| Formulary Chapter 8: Malignant disease and immunosuppression - Full Chapter
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| Details... |
| 08.02 |
Drugs affecting the immune response |
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Ozanimod (Zeposia®)
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Formulary
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Capsules 230microgram, 460microgram, 920 microgram
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NICE TA706: Ozanimod for treating relapsing–remitting multiple sclerosis
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| 08.02 |
Immunosuppressant therapy |
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Diroximel Fumarate (Vumerity ®)
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Formulary
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Capsules 231mg
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NICE TA794: Diroximel fumarate for treating relapsing–remitting multiple sclerosis
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Imlifidase  (Idefirix®)
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Formulary
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Powder for concentrate for solution for infusion 11mg
Specialist centre only
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NICE TA809: Imlifidase for desensitisation treatment before kidney transplant in people with chronic kidney disease
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| 08.02.01 |
Antiproliferative immunosuppressants |
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Azathioprine
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Formulary
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Tablets 25mg, 50mg
 Inflammatory bowel disease, Rheumatic diseases, Dermatology.
 Myasthenia Gravis.
Transplant rejection.
See section 01.05.03 and 13.05.03.
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 LSCMMG: Shared care guideline - Azathioprine
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Mycophenolate Mofetil
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Formulary
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Capsules 250mg
Tablets 500mg
Oral suspension 1g/5mL
 Cellcept® for transplant patients only.
 Generic prescribing for dermatology use.
Complex pain syndrome.
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LSCMMG: Shared care guideline: Mycophenolate Mofetil
MHRA: Mycophenolate mofetil, mycophenolic acid: new pregnancy-prevention advice for women and men
MHRA: Mycophenolate mofetil, mycophenolic acid: updated contraception advice for male patients
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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| 08.02.02 |
Corticosteroids and other immunosuppressants |
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Avacopan (Tavneos ®)
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Formulary
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Hard Capsules, 10mg
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NICE TA825: Avacopan for treating severe active granulomatosis with polyangiitis or microscopic polyangiitis
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Ciclosporin (Neoral®)
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Formulary
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Capsules 25mg, 50mg, 100mg
Liquid 100mg/1mL
Concentrate for intravenous infusion 50mg/1mL
Prescribe by brand name for transplant patients.
For use in other indications see sections 01.05.03, 10.01.03, and 11.11.
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LSCMMG: Shared care guideline: Ciclosporin
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Pegcetacoplan (Aspaveli®)
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Formulary
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Solution for infusion. Each 20 mL vial contains 1 080 mg of pegcetacoplan.
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NICE TA778: Pegcetacoplan for treating paroxysmal nocturnal haemoglobinuria
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Prednisolone
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Formulary
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Tablets 1mg, 5mg
e/c tablets 2.5mg
25mg tablets are classified as
There is no evidence that e/c prednisolone reduces the risk of gastrointestinal side effects. Uncoated tablets should be prescribed first line together with a PPI if necessary.
Also see sections 10.01.02.02, 06.03.02, 01.05.02, 11.04.01.
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Sirolimus (Rapamune®)
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Formulary
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Tablets 500micrograms, 1mg, 2mg
The 500 microgram tablet is not bioequivalent to the 1 mg and 2 mg tablets. Multiples of 500 microgram tablets should not be used as a substitute for other tablet strengths.
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MHRA: Sirolimus: different immunoassays for therapeutic drug monitoring—risk of incorrect dose adjustment
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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Tacrolimus
(Always prescribe by brand name)
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Formulary
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Brand name prescribing essential
See section 13.05.03 for use in dermatology.
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LSCMMG: Position Statement Prescribing of Oral Tacrolimus
MHRA: Oral tacrolimus products: reminder to prescribe and dispense by brand name only
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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Voclosporin (Lupkynis®)
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Formulary
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Capsules 7.9mg
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NICE TA882: Voclosporin with mycophenolate mofetil for treating lupus nephritis
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| 08.02.03 |
Anti-lymphocyte monoclonal antibodies |
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Alemtuzumab (Lemtrada®)
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Formulary
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Concentrate for solution for infusion vials 12mg/1.2ml
For treating relapsing-remitting multiple sclerosis.
Tertiary centre only.
All anti-lymphocyte monoclonal antibodies should be given under the supervision of an experienced specialist, in an environment where full resuscitation facilities are immediately available.
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MHRA: Lemtrada (alemtuzumab) and serious cardiovascular and immune-mediated adverse reactions: new restrictions to use and strengthened monitoring requirements
NICE TA312: Alemtuzumab for treating highly active relapsing–remitting multiple sclerosis
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Ocrelizumab (Ocrevus®)
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Formulary
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Concentrate for solution for infusion 300mg/10ml
Solution for injection 920mg
All anti-lymphocyte monoclonal antibodies should be given under the supervision of an experienced specialist, in an environment where full resuscitation facilities are immediately available.
