| Formulary Chapter 8: Malignant disease and immunosuppression - Full Chapter
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| Chapter Links... |
 Cancer Drug Fund List |
| Northern Cancer Alliance |
 Northern England Clinical Networks Palliative and End of Life Care Guidelines |
| Details... |
| 08.02.02 |
Corticosteroids and other immunosuppressants |
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Belumosudil (Rezurock®)
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Formulary
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- 200mg tablets
- Approved for chronic graft-versus-host disease in people 12 years and over after 2 or more systemic treatments in line with NICE
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NICE TA949: Belumosudil for treating chronic graft-versus-host disease after 2 or more systemic treatments in people 12 years and over
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Ciclosporin
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Formulary
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- Approved formulations include:
- 10mg, 25mg, 50mg, and 100mg capsules;
- 100mg in 1ml sugar free oral solution (oily).
- Should be prescribed by brand for transplant indications
- For Transplant indications
 unless from a Trust/speciality that hasn't formally repatriated its patients or for patients who require weekly scripts for MDS boxes  .
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Sirolimus
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Formulary
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- Approved for renal transplantation in children and adolescents in line with NICE.
- For Transplant indications unless from a Trust/speciality that hasn't formally repatriated its patients or for patients who require weekly scripts for MDS boxes .
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Tacrolimus
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Formulary
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Approved tacrolimus formulations include:
- 500 microgram, 1mg & 5mg capsules (Prograf® & Adoport®).
- 1mg in 1ml oral suspension (
 unlicensed) - 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.
- For Transplant indications unless from a Trust/speciality that hasn't formally repatriated its patients or for patients who require weekly scripts for MDS boxes .
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NICE TA481: Immunosuppressive therapy for kidney transplant in adults
NICE TA482: Immunosuppressive therapy for kidney transplant in children and young people
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.
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Voclosporin (Lupkynis®)
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Formulary
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- 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
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NICE TA882: Voclosporin with mycophenolate mofetil for treating lupus nephritis
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Antithymocyte immunoglobulin (horse) (Thymoglobuline®)
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Alternatives
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- NETAG approved for aplastic anaemia in adults (unlicensed).
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Antithymocyte immunoglobulin (rabbit) (Thymoglobuline®)
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Alternatives
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- Used in the management of transplant rejection.
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Basiliximab
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Alternatives
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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.
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NICE TA481: Immunosuppressive therapy for kidney transplant in adults
NICE TA482: Immunosuppressive therapy for kidney transplant in children and young people
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Ciclosporin (Sandimmun®)
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Alternatives
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| Non Formulary Items |
Ciclosporin (Deximune®)
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Non Formulary
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Sirolimus (Hyftor®)
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Non Formulary
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- Sirolimus for treating facial angiofibroma caused by tuberous sclerosis complex in people 6 years and over (terminated appraisal)
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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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Description |
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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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