Download CHAPTER 8 Malignant disease and immunosuppression

CHAPTER 8 Malignant Disease and Immunosuppression
First line drugs – drugs
recommended in both
primary and secondary care
Second line drugs –
alternatives (often in specific
conditions) in both primary
and secondary care
Specialist drugs – Drugs
where specialist input is
needed (see introduction for
definition
Specialist only drugs –
prescribing within specialist
service only.
Page
8.1
Cytotoxic drugs
2
8.2
Drugs affecting the immune response
8
8.3
Sex hormones and hormone antagonists in malignant disease
12
Date
Nov 2012
Jan 2013
03/13
02/14
03/14
04/14
06/14
07/14
08/14
09/14
10/14
11/14
12/14
01/15
02/15
05/15
09/15
10/15
02/16
03/16
04/16
09/16
10/16
01/17
03/17
Revision
8.2.4 (MHRA Drug Safety Update, Novartis letter)
8.1.5 (NICE guidance)
8.1 (Minor update) 8.2.4 (NICE guidance)
8.1 (Minor update)
8.2.4 (NICE guidance)
8.1.2 (NICE guidance)
8.1.3 (NICE guidance) 8.1.5 (NICE guidance)
8.2.3 (NICE guidance)
8.2.3 (new formulation)
8.1.5 (NICE guidance) 8.3.4 (NICE guidance)
8.2.4 (NICE guidance)
8.2.4 (NICE guidance)
8.1.5 (NICE guidance), 8.3.4 (Formulation addition)
8.1.5 (NICE guidance)
8.1.5 (NICE guidance)
8.2.3 (NICE guidance)
8.2.3 (NICE guidance)
8.2. (NICE guidance)
8.2. (NICE guidance)
8.1 (NICE guidance), 8.2 (NICE guidance)
8.1 ( NICE guidance)
8.3 (minor amendment) 8.2 (NICE guidance)
NICE guidance)
NICE guidance
First line drugs
Second line drugs
Contributor
G Ells, K Wildman, N Sharma
A Luck
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Specialist drugs
Chapter 8 Malignant disease and immunosuppression
Adapted from Plymouth Area Joint Formulary and Brighton Joint Formulary
Page 1 of 15
Specialist only drugs
8.1 Cytotoxic Drugs
NHS England is responsible for the commissioning of cancer treatments in England. Some of the drugs
listed below may not be funded for all licensed indications but all treatments are funded for NICE approved
indications in accordance with the technology appraisal guidance.
Some cytotoxic drugs and many newer antineoplastic agents are available as oral formulations. This chapter
deals with these plus others available as subcutaneous injections and implants and identifies whether they
are deemed suitable for prescribing in primary care or not.
Some cytotoxic drugs at lower doses are used for indications other than cancer. See appropriate BNF
section for uses outside of cancer.
NPSA Rapid Response Report (Jan 2008): Risks of incorrect dosing of oral anticancer drugs
The NPSA is alerting all healthcare staff involved in the use of oral anti-cancer medicines of potentially fatal
outcomes if incorrect doses of these medicines are used. These oral anti-cancer medicines are increasingly
being used in hospitals and in the community.
The number of orally active agents available, particularly the targeted therapies, is likely to increase
substantially in the near future. The term oral anti-cancer medicines include those with direct anti-tumour
activity, including: bexarotene, busulfan, capecitabine, chlorambucil, cyclophosphamide, estramustine,
etoposide, fludarabine, hydroxycarbamide, idarubicin, lomustine, melphalan, mercaptopurine, methotrexate,
mitotane, procarbazine, tegafur/uracil, temozolomide, tioguanine, treosulfan and vinorelbine. In addition
targeted therapies such as the kinase inhibitors are also included. This list is not exhaustive so if unsure,
please check with the hospital Pharmacy Department or the primary care medicines management team.
Use of this term does not include hormonal or anti-hormonal therapy used to treat cancer.
The prescribing, dispensing and administering of oral anti-cancer medicines should be carried out and
monitored to the same standard as injected therapy. This requires that:

Treatment should be initiated by a cancer specialist and all oral anti-cancer medicines should be
prescribed only in the context of a written protocol and treatment plan.

Non-specialists who prescribe or administer on-going oral anti-cancer medication should have ready
access to appropriate written protocols and treatment plans including guidance on monitoring and
treatment of toxicity.

Staff dispensing oral anti-cancer medicines should be able to confirm that the prescribed dose is
appropriate for the patient, and that the patient is aware of the required monitoring arrangements, by
having access to information in the written protocol and treatment plan from the hospital where
treatment is initiated and advice from a pharmacist with experience in cancer treatment in that hospital.

Patients should be fully informed and receive verbal and up-to-date written information about their oral
anticancer therapy from the initiating hospital. This information should include contact details for
specialist advice, which can be shared with non-specialist practitioners. Written information, including
details of the intended oral anti-cancer regimen, treatment plan and arrangements for monitoring, taken
from the original protocol should be given to the patient.
8.1 Cytotoxic Drugs – Side effects
Treatments for cytotoxic-induced side effects
Dexrazoxane

Savene® Intravenous infusion
500mg vial with diluent
Emergency treatment of
anthracycline extravasation
Calcium Folinate

Tablets 15mg

Injection 3mg in 1ml, 30mg in
10ml, 350mg in 35ml
Folinic acid rescue following highdose methotrexate.

