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8.2 Drugs affecting the immune response


8.2.1 Cytotoxic immunosuppressants

Azathioprine tablets (see section 10.1.3 for additional information)
Mycophenolate mofetil capsules, tablets, IV infusion (also approved for last line treatment of SLE)

Note:

Generic prescribing of mycophenolate is encouraged in non-transplant patients only. When prescribing for prophylaxis of transplant rejection the clinician should specify the brand to be dispensed.

Mycophenolate has been linked with a possible increased risk of hypogammaglobulinaemia and risk of bronchiectasis. Monitor for recurrent infections, and persistent respiratory symptoms. See DSU January 2015. Mycophenolate is associated with a high rate of serious birth defects and spontaneous abortion: new pregnancy-prevention advice for women and men is given in: DSU December 2015

 

8.2.2 Corticosteroids and other immunosuppressants

Ciclosporin capsules, oral solution, IV infusion click here for shared care guidelines
Tacrolimus capsules, concentrate for intravenous infusion (for patients stabilised on tablets but currently NBM)
Sirolimus tablets - RED drug - consultant nephrologist only.

Note:

Tacrolimus should be prescribed by brand name. Because of bioavailability differences between products, switching patients between different tacrolimus formulations is not recommended without careful therapeutic monitoring. See the BNF for further information. Please also refer to the Drug Safety Update for June 2012.

 

8.2.3 Rituximab & Alemtuzumab

Alemtuzumab injection
Rituximab injection
- see NICE TA 137 - Rituximab for follicular non-Hodgkins lymphoma
- see NICE TA 65 - Rituximab for aggressive non-Hodgkin's lymphoma
- see NICE TA 174 - Rituximab for first line treatment of chronic lymphocytic leukaemia
- see NICE TA 193 - Rituximab for relapsed/refractory chronic lymphocytic leukaemia
- see NICE TA 226 - Rituximab for first line maintenance of follicular non-Hodgkins lymphoma
- see NICE TA 243 - Rituximab for first line treatment of stage III-IV of follicular lymphoma
- see NICE TA 308 - Rituximab in combination with glucocorticoids for treating anti-neutrophil cytoplasmic antibody-associated vasculitis
- see NICE TA 312 - Alemtuzumab for Relapsing Remitting Multiple Sclerosis
- see NHSE Commissioning policy – Rituximab for the treatment of ANCA-associated vasculitis in adults
- See NHSE Commissioning statement – Rituximab for the treatment of SLE in adults

Notes:

1. Rituximab has been associated with reactivation of hepatitis B virus, leading to fulminant hepatitis in some cases, some of which were fatal. All patients should be screened for hepatitis B virus prior to starting treatment. See DSU December 2013

    

    

8.2.4 Other Immunomodulating Drugs

Interferon alfa injection -2a (Roferon A) and -2b (Intron A; Viraferon)
Peginterferon alfa injection -2a (Pegasys) and -2b (ViraferonPeg)
Peginterferon beta-1a (Plegridy) – see NHSE commissioned drugs for MS: here and here
Interferon beta - 1a injection - see note & NICE TA 32
Interferon beta - 1b injection - see note &  NICE TA 32
Glatiramer acetate injection - see note & NICE TA 32
Dimethyl