Azacitidine

• Tablets 200mg, 300mg
• Powder for suspension for injection vials 100mg

Notes

1. NICE TA399: Azacitidine (Vidaza) is not recommended, within its marketing authorisation, for treating acute myeloid leukaemia with more than 30% bone marrow blasts in people of 65 years or older who are not eligible for haematopoietic stem cell transplant (July 2016)
2. NICE TA827: Oral azacitidine (Onureg) is recommended, within its marketing authorisation, as an option for maintenance treatment for acute myeloid leukaemia (AML) (October 2022), in adults who:
   1. are in complete remission, or complete remission with incomplete blood count recovery, after induction therapy with or without consolidation treatment, and
   2. cannot have or do not want a haematopoietic stem cell transplant and
   3. the company provides oral azacitidine according to the commercial arrangement
3. NICE TA218: Azacitidine (Vidaza) is recommended as a treatment option for adults who are not eligible for haematopoietic stem cell transplantation (March 2011), and have:
   1. intermediate-2 and high-risk myelodysplastic syndromes according to the International Prognostic Scoring System (IPSS) or
   2. chronic myelomonocytic leukaemia with 10-29% marrow blasts without myeloproliferative disorder or
   3. acute myeloid leukaemia with 20-30% blasts and multilineage dysplasia, according to the World Health Organisation classification and
   4. if the manufacturer provides azacitidine with the discount agreed as part of the patient access scheme

Capecitabine

• Tablets 150mg, 500mg

Notes

1. NICE TA263: Bevacizumab (Avastin), in combination with capecitabine is not recommended for the first-line treatment of metastatic breast cancer, that is, when treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate, or when taxanes or anthracyclines have been used as part of adjuvant treatment within the past 12 months (August 2012)
2. NICE TA212 : Bevacizumab (Avastin) in combination with oxaliplatin and either fluorouracil plus folinic acid or capecitabine is not recommended for the treatment of metastatic colorectal cancer (December 2010)
3. NICE TA191: Capecitabine in combination with a platinum-based regimen is recommended for the first-line treatment of inoperable advanced gastric cancer (July 2010)
4. NICE TA61: Oral therapy with capecitabine is recommended as an option for the first-line treatment of metastatic colorectal cancer (May 2003)
5. NICE TA100: Capecitabine as monotherapy is recommended an option for the adjuvant treatment of patients with stage III (Duke's C) colon cancer following surgery for the condition (April 2006)
6. MHRA Drug Safety Update (December 2014): Capecitabine: risk of severe skin reactions - discontinue treatment
   1. Severe skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported during treatment with capecitabine
7. 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
   1. Patients with complete or partial dihydropyrimidine dehydrogenase (DPD) deficiency are at increased risk of severe and fatal toxicity during treatment with medicines containing 5-fluorouracil (intravenous), capecitabine, and tegafur

Cladribine

• Tablets 10mg
• Solution for injection vials 10mg in 5ml

Notes

1. NICE TA616: Cladribine tablets (Mavenclad) are recommended as an option for treating highly active multiple sclerosis in adults (December 2019), only if the person has:
   1. rapidly evolving severe relapsing–remitting multiple sclerosis, that is with at least:
      • 2 relapses in the previous year and
      • 1 T1 gadolinium-enhancing lesion at baseline MRI or a significant increase in T2 lesion load compared with a previous MRI, or
   2. relapsing–remitting multiple sclerosis that has responded inadequately to treatment with disease-modifying therapy, defined as 1 relapse in the previous year and MRI evidence of disease activity
2. MHRA Drug Safety Update (December 2017): Cladribine (Litak, Leustat) for leukaemia: reports of progressive multifocal encephalopathy (PML); stop treatment if PML suspected
3. MHRA Drug Safety Update (March 2022): Cladribine (Mavenclad): new advice to minimise risk of serious liver injury
   1. urgently check liver function tests (including bilirubin) in patients with symptoms or signs of liver injury
   2. discontinue or interrupt cladribine treatment in patients with hepatic dysfunction or unexplained increases in liver enzymes
   3. See the safety update for advice to give to patients

Cytarabine

• Solution for injection vials 100mg in 1ml, 100mg in 5ml, 500mg in 5ml, 500mg in 25ml, 1g in 10ml, 2g in 20ml

Fludarabine phosphate

• Tablets 10mg
• Concentrate for solution for injection vials 50mg in 2ml
• Powder for solution for injection vials 50mg