Tablets 400mg, 600mg

Injection 100mg in 4ml, 1g in
10ml

1% injection (10ml)
Mesna
Methylthioninium
chloride (Methylene
Blue)
First line drugs
Second line drugs
Prevention and treatment of
cyclophosphamide/ifosfamide
induced haemorrhagic cystitis
Treatment of ifosfamide induced
neurotoxicity
Specialist drugs
Chapter 8 Malignant disease and immunosuppression
Adapted from Plymouth Area Joint Formulary and Brighton Joint Formulary
Page 2 of 15
Specialist only drugs
8.1.1 Alkylating drugs
Bendamustine▼

Levact® Injection 25mg vial,
100mg vial
Busulfan

Myleran® Tablets 2mg
Carmustine

BiCNU® injection, powder for
reconstitution 100mg vial

Gliadel® Implant 7.7mg
Chlorambucil

Leukeran® tablets 2mg
Cyclophosphamide

Injection, powder for
reconstitution 500mg vial, 1g vial

Tablets 50mg
Estramustine
phosphate

Estracyt® Capsules 140mg
Ifosfamide

Ifosfamide Injection, powder for
reconstitution 1g vial, 2g vial
Lomustine

CCNU® capsules 40mg
Melphalan

Alkeran® Tablets 2mg

Injection, powder for
reconstitution 50mg vial
Chlormethine
hydrochloride
(Mustine)

Injection, powder for
reconstitution 10mg vial
Thiotepa

Injection, powder for
reconstitution 15mg vial
Treosulfan

Capsules 250mg

Injection, powder for
reconstitution 1g vial, 5g vial
NICE TA: Chronic lymphocytic
leukaemia
Unlicensed
NICE TA: Carmustine implants
and temozolomide for the
treatment of newly diagnosed
high-grade glioma
Available by importation only
(Unlicensed)
8.1.2 Anthracyclines and other cytotoxic antibiotics
Bleomycin

Injection, powder for
reconstitution 15000 unit vial
Dactinomycin
(Actinomycin D)

Injection, powder for
reconstitution 500 microgram vial
Daunorubicin

Injection, powder for
reconstitution 20mg vial
Doxorubicin - lipid
formulation

Caelyx® concentrate for IV
infusion 20mg in 10ml vial, 50mg
in 25ml vial
First line drugs
Second line drugs
NICE TA: Paclitaxel, pegylated
liposomal doxorubicin and
topotecan for advanced ovarian
cancer
NICE TA: Topotecan, pegylated
liposomal doxorubicin
hydrochloride, paclitaxel,
trabectedin and gemcitabine for
treating recurrent ovarian cancer
Specialist drugs
Chapter 8 Malignant disease and immunosuppression
Adapted from Plymouth Area Joint Formulary and Brighton Joint Formulary
Page 3 of 15
Specialist only drugs

Injection, powder for
reconstitution 10mg

Injection 10mg in 5ml vial

Zavedos® Capsules 5mg, 10mg,
25mg

Injection, powder for
reconstitution 5mg vial, 10mg vial
Mitomycin

Injection, powder for
reconstitution 2mg, 10mg, 20mg,
40mg vial
Mitoxantrone

Concentrate for IV infusion 20mg
in 10ml, 25mg in 12.5ml, 30mg in
15ml
Pixantrone▼

Pixuvri® Injection, powder for
reconstitution 29mg
NICE TA: multiply relapsed or
refractory aggressive nonHodgkin's B-cell lymphoma
Streptozocin

1g vials
Unlicensed
Azacitidine▼

Vidza® Injection 100mg vial
NICE TA: Myelodysplastic
syndromes, chronic
myelomonocytic leukaemia and
acute myeloid leukaemia
Capecitabine

Xeloda® Tablets 150mg, 500mg
NICE TA: Metastatic cancer
NICE TA: Adjuvant treatment of
stage III (Duke’s C) colon cancer
NICE TA: Advanced gastric
cancer
Cladribine

Litak® Injection (s/c), 2mg/ml 5ml
vial

Leustat® Concentrate for IV
infusion 1mg/ml 10ml vial

Injection 100mg in 5ml, 500mg in
5ml, 1g in 10ml, 2g in 20ml

DepoCyte® lipid formulation
intrathecal injection 50mg vial
Eribulin

Halaven® solution for
injection0.88mg in 2ml vial
NICE TA: Eribulin for treating
locally advanced or metastatic
breast cancer after 2 or more
chemotherapy regimens
Fludarabine phosphate

Fludara® Tablets 10mg

Injection, powder for
reconstitution 50mg vial
NICE TA: First-line treatment of
chronic lymphocytic leukaemia
Fluorouracil - systemic

