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 Formulary Chapter 8: Malignant disease and immunosuppression - Full Chapter
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08.02  Expand sub section  Drugs affecting the immune response
 note 

Shared care guidelines are available for:

BlinatumomabBlack Triangle (Blincyto®)
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  • Approved for use in previously treated Philadelphia-chromosome-negative acute lymphosblastic leukaemia in line with NICE and NHS England Commissioning Policy.
  • Approved for the treatment of acute lymphoblastic leukaemia in remission with minimal residual disease activity in line with NICE
  • Only to be used in line with a current chemotherapy protocol from the North of England Cancer Alliance in line with the appropriate Network Site Specific Group’s clinical guidelines or chemotherapy algorithm

 

 
Link  NICE TA450 Blinatumomab for previously treated Philadelphia-chromosome-negative acute lymphoblastic leukaemia
Link  NICE TA589: Blinatumomab for treating acute lymphoblastic leukaemia in remission with minimal residual disease activity
 
Cytotoxic Drug Tepotinib (Tepmetko®)
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High Cost Medicine
NHS England
  • Approved for treating advanced non-small-cell lung cancer (NSCLC) with METex14 skipping alterations in adults in line with NICE.
 
Link  NICE TA789: Tepotinib for treating advanced non-small-cell lung cancer with MET gene alterations
 
08.02  Expand sub section  Immunosuppressant therapy
08.02.01  Expand sub section  Antiproliferative immunosuppressants
Cytotoxic Drug Azathioprine
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  • An azathioprine 50mg in 5ml suspension (unlicensedunlicensed) is also available.
 
Link  North of Tyne, Gateshead and North Cumbria - Azathioprine Shared Care Agreement (Renal Transplant in adults)
Link  South Tyneside & Sunderland APC Shared Care Guideline - Azathioprine in Neurology
 
Mycophenolate Mofetil
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Link  MHRA Drug Safety Updates - Mycophenolate
Link  NICE TA481: Immunosuppressive therapy for kidney transplant in adults
Link  South Tyneside & Sunderland APC Shared Care Guideline - Mycophenolate in Neurology
 
Mycophenolate Sodium (Myfortic®)
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  • Approved as second-line therapy in patients who do not tolerate mycophenolate mofetil.
 
Link  MHRA Drug Safety Updates - Mycophenolate
 
08.02.02  Expand sub section  Corticosteroids and other immunosuppressants
Azathioprine
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For transplant indications

 
 
Ciclosporin (Neoral®)
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  • Neoral® is the preferred product for most indications.
  • Approved formulations include:
    • 10mg, 25mg, 50mg, and 100mg capsules;
    • 100mg in 1ml sugar free oral solution (oily).

 
 
Mycophenolate Mofetil
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Link  MHRA Drug Safety Updates - Mycophenolate
 
Mycophenolic Acid
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Red
 
Link  MHRA Drug Safety Updates - Mycophenolate
 
Cytotoxic Drug Sirolimus
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  • Approved for renal transplantation in children and adolescents in line with NICE.
 
 
Cytotoxic Drug Tacrolimus
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Approved tacrolimus formulations include:

  • 500 microgram, 1mg & 5mg capsules (Prograf® & Adoport®).
  • 1mg in 1ml oral suspension (unlicensedunlicensed) - this replaces 0.5mg/ml oral
    suspension. 
  • 5mg in 1 ml concentrate for preparing IV infusion - approved for renal transplantation in children and adolescents in line with NICE.
  • 500microgram, 1mg, 3mg & 5mg MR capsules (Advagraf®) approved for use for prophylaxis of organ rejection in kidney and liver transplantation. Advagraf® is also approved for use in patients who are currently prescribed Prograf®, and de novo patients should be prescribed Adoport®.
  • 750microgram, 1 mg and 4 mg m/r tablets (Envarsus®)
    • approved for the treatment of renal and liver transplant patients who are suffering from neurotoxicity with other formulations or for patients requiring large doses of tacrolimus. 

