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Bedfordshire and Luton Joint Formulary
Bedfordshire Hospitals NHS Foundation Trust
Bedfordshire, Luton and Milton Keynes ICB
Formulary Chapter: 8 - Malignant disease and immunosuppression 
Notes:

Any drug not listed on the Formulary should be considered Non-Formulary - Not recommended for prescribing
08.01.03 Antimetabolites

Azacitidine (Vidaza® Onureg®)

RED
Restricted Drug Restricted

FOR ALL PRESCRIBING – Blueteq or High cost drug form required – see link from Formulary homepage.

25 mg/mL powder for suspension for injection

200mg, 300mg film-coated tablets


unlicensedunlicensed pre-filled syringes 57.5mg/2.3mL, 60mg/2.4mL, 62.5mg/2.5mL, 65mg/2.6mL, 67.5mg/2.7mL, 70mg/2.8mL, 75mg/3mL & 80mg/3.2mL Subcutaneous Injection

Approved in accordance with the following NICE TAs:

BNF BNFc SPC
NICE TA218: azacitidine for myelodysplastic syndromes NICE TA827: Oral azacitidine for maintenance treatment of acute myeloid leukaemia after induction therapy NICE TA979: Ivosidenib with azacitidine for untreated acute myeloid leukaemia with an IDH1 R132 mutation

Capecitabine

RED
Restricted Drug Restricted

150mg & 500mg Tablets

Approved in accordance with the following NICE TAs.

BNF BNFc SPC
MHRA Drug Safety update (October 2020): 5-fluorouracil (intravenous), capecitabine, tegafur: DPD testing recommended before initiation to identify patients at increased risk of severe and fatal toxicity NICE TA100: Colon cancer (adjuvant) - capecitabine and oxaliplatin NICE TA191: Gastric cancer (advanced) - capecitabine NICE TA61: Metastatic colorectal cancer - capecitabine and tegafur uracil NICE TA786 Tucatinib with trastuzumab and capecitabine for treating HER2-positive advanced breast cancer after 2 or more anti-HER2 therapies

Cladribine
(Tablets)

RED
Restricted Drug Restricted

FOR ALL PRESCRIBING – Blueteq or High cost drug form required – see link from Formulary homepage.

To be prescribed by specialist in line with NICE TA616.

BNF BNFc SPC
Cladribine (Mavenclad): new advice to minimise risk of serious liver injury DSU March 2022 NICE TA 616 Cladribine for treating relapsing–remitting multiple sclerosis NICE TA1053: Cladribine for treating active relapsing forms of multiple sclerosis

Cytarabine

RED
Restricted Drug Restricted
unlicensedunlicensed 20mg, 40mg, 44mg, 46mg, 48mg, 50mg, 58mg, 72mg, 82mg, 128mg & 136mg Pre-filled Syringe
unlicensedunlicensed 60mg/3mL Intravenous Injection
BNF BNFc SPC
NICE TA787 Venetoclax with low dose cytarabine for untreated acute myeloid leukaemia when intensive chemotherapy is unsuitable

Fludarabine Phosphate (Fludara®)

RED
Restricted Drug Restricted
FOR ALL PRESCRIBING – Blueteq or High cost drug form required – see link from Formulary homepage.
10mg Tablets
50mg Injection Solution

Approved in accordance with NICE TA29 for the treatment of B-cell chronic lymphocytic leukaemia. It is not recommended to prescribe fludarabine on its own as an initial treatment for chronic lymphocytic leukaemia.

BNF BNFc SPC
NICE TA29: Guidance on the use of fludarabine for B-cell chronic lymphocytic leukaemia NICE TA119: Fludarabine monotherapy for the first-line treatment of chronic lymphocytic leukaemia NICE TA640: Treosulfan with fludarabine for malignant disease before allogeneic stem cell transplant NICE TA945: Treosulfan with fludarabine before allogeneic stem cell transplant for people aged 1 month to 17 years with non-malignant diseases (terminated appraisal)

Fluorouracil

RED
Restricted Drug Restricted
2.5g Injection
unlicensedunlicensed 50mg/2mL 100mg/4mL, 200mg/8mL & 500mg/20mL Syringe
unlicensedunlicensed 1250mg - 2400mg/252mL LV1.5 Infuser device Infusion
unlicensedunlicensed 1250mg - 2650mg/84mL SV0.5 Infusor device Infusion
unlicensedunlicensed 2100mg - 4800/220mL LV5 Infusor device Infusion

BNF BNFc SPC
MHRA Drug Safety Updayte (October 2020) DPD testing recommended before initiation to identify patients at increased risk of severe and fatal toxicity