Injection 25mg/ml
For topical preparation see Ch
13.8.1
Gemcitabine

Injection, powder for
reconstitution 200mg vial, 1g vial
NICE TA: Metastatic breast
cancer
NICE TA: Pancreatic cancer
Epirubicin
hydrochloride
Idarubicin
8.1.3 Antimetabolites
Cytarabine
First line drugs
Second line drugs
Specialist drugs
Chapter 8 Malignant disease and immunosuppression
Adapted from Plymouth Area Joint Formulary and Brighton Joint Formulary
Page 4 of 15
Specialist only drugs
Mercaptopurine

Puri-Nethol® Tablets 50mg

Suspension 100mg in 5ml
(Unlicensed)
Red for oncology use
Orange for patients with other
indications
For use in inflammatory bowel
disease see Ch1.5.3

Tablets 10mg

Injection 50mg in 2ml vial,
500mg in 20ml vial, 1000mg in
10ml vial, 5000mg in 50ml vial
Pemetrexed

Alimta® Injection, powder for
reconstitution 500mg vial
NICE TA: Malignant pleural
mesothelioma
NICE TA: non-small cell lung
cancer
NICE TA: First-line treatment of
non-small-cell lung cancer
NICE TA: Maintenance treatment
of non-small-cell lung cancer)
NICE TA: Pemetrexed
maintenance treatment for nonsquamous non-small-cell lung
cancer after pemetrexed and
cisplatin
Raltitrexed

Tomudex® Injection, powder for
reconstitution 2mg
NICE CG: Colorectal cancer
Tegafur with Uracil

Uftoral® Capsules containing
tegafur 100mg and uracil 224mg
NICE TA: Capecitabine and
tegafur with uracil for metastatic
colorectal cancer
Tioguanine

Lanvis® Tablets 40mg

Capsules 10mg
Unlicensed
Unlicensed

Suspension 10mg in 1ml

Lonsurf® Tablets 15 mg/6.14 mg
Methotrexate
Trifluridine and
tipiracil▼
For use in inflammatory bowel
disease (unlicensed) see Ch 1.5.3;
Rheumatoid arthritis Ch 10.1.3;
psoriasis 13.5.3
NICE TA:Trifluridine–tipiracil for
previously treated metastatic
colorectal cancer
8.1.4 Vinca alkaloids and etoposide

Vepesid® Capsules 50mg,
100mg

Concentrate for IV infusion
100mg in 5ml, 500mg in 25ml
Vinblastine sulphate

Injection 10mg in 10ml
Vincristine sulphate

Injection 1mg in 1ml, 2mg in 2ml
Vindesine sulphate

Injection, powder for
reconstitution 5mg vial
Vinorelbine

Navelbine® Capsules 20mg,
30mg

Injection concentrate 10mg in
1ml, 50mg in 5ml
Etoposide
First line drugs
Second line drugs
NICE CG: Advanced breast cancer
NICE CG: Lung Cancer
Specialist drugs
Chapter 8 Malignant disease and immunosuppression
Adapted from Plymouth Area Joint Formulary and Brighton Joint Formulary
Page 5 of 15
Specialist only drugs
8.1.5 Other antineoplastic drugs
Amsacrine

Amsidine® Concentrate for
IV infusion 75mg in 1.5ml
Bortezomib▼

Injection, powder for
reconstitution 3.5g vial
NICE TA: Monotherapy - relapsed
multiple myeloma
NICE TA: With thalidomide for the firstline treatment of multiple myeloma
NICE TA: Bortezomib for induction
therapy in multiple myeloma before
high dose chemo & autologous stem
cell transplantation
NICE TA: Bortezomib for previously
untreated mantle cell lymphoma
Panobinostat▼

Farydak® 10mg,15mg,
20mg capsules
NICE TA: Panobinostat for treating
multiple myeloma after at least 2
previous treatments
Pegaspargase▼

Oncaspar® solution for
injection/infusion 3,750 units
in 5ml
NICE TA:Pegaspargase for treating
acute lymphoblastic leukaemia
Cetuximab

IV infusion 5mg/ml, 20ml vial
NICE TA: Locally advance squamous
cell cancer of the head and neck.
NICE TA: Recurrent and/or metastatic
squamous cell cancer of the head and
neck
NICE TA: First line treatment of
metastatic colorectal cancer
Patient access scheme
Cobimetinib▼

Cottelic® Tablets 20mg
NICE TA:Cobimetinib in combination
with vemurafenib for treating
unresectable or metastatic BRAF V600
mutation-positive melanoma
Crisantaspase
(erwinia asparaginase)

Erwinase® Injection, powder
for reconstitution 10000 unit
vial
NB/ ewinia and e.coli asparaginase
products are NOT equivalent
Dacarbazine

Injection, powder for
reconstitution 100mg,
200mg,1g vial
Temozolomide

Capsules 5mg, 20mg,
100mg, 140mg, 180mg,
250mg
NICE TA: Carmustine implants and
temozolomide for the treatment of
newly diagnosed high-grade glioma
NICE TA: Brain cancer - temozolomide
Hydroxycarbamide