Notes

1. NICE TA29: Guidance on the use of fludarabine for B-cell chronic lymphocytic leukaemia (September 2001):
   1. Oral fludarabine is recommended as second-line therapy for B-cell chronic lymphocytic leukaemia (CLL) for patients who have either failed, or are intolerant of, first-line chemotherapy, and who would otherwise have received combination chemotherapy of either:
      • cyclophosphamide, doxorubicin, vincristine and prednisolone (CHOP)
      • cyclophosphamide, doxorubicin and prednisolone (CAP) or
      • cyclophosphamide, vincristine and prednisolone (CVP)
   2. The oral formulation of fludarabine is preferred to the intravenous formulation on the basis of more favourable cost effectiveness. Intravenous fludarabine should only be used when oral fludarabine is contra-indicated
2. NICE TA119: Fludarabine (Fludara) monotherapy, within its licensed indication, is not recommended for the first-line treatment of chronic lymphocytic leukaemia (February 2007)

Fluorouracil sodium

• Solution for injection vials 500mg in 10ml, 500mg in 20ml, 1g in 20ml
• Capsules 250mg (unlicensed preparation)

Notes

1. 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
   1. Patients with complete or partial dihydropyrimidine dehydrogenase (DPD) deficiency are at increased risk of severe and fatal toxicity during treatment with medicines containing 5-fluorouracil (intravenous), capecitabine, and tegafur

Gemcitabine hydrochloride

• Concentrate for solution for infusion vials 200mg in 2ml, 200mg in 5.26ml, 1g in 10ml, 1g in 26.3ml, 2g in 20ml, 2g in 52.6ml
• Powder for solution for infusion vials 200mg, 1g, 2g

Notes

1. NICE TA116: Gemcitabine in combination with paclitaxel, within its licensed indication, is recommended as an option for the treatment of metastatic breast cancer only when docetaxel monotherapy or docetaxel plus capecitabine are also considered appropriate (January 2007)
2. NICE TA285: Bevacizumab (Avastin) in combination with gemcitabine and carboplatin is not recommended, within its marketing authorisation, that is, for treating people with the first recurrence of platinum-sensitive advanced ovarian cancer (including fallopian tube and primary peritoneal cancer) who have not received prior therapy with bevacizumab or other vascular endothelial growth factor (VEGF) inhibitors or VEGF receptor-targeted agents (May 2013)
3. NICE TA389: Topotecan, pegylated liposomal doxorubicin hydrochloride (Caelyx; PLDH), paclitaxel, trabectedin (Yondelis) and gemcitabine for treating recurrent ovarian cancer (April 2016):
   1. Gemcitabine in combination with carboplatin is not recommended for treating the first recurrence of platinum-sensitive ovarian cancer
4. NICE TA476: Paclitaxel as albumin-bound nanoparticles (nab paclitaxel; Abraxane) with gemcitabine is recommended as an option for untreated metastatic adenocarcinoma of the pancreas in adults, only if:
   1. other combination chemotherapies are unsuitable and they would otherwise have gemcitabine monotherapy and
   2. the company provides nab‑paclitaxel with the discount agreed in the patient access scheme

Mercaptopurine

• Tablets 50mg (£8.43 = 25 tablets)
• Oral suspension 20mg in 1ml (£170.00 = 100ml)
• Capsules 10mg (unlicensed preparation)
• Tablets 10mg (unlicensed preparation)

Notes

1. Refer to individual shared care guidelines for use in Gastroenterology conditions
2. Avoid concomitant use of mercaptopurine with allopurinol, unless supervised by an appropriate specialist.
3. Mercaptopurine is used in the management of acute leukaemias, chronic myeloid leukaemia, and in the management of ulcerative colitis and Crohn's disease (unlicensed indication)
4. MHRA Drug Safety Update (October 2010): Mercaptamine and mercaptopurine: confusion between drug names
   1. Prescribers should remain vigilant with regards to the similarity of these 2 drug names

Tioguanine

• Tablets 40mg
• Capsules 10mg (unlicensed preparation)
• Oral suspension 50mg in 5ml (unlicensed preparation)

Clofarabine

• Not routinely commissioned. It has been approved for use for certain conditions where all the criteria set out by the Cancer Drugs Fund are met.

Nelarabine

• Not routinely commissioned. It has been approved for use for certain conditions where all the criteria set out by the Cancer Drugs Fund are met.