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 Formulary Chapter 8: Malignant disease and immunosuppression - Full Chapter
08.01  Cytotoxic drugs
 note 

The chemotherapy of cancer is complex and should be confined to specialists in oncologyand haematology. NPSA anti-cancer drug recommendations.

NOTE: a number of cytotoxic medicines that are used for indications other than cancer are listed elsewhere in this formulary under the relevant chapter e.g. methotrexate for rheumatological indications in chapter 10.

Only trained pharmacy personnel should reconstitute cytotoxics and prescription validation should only be carried out by suitably trained pharmacists. 

All cytotoxics with a positive NICE Health Technology Appraisal are approved for use in Greater Manchester.

NHS England's Cancer Drug Fund provides a further list of approved uses of cytotoxic drugs and the latest national funding policies.

08.01  Side-effects of cytotoxic drugs
08.01  Drugs for cytotoxic-induced side-effects
Calcium Folinate
(Folinic Acid)
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Formulary Tablets
Injection 
   
Dexrazoxane (Savene®)
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Formulary
High Cost Medicine
Intravenous Infusion 
   
Mesna
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Formulary Tablets
Injection 
   
08.01.01  Alkylating drugs
 note 

All cytotoxics with a positive NICE Health Technology Appraisal are approved for use in Greater Manchester. NHS England's Cancer Drug Fund provides a further list of approved uses of cytotoxic drugs and the latest national funding policies.

08.01.02  Anthracyclines and other cytotoxic antibiotics to top
 note 

All cytotoxics with a positive NICE Health Technology Appraisal are approved for use in Greater Manchester. NHS England's Cancer Drug Fund provides a further list of approved uses of cytotoxic drugs and the latest national funding policies.

08.01.03  Antimetabolites
 note 

All cytotoxics with a positive NICE Health Technology Appraisal are approved for use in Greater Manchester. NHS England's Cancer Drug Fund provides a further list of approved uses of cytotoxic drugs and the latest national funding policies.

08.01.04  Vinca alkaloids and etoposide
 note 

All cytotoxics with a positive NICE Health Technology Appraisal are approved for use in Greater Manchester. NHS England's Cancer Drug Fund provides a further list of approved uses of cytotoxic drugs and the latest national funding policies.

08.01.05  Other antineoplastic drugs
 note 

All cytotoxics with a positive NICE Health Technology Appraisal are approved for use in Greater Manchester. NHS England's Cancer Drug Fund provides a further list of approved uses of cytotoxic drugs and the latest national funding policies.

08.01.05  Hydroxycarbamide
Hydroxycarbamide (Hydrea®)
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Formulary


Amber Traffic Light  for essential thrombocythaemia, myelofibrosis or polycythaemia with high risk of complications



Red Traffic Light  for chemotherapy

 
   
08.02  Drugs affecting the immune response to top
08.02  Immunosuppressant therapy
08.02.01  Antiproliferative immunosuppressants
Azathioprine
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Formulary
Amber
Tablets
Injection


Red Traffic Light  Red if there is no shared care protocol (licensed indications only)

 
Link  GMMMG Shared Care Protocols
Link  UKMI Q&A: Can mothers breast feed while taking azathioprine?
   
Mycophenolate Mofetil
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Formulary
Amber
Capsules
Tablets
Oral suspension

note All new patients commenced on mycophenolate mofetil should be commenced on a "branded generic" preparation.  
Link  MHRA Safety Alert: Contraception advice for male patients
Link  MHRA Safety Alert: Pregnancy prevention advice
Link  NICE TA481: Immunosuppressive therapy for renal transplantation in adults
Link  NICE TA99: Immunosuppressive therapy for renal transplantation in children and adolescents
   
Mycophenolic Acid (Myfortic®)
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Formulary
Amber
Gastro-resistant tablets

note Mycophenolate and mycophenolic acid are not interchangeable. Patients on Myfortic® must remain on Myfortic®.
 
Link  MHRA Safety Alert: Contraception advice for male patients
Link  MHRA Safety Alert: Pregnancy prevention advice
   
08.02.02  Other immunosuppressants
Ciclosporin
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Formulary
Amber
Capsules
Oral solution

note Prescribe by brand. Do not switch between brands.
Brands:
  • Capimune®
  • Capsorin®
  • Deximune®
  • Neoral®


    Red Traffic Light  Red if no shared care protocol (licensed indications only)

     
  • Link  GMMMG Shared Care Protocols
       
    Tacrolimus
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    Formulary
    Amber
    Capsules
    Granules
    Modified-release capsules
    Concentrate for intravenous infusion

    note Prescribe by brand. Do not switch between brands.