Capsules 500mg
Pentostatin

Nipent® injection, powder for
reconstitution 10mg vial
Ipilimumab▼

Yervoy® concentrate for IV
infusion 5mg in 1ml 10ml,
40ml vial
First line drugs
Second line drugs
NICE TA: Ipilimumab for previously
treated advanced melanoma
NICE TA: Ipilimumab for previously
untreated advanced melanoma
Specialist drugs
Chapter 8 Malignant disease and immunosuppression
Adapted from Plymouth Area Joint Formulary and Brighton Joint Formulary
Page 6 of 15
Specialist only drugs
Necitumumab▼

Portrazza® solution for
infusion, 800mg in 50ml
NICE TA:Necitumumab for untreated
advanced or metastatic squamous nonsmall-cell lung cancer
Pembrolizumab▼

Keytruda® injection, powder
for reconstitution 50mg vial
NICE TA: Pembrolizumab for treating
advanced melanoma after disease
progression with ipilimumab
NICE TA: Pembrolizumab for advanced
melanoma not previously treated with
ipilimumab
Pertuzumab▼

Perjeta® concentrate for
solution for infusion 420mg
in 14ml vial
Carboplatin

Injection 50mg in 5ml, 150mg
in 15ml, 450mg in 45ml,
600mg in 60ml
Cisplatin

Injection 10mg in 10ml, 50mg
in 50ml, 100mg in 100ml
Oxaliplatin

Injection, powder for
reconstitution 50mg vial,
100mg vial
Procarbazine

Capsules 50mg
Talimogene
laherparepvec ▼

Imlygic® solution for
injection, 106 PFUs/ml, 108
PFUs/ml
Afatinib▼

Giotrif® Tablets 20mg, 30mg,
40mg, 50mg
NICE TA: Afatinib for EGFR +ve
locally advanced or metastatic NSCLC
Axitinib▼

Inlyta® Tablets, 1mg, 3mg,
5mg, 7mg
NICE TA: Axitinib for treating
advanced renal cell carcinoma after
failure of prior systemic treatment
Bosutinib▼

Bosulif® Tablet, 100mg,
500mg
NICE TA: Bosutinib for previously
treated chronic myeloid leukaemia
Ceritinib▼

Zykadia® Capsules 150mg
NICE TA: Ceritinib for previously
treated anaplastic lymphoma kinase
positive non-small-cell lung cancer
Crizotinib▼

Xalcori® Capsules, 200mg,
250mg
NICE TA:Crizotinib for untreated
anaplastic lymphoma kinase-positive
advanced non-small-cell lung cancer
NICE TA: Crizotinib for previously
treated anaplastic lymphoma kinasepositive advanced non-small-cell lung
cancer
Dabrafenib▼

Tafinlar® Capsules 50mg,
75mg
NICE TA: Dabrafenib for unresectable
or metastatic BRAF V600 mutation
positive melanoma
Dasatinib

Sprycel® Tablets 20mg, 50mg,
80mg, 100mg, 140mg
NICE TA: Dasatinib, nilotinib and
high-dose imatinib for treating
imatinib-resistant or intolerant
chronic myeloid leukaemia
NICE TA: Dasatinib, nilotinib and
imatinib for untreated chronic myeloid
leukaemia
NICE TA: Pertuzumab for the
neoadjuvant treatment of HER2-positive
breast cancer
NICE CG: Colorectal cancer
NICE TA:Talimogene laherparepvec for
treating unresectable metastatic
melanoma
Protein Kinase inhibitors
First line drugs
Second line drugs
Specialist drugs
Chapter 8 Malignant disease and immunosuppression
Adapted from Plymouth Area Joint Formulary and Brighton Joint Formulary
Page 7 of 15
Specialist only drugs
Erlotinib

Tarceva® Tablets 25mg,
100mg, 150mg
NICE TA: Erlotinib for metastatic
EGFR-TK positive NSCLC
NICE TA: Non-small-cell lung cancer
NICE TA: Erlotinib and gefitinib for
treating non-small-cell lung cancer
that has progressed after prior
chemotherapy
Everolimus

Afinitor® Tablets 2.5mg, 5mg,
10mg
NICE TA: Everolimus with
exemestane for treating advanced
breast cancer after endocrine therapy
Gefitinib

Irressa® Tablets 250mg
NICE TA: First-line treatment of
locally advanced or metastatic nonsmall-cell lung cancer
Patient access scheme details
Idelalisib▼

Zydelig tablets 100mg
NICE TA: Idelalisib for chronic
lymphocytic leukaemia
Imatinib

Glivec® Tablets 100mg,
400mg
NICE TA: Dasatinib, nilotinib and
imatinib for untreated chronic myeloid
leukaemia
NICE TA: Imatinib for gastrointestinal
stromal tumours
NICE TA: Imatinib for adjuvant
treatment of gastrointestinal stromal
tumours
Nilotinib

