North East and North Cumbria
ICS Formulary
 
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8 Malignant disease and immunosuppression
08-01-03 Antimetabolites

Azacitidine
Formulary
  • 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
Link  NICE TA827: Oral azacitidine for maintenance treatment of acute myeloid leukaemia after induction therapy

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Capecitabine
Formulary
  • 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: Capecitabine and oxaliplatin in the adjuvant treatment of stage 3 (Dukes’ C) colon cancer
Link  NICE TA191: Capecitabine for the treatment of advanced gastric cancer
Link  NICE TA61: Guidance on the use of capecitabine and tegafur with uracil for metastatic colorectal cancer
Link  NHS England SSC1959 - Clinical Commissioning Policy: Gemcitabine and capecitabine following surgery for pancreatic cancer (all ages)
Link  MHRA Drug Safety Update (Jan 2014): Capecitabine: risk of severe skin reactions - discontinue treatment
Link  MHRA Drug Safety Update (Oct 2020): 5-fluorouracil (intravenous), capecitabine, tegafur: DPD testing recommended before initiation to identify patients at increased risk of severe and fatal toxicity

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Cladribine
Formulary
  • 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
  • Approved for treating active relapsing forms of multiple sclerosis in adults in line with NICE
Link  MHRA Drug Safety Update (Dec 2017): Cladribine (Litak, Leustat) for leukaemia: reports of progressive multifocal encephalopathy (PML); stop treatment if PML suspected
Link  MHRA Drug Safety Update (Mar 2022): Cladribine (Mavenclad): new advice to minimise risk of serious liver injury
Link  NICE TA1053: Cladribine for treating active relapsing forms of multiple sclerosis
Link  NICE TA616: Cladribine for treating relapsing–remitting multiple sclerosis

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Clofarabine
Formulary

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Cytarabine
Formulary
  • A cytarabine 50mg vial - intrathecal injection (cytarabine encapsulated in liposomes) is also approved for use. 

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Daunorubicin/cytarabine Vyxeos®
Formulary

  • 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
Link  MHRA Drug Safety Update (July 2020): Liposomal and lipid- complex formulations: name change to reduce medication errors

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Fludarabine Phosphate
Formulary
  • 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

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Fluorouracil
Formulary
  • 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.
Link  MHRA Drug Safety Update (Oct 2020): 5-fluorouracil (intravenous), capecitabine, tegafur: DPD testing recommended before initiation to identify patients at increased risk of severe and fatal toxicity

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Gemcitabine
Formulary

  • 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 NG85: Pancreatic cancer in adults: diagnosis and management
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)

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Mercaptopurine
Formulary
  • A mercaptopurine 20mg in 1ml suspension (unlicensedunlicensed) is also approved for use. 
  • Note: when prescribed for inflammatory bowel disease. Amber Traffic Light
Link  MHRA: Thiopurines and intrahepatic cholestasis of pregnancy
Link  NENC Shared Care Protocol - Azathioprine and mercaptopurine within adult services (non-transplant indications)

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Methotrexate
Formulary
  •  Approved formulations:
    • Methotrexate 2.5mg tablets
    • Methotrexate 10mg in 5ml oral solution. unlicensed unlicensed
    • Methotrexate injections (various strengths) – including prefilled syringes.
    • Methotrexate 5mg in 2ml intrathecal injection.
  • See NENC Shared Care Protocol for approved indications and formulations that can be prescribed under shared care. 
  • Subcutaneous methotrexate is always prescribed by secondary care. 
Link  MHRA Drug Safety Update (August 2023): Methotrexate: advise patients to take precautions in the sun to avoid photosensitivity reactions
Link  MHRA Drug Safety Update (Sept 2020): Methotrexate once weekly for autoimmune diseases: new measures to reduce risk of fatal overdose due to inadvertent daily instead of weekly dosing
Link  NENC Shared Care Protocol - Methotrexate (oral and subcutaneous) for patients in adult services (excluding cancer care)

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Nelarabine Atriance®
Formulary

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Pemetrexed
Formulary
  • 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

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Raltitrexed Tomudex®
Formulary

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Tegafur with Gimeracil and Oteracil
Formulary
Link  MHRA Drug Safety Update (Oct 2020): 5-fluorouracil (intravenous), capecitabine, tegafur: DPD testing recommended before initiation to identify patients at increased risk of severe and fatal toxicity

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Tegafur with Uracil
Formulary
  • 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
Link  MHRA Drug Safety Update (Oct 2020): 5-fluorouracil (intravenous), capecitabine, tegafur: DPD testing recommended before initiation to identify patients at increased risk of severe and fatal toxicity

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Tioguanine
Formulary
  • 50mg in 1ml suspension is also approved.unlicensedunlicensed
Link  MHRA: Thiopurines and intrahepatic cholestasis of pregnancy

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Trifluridine and tipiracil
Formulary

  • 15 mg/6.14 mg, 20 mg/8.19 mg film-coated tablets

  • Approved for previously treated metastatic colorectal cancer in adults in line with NICE and NHS England Commissioning Policy (SSC1662). 
  • Approved for treating metastatic colorectal cancer in adults who have had 2 lines of treatment in line with NICE
Link  NICE TA 405 - Trifluridine–tipiracil for previously treated metastatic colorectal cancer
Link  NICE TA1008 : Trifluridine–tipiracil with bevacizumab for treating metastatic colorectal cancer after 2 systemic treatments
Link  NICE TA852: Trifluridine–tipiracil for treating metastatic gastric cancer or gastro-oesophageal junction adenocarcinoma after 2 or more treatments

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