Chapter 8 Malignant Disease and Immunosuppression

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Chapter 8 page number 1 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 initiated drugs Secondary care or GP with special interest initiation. Suitable for continuation by primary care. Shared care agreements may be applicable. Secondary care only drugs Drugs only suitable for secondary care use and initiated by appropriate team or specialist. Primary care prescribers should not be asked to prescribe. Primary & Secondary Care Notes Secondary Care For Malignant Disease, follow Thames Valley Cancer Network (TVCN) protocols. 8.1 Cytotoxic drugs For use of Folinic acid in epilepsy, see 3Ts chapter 4.8.1 8.1.1 Alkylating drugs Cyclophosphamide tablets 8.1.3 Antimetabolites Methotrexate 2.5mg tablets Specialist initiation only (with SCA) (see sections 10.1.3 and 13.5.2 and 1.5). Prescribe in multiples of 2.5mg tablets only do not use the 10mg tablets. Note ONCE WEEKLY dose. See NPSA alert for details on safer use of oral methotrexate Please refer to primary and secondary care guidelines for prescribing and monitoring of Methotrexate. Red for cancer treatment and MUST NOT BE ONWARDLY PRESCRIBED by GPs for this Cyclophosphamide injection (see section 10.1.3) Red for cancer treatment and MUST NOT BE ONWARDLY PRESCRIBED by GPs for this Methotrexate oral solution Methotrexate 10mg tablets Methotrexate injection Mercaptopurine 8.1.5 Other antineoplastic drugs Hydroxycarbamide 8.2 Drugs affecting the immune response 8.2.1 Antiproliferative immunosuppresants For management of Inflammatory Bowel Disease. Gastroenterologist initiation only (see section 1.5). Red for cancer treatment and MUST NOT BE ONWARDLY PRESCRIBED by GPs for this Haematology consultant initiation only (with SCA).

Chapter 8 page number 2 Azathioprine Specialist initiation only including organ transplant pts, (with SCA, where appropriate also see sections 1.5, 10.1.3 and 13.5.2). Mycophenolate Specialist initiation only including organ transplant pts, (with SCA, where appropriate also see sections 1.5, 10.1.3 and 13.5.2). Jan 2015 for information on risk of bronchiectasis and risk of hypogammaglobulinaemia. For new pregnancy-prevention advice for women and men see MHRA Drug Safety Update Dec 15. Feb 18 for updated contraceptive advice for male patients. 8.2.2 Corticosteroids and other immunosuppressants Ciclosporin Specialist initiation only including organ transplant pts, (with SCA, where appropriate also see sections 1.5, 10.1.3 and 13.5.2). Patients should be stabilised on a particular brand of oral ciclosporin because switching between formulations without close monitoring may lead to clinically important changes in blood-ciclosporin concentration. Prescribing and dispensing of ciclosporin should be by brand name to avoid inadvertent switching. (1) Tacrolimus Specialist initiation only including organ transplant patients. Prescribers should ONLY prescribe oral tacrolimus by brand. There are numerous brands now available and extreme care is needed to ensure the patient remains on the same brand throughout their treatment. If a prescriber intends to switch between brands, careful medical supervision and close therapeutic monitoring are required. Substitution should be made only under the close supervision of a transplant specialist. See CMH letter for further information. (See section 13.5.2 for tacrolimus ointment). Nov17 for further information on prescribing and dispensing by brand. Sirolimus Specialist initiation only including organ transplant pts. 8.2.3 Anti-lymphocyte monoclonal antibodies Alemtuzumab -For initiation by with NICE TA312. Rituximab (see section 10.1.3) See MHRA drug safety letter (November 2013) 8.2.4 Other immunomodulating drugs Please see NHS England s Treatment Algorithm for Multiple Sclerosis Disease-modifying Treatments Sept 18 for information on treatment pathway commissioned. See MRHA Drug Safety Update April 17 for information on the risk of rebound effects on stopping or switching Multiple Sclerosis therapies.