Tasigna® Capsules 150mg,
200mg
NICE TA: Dasatinib, nilotinib and
high-dose imatinib for treating
imatinib-resistant or intolerant
chronic myeloid leukaemia
NICE TA: Dasatinib, nilotinib and
imatinib for untreated chronic myeloid
leukaemia
Nintedanib▼

Vargatef® Capsules 100mg,
150mg
NICE TA: locally advanced, metastatic
or locally recurrent non-small-cell
lung cancer
Osimertinib▼

Tagrisso® Tablets 40mg,
80mg
NICE TA:Osimertinib for treating
locally advanced or metastatic EGFR
T790M mutation-positive non-smallcell lung cancer
Pazopanib

Votrient® Tablets 200mg,
400mg
NICE TA: Metastatic renal cell
carcinoma
Ruxolitinib▼

Jakavi® tablets 5mg, 10mg,
15mg, 20mg
NICE TA: treatment of disease-related
splenomegaly or symptoms in adults
with myelofibrosis
Sunitinib

Sutent® Capsules 12.5mg.
25mg, 50mg
Trametinib▼

Mekinist® tablets 0.5mg, 2mg
Vemurafenib

Zelboraf® capsules 240mg
NICE TA: First line advanced and/or
metastatic renal cell carcinoma
NICE TA: Gastrointestinal stromal
tumours
Patient access scheme details
NICE TA: In combination with
dabrafenib for treating unresectable
or metastatic melanoma
NICE TA: locally advanced or
metastatic BRAF V600 mutationpositive malignant melanoma
First line drugs
Second line drugs
Specialist drugs
Chapter 8 Malignant disease and immunosuppression
Adapted from Plymouth Area Joint Formulary and Brighton Joint Formulary
Page 8 of 15
Specialist only drugs
Cabazitaxel

Jevtana® Concentrate plus
diluent
NICE TA: hormone-relapsed
metastatic prostate cancer
Docetaxel

Concentrate for IV infusion
20mg in 0.5ml, 80mg in 2ml
NICE TA: Hormone refractory prostate
cancer
NICE CG: Early and locally advanced
breast cancer
NICE CG: Advanced breast cancer
Paclitaxel

Concentrate for IV infusion
30mg in 5ml, 100mg in 16.7ml,
300mg in 50ml
NICE CG: Advanced breast cancer
NICE TA: Paclitaxel, pegylated
liposomal doxorubicin and topotecan
for advanced ovarian cancer
NICE TA: Topotecan, pegylated
liposomal doxorubicin hydrochloride,
paclitaxel, trabectedin and
gemcitabine for treating recurrent
ovarian cancer
Irinotecan

Concentrate for IV infusion
100mg in 5ml, 300mg in 15ml
NICE CG: Colorectal cancer
Olaparib▼

Lynparza® 50mg capsules
NICE TA: Olaparib for maintenance
treatment of relapsed, BRCA
mutation-positive ovarian, fallopian
tube and peritoneal cancer after
response to second-line or
subsequent platinum-based
chemotherapy
Topotecan

Hycamptin® Capsules 250
micrograms, 1mg

IV infusion, powder for
reconstitution 1mg, 4mg vial
NICE TA: relapsed small-cell lung
cancer
NICE TA: Paclitaxel, pegylated
liposomal doxorubicin and topotecan
for advanced ovarian cancer
NICE TA: topotecan for recurrent
cervical cancer
Trabectedin

Injection, powder for
reconstitution 250 microgram
vial, 1mg vial
NICE TA: Advanced soft tissue
sarcoma
Trastuzumab

Injection, powder for
reconstitution 150mg vial
NICE CG: Early and locally advanced
breast cancer
NICE TA:HER2-positive metastatic
gastric cancer
Tretinoin

Vesanoid® Capsules 10mg
First line drugs
Second line drugs
Specialist drugs
Chapter 8 Malignant disease and immunosuppression
Adapted from Plymouth Area Joint Formulary and Brighton Joint Formulary
Page 9 of 15
Specialist only drugs
8.2 Drugs affecting the immune response
8.2.1 Antiproliferative immunosuppressants
Azathioprine

Tablets 25mg, 50mg
Red for transplant patients
Orange for patients with other
indications
For use in inflammatory bowel disease
(unlicensed indication), rheumatoid
arthritis( unlicensed indication) see
Ch1.5.3 and 10.1.3 respectively

Injection 50mg vial
Oncology only
Patients with reduced or absent activity of the enzyme thiopurinemethyltransferase (TPMT) are at increased risk
of myelosuppression if treated with azathioprine, mercaptopurine or tioguanine. TPMT activity should be
measured prior to starting these treatments.
Mycophenolate mofetil