 
Link  NICE TA481: Immunosuppressive therapy for kidney transplant in adults
Link  NICE TA482: Immunosuppressive therapy for kidney transplant in children and young people
Link  MHRA Drug Safety Alert (November 2017): Oral tacrolimus products: reminder to prescribe and dispense by brand name only RED drug also for non-transplant indications.
 
Voclosporin  (Lupkynis®)
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High Cost Medicine
NHS England
  • 7.9mg capsules
  • Approved with mycophenolate mofetil for treating lupus nephritis in adults in line with NICE and NHSe Specialised Commissioning Policy (SSC2540)
  • Only available from:
    • North Cumbria University Hospital NHS Trust
    • South Tyneside and Sunderland NHS Foundation Trust
    • South Tees Hopsitals NHS Foundation Trust
    • The Newcastle upon Tyne Hospitals NHS Foundation Trust
 
Link  NICE TA882: Voclosporin with mycophenolate mofetil for treating lupus nephritis
 
Antithymocyte immunoglobulin (horse)  (Thymoglobuline®)
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Alternatives
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  • NETAG approved for aplastic anaemia in adults (unlicensedunlicensed).
 
 
Antithymocyte immunoglobulin (rabbit)  (Thymoglobuline®)
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High Cost Medicine
  • Used in the management of transplant rejection.
 
 
Basiliximab
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  • Approved for limited use in adult renal transplant patients with high risk of acute organ rejection.
  • Approved for severe graft versus host disease post haematopoietic stem cell transplantation.
  • Approved for induction therapy in renal transplantation in children and adolescents in with combinations that include ciclosporin in line with NICE.
 
Link  NICE TA481: Immunosuppressive therapy for kidney transplant in adults
Link  NICE TA482: Immunosuppressive therapy for kidney transplant in children and young people
 
Cytotoxic Drug Ciclosporin (Sandimmun®)
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Alternatives
Red
 
 
08.02.03  Expand sub section  Anti-lymphocyte monoclonal antibodies to top
Alemtuzumab
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NHS England
  • Alemtuzumab 30mg in 1ml concentrate for IV infusion is approved for use in, lymphocytic leukaemia & prevention of graft vs. host disease in bone marrow transplant patients, and high-risk kidney and pancreas transplantation.
  • Alemtuzumab 12mg in 1.2ml concentrate for IV infusion is approved for treating adults with active relapsing– remitting multiple sclerosis in line with NICE and NHS England commissioning policy. 

 

 
Link  NICE TA312: Alemtuzumab for relapsing‑remitting multiple sclerosis
Link  MHRA Drug Safety Update (Feb 2020): Lemtrada▼ (alemtuzumab): updated restrictions and strengthened monitoring requirements following review of serious cardiovascular and immune-mediated reactions
Link  MHRA Drug Safety Update (May 2019): Lemtrada (alemtuzumab) and serious cardiovascular and immune- mediated adverse reactions: new restrictions to use and strengthened monitoring requirements
 
Cytotoxic Drug AvelumabBlack Triangle (Bavencio®)
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High Cost Medicine
NHS England
  • Approved for  for maintenance treatment of locally advanced or metastatic urothelial cancer after platinum-based chemotherapy in adults in line with NICE
  • as an option for treating metastatic Merkel cell carcinoma in adults who have not had chemotherapy for metastatic disease in line with NICE
 
Link  NICE TA645: Avelumab with axitinib for untreated advanced renal cell carcinoma
Link  NICE TA691: Avelumab for treating metastatic Merkel cell carcinoma
Link  NICE TA788: Avelumab for maintenance treatment of locally advanced or metastatic urothelial cancer after platinum-based chemotherapy
 