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NICE TA533: Ocrelizumab for treating relapsing–remitting multiple sclerosis
NICE TA585: Ocrelizumab for treating primary progressive multiple sclerosis
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Ofatumumab (Arzerra®)
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Formulary
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Concentrate for intravenous infusion 20 mg/mL,5-mL vial ,50-mL vial
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MHRA: Ofatumumab▼: reminder of risk of serious and fatal infusion reactions
MHRA: Ofatumumab: screen for hepatitis B virus before treatment
NICE TA699: Ofatumumab for treating relapsing multiple sclerosis
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Rituximab
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Formulary
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Concentrate for intravenous infusion 100mg/10mL, 500mg/50mL
Truxima® First choice rituximab for new patients.
MabThera®
For NICE guidelines relating to rituximab please consult the National funding /access decisions section of rituximab's BNF entry.
Also see sections 09.01.03, 09.01.04 and 10.01.03
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Ublituximab (Briumvi®)
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Formulary
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NICE TA1025: Ublituximab for treating relapsing multiple sclerosis
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| 08.02.04 |
Other immunomodulating drugs |
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Dimethyl fumarate (Tecfidera®)
(Multiple Sclerosis)
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Formulary
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Capsules e/c 120mg, 240mg
Also see section 13.05.02.
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NICE TA320: Dimethyl fumarate for treating relapsing‑remitting multiple sclerosis
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Fingolimod
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Formulary
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Capsules 500 micrograms
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MHRA: Fingolimod (Gilenya▼): increased risk of congenital malformations; new contraindication during pregnancy and in women of childbearing potential not using effective contraception
MHRA: Fingolimod (Gilenya▼): new contraindications in relation to cardiac risk
MHRA: Fingolimod (Gilenya▼): risks of progressive multifocal leukoencephalopathy, basal-cell carcinoma, and opportunistic infections
MHRA: Fingolimod (Gilenya▼): updated advice about risk of cancers and serious infections
MHRA: Fingolimod (Gilenya▼): updated advice about the risks of serious liver injury and herpes meningoencephalitis
NICE TA254: Fingolimod for the treatment of highly active relapsing–remitting multiple sclerosis
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Peginterferon beta‑1a (Plegridy®)
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Formulary
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Solution for injection pre-filled pens 63micrograms/0.5ml, 94micrograms/0.5ml
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NICE TA624: Peginterferon beta-1a for treating relapsing–remitting multiple sclerosis
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Ponesimod (Ponvory® )
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Formulary
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Tablets 2mg, 3mg, 4mg, 5mg, 6mg, 7mg, 8mg, 9mg, 10mg
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NICE TA767: Ponesimod for treating relapsing–remitting multiple sclerosis
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Siponimod (Mayzent®)
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Formulary
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Tablets 0.25mg, 2mg
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NICE TA656: Siponimod for treating secondary progressive multiple sclerosis
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| 08.02.04 |
Interferon Alfa |
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Interferon Alfa
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Formulary
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Intron A prefilled multidose pen 30million units in 1.2mL
Roferon-A prefilled syringes 3 million units, 4.5 million units and 9 million units in 0.5mL
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NICE TA75: Interferon alfa (pegylated and non-pegylated) and ribavirin for the treatment of chronic hepatitis C
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Peginterferon Alfa (Pegasys®)
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Formulary
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90micrograms, 135micrograms, 180micrograms solution for injection in pre-filled syringe
For the treatment of myleoproliferative neoplasms (See attached NHSE interim clinical commissioning policy).
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NHSE: Peginterferon alfa-2a and ropeginterferon alfa-2b to treat myeloproliferative neoplasms (all ages) [2420]
NICE TA106: Peginterferon alfa and ribavirin for the treatment of mild chronic hepatitis C
NICE TA200:Peginterferon alfa and ribavirin for the treatment of chronic hepatitis C
NICE TA75: Interferon alfa (pegylated and non-pegylated) and ribavirin for the treatment of chronic hepatitis C
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Ropeginterferon Alfa-2b (Besremi®)
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Formulary
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For the treatment of myleoproliferative neoplasms (See attached NHSE interim clinical commissioning policy).
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NHSE: Peginterferon alfa-2a and ropeginterferon alfa-2b to treat myeloproliferative neoplasms (all ages) [2420]
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| 08.02.04 |
Interferon beta |
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Interferon Beta (Avonex®)
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Formulary
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MHRA: Interferon-beta: risk of thrombotic microangiopathy and risk of nephrotic syndrome
NICE TA527: Beta interferons and glatiramer acetate for treating multiple sclerosis
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Interferon beta (Extavia®)
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Formulary
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MHRA: Interferon-beta: risk of thrombotic microangiopathy and risk of nephrotic syndrome
NICE TA527: Beta interferons and glatiramer acetate for treating multiple sclerosis
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Interferon Beta (Rebif®)
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Formulary
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MHRA: Interferon-beta: risk of thrombotic microangiopathy and risk of nephrotic syndrome
NICE TA527: Beta interferons and glatiramer acetate for treating multiple sclerosis
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| 08.02.04 |
Interferon gamma |
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| 08.02.04 |
Aldesleukin |
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| 08.02.04 |
BCG bladder instillation |
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BCG bladder instillation (OncoTICE®)
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Formulary
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Bladder instillation 12.5mg
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| 08.02.04 |
Canakinumab |
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| 08.02.04 |
Dimethyl fumarate |
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| 08.02.04 |
Fingolimod |
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| 08.02.04 |
Glatiramer acetate |
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Glatiramer Acetate (Copaxone®)
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Formulary
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pre-filled syringe 20mg/1ml, 40mg/1ml
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NICE TA527: Beta interferons and glatiramer acetate for treating multiple sclerosis
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| 08.02.04 |
Histamine |
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| 08.02.04 |
Lenalidomide, pomalidomide, and thalidomide |
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| 08.02.04 |
Mifamurtide |
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| 08.02.04 |
Natalizumab |
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Natalizumab (Tysabri®)
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Formulary
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Concentrate for intravenous infusion 20mg/mL (15mL vial)
Pre-filled syringe 150mg
All anti-lymphocyte monoclonal antibodies should be given under the supervision of an experienced specialist, in an environment where full resuscitation facilities are immediately available.