Capsules 250mg, tablets
500mg

also available as the brand
CellCept®

CellCept® Suspension 1g/5ml

CellCept® IV infusion, powder
for reconstitution 500mg vial
 Myfortic® Tablets 180mg,
Mycophenolic acid
360mg
(Mycophenolate sodium)
Red for transplant patients
Orange for patients with other
indications
Prescriber must prescribe as CellCept if
brand required.
Hospital Only
Red for transplant patients
Orange for patients with other
indications
Different formulations of the same immunosuppressant may vary in bioavailability hence switching between
brands should be avoided except on the advice of a transplant specialist.
Mycophenolate mofetil and mycophenolic acid are licensed for use to suppress organ rejection in renal
transplantation. Mycophenolate mofetil is also licensed for use in cardiac and hepatic transplantation.
Further guidance on treatments used in renal transplantation can be found in
NICE TA: Immunosuppressive therapy for renal transplantation in adults and
NICE TA: Immunosuppressive therapy for renal transplantation in children and adolescents
8.2.2 Corticosteroids and other immunosuppressants
Antithymocyte
Immunoglobulin (rabbit)

Thymoglobuline® IV infusion,
powder for reconstitution 25mg
vial
Renal centre only
The following drugs all feature in the management of transplant rejection. Guidance on the sequence of
treatments used in renal transplantation can be found in
NICE TA: Immunosuppressive therapy for renal transplantation in adults and
NICE TA: Immunosuppressive therapy for renal transplantation in children and adolescents
Ciclosporin

Neoral® capsules 10mg, 25mg,
50mg, 100mg

Neoral® oral solution 100mg in
1ml

Sandimmun® concentrate for IV
infusion 50mg in 1ml, 250mg in
5ml
Prescribe by brand.
Red for transplant patients
Orange for patients with other
indications
Hospital Only
Patients should be stabilised on a particular brand of oral ciclosporin to avoid the possibility of clinically significant
fluctuations in ciclosporin levels that may occur between different formulations. To minimise the risk of this
occurring ciclosporin should always be prescribed by brand name.
First line drugs
Second line drugs
Specialist drugs
Chapter 8 Malignant disease and immunosuppression
Adapted from Plymouth Area Joint Formulary and Brighton Joint Formulary
Page 10 of 15
Specialist only drugs
Basiliximab

Simulect® Injection, powder for
reconstitution 10mg, 20mg vial
Sirolimus

Rapamune® Tablets 1mg

Oral Solution 1mg/ml

Prograf® Capsules 500
micrograms, 1mg, 5mg

Adoport® Capsules 500
micrograms, 1mg, 5mg

Prograf® Concentrate for IV
infusion 5mg in 1ml
Tacrolimus
Prescribe by brand. Not
interchangeable
MHRA/CHM advice on oral tacrolimus products (June 2012) says that:
The growing number of oral tacrolimus products available on the market increases the potential for inadvertent
switching between products, which has been associated with reports of toxicity and graft rejection. Therefore, to
ensure maintenance of therapeutic response when a patient is stabilised on a particular brand, oral tacrolimus
products should be prescribed and dispensed by brand name only.
If a prescriber considers that switching a patient to a different brand of oral tacrolimus would be of
benefit, the change requires careful supervision and therapeutic monitoring by an appropriate specialist
8.2.3 Monoclonal antibodies and immunostimulants
Alemtuzumab▼

Lemtrada® Concentrate for
IV infusion 10mg in 1ml
NICE TA: Relapsing-remitting multiple
sclerosis
Belimumab▼

Benylsta® powder for
Concentrate for IV infusion
120mg, 400mg
NICE TA: Autoantibody-positive systemic
lupus erythematosus
Nivolumab▼

Opdivo® concentrate for IV
infusion 10mg in 1ml
NICE TA: advanced (unresectable or
metastatic) melanoma
NICE TA: Previously treated advanced
renal cell carcinoma
Obinutuzumab▼

Gazyvaro® Concentrate for
IV infusion 25mg in 1ml
NICE TA: Untreated chronic lymphocytic
leukaemia
Ofatumumab▼

Azerra® Concentrate for IV
infusion 20mg in 1ml
NICE TA: Untreated chronic lymphocytic
leukaemia
Rituximab
(Oncology Indications)

MabThera® Concentrate for
IV infusion 10mg in 1ml

MabThera® Solution for SC
injection 120mg/ml (1,400mg
per vial)
NICE TA: Aggressive non-hodgkin's
lymphoma
NICE TA: Follicular lymphoma
NICE TA: Relapsed or refractory stage III
or IV follicular non-Hodgkin’s lymphoma
NICE TA: First-line treatment of chronic
lymphocytic leukaemia
NICE TA: Relapsed chronic lymphocytic
leukaemia
NICE TA: Follicular non-Hodgkins
lymphoma (maintenance treatment)
NICE TA: ANCA-associated Vasculitis
8.2.4 Other immunomodulating drugs
Interferon alfa – 2a
First line drugs

Roferon-A® pre-filled syringe
3 million units, 6 million units,
9 million units, 18 million
units.