Obinutuzumab
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High Cost Medicine
NHS England
  • Approved for use in chronic lymphocytic leukaemia in combination with chlorambucil in patients who have co-morbitities that make full‑dose fludarabine‑based therapy unsuitable for them, only if bendamustine‑based therapy is not suitable and the company provides obinutuzumab with the discount agreed in the patient access scheme in line with NICE (subject to NHS England funding).
  • Approved for the treatment of rituximab-refractory follicular lymphoma in combination bendamustine in line with NICE and NHS England Commissioning Policy
  • Approved with bendamustine for follicular lymphoma that has not responded or has progressed up to 6 months after treatment with rituximab or a rituximab-containing regimen in adults in line with NICE
 
Link  NICE TA343: Obinutuzumab with chlorambucil for CLL
Link  NICE TA629: Obinutuzumab with bendamustine for treating follicular lymphoma after rituximab
 
Ocrelizumab (Ocrevus®)
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High Cost Medicine
NHS England
BlueTeq
  • Approved for the treatment of relapsing-remitting multiple sclerosis in line with NICE

     

 
Link  NICE TA 533: Ocrelizumab for treating relapsing–remitting multiple sclerosis
Link  NICE TA585: Ocrelizumab for treating primary progressive multiple sclerosis
 
Ofatumumab  (Kesimpta®)
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NHS England
BlueTeq
  • 20mg/0.4ml solution for injection (pre-filled pens)
    • Approved for the treatment of relapsing-remitting multiple sclerosis in adults with active diseases defined by clinical or imaging features in line with NICE

 

 
Link  NICE TA699: Ofatumumab for treating relapsing multiple sclerosis
 
Rituximab
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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

 
Link  NICE TA137: Rituximab for the treatment of relapsed or refractory stage III or IV follicular non- Hodgkin’s lymphoma
Link  NICE TA174: Rituximab for the first-line treatment of chronic lymphocytic leukaemia
Link  NICE TA193: Rituximab for the treatment of relapsed or refractory chronic lymphocytic leukaemia
Link  NICE TA226: Rituximab for the first-line maintenance treatment of follicular non-Hodgkin’s lymphoma
Link  NICE TA243: Rituximab for the first-line treatment of stage III-IV follicular lymphoma
Link  NTAG - Rituximab for ITP in adults and children
Link  MHRA Drug Safety Update (Dec 2014): Rituximab: progressive multifocal leukoencephalopathy in a patient
Link  MHRA Drug Safety Update (Dec 2013): Rituximab: screen for hepatitis B virus before treatment.
 
08.02.04  Expand sub section  Other immunomodulating drugs
Daclizumab (Zinbryta®)
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High Cost Medicine
  • 150mg subcutaneous injection
    • Approved for the treatment of highly active relapsing-remitting mutiple sclerosis that has failed to respond to other treatment in adults in line with NICE and NHS England Commissioning Policy. 
    • Subject to restricted use by EMA
 
 
Diroximel fumarate (Vumerity®)
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High Cost Medicine
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BlueTeq
  • 231mg capsules
    • Approved for treating relapsing-remitting multiple sclerosis in line with NICE
 
Link  NICE TA794: Diroximel fumarate for treating relapsing–remitting multiple sclerosis
 
Osimertinib (Tagrisso)
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  • 40mg and 80mg tablet
  • Approved for the treatment of EGFR mutation-positive non-small-cell lung cancer in line with NICE
  • Approved for treating epidermal growth factor receptor (EGFR) T790M mutation-positive locally advanced or metastatic non-small-cell lung cancer (NSCLC) in adults in line with NICE 

 

 
Link  NICE TA 653: Osimertinib for treating EGFR T790M mutation-positive advanced non-small-cell lung cancer
Link  NICE TA654: Osimertinib for untreated EGFR mutation-positive non-small-cell lung cancer
Link  NICE TA761 Osimertinib for adjuvant treatment of EGFR mutation-positive non-small-cell lung cancer after complete tumour resection
 
Ponesimod (Ponvory®)
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High Cost Medicine
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BlueTeq
  • 20mg tablets
    • Approved for treating relapsing–remitting multiple sclerosis with active disease defined by clinical or imaging features in adults in line with NICE


 