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MHRA: Natalizumab (Tysabri▼): progressive multifocal leukoencephalopathy—updated advice to support early detection
NICE TA127: Natalizumab for the treatment of adults with highly active relapsing–remitting multiple sclerosis
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| 08.02.04 |
Teriflunomide |
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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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Cancer Drugs Fund
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NHS England |
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Homecare |
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CCG |
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Low carbon footprint |
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Medium carbon footprint |
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High carbon footprint |
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Traffic Light Status Information
| Status |
Description |
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Green:
Appropriate for initiation and ongoing prescribing in both primary and secondary care.
Generally, little or no routine drug monitoring is required. |
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Green (Restricted):
Appropriate for initiation and ongoing prescribing in both primary and secondary care provided:
Additional criteria specific to the medicine or device are met, or
The medicine or device is used following the failure of other therapies as defined by the relevant LSCMMG pathway.
Generally, little or no routine drug monitoring is required.
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Red medicines:
Medicine is supplied by the hospital for the duration of the treatment course.
Primary care initiation or continuation of treatment is not recommended unless exceptional circumstances such as specialist GP.
Red medicines are those where primary care prescribing is not recommended. These treatments should be initiated by specialists only and prescribing retained within secondary care. They require specialist knowledge, intensive monitoring, specific dose adjustments or further evaluation in use. If however, a primary care prescriber has particular specialist knowledge or experience of prescribing a particular drug for a particular patient it would not always be appropriate for them to expect to transfer that prescribing responsibility back to secondary care. There should be a specific reason and a specific risk agreement, protocol and service set up to support this.
Primary care prescribers may prescribe RED medicines in exceptional circumstances to patients to ensure continuity of supply while arrangements are made to obtain ongoing supplies from secondary care. |
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Amber level 0:
Suitable for prescribing in primary care following recommendation or initiation by a specialist.
Little or no specific monitoring required.
Patient may need a regular review, but this would not exceed that required for other medicines routinely prescribed in primary care.
Brief prescribing document or information sheet may be required.
Primary care prescribers must be familiar with the drug to take on prescribing responsibility or must get the required information.
When recommending or handing over care, specialists should ask primary care prescribers to take over prescribing responsibility, and should give enough information about the indication, dose, monitoring requirements, use outside product licence and any necessary dose adjustments to allow them to confidently prescribe. |
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Amber level 1 (with shared care):
Suitable for prescribing in primary care following recommendation or initiation by a specialist.
Minimal monitoring required.
Patient may need a regular review, but this would not exceed that required for other medicines routinely prescribed in primary care.
Full prior agreement about patient’s on-going care must be reached under the shared care agreement.
Primary care prescribers are advised not to take on prescribing of these medicines unless they have been adequately informed by letter of their responsibilities with regards monitoring, side effects and interactions and are happy to take on the prescribing responsibility. A copy of locally approved shared care guidelines should accompany this letter which outlines these responsibilities. Primary care prescribers should then tell secondary care of their intentions as soon as possible by letter so that arrangements can be made for the transfer of care. |
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Amber level 2 (with shared care and enhanced service):
Initiated by specialist and transferred to primary care following a successful initiation period.
Significant monitoring required on an on-going basis.
Full prior agreement about patient’s on-going care must be reached under the shared care agreement.
Suitable for enhanced service.
These medicines are considered suitable for GP prescribing following specialist initiation of therapy, as per shared care document which will be sent out with the request to prescribe, with on-going communication between the primary care prescriber and specialist. Amber Level 2 medicines require significant monitoring for which an enhanced service may be suitable. (Subject to local commissioning agreements). |
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Do not prescribe: NOT recommended for use by the NHS in Lancashire and South Cumbria.
Includes medicines that NICE has not recommended for use and terminated technology appraisals, unless there is a local need. |
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Grey medicines:
Medicines which have not yet been reviewed or are under the review process.
GPs and specialists are recommended not to prescribe these drugs.
This category includes drugs where funding has not yet been agreed.
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Refer to local guidance. |
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