Roferon-A® cartridge 18
Second line drugs
Specialist drugs
Chapter 8 Malignant disease and immunosuppression
Adapted from Plymouth Area Joint Formulary and Brighton Joint Formulary
Page 11 of 15
Specialist only drugs
million unit in 0.6ml

IntronA® 1.5ml cartridge 15
million units/ml, 25 million
units/ml, 50 million units/ml

IntronA® 10 million units vial
powder for reconstitution

Pegasys® Prefilled syringe,
135 microgram, 180
microgram

Pegasys® Prefilled pen 135
microgram, 180 microgram
Peginterferon alfa–2b

ViraferonPeg® prefilled pen,
powder for reconstitution
50microgram, 80microgram,
100microgram,
120microgram,
150microgram
NICE TA: Interferon alfa (pegylated and
non-pegylated) and ribavirin for hepatitis
C
NICE TA: Peginterferon alfa and ribavirin
for mild chronic hepatitis C
NICE TA: Peginterferon alfa and ribavirin
for hepatitis C
Interferon beta – 1a

Avonex® pre-filled syringe 30
microgram (6 million units),
prefilled pen 30micrograms
(6 million units)
NICE TA: Multiple sclerosis
DH Provision of disease-modifying
therapies for MS

Rebif® pre-filled syringe 22
microgram (6 million units),
44 microgram (12 million
units) Cartridge
44microgram, 66microgram,
88microgram, 132 microgram
for use with RebiSmart®
device

RebiDose® prefilled pen
22microgram, 44microgram
Interferon beta – 1b

Betaferon® injection 300
microgram (9.6 million unit)
vial
Bacillus CalmetteGuérin

ImmuCyst® bladder
instillation 81mg vial
Dimethyl fumarate▼

Tecfidera® capsules 120mg,
240mg
NICE TA: dimethylfumarate for relapsingremitting multiple sclerosis
Fingolimod▼

Gilenya® capsules 500
micrograms
NICE TA: Fingolimod for multiple
sclerosis
Commissioned from specialist MS service
providers only
Interferon alfa – 2b
Peginterferon alfa-2a
NICE TA: PegInterferon alfa-2a for
Hepatitis B
NICE TA: Peginterferon alfa and ribavirin
for mild chronic hepatitis C
NICE TA: Peginterferon alfa and ribavirin
for hepatitis C
NICE TA: Peginterferon alfa and ribavirin
for hepatitis C (children & young adults)
NICE TA: Multiple sclerosis
DH Provision of disease-modifying
therapies for MS
MHRA/CHM advice: Fingolimod not recommended for patients at known risk of cardiovascular events
(May 2012)
Fingolimod is known to cause transient bradycardias and heart block after the first dose. Fingolimod is now not
recommended in patient groups at high risk of cardiovascular adverse events, such as those with significant QT
prolongation or history of bradycardia, ischaemic heart disease, cardiac failure, cerebrovascular disease,
uncontrolled hypertension, and those receiving antiarrhythmic or heart-rate lowering drugs.
All patients should be monitored before, during, and immediately after the first 6 hours of treatment. If the
First line drugs
Second line drugs
Specialist drugs
Chapter 8 Malignant disease and immunosuppression
Adapted from Plymouth Area Joint Formulary and Brighton Joint Formulary
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Specialist only drugs
patient’s heart rate decreases to its lowest point at the end of the 6-hour treatment period, monitoring should be
extended until heart rate increases. Monitoring should also be extended at least overnight if significant
atrioventricular block, bradycardia, or QTc prolongation occurs.
MHRA Drug Safety Update : Bradycardia and heart block – repeat enhanced cardiovascular monitoring
when restarting fingolimod after treatment interruption (January 2013)
Starting fingolimod treatment, or re-starting fingolimod after treatment interruption, results in transient decreases
in heart rate. In some patients it can also cause transient bradycardias and heart block. This risk is minimised
through enhanced monitoring.
Guidance on when enhanced cardiac monitoring is required following treatment interruption has now been
updated on the basis of new clinical pharmacology analyses and dose titration data.
The new monitoring advice depends both on the time since treatment started, and how long treatment has been
interrupted for. NOVARTIS Direct Healthcare Professional Communication (January 2013)
Glatiramer Acetate
Lenalidomide


Copaxone® Injection 20mg in
1ml
NICE TA: Multiple sclerosis
DH Provision of disease-modifying
therapies for MS
NICE TA: Multiple myeloma
NICE TA: Myelodysplastic syndromes
Mandatory compliance with pregnancy
prevention programme
Patient access scheme
Revlemid® Capsules 5mg,
10mg, 15mg, 25mg
MHRA Drug Safety Update – Lenalidomide (Revlimid) : Risk of serious hepatic adverse drug reactions –
routine monitoring of liver function now recommended (January 2013)
Elevations of liver enzymes occur in 1-10 patients out of every 100 treated with lenalidomide for multiple
myeloma in clinical trials; the majority of these are non-serious. Serious (potentially fatal) liver injuries such as
acute hepatic failure, toxic hepatitis, hepatocellular hepatitis, and cholestatic hepatitis have been reported overall
in <1% of treated patients.
Hepatic function should be routinely monitored (with the same frequency as haematological monitoring*),
particularly in patients with a history of, or concurrent, viral liver infection, or when lenalidomide is given at the
same time as other medications known to be associated with liver injury.
Thalidomide