    There are 3 different oral formulations of tacrolimus:
  • Adoport®, Prograf®, Capexion®, Tacni®, and Vivadex® are immediate-release capsules that are taken twice daily, once in the morning and once in the evening;
  • Modigraf® granules are used to prepare an immediate-release oral suspension which is taken twice daily, once in the morning and once in the evening;
  • Advagraf® is a prolonged-release capsule that is taken once daily, in the morning.  
  • Link  MHRA Drug Safety Update, June 2012. Oral tacrolimus products - prescribe by brand
       
    08.02.03  Anti-lymphocyte monoclonal antibodies
    Cytotoxic Drug Rituximab (MabThera®)
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    First Choice
    Red
    Concentrate for intravenous infusion

    Restricted Item Specialist use only 
    Alemtuzumab (MabCampath®)
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    Formulary
    Red
    Concentrate for intravenous infusion

    Restricted Item Specialist use only

    Patient access scheme may be available. Patient access and monitoring form available from pharmacy. 
    Link  NICE TA312: Alemtuzumab for treating relapsing-remitting multiple sclerosis
       
    Obinutuzumab (Gazyvaro®)
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    Formulary
    Red
    Concentrate for intravenous infusion
    Restricted Item Specialist use only; for previously untreated chronic lymphocytic leukaemia (CLL) in patients with comorbidities making them unsuitable for full-dose fludarabine-based therapy 
       
    Ofatumumab (Arzerra®)
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    Formulary
    Red
    Cancer Drugs Fund
    Concentrate for intravenous infusion

    Restricted Item Specialist use only; CDF criteria must be met & funding approval received. 
    Link  MHRA Drug Safety Update, August 2014: Ofatumumab: reminder of risk of serious and fatal infusion reactions
    Link  MHRA Drug Safety Update, January 2014: Ofatumumab: Screen for hepatitis B virus before treatment
       
    08.02.04  Other immunomodulating drugs to top
    08.02.04  Interferon Alfa
    Peginterferon Alfa (Pegasys®)
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    First Choice
    Red
    First line choice for chronic hepatitis C 
    Peginterferon Alfa (ViraferonPeg®)
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    Formulary
    Red
    For chronic hepatitis C patients >120kg in weight.  
    Link  NICE TA200: Hepatitis C - peginterferon alfa and ribavirin
    Link  NICE TA106: Hepatitis C - peginterferon alfa and ribavirin
    Link  NICE TA75: Hepatitis C - pegylated interferons, ribavirin and alfa interferon
       
    Interferon Alfa-2b (IntronA®)
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    Formulary
    Red
     
       
    Interferon Alfa-2b (Roferon-A®)
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    Formulary
    Red
     
       
    08.02.04  Interferon beta
    08.02.04  Interferon gamma
    08.02.04  Aldesleukin
    08.02.04  BCG bladder instillation to top
    BCG bladder instillation (OncoTICE®)
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    Formulary Restricted Item Specialist use only 
       
    08.02.04  Canakinumab
    08.02.04  Dimethyl fumarate
    08.02.04  Fingolimod
    08.02.04  Glatiramer acetate
    08.02.04  Histamine to top
    08.02.04  Lenalidomide, pomalidomide, and thalidomide
    Thalidomide (Thalidomide Celgene®)
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    Formulary
    Red
    Capsules 
    Link  THALIDOMIDE CELGENE™ (thalidomide) Healthcare Professional’s Information Pack (HCPIP)
    Link  Male treatment initiation form
    Link  Prescription authorisation form
    Link  Women of childbearing potential initiation form
    Link  Women of non-childbearing potential initiation form
    Link  NICE TA228: bortezomib and thalidomide for the first-line treatment of multiple myeloma.
       
