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Area Prescribing Committee Formulary  
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 Formulary Chapter 8: Malignant disease and immunosuppression - Full Chapter
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08.01.03  Expand sub section  Antimetabolites
Cytotoxic Drug Azacitidine
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Formulary
Red
  • Approved for myelodysplastic syndromes, CLL and AML - in line with NICE guidance.
 
Link  NICE TA218: Azacitidine for myelodysplastic syndromes
Link  NICE TA399: Azacitidine for treating acute myeloid leukaemia with more than 30% bone marrow blasts
   
Cytotoxic Drug Capecitabine
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Formulary
Red
  • Only approved for use in accordance with NICE guidance.
  • Approved in combination with gemcitabine following surgery for pancreatic cancer in line with NHS England Clinical Commissioning Policy
 
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  NHS England SSC1959 - Clinical Commissioning Policy: Gemcitabine and capecitabine following surgery for pancreatic cancer (all ages)
   
Cytotoxic Drug Cladribine
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Formulary
Red
  • 10mg in 10ml solution for preparing infusions; 2mg in 1ml subcutaneous injection 
  • Approved for Hairy cell leukaemia only.

  • 10mg tablets
  • Approved for treating highly active multiple sclerosis in adults in line with NICE
 
Link  NICE TA493: Cladribine tablets for treating relapsing–remitting multiple sclerosis
Link  NICE TA616: Cladribine for treating relapsing–remitting multiple sclerosis
   
Cytotoxic Drug Cytarabine
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Formulary
Red
  • A cytarabine 50mg vial - intrathecal injection (cytarabine encapsulated in liposomes) is also approved for use. 
 
   
Cytotoxic Drug Daunorubicin/cytarabine (Vyxeos®)
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Formulary
Red
High Cost Medicine
NHS England
  • Daunorubicin 44mg/cytarabine 100mg powder for solution for infusion
  • Approved for untreated acute myeloid leukaemia in line with NICE
 
Link  NICE TA 552: Liposomal cytarabine–daunorubicin for untreated acute myeloid leukaemia
   
Cytotoxic Drug Fludarabine Phosphate
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Formulary
Red
  • Approved for the second line therapy of B-cell CLL in line with NICE.
  • Note: fludarabine is not approved for monotherapy in the first line treatment of CLL - this is in line with NICE.
 
Link  NICE TA119: Fludarabine monotherapy for the first-line treatment of chronic lymphocytic leukaemia
Link  NICE TA29: Guidance on the use of fludarabine for B-cell chronic lymphocytic leukaemia
   
Cytotoxic Drug Fluorouracil
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Formulary
Red
  • A fluorouracil 10mg in 0.4ml subconjunctival injection (unlicensedunlicensed) is also approved for use. 
  • FOLFIRINOX is approved for the management of selected patients with inoperable pancreatic cancer in patients with performance status 0-1.
 
   
Cytotoxic Drug Gemcitabine
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Formulary
Red
  • Approved in combination with paclitaxel for metastatic breast cancer in line with NICE. 
  • NECDAG approved for the second line treatment of women with partially platinum – sensitive, platinum resistant or platinum refractory advanced ovarian cancer (To be used when liposomal doxorubicin [Caelyx] is unavailable). 
  • Approved for pancreatic cancer in line with NICE. 
  • Approved for the treatment of recurrent ovarian cancer in line with NICE.
  • Approved in combination with capecitabine following surgery for pancreatic cancer in line with NHS England Clinical Commissioning Policy
 
Link  NICE TA25: Guidance on the use of gemcitabine for the treatment of pancreatic cancer
Link  NICE TA116: Gemcitabine for the treatment of metastatic breast cancer
Link  NICE TA389: Topotecan, pegylated liposomal doxorubicin hydrochloride, paclitaxel, trabectedin and gemcitabine for treating recurrent ovarian cancer
Link  NHS England SSC1959 - Clinical Commissioning Policy: Gemcitabine and capecitabine following surgery for pancreatic cancer (all ages)
   
Cytotoxic Drug Mercaptopurine
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Formulary
Red
  • A mercaptopurine 20mg in 1ml suspension (unlicensedunlicensed) is also approved for use. 
  • Note: when prescribed for inflammatory bowel disease. Amber Traffic Light
 
   
Cytotoxic Drug Methotrexate
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Formulary
Red
  • approved formulations:
    • Methotrexate 2.5mg tablets
    • Methotrexate 10mg in 5ml oral solution. unlicensedunlicensed
    • Methotrexate injections (various strengths) – including prefilled syringes.
    • Methotrexate 5mg in 2ml intrathecal injection.
  • Note: when used in chronic inflammatory conditions, e.g. Crohn’s disease, rheumatoid arthritis.Amber Traffic Light
 
   
Cytotoxic Drug Pemetrexed
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Formulary
Red
  • Approved for:
    • Mesothelioma in line with NICE (funding has to be agreed on an individual patient basis if treatment is not in line with NICE).
    • Combination with cisplatin for the first line treatment of locally advanced or metastatic NSCLC (non-squamous cell histology) in line with NICE.
    • Maintenance treatment of locally advanced or metastatic NSCLC (non-squamous cell histology) in line with NICE.
    • Maintenance treatment of non-squamous non-small lung cancer after pemetrexed and cisplatin in line with NICE and NHS England Commissioning Policy.

  • Note: pemetrexed is not approved for locally advanced or metastatic NSCLC as per NICE. 
 
Link  NICE TA124: Pemetrexed for the treatment of non-small-cell lung cancer
Link  NICE TA135: Pemetrexed for the treatment of malignant pleural mesothelioma
Link  NICE TA181: Pemetrexed for the first-line treatment of non-small-cell lung cancer
Link  NICE TA190: Pemetrexed for the maintenance treatment of non-small-cell lung cancer
Link  NICE TA402: Pemetrexed maintenance treatment for non-squamous non-small-cell lung cancer after pemetrexed and cisplatin
   
Cytotoxic Drug Tegafur with Uracil
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Formulary
Red
  • Approved for metastatic colorectal cancer in line with NICE.
 
Link  NICE TA61: Guidance on the use of capecitabine and tegafur with uracil for metastatic colorectal cancer
   
Cytotoxic Drug Tioguanine
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Formulary
Red
  • 50mg in 1ml suspension is also approved.unlicensedunlicensed
 
   
Trifluridine and tipiracil
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Formulary
Red
  • Approved for previously treated metastatic colorectal cancer in adults in line with NICE and NHS England Commissioning Policy (SSC1662). 
 
Link  NICE TA 405 - Trifluridine–tipiracil for previously treated metastatic colorectal cancer
   
 ....
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
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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

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.   

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 hospital specialist, but where the provision of an information leaflet may be appropriate to facilitate continuing treatment by GPs. Many of these information sheets are in the process of development.  

Green

Drugs where prescribing by GPs is appropriate. Drugs not classified as Red, Amber or Green Plus (formerly blue in North of Tyne) are generally classified as ‘Green’ by default. The Green drugs listed here include those products normally initiated by hospital specialists where there was a need for discussion and debate as to the category in which they should be placed.  

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