 
Link  NICE TA767: Ponesimod for treating relapsing–remitting multiple sclerosis
 
Siponimod (Mayzent®)
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High Cost Medicine
NHS England
BlueTeq
  • 0.25mg and 2mg tablets
    • approved for treating secondary progressive multiple sclerosis in adults in line with NICE


 
Link  NICE TA656: Siponimod for treating secondary progressive multiple sclerosis
 
08.02.04  Expand sub section  Interferon Alfa
Interferon Alfa-2b
(IntronA)
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Interferon Alfa-2b (Roferon-A®)
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Red
High Cost Medicine
 
 
Peginterferon Alfa (Pegasys®, ViraferonPeg®)
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  • Approved  for hepatitis B and C in accordance with NICE guidelines and NHS England Commissioning Policies. 
 
Link  NICE CG165: Hepatitis B (chronic): diagnosis and management
Link  NICE TA106: Hepatitis C - peginterferon alfa & ribavirin
Link  NICE TA200: Hepatitis C - peginterferon alfa & ribavirin
Link  NICE TA300: Hepatitis C - peginterferon alfa
Link  NICE TA75: Hepatitis C - pegylated interferons, ribavirin & alfa interferon
Link  NICE TA96: Hepatitis B - peginterferon alfa
 
08.02.04  Expand sub section  Interferon beta
Interferon Beta (Avonex®)
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Red
High Cost Medicine
NHS England
Homecare
 
Link  MHRA Drug Safety Update (Oct 2014): risk of thrombotic microangiopathy and risk of nephrotic syndrome
Link  NICE TA527: Beta interferons and glatiramer acetate for treating multiple sclerosis
 
Interferon Beta (Betaferon®)
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Red
High Cost Medicine
NHS England
Homecare
 
Link  MHRA Drug Safety Update (Oct 2014): risk of thrombotic microangiopathy and risk of nephrotic syndrome
Link  NICE TA527: Beta interferons and glatiramer acetate for treating multiple sclerosis
 
Interferon beta (Extavia®)
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Red
High Cost Medicine
NHS England
Homecare
 
Link  MHRA Drug Safety Update (Oct 2014): risk of thrombotic microangiopathy and risk of nephrotic syndrome
Link  NICE TA527: Beta interferons and glatiramer acetate for treating multiple sclerosis
 
Interferon Beta (Rebif®)
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High Cost Medicine
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Homecare
 
Link  MHRA Drug Safety Update (Oct 2014): risk of thrombotic microangiopathy and risk of nephrotic syndrome
Link  NICE TA527: Beta interferons and glatiramer acetate for treating multiple sclerosis
 
Peginterferon Beta-1a (Plegridy®)
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High Cost Medicine
NHS England
Homecare

  • Approved treating relapsing–remitting multiple sclerosis in adults in line with NICE.

 
Link  NICE TA624: Peginterferon beta-1a for treating relapsing–remitting multiple sclerosis
 
08.02.04  Expand sub section  Interferon gamma
08.02.04  Expand sub section  Aldesleukin to top
08.02.04  Expand sub section  BCG bladder instillation
BCG 81mg vial (connaught)
(bladder instillation)
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08.02.04  Expand sub section  Canakinumab
08.02.04  Expand sub section  Dimethyl fumarate
Dimethyl fumarate (Tecfidera®)
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High Cost Medicine
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Homecare

  • Approved as a option for treating adults with active relapsing-remitting multiple sclerosis that isn’t highly active or rapidly evolving severe relapsing-remitting multiple sclerosis NICE and NHS England Commissioning Policy. 

 
Link  Disease Modifying Therapies for Patients with Multiple Sclerosis (MS)
Link  MHRA Drug safety Update (April 2016): Dimethyl fumarate (Tecfidera): updated advice on risk of progressive multifocal leukoencephalopathy.
Link  MHRA Drug Safety Update (January 2021): Dimethyl fumarate (Tecfidera): updated advice on the risk of progressive multifocal leukoencephalopathy (PML) associated with mild lymphopenia
Link  MHRA Drug Safety Update (March 2015): Dimethyl fumarate (Tecfidera): fatal PML in an MS patient with severe, prolonged lymphopenia
Link  NICE TA320: Dimethyl fumarate for multiple sclerosis
 
08.02.04  Expand sub section  Fingolimod
Fingolimod
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High Cost Medicine
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Homecare

  • Approved for the treatment of highly active relapsing–remitting multiple sclerosis in line with NICE and NHS England Commissioning Policy.

