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 Formulary Chapter 8: Malignant disease and immunosuppression - Full Chapter
Notes:
For patient information about chemotherapy and chemotherapy regimens, please see the Macmillan cancer support website: 
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08.01.03  Expand sub section  Antimetabolites
Cytotoxic Drug Azacitidine (Vidaza®)
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Restricted Drug Restricted
Red
High Cost Medicine
Injection
  • Approved for use in line with NICE TA218 and. For more information see the D&T website at NUH, or contact Cancer services pharmacist (ext 3156)at SFH.
     
  • Link  Link to reviews
    Link  NICE TA218: azacitidine for myelodysplastic syndromes
    Link  NICE TA399: Azacitidine for treating acute myeloid leukaemia with more than 30% bone marrow blasts
    Link  NUH Drugs and Therapeutics Website
    Link  SFH: AZA-MDS-003 trial protocol (oral Azacitidine)
       
    Cytotoxic Drug Capecitabine (Xeloda®)
    View adult BNF View SPC online View childrens BNF
    Formulary
    Red
    Tablet
     
    Link  Link to review
    Link  MHRA: risk of severe skin reactions—discontinue treatment
    Link  NICE TA100: Colon cancer (adjuvant) - capecitabine and oxaliplatin
    Link  NICE TA191: Gastric cancer (advanced) - capecitabine
    Link  NICE TA61: Colorectal cancer - capecitabine and tegafur uracil
    Link  SFH oral chemotherapy regimens
       
    Cytotoxic Drug Cladribine
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    Formulary
    Red
    High Cost Medicine
    Infusion
  • At NUH, SC cladribine is non-formulary.
  • Use in multiple sclerosis and pulmonary langerhans histiocytosis is not routinely commissioned - IFR approval must be sought before initiation.  
  • Link  Link to reviews
    Link  MHRA Drug Safety Update (December 2017): Cladribine and PML
    Link  SFH Cladribine regimen
       
    Cytotoxic Drug Cladribine (Mavenclad®)
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    Formulary
    Red
    High Cost Medicine
    Homecare

    Tablets

    • NUH: Approved in accordance with NICE TA616 for treating relapsing–remitting multiple sclerosis.
    • Available through homecare for NUH patients. Please contact pharmacy medicines homecare team for further information
     
    Link  NICE TA616: Cladribine tablets for treating relapsing–remitting multiple sclerosis
       
    Cytotoxic Drug Clofarabine
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    Restricted Drug Restricted
    Red
    High Cost Medicine
    Cancer Drugs Fund

    Intravenous Infusion- NUH only
    NUH: Approved in accordance with the National Cancer Drugs Fund List for the indication(s) below where the specified criteria are met:

    • The treatment of relapsed/refractory acute lymphoblastic leukaemia
    • The treatment of relapsed/refractory acute myeloblastic leukaemia. Removed from the CDF list January 2019 remains on formulary for patients with funding approved prior to removal.


    NUH: For more information, including criteria, see the DTC website; available here

    • At NUH, confirm funding approved on BlueTeq for all new starters
     
    Link  Drugs and Therapeutics Website
       
    Cytotoxic Drug Cytarabine
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    Formulary
    Red
    Injection
    NUH only:
  • Depot Intrathecal Injection (Depocyte®) for lymphomatous meningitis
  • Pre-filled syringes for ALL paediatric patients (Emergency chemotherapy). Unlicensed medicine - named patient use only
  • Pre-filled 20mg in 0.2mL syringes for subcutaneous administration in adult haematology. Unlicensed medicine - named patient use only
     
  • Link  Link to reviews
       
    Cytotoxic Drug Fludarabine Phosphate (Fludara®)
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    Formulary
    Red
    Tablet, Injection
     
    Link  NICE TA119: Leukaemia (lymphocytic) - fludarabine
    Link  NICE TA29: Leukaemia (lymphocytic) - fludarabine
    Link  SFH oral chemotherapy regimens
       
    Cytotoxic Drug Fluorouracil
    (Chemotherapy)
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    Formulary
    Red
    Capsule, Injection
     
       
    Cytotoxic Drug Gemcitabine (Gemzar®)
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    Formulary
    Red
    Injection
  • Gemcitabine in combination with carboplatin is not recommended for treatment of the first recurrence of platinum-sensitive ovarian cancer as per NICE TA389 
  • Link  Link to reviews
    Link  NICE TA116: Breast cancer - gemcitabine
    Link  NICE TA389 - Topotecan, pegylated liposomal doxorubicin hydrochloride, paclitaxel, trabectedin and gemcitabine for treating recurrent ovarian cancer
    Link  NICE TA85: Pancreatic cancer - gemcitabine
       
    Cytotoxic Drug Mercaptopurine
    (chemotherapy)
    View adult BNF View SPC online View childrens BNF
    Formulary
    Red
    Tablet, Suspension.
  • Classified red for the treatment of acute leukaemias, chronic myeloid leukaemia, cancer. See section 1.5.3 for IBD indication.
  • Suspension (Xaluprine®) (expensive) only for patients where tablets are not suitable (i.e. small doses in paediatrics) 
  • Link  UKMI Q&A: Which medicines require extra care when switching between liquid and tablet/capsule formulations?
       