    Lenalidomide (Revlimid®)
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    Formulary
    Red
    Cancer Drugs Fund
    Capsules 
    Link  REVLIMID® (lenalidomide) Healthcare Professional’s Information Pack (HCPIP)
    Link  Revlimid® Prescription Authorisation Form
    Link  NICE TA171: Lenalidomide for the treatment of multiple myeloma
    Link  NICE TA322: Lenalidomide for treating myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality
       
    Pomalidomide
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    Formulary
    Cancer Drugs Fund
    Capsules 
       
    08.02.04  Mifamurtide
    08.02.04  Natalizumab
    08.02.04  Teriflunomide
    08.03  Sex hormones and hormone antagonists in malignant disease to top
    08.03.01  Oestrogens
    Diethylstilbestrol
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    Formulary
    Green 3
    Tablets


     
       
    Ethinylestradiol
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    Formulary Tablets 
       
    08.03.02  Progestogens
    Medroxyprogesterone Acetate (Provera®)
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    Formulary Tablets 
       
    Megestrol Acetate (Megace®)
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    Formulary Tablets 
       
    08.03.03  Androgens
    08.03.04  Hormone antagonists
    08.03.04.01  Breast cancer to top
    Anastrozole (Arimidex®)
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    Formulary
    Green 3
    Tablets

     
       
    Exemestane
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    Formulary
    Green 3
    Tablets

     
       
    Letrozole
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    Formulary
    Green 3
    Tablets

     
       
    Tamoxifen
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    Formulary
    Green 3
    Tablets

     
       
    Fulvestrant (Faslodex®)
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    Formulary
    Red
    Intramuscular injection


    Red Traffic Light  Red for new patients. Not recommended by NICE.  

    Link  NICE TA239: Fulvestrant for the treatment of locally advanced or metastatic breast cancer
       
    08.03.04.02  Prostate cancer and gonadorelin analogues
    08.03.04.02  Gonadorelin analogues
    Leuprorelin Acetate (Prostap® )
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    First Choice
    Amber
    Prostap®3 DCS 11.25mg injection
    Prostap® SR DCS 3.75mg injection

    1st choice for prostate cancer


    Amber Traffic Light  For licensed indications


     
    Goserelin (Zoladex®)
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    Formulary
    Amber
    Zoladex® implant
    Zoladex®LA implant

    Amber Traffic Light  For licensed indications


     
       
    08.03.04.02  Anti-androgens
    Bicalutamide
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    Formulary
    Green 3
    Tablets
     
       
    Cyproterone Acetate
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    Formulary
    Green
    Tablets


    Green Traffic Light  Following specialist initiation

     
       
    08.03.04.02  Gonadotrophin-releasing hormone antagonists
    Degarelix (Firmagon®)
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    Formulary
    Amber

    Subcutaneous injection

    Restricted Item Consultant prescribing only. For patients with prostate cancer with spinal metastases.

     
    Link  Shared Care Protocol
    Link  NICE TA404: Degarelix for treating advanced hormone-dependent prostate cancer
       
    08.03.04.03  Somatostatin analogues to top
    Octreotide
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    First Choice
    Red

    Solution for injection (various forms)
    Depot injection (Sandostatin LAR®)

     
    Lanreotide (Somatuline® )
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    Formulary
    Red

    Injection (Somatuline® LA and Somatuline® Autogel)

     
       
     ....
     Non Formulary Items
    Abiraterone  (Zytiga®)

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    Non Formulary
    Red
    Cancer Drugs Fund
    Link  NICE TA259: Abiraterone for castration-resistant metastatic prostate cancer previously treated with a docetaxel-containing regimen
     
    Aldesleukin  (Proleukin®)

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    Non Formulary
    Red
     
    Amifostine  (Ethyol®)

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    Non Formulary
    Red
     
    Basiliximab  (Simulect®)

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    Non Formulary
    Red
     
    BCG bladder instillation  (ImmuCyst®)

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    Non Formulary
    Link  UKMI report on differences between bcg products
     
    Belatacept  (Nulojix®)

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    Non Formulary
    Red
     
    Buserelin

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    Non Formulary
     
    Calcium Leofolinate  (Isovorin®)

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    Non Formulary
     
    Canakinumab  (Ilaris®)

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    Non Formulary
    Red
     
    Dabrafenib

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    Non Formulary
    Red
    Cancer Drugs Fund
     
    Daclizumab  (Zenapax®)

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    Non Formulary
     
    Dimethyl fumarate  (Tecfidera®)

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    Non Formulary
     
    Disodium Folinate  (Sodiofolin®)

