeloma is restricted to use in accordance with regional protocol.

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/201478.htm

BAILLUS CALMETTE GUERIN

Restrictions: Restricted to specialist use only. Restricted to use by consultant urologists.

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/88706.htm

NATALIZUMAB

Restrictions: Restricted to specialist use only. Restricted to specialist use in accordance with agreed local protocol and SMC restrictions. Use of natalizumab as a single disease modifying therapy in highly active relapsing remitting multiple sclerosis (RRMS) is not recommended for use by the Scottish Medicines Consortium and is non-Formulary.

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/129974.htm

MIFAMURTIDE (Mepact) (infusion)

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

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/208464.htm

DACLIZUMAB (injection)

Restrictions:

Restricted to specialist use in patients with rapidly evolving severe (RES) relapsing remitting multiple sclerosis (RRMS) or in patients with RRMS with an inadequate response to disease modifying therapy.

DIMETHYL FUMARATE (Tecfidera) (capsules)

Restrictions: Restricted to specialist use in accordance with local guidelines

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/PHP34444-dimethyl-fumarate.htm?q=dimethyl&t=search&ss=text&p=1#_hit

FINGOLIMOD (capsules)

Restrictions: Use is restricted in accordance to prescribing notes below.

Prescribing Notes:

Use as a single therapy in highly active relapsing remitting multiple sclerosis (RRMS) is restricted to use in the following adult patient groups:

  • Patients with high disease activity despite treatment with at least one disease modifying therapy
  • Patients with rapidly evolving severe relapsing remitting multiple sclerosis (defined by two or more disabling relapses in one year, and with one or more Gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI.)

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/PHP5701-fingolimod.htm?q=fingolimod&t=search&ss=text&p=1#_hit

GLATIRAMER ACETATE

Restrictions: Restricted to specialist use only. Restricted to use under the provision of the ‘Risk Sharing Scheme’ between the Scottish Executive Health Department and the manufacturers (NHS HDL (2002)6).

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/88674.htm

INTERFERON ALFA

Restrictions: Restricted to specialist use only. Not approved for non-Hodgkin’s lymphoma or malignant melanoma.

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/37082.htm

INTERFERON BETA

Restrictions: Restricted to specialist use only. Restricted to use under the provision of the ‘Risk Sharing Scheme’ between the Scottish Executive Health Department and the manufacturers (NHS HDL (2002)6). Treatment of a single demyelinating event with an active inflammatory process has not been accepted by SMC and is non-Formulary.

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/37083.htm

LENALIDOMIDE (Revlimid)

Restrictions: Formulary indications and restrictions on use are detailed in the Prescribing Notes below.

Prescribing Notes:

Muliple myeloma

  • 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 reviously untreated multiple myeloma who are not eligible for transplant. It is restricted to specialist use in accordance with regional protocol (in development) for use in patients unsuitable for thalidomide-containing regimens.

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.

 

Treatment of adult patients with relapsed or refractory mantle cell lymphoma is not recommended by SMC and remains non-formulary.

BNF Link: https://www.medicinescomplete.com/mc/bnf/current/PHP5713-lenalidomide.htm?q=lenalidomide&t=search&ss=text&p=1#_hit

PANOBINOSTAT (FARYDAK) (capsules)

Restrictions: Use in combination with bortezomib and dexamethasone, for the treatment of adult patients with relapsed and/or refractory multiple myeloma who have received at least two prior regimens including bortezomib and an immunomodulatory agent is restricted to use in accordance with regional protocol.

PEGINTERFERON ALFA 2A

Restrictions: Restricted to specialist use only. Restricted to use in adults for the treatment of hepatitis C in combination with ribavirin in accordance with Hepatits MCN protocol.

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/106504.htm

PEGINTERFERON ALFA 2B

Restrictions: Restricted to specialist use only. Restricted to use for chronic hepatitis C in combination with ribavirin in accordance with Hepatitis MCN protocol.

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/88653.htm

PEGINTERFERON BETA 1A (PLEGRIDY) (sub-cutaneous injection)

Restrictions: Restricted to specialist use for the treatment of relapsing remitting multiple sclerosis in adults.

BNF Link: https://www.medicinescomplete.com/mc/bnf/current/PHP34928-plegridy.htm?q=PLEGRidy&t=search&ss=text&p=1#PHP34928-plegridy

POMALIDOMIDE

Restrictions: Restricted to specialist use in accordance with regional protocol.

Prescribing Notes:

To access regional protocol please click here

BNF Link: https://www.medicinescomplete.com/mc/bnf/current/PHP34116-pomalidomide.htm

TERIFLUNOMIDE (AUBAGIO) (tablets)

Restrictions: The treatment of adults with relapsing remitting multiple sclerosis (MS) is restricted to specialist use as an alternative to treatment with interferon beta or glatiramer acetate. Teriflunomide is not expected to be used for the treatment of patients with highly active disease.

BNF Link: http://www.medicinescomplete.com/mc/bnf/current/PHP34469-teriflunomide.htm