    Cytotoxic Drug Methotrexate
    (Chemotherapy)
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    Formulary
    Red
    Tablet 2.5mg, Injection
  • Liquid can be made obtained if required.
  • Classified red for cancer indications- see sections 10.1.3 and 13.5.3 for rheumatology and psoriasis indications 
  • Link  NUH Lite Bite: Safer use of weekly oral methotrexate (Nov 2018)
    Link  SFH intrathecal policy
    Link  SFH methotrexate policy- see medicines policy section 4.5.1
    Link  SFH:Methotrexate oral regimen in LGL (haematology patients)
    Link  UKMI Q&A: alcohol and methotrexate guidance
    Link  UKMI Q&A: What is the clinical significance of the interaction between methotrexate and penicillins? (Oct13)
       
    Nelarabine (Atriance®)
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    Restricted Drug Restricted
    Red
    High Cost Medicine
    Cancer Drugs Fund
    Intravenous infusion
    Approved in accordance with the National Cancer Drugs Fund for the treatment of refractory T-cell acute lymphoblastic leukaemia or refractory T-cell lymphoblastic non-Hodgkin's lymphoma
    NUH: For more information, including criteria, see the DTC website; available here
    Confirm funding approved on BlueTeq for all new starters
    SFH: Ensure CDF funding approved by contacting the HCD Team on 4660. 
       
    Cytotoxic Drug Pemetrexed (Alimta®)
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    Restricted Drug Restricted
    Red
    High Cost Medicine
    Injection
    Approved in accordance with NICE:
  • TA135 for the treatment of malignant pleural mesothelioma

  • TA190 for the maintenance treatment of non-small-cell lung cancer

  • TA181 for the first-line treatment of non-small-cell lung cancer

  • TA402 for maintenance treatment for non-squamous non-small-cell lung cancer after pemetrexed and cisplatin

  • Confirm funding approved on BlueTeq for all new starters.
    SFH: Ensure funding approved by contacting the HCD team on 4660.
     
    Link  Link to reviews
    Link  NICE TA135: Mesothelioma - pemetrexed disodium
    Link  NICE TA181: Lung cancer (non-small cell, first line treatment) - pemetrexed
    Link  NICE TA190: Lung cancer (non-small-cell) - pemetrexed (maintenance)
    Link  NICE TA402:Pemetrexed maintenance treatment for non-squamous non-small-cell lung cancer after pemetrexed and cisplatin
       
    Cytotoxic Drug Raltitrexed (Tomudex®)
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    Restricted Drug Restricted
    Red

    Infusion

    Available at NUH only: Approved for metastatic colorectal cancer

     

     
       
    Cytotoxic Drug Tegafur with Uracil (Uftoral®)
    View adult BNF View SPC online View childrens BNF
    Formulary
    Red
    Capsule

     
    Link  NICE TA61: Capcitabine and tegafur - Colorectal cancer
    Link  SFH regimen: Tegafur with Uracil Regimen in Colorectal Cancer
       
    Cytotoxic Drug Tioguanine (Lanvis®)
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    Formulary
    Red
     
       
     ....
     Non Formulary Items
    Cytotoxic Drug  Decitabine  (Dacogen®)

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    Non Formulary
    Grey
    High Cost Medicine
  • Non-formulary as per NICE TA270.
  • May only be used after IFR approval
  • Link  Link to reviews
    Link  NICE: Leukaemia (acute myeloid ) - decitabine (terminated appraisal) (TA270)
     
      
    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

    Grey

    Grey / Non-Formulary: Medicines, which the Nottinghamshire APC has actively reviewed and does not recommend for use at present due to limited clinical and/or cost effective data.
    Grey / Non-Formulary (undergoing assessment): Work is ongoing and will be reviewed at a future APC meeting.
    Grey / Non-Formulary (no formal assessment): APC has not formally reviewed this medicine or indication because it had never been requested for formulary inclusion. Often used for drugs new to market.
      

    Red

    Medicines which should normally be prescribed by specialists only. eg hospital only.
    For patients already receiving prescriptions in primary care - continue. No new patients to receive prescriptions in primary care.
      

    Amber 1

    Medicines that should be initiated by a specialist and prescribed by primary care prescribers only under a shared care protocol, once the patient has been stabilised.
    Prior agreement must be obtained by the specialist from the primary care provider before prescribing responsibility is transferred. The shared care protocol must have been agreed by the relevant secondary care trust Drugs and Therapeutics Committee(s) (DTC) and approved by the Nottinghamshire APC.
      

    Amber 2

    Medicines suitable to be prescribed in primary care / general practice after specialist* recommendation or initiation.
    A supporting prescribing guideline may be requested which must have been agreed by the relevant secondary care trust DTCs and approved by the Nottinghamshire APC.
    *Specialist is defined by the APC as a clinician who has undertaken an appropriate formal qualification or recognised training programme within the described area of practice
      

    Amber 3

    Primary care/ non specialist may initiate as per APC guideline.
    The supporting prescribing guideline must have been agreed by the relevant secondary care trust D&TC(s) and approved by the Nottinghamshire APC.
      

    Green

    Medicines suitable for routine use within primary care.
    Can be initiated within primary care within their licensed indication, in accordance with nationally recognised formularies, for example the BNF, BNF for Children, Medicines for Children or Palliative Care Formulary. Primary care prescribers take full responsibility for prescribing.   

    OTC

      

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