Gemcitabine (Gemzar®)

RED
Restricted Drug Restricted

1g Injection
750mg - 2500mg in 0.9% Sodium Chloride Infusion (250mL)

Approved in accordance with the NICE TAs below:

BNF BNFc SPC
NICE TA25: Gemcitabine for the treatment of pancreatic cancer (replaced by NICE guideline NG85) NICE TA116: Gemcitabine for the treatment of metastatic breast cancer NICE TA476: Paclitaxel as albumin-bound nanoparticles with gemcitabine for untreated metastatic pancreatic cancer NICE TA944: Durvalumab with gemcitabine and cisplatin for treating unresectable or advanced biliary tract cancer NICE TA966: Pembrolizumab with gemcitabine and cisplatin for untreated advanced biliary tract cancer (terminated appraisal)

Mercaptopurine

RED
Restricted Drug Restricted

unlicensedunlicensed 10mg Tablets
50mg Tablets
100mg/5mL Suspension

Restricted - this medication requires authorisation from a consultant before prescribing

 

BNF BNFc SPC
Drug Safety Update Thiopurines and intrahepatic cholestasis of pregnancy

Methotrexate
(For oncology)

RED
Formulary

7.5mg/0.15mL, 10mg/0.2mL, 12.5mg/0.25mL, 15mg/0.3mL,
17.5mg/0.35mL, 20mg/0.4mL, 22.5mg/0.45mL, 25mg/0.5mL
27.5mg/0.55mL & 30mg/0.6mL Subcutaneous Injection

 

Important: Metoject new pen device (available from March 2024): Manufacturer is updating the pen device to a button free autoinjector. Please ensure patients are aware and counselled appropriately on how to use the new device. Further details can be found here.

BNF BNFc SPC
MHRA DSU Aug 2023 Methotrexate: advise patients to take precautions in the sun to avoid photosensitivity reactions

Pemetrexed (Alimta®)

RED
Restricted Drug Restricted
FOR ALL PRESCRIBING – Blueteq or High cost drug form required – see link from Formulary homepage.
Restricted to prescribing by Oncologists in accordance with NICE TA's below.
BNF BNFc SPC
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 NICE TA683: Pembrolizumab with pemetrexed and platinum chemotherapy for untreated, metastatic, non-squamous non-small-cell lung cancer NICE TA1060: Osimertinib with pemetrexed and platinum-based chemotherapy for untreated EGFR mutation-positive advanced non-small-cell lung cancer

Raltitrexed (Tomudex®)

RED
Restricted Drug Restricted
4mg - 6mg in 0.9% Sodium Chloride Infusion (100mL)

Restricted - prescribing by consultant oncologists only in accordance with NICE clinical guideline 131.
BNF BNFc SPC
NICE CG131: Colorectal cancer: diagnosis and management

Tegafur with Uracil (Uftoral®)

RED
Restricted Drug Restricted

FOR ALL PRESCRIBING – Blueteq or High cost drug form required – see link from Formulary homepage

Restricted to prescribing according to the NICE TA(s) below.

BNF BNFc SPC
MHRA Drug Safety Update (October 2020): 5-fluorouracil (intravenous), capecitabine, tegafur: DPD testing recommended before initiation to identify patients at increased risk of severe and fatal toxicity NICE TA61: Capcitabine and tegafur - Colorectal cancer

Trifluridine-tipiracil 15mg/6.14mg, 20mg/8.19mg (Lonsurf®)
(Tablets)

RED
Restricted Drug Restricted

FOR ALL PRESCRIBING – Blueteq or High cost drug form required – see link from Formulary homepage.

Restricted to prescribing according to the NICE TA(s) below.

BNF BNFc SPC
NICE TA405: 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 NICE TA1008: Trifluridine–tipiracil with bevacizumab for treating metastatic colorectal cancer after 2 systemic treatments
Classifications
GREEN
May be initiated in any care setting
Amber SPA
Specialist to advise therapy and provide first 28 days supply, continuation in Primary Care
Amber SPIS
Specialist to initiate and stabilise medicine prior to continuation in Primary Care
SCG
To be prescribed as per Shared Care Guidance. If no SCG in place status reverts to red.
RED
Red medicines are designated as specialist only medicines which should only be prescribed by a specialist, usually within secondary care (either due to the requirement for specialist knowledge, long-term monitoring requirements, or restrictions that mean medicine supplies are only available to hospitals).
DNP
A decision has been made either locally and/or nationally not to routinely commission this preparation. Do not prescribe.
SELF
To be purchased over the counter. May be prescribed for chronic, long term conditions or on admission to hospital if essential.