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 Formulary Chapter 8: Malignant disease and immunosuppression - Full Chapter
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08.02.02  Expand sub section  Corticosteroids and other immunosuppressants
Azathioprine
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Formulary
Red

For transplant indications

 
 
Ciclosporin (Neoral®)
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Formulary
Amber
  • 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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Formulary
Red
 
Link  MHRA Drug Safety Updates - Mycophenolate
 
Mycophenolic Acid
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Formulary
Red
 
Link  MHRA Drug Safety Updates - Mycophenolate
 
Cytotoxic Drug Sirolimus
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Formulary
Amber
  • Approved for renal transplantation in children and adolescents in line with NICE.
 
 
Cytotoxic Drug Tacrolimus
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Formulary
Amber

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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Formulary
Red
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
Red
  • NETAG approved for aplastic anaemia in adults (unlicensedunlicensed).
 
 
Antithymocyte immunoglobulin (rabbit)  (Thymoglobuline®)
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Alternatives
Red
High Cost Medicine
  • Used in the management of transplant rejection.
 
 
Basiliximab
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Alternatives
Red
  • 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
 
 
 ....
 Non Formulary Items
Ciclosporin  (Deximune®)

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Non Formulary
  
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
Track Changes
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Link to adult BNF
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Link to SPCs
Cytotoxic Drug
Cytotoxic Drug
CD
Controlled Drug
High Cost Medicine
High Cost Medicine
NHSE
NHS England
Homecare
Homecare
CCG
CCG

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.  

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