North East and North Cumbria Formulary


	North East and North Cumbria ICS Formulary

Search

Formulary Chapter 8: Malignant disease and immunosuppression - Full Chapter

Chapter Links...

Cancer Drug Fund List

Northern Cancer Alliance

Northern England Clinical Networks Palliative and End of Life Care Guidelines

Details...

08.01.03

Antimetabolites

Azacitidine

Formulary

Approved for myelodysplastic syndromes, CLL and AML - in line with NICE guidance.

NICE TA218: Azacitidine for myelodysplastic syndromes

NICE TA399: Azacitidine for treating acute myeloid leukaemia with more than 30% bone marrow blasts

NICE TA827: Oral azacitidine for maintenance treatment of acute myeloid leukaemia after induction therapy

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

NICE TA100: Colon cancer (adjuvant) - capecitabine and oxaliplatin

NICE TA191: Gastric cancer (advanced) - capecitabine

NICE TA61: Colorectal cancer - capecitabine and tegafur uracil

NHS England SSC1959 - Clinical Commissioning Policy: Gemcitabine and capecitabine following surgery for pancreatic cancer (all ages)

MHRA Drug Safety Update (Jan 2014): Capecitabine: risk of severe skin reactions - discontinue treatment

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

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

MHRA Drug Safety Update (Dec 2017): Cladribine (Litak, Leustat) for leukaemia: reports of progressive multifocal encephalopathy (PML); stop treatment if PML suspected

MHRA Drug Safety Update (Mar 2022): Cladribine (Mavenclad): new advice to minimise risk of serious liver injury

NICE TA616: Cladribine for treating relapsing–remitting multiple sclerosis

Clofarabine (Evoltra^®)

Formulary

Cytarabine

Formulary

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

Daunorubicin/cytarabine (Vyxeos^®)

Formulary

Daunorubicin 44mg/cytarabine 100mg powder for solution for infusion

Approved for untreated acute myeloid leukaemia in line with NICE

NICE TA 552: Liposomal cytarabine–daunorubicin for untreated acute myeloid leukaemia

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

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.

NICE TA119: Fludarabine monotherapy for the first-line treatment of chronic lymphocytic leukaemia

NICE TA29: Guidance on the use of fludarabine for B-cell chronic lymphocytic leukaemia

Fluorouracil

Formulary

A fluorouracil 10mg in 0.4ml subconjunctival injection (unlicensed) 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.

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

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

NICE NG85: Pancreatic cancer in adults: diagnosis and management

NICE TA116: Gemcitabine for the treatment of metastatic breast cancer

NICE TA389: Topotecan, pegylated liposomal doxorubicin hydrochloride, paclitaxel, trabectedin and gemcitabine for treating recurrent ovarian cancer

NHS England SSC1959 - Clinical Commissioning Policy: Gemcitabine and capecitabine following surgery for pancreatic cancer (all ages)

Mercaptopurine

Formulary

A mercaptopurine 20mg in 1ml suspension (unlicensed) is also approved for use.
Note: when prescribed for inflammatory bowel disease.

Methotrexate

Formulary

Approved formulations:
- Methotrexate 2.5mg tablets
- Methotrexate 10mg in 5ml oral solution. unlicensed
- 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.
NOTE: Subcutaneous injection for chronic inflammatory conditions in Tees SICBL

MHRA Drug Safety Update (August 2023): Methotrexate: advise patients to take precautions in the sun to avoid photosensitivity reactions

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

South Tyneside & Sunderland APC Shared Care Guideline - Methotrexate in Neurology

Nelarabine

(Atriance^®)

Formulary

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.

NICE TA124: Pemetrexed for the treatment of non-small-cell lung cancer

NICE TA135: Pemetrexed for the treatment of malignant pleural mesothelioma

NICE TA181: Pemetrexed for the first-line treatment of non-small-cell lung cancer

NICE TA190: Pemetrexed for the maintenance treatment of non-small-cell lung cancer

NICE TA402: Pemetrexed maintenance treatment for non-squamous non-small-cell lung cancer after pemetrexed and cisplatin

Raltitrexed (Tomudex^®)

Formulary

Tegafur with Gimeracil and Oteracil

Formulary

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

Tegafur with Uracil

Formulary

Approved for metastatic colorectal cancer in line with NICE.

NICE TA61: Guidance on the use of capecitabine and tegafur with uracil for metastatic colorectal cancer

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

Tioguanine

Formulary

50mg in 1ml suspension is also approved.unlicensed

Trifluridine and tipiracil

Formulary

Approved for previously treated metastatic colorectal cancer in adults in line with NICE and NHS England Commissioning Policy (SSC1662).

NICE TA 405 - Trifluridine–tipiracil for previously treated metastatic colorectal cancer

NICE TA852: Trifluridine–tipiracil for treating metastatic gastric cancer or gastro-oesophageal junction adenocarcinoma after 2 or more treatments

....

Key

	Notes
	Section Title (top level)
	Section Title (sub level)
	First Choice item
	Non Formulary section
	Restricted Drug
	Unlicensed
	Display tracking information
	Link to adult BNF
	Link to children's BNF
	Link to SPCs

	Cytotoxic Drug
	Controlled Drug
	High Cost Medicine
	NHS England
	Homecare
	CCG

Traffic Light Status Information

Status	Description
	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. For all RED drugs automatically added to the formulary in response to a positive NICE TA: Prescribers need to ensure that local Trust new drug governance procedures and pharmacy processes are followed before any prescribing.
	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.
	Drugs normally recommended or initiated by a specialist (hospital or GP with an extended role https://www.rcgp.org.uk/gpwer), but can be safely maintained in primary care with very little or no monitoring required. In some cases there may be a further restriction for use outlined - these will be defined in each case. Provision of additional information, or an information leaflet, may be appropriate in some cases to facilitate continuing treatment by GPs.
	Drugs where prescribing by GPs is appropriate. Can be initiated and prescribed in all care settings, and if appropriate, discontinued without recourse to secondary care.
	NOT APPROVED: Drugs that have been considered by NTAG or the NENC ICB Medicines Subcommittee (or other approved body) and are not approved for prescribing within the North East and North Cumbria.
	UNDER REVIEW: drugs whose current formulary status or RAG status is currently under review.
	NOT REVIEWED: Drugs that haven not been reviewed yet. This usually means that an application is in progress. These drugs are not normally considered appropriate for prescribing in the North East and North Cumbria until such time that a decision is taken on their formulary status.