  • Approved for patients who have progressed on glatiramer acetate and for those patients who are at high risk of progressive multifocal leukoencephalopathy (PML) in line with NHS EnglandClinical Commissioning Policy.

 
Link  Disease Modifying Therapies for Patients with Multiple Sclerosis (MS)
Link  Letter sent to healthcare professionals (Jan 2016): Fingolimod (Gilenya▼): risks related to effects on the immune system
Link  MHRA Drug Safety Update (Apr 2016): Fingolimod (Gilenya▼): risks of progressive multifocal leukoencephalopathy, basal-cell carcinoma, and opportunistic infections
Link  MHRA Drug Safety Update (Apr 2017): Multiple sclerosis therapies: signal of rebound effect after stopping or switching therapy
Link  MHRA Drug Safety Update (Dec 2017): Fingolimod (Gilenya▼): new contraindications in relation to cardiac risk
Link  MHRA Drug Safety Update (Dec 2017): Fingolimod (Gilenya▼): updated advice about risk of cancers and serious infections
Link  MHRA Drug Safety Update (Jan 2021): Fingolimod (Gilenya▼): updated advice about the risks of serious liver injury and herpes meningoencephalitis
Link  MHRA Drug Safety Update (Sept 2019): Fingolimod (Gilenya▼): increased risk of congenital malformations; new contraindication during pregnancy and in women of childbearing potential not using effective contraception
Link  NICE TA254: Fingolimod for highly active relapsing remitting multiple sclerosis
 
08.02.04  Expand sub section  Glatiramer acetate to top
Glatiramer Acetate
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Homecare

  • Approved for treating multiple sclerosis in line with NICE and NHS Engand commissioning policy.

 
Link  NICE TA527: Beta interferons and glatiramer acetate for treating multiple sclerosis
Link  Disease Modifying Therapies for Patients with Multiple Sclerosis (MS)
 
08.02.04  Expand sub section  Histamine
08.02.04  Expand sub section  Lenalidomide, pomalidomide, and thalidomide
Lenalidomide
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NHS England
  • Approved for multiple myeloma in line with NICE - approved for myelodysplastic syndrome with 5q deletion in line with NICE. 
  • Approved in combination with dexamethasone for previously untreated multiple myeloma in line with NICE 
  • Approved in combination with dexamethasone for multiple myeloma after one treatment with bortezomib
  • Approved for maintenance treatment after an autologous stem cell transplant for newly diagnosed multiple myeloma in adults in line with NICE
  • Approved with rituximab for previously treated follicular lymphoma (grade 1 to 3A) in adults in line with NICE

 



 
Link  Letter sent to healthcare professionals (Nov 2016): lenalidomide (Revlimid▼): new advice about viral reactivation
Link  MHRA Drug Safety Update (Feb 2011): Lenalidomide: risk of thrombosis and thromboembolism
Link  MHRA Drug Safety Update (Jan 2013): Lenalidomide (Revlimid): risk of serious hepatic adverse drug reactions
Link  MHRA Drug Safety Update (May 2020): Immunomodulatory drugs and pregnancy prevention: temporary advice for management during coronavirus (COVID-19)
Link  MHRA Drug Safety Update (Nov 2011): Lenalidomide (Revlimid▼): update on risk of second primary malignancy
Link  NICE TA171: Lenalidomide for the treatment of multiple myeloma in people who have received at least 2 prior therapies
Link  NICE TA27: Lenalidomide with rituximab for previously treated follicular lymphoma
Link  NICE TA322: Lenalidomide for treating myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality
Link  NICE TA586: Lenalidomide plus dexamethasone for multiple myeloma after 1 treatment with bortezomib
Link  NICE TA587: Lenalidomide plus dexamethasone for previously untreated multiple myeloma
Link  NICE TA680: Lenalidomide maintenance treatment after an autologous stem cell transplant for newly diagnosed multiple myeloma
 