Chapter 8 page number 3 Interferon alfa Interferon beta (Extavia) - Neurology consultant initiation only. (Oct 2014) for information on risk of thrombotic microangiopathy and nephrotic syndrome. Cladribine - For initiation by with NICE TA493. Dimethyl fumarate (Tecfidera)- For initiation by consultant neurologist only, in line with NICE TA320. for further information on risk of lymphopenia and PML. the risk of, serious adverse effects. Fingolimod For initiation by with NICE TA254. See MHRA drug safety letter (November 2013). the risk of, serious adverse effects. Dec 17 for information on new contraindications relating to cardiac risk and updated advice on risk of cancers and serious infections. Glatiramer acetate - Neurology consultant initiation only. Natalizumab For initiation by with NICE TA127. the risk of, serious adverse effects Ocrelizumab For initiation by with NICE TA533. Teriflunomide - For initiation by with NICE TA303.

Chapter 8 page number 4 8.3 Sex hormones and hormone antagonists in malignant disease 8.3.1 Oestregens Diethylstilbestrol Ethinylestradiol 8.3.2 Progestens Medroxyprogeserone acetate Megestrol Specialist initiation only for prostate cancer (palliative), (see also section 6.4.1.1). Specialist initiation only for endometrial cancer, (see also section 7.3.2.2). Specialist initiation only for endometrial cancer. Norethisterone Specialist initiation only for endometrial cancer, (see also section 6.4.1.2). 8.3.4 Hormone antagonists 8.3.4.1 Breast cancer See NICE TA 112: Hormonal therapies for the adjuvant treatment of early oestrogen-receptor-positive breast cancer. Anastrozole Exemestane Letrozole Tamoxifen Goserelin (Zoladex ) Specialist initiation only, (see also section 6.5.1). Specialist initiation only and only for licensed indications for breast cancer. Zoladex 3.6mg Implant is licensed for treatment of advanced breast cancer in pre and perimenopausal women suitable for hormonal manipulation, or as an alternative to chemotherapy in the standard of care for pre/perimenopausal women with oestrogen receptor (ER) positive early breast cancer. 8.3.4.2 Prostate cancer See NICE CG175 Prostate cancer diagnosis and management. Gonadorelin analogues Please note GWH Urology team has no particular preference of LHRH agonist. Goserelin Leuprorelin Please be aware of dose difference between Prostap 3 DCS (11.25mg every three months) and Lutrate 3-month depot (22.5mg every three months). Buserelin injection and nasal spray (see also section 6.7.2) Triptorelin Anti-androgens

Chapter 8 page number 5 Bicalutamide Cyproterone acetate Specialist initiation only for prostate cancer. 50mg once daily - In combination with LHRHa therapy or surgical castration in men with locallly advanced prostate cancer. In combination with LHRHa treatment, bicalutamine should commence at least 3-7 days before administration of LHRHa. 150mg once daily - Either alone or as an adjuvant to radical prostatectomy or radiotherapy in patients with locally advanced prostate cancer at high risk of disease progression. Specialist initiation only, (see sections 13.6.2 & 6.4.2). Hepatotoxicity: Liver function tests should be performed before treatment & whenever symptoms suggestive of hepatotoxicity occur- if confirmed cyproterone should be withdrawn. Cyproterone is no longer recommended for long term use. Abiraterone See NICE TA259 & NICE TA387. Enzalutamide See NICE TA316 & NICE TA377. Flutamide Specialist initiation only for prostate cancer. Gonadotrophin releasing hormone antagonists Degarelix See NICE TA 404. Please note it is envisaged that most patients will require only a single dose of degarelix before switching to ongoing treatment with an LHRH agonist. However, on occasion, a complex patient will need to continue ongoing treatment with degarelix and GPs will be advised of this in writing by the GWH Urology team. 8.3.4.3 Somatostatin analogues - See Swindon PCT Somatostatin policy statement. Octreotide (including Specialist initiation only, (with SCA) long-acting Amber for acromegaly. preparation) Amber for Carcinoid Syndrome. Amber for use in high output stomas and in palliative care (unlicensed). Lanreotide Specialist initiation only, (with SCA). Amber for Treatment of acromegaly and Neuroendocrine tumours and carcinoid syndrome (Somatuline Autogel ). NHS Swindon, NHS Wiltshire and Great Western Hospitals NHS Foundation Trust in collaboration with Avon & Wilts Mental Healthcare Partnership Trust. Reference 1. British National Formulary 60 th edition September 2010