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    Non Formulary
     
    Disodium Levofolinate

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    Non Formulary
     
    Enzalutamide  (Xtandi®)

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    Non Formulary
    Cancer Drugs Fund
     
    Fampridine

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    Non Formulary
     
    Fingolimod

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    Non Formulary
    Link  NICE TA254: Fingolimod for highly active relapsing remitting multiple sclerosis
     
    Flutamide

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    Non Formulary
     
    Glatiramer Acetate  (Copaxone®)

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    Non Formulary
     
    Histrelin  (Vantas®)

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    Non Formulary
     
    Interferon Beta  (Avonex®)

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    Non Formulary
     
    Interferon Beta  (Betaferon®)

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    Non Formulary
     
    Interferon beta  (Extavia®)

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    Non Formulary
     
    Interferon Beta  (Proleukin®)

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    Non Formulary
     
    Interferon Beta  (Rebif®)

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    Non Formulary
     
    Mifamurtide

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    Non Formulary
     
    Natalizumab  (Tysabri®)

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    Non Formulary
    Link  NICE TA127: Multiple sclerosis - natalizumab
     
    Palifermin  (Kepivance®)

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    Non Formulary
     
    Pasireotide  (Signifor®)

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    Non Formulary
     
    Ponatinib

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    Non Formulary
    Cancer Drugs Fund
    Link  MHRA Safety Alert: reports of posterior reversible encephalopathy syndrome
     
    Sirolimus  (Rapamune®)

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    Non Formulary
    Amber
    MAY BE USED FOR ESTABLISHED PATIENTS ONLY

    note The 500 microgram tablets are not bioequivalent with the 1mg and 2mg tablets and multiples must not be used as a substitute for the other tablet strengths.

     
    Teriflunomide  (Aubagio®)

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    Non Formulary
     
    Toremifene  (Fareston®)

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    Non Formulary
     
    Triptorelin  (Gonapeptyl Depot®)

    View adult BNF View SPC online View childrens BNF Track Changes
    Non Formulary
    Amber
     
    Triptorelin- Decapeptyl® SR

    View adult BNF View SPC online View childrens BNF Track Changes
    Non Formulary
    Amber
     
      
    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
    Display tracking information
    click to search medicines.org.uk
    Link to adult BNF
    click to search medicines.org.uk
    Link to children's BNF
    click to search medicines.org.uk
    Link to SPCs
    SMC
    Scottish Medicines Consortium
    Cytotoxic Drug
    Cytotoxic Drug
    CD
    Controlled Drug
    High Cost Medicine
    High Cost Medicine
    Cancer Drugs Fund
    Cancer Drugs Fund
    NHSE
    NHS England
    Homecare
    Homecare
    CCG
    CCG

    Traffic Light Status Information

    Status Description

    Amber

    Drugs designated amber are suitable for shared care arrangements under a shared care protocol. Prescribing may be transferred from secondary to primary care once the patient is stabilised and agreed shared care arrangements have been established. Alternatively primary care may initiate under the supervision of secondary care if this option is given in the shared care document. It is recommended that shared care arrangements should be drawn up following local discussion and agreement by prescribing parties.   

    Black

    These products have been reviewed by the GM Joint Formulary Group and have been deemed not suitable for prescribing for adults in primary or secondary care within Greater Manchester. These decisions have been made on the basis of safety, efficacy and cost-effectiveness of the products.  

    Green

    Not used   

    Green 1

    Drugs designated green1 are suitable for initiation and ongoing prescribing within primary care.   

    Green 2

    Drugs designated green2 can be initiated by primary care following written or verbal advice from a specialist and then be subsequently safely prescribed in primary care with little or no monitoring required.  

    Green 3

    Drugs designated green3 are suitable for on-going prescribing within primary care after specialist initiation and an initial review (unless specified) in secondary care. Little or no monitoring is required.  

    Grey

    Not suitable for routine prescribing but may be suitable for a defined patient population. Whilst prescribers should think very carefully before prescribing or recommending any of the products on the grey list, there may be exceptional instances when the use of one of these products is necessary for a particular patient.   

    Red

    Drugs designated red are considered to be specialist medicines and prescribing responsibility for these medicines should normally remain with the consultant or specialist clinician. These drugs should not be initiated or prescribed in primary care. It is recommended that the supply of these specialist medicines should be organised via the hospital pharmacy, this may include arranging for supply via a home care company.   

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