Pomalidomide (Imnovid®)
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High Cost Medicine
  • For the treatment of multiple myeloma previously treated with lenalidomide and bortezomib in line with NICE and NHS Commissioning Policy
 
Link  NICE TA427: Pomalidomide for multiple myeloma previously treated with lenalidomide and bortezomib
 
Thalidomide
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  • Approved in combination with an alkylating agent and a corticosteroid for the first-line treatment of multiple myeloma in line with NICE. 
  • Approved for the treatment of bleeding from bowel angiodysplasia in patients with an inherited/acquired bleeding disorder on specialist advice only.
  • Approved for the treatment of severe epistaxis as a result of hereditary haemorrhagic telangiectasia (HHT) who have failed all other treatments.
 
Link  Letter sent to healthcare professionals in June 2016: Thalidomide Celgene®: New important advice regarding viral reactivation and pulmonary hypertension
Link  MHRA Drug Safety Update (December 2015): Thalidomide: reduced starting dose in patients older than age 75 years
Link  MHRA Drug Safety Update (July 2011): Thalidomide: risk of arterial and venous thromboembolism
Link  MHRA Drug Safety Update (May 2013): Thalidomide: risk of second primary malignancies
Link  MHRA Drug Safety Update (May 2020): Immunomodulatory drugs and pregnancy prevention: temporary advice for management during coronavirus (COVID-19)
Link  NICE TA228: Bortezomib and thalidomide for the first‑line treatment of multiple myeloma
 
08.02.04  Expand sub section  Mifamurtide
Mifamurtide
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  • Approved for high-grade resectable non-metastatic osteosarcoma in line with NICE.
 
Link  NICE TA235: Osteosarcoma - mifamurtide: guidance
 
08.02.04  Expand sub section  Natalizumab
Natalizumab
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High Cost Medicine
NHS England
Homecare

  • Approved for rapidly evolving severe relapsing remitting multiple sclerosis in line with NICE and NHS England commissioning policy.

 
Link  Disease Modifying Therapies for Patients with Multiple Sclerosis (MS)
Link  MHRA Drug Safety Update (Apr 2016): Natalizumab (Tysabri▼): progressive multifocal leukoencephalopathy— updated advice to support early detection
Link  MHRA Drug Safety Update (May 2011): Natalizumab (Tysabri▼): risk of progressive multifocal leukoencephalopathy is increased in patients who have had previous immunosuppressant treatment
Link  NICE TA127: Natalizumab for the treatment of adults with highly active relapsing–remitting multiple sclerosis
 
08.02.04  Expand sub section  Teriflunomide to top
Teriflunomide
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High Cost Medicine
NHS England
Homecare

  • Approved as a option for treating adults with active relapsing-remitting multiple sclerosis that isn’t highly active or rapidly evolving severe relapsing-remitting multiple sclerosis NICE and NHS England Commissioning Policy.

 
Link  Disease Modifying Therapies for Patients with Multiple Sclerosis (MS)
Link  NICE TA303: Teriflunomide for treating relapsing–remitting multiple sclerosis
 
 ....
 Non Formulary Items
Ciclosporin  (Deximune®)

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Key
note Notes
Section Title Section Title (top level)
Section Title Section Title (sub level)
First Choice Item First Choice item
Non Formulary Item Non Formulary section
Restricted Drug
Restricted Drug
Unlicensed Drug
Unlicensed
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Traffic Light Status Information

Status Description

Red

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.  

Amber

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.  

Green plus

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.  

Green

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.  

Black

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.   

Brown

UNDER REVIEW: drugs whose current formulary status or RAG status is currently under review.  

Not Recomended

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.  

netFormulary