NICE TA: Bortezomib and thalidomide
for the first-line treatment of multiple
myeloma
Mandatory compliance with pregnancy
prevention programme
Capsules 50mg
Mifamurtide▼

Mepact® Intravenous infusion,
powder for reconstitution, 4-mg
vial
NICE TA: Osteosarcoma
Natalizumab▼

Tysabri® Concentrate for IV
infusion 20mg/ml 15ml vial
NICE TA: Adults with highly active
relapsing-remitting multiple sclerosis
Commissioned from specialist MS service
providers only
Teriflunomide▼

Aubagio® Tablets 14mg
NICE TA: Relapsing–remitting multiple
sclerosis
8.3 Sex hormones and hormone antagonists in malignant disease
8.3.1 Oestrogens
Diethylstilbestrol

Tablets 1mg, 5mg
Ethinylestradiol

Tablets 10 micrograms, 50
micrograms, 1mg
First line drugs
Second line drugs
Specialist drugs
Chapter 8 Malignant disease and immunosuppression
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Specialist only drugs
8.3.2 Progestogens
Medroxyprogesterone
acetate

Provera® Tablets 100mg,
200mg, 400mg
Megestrol acetate

Megace® Tablets 160mg
8.3.3 Androgens
.
Note: Testosterone esters (section 6.4.2) have largely been superseded by other drugs for breast cancer
8.3.4 Hormone antagonists
8.3.4.1 Breast cancer
Anastrozole

Tablets 1mg
Exemestane

Aromasin® Tablets 25mg
Letrozole

Tablets 2.5mg
Tamoxifen

Tablets 10mg, 20mg, 40mg
NICE TA: Adjuvant treatment of early
oestrogen-receptor-positive breast
cancer
8.3.4.2 Gonadorelin analogues and GnRH-releasing hormone antagonists
Leuprorelin (Prostap®) is the preferred first choice GnRH analogue where appropriate for newly diagnosed
patients.
Goserelin (Zoladex®) is included as a second line alternative being the only licensed product for use in the
treatment of breast cancer.
Local specialists agree that all GnRH analogues are equally effective and will continue to recommend treatment
with a 'GnRH analogue' rather than a specific brand of product to be used unless clinically indicated. Specialists
agree that general practitioners can change the product prescribed within this class of therapy to complete
courses of therapy for existing patients as clinically appropriate and after informed discussions with the patient.
Degarelix is a GnRH antagonist which is approved for use as a 1st line treatment option in patients with
significant metastatic disease and symptoms who need a rapid response to anti-androgen therapy and where
there is a significant risk to tumour flare.
Leuprorelin
(1st choice)

Prostap® R DCS 3.75mg (every
month)

Prostap® 3 DCS 11.25mg
(every 3 months)
Goserelin

Zoladex® Implant 3.6mg
(4weeks), 10.8mg (12 weeks),
Triptorelin

Decapeptyl® SR powder for
suspension 3mg (4 weeks),
11.25mg (12 weeks), 22.5mg (6
months)
Degarelix

Firmagon® powder for
reconstitution
120mg vial, 80mg vial
NICE TA:Degarelix for treating
advanced hormone-dependent
prostate cancer
Starting dose to be administered in
secondary care
First line drugs
Second line drugs
Specialist drugs
Chapter 8 Malignant disease and immunosuppression
Adapted from Plymouth Area Joint Formulary and Brighton Joint Formulary
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Specialist only drugs
Anti-androgens
Abiraterone

Zytiga® tablets 250mg
NICE TA: for treating metastatic
prostate cancer
NICE TA: for treating metastatic
hormone-relapsed prostate cancer
before chemotherapy is indicated
Enzalutamide▼

Xtandi® capsules 40mg
NICE TA: for treating metastatic
prostate cancer
NICE TA: for treating metastatic
hormone-relapsed prostate cancer
before chemotherapy is indicated
Bicalutamide

Tablets 50mg, 150mg
Cyproterone acetate

Tablets 50mg, 100mg
Flutamide

Tablets 250mg
8.3.4.3 Somatostatin analogues
Lanreotide

Somatuline LA copolymer
microparticles for aqueous
suspension Injection pre-filled
syringe 30mg, LA Autogel 60mg,
90mg, 120mg
Octreotide

Injection 50 micrograms in 1ml,
100 micrograms in 1ml, 500
micrograms in 1ml, 1mg in 5ml

Sandostatin LAR Depot injection
10mg, 20mg, 30mg
8. Other treatments
Radium-223 dichloride▼
First line drugs

Xofigo 1100 kBq/mL
solution for injection
Second line drugs
NICE TA:Radium-223 dichloride for
treating hormone-relapsed prostate
cancer with bone metastases
Specialist drugs
Chapter 8 Malignant disease and immunosuppression
Adapted from Plymouth Area Joint Formulary and Brighton Joint Formulary
Page 15 of 15
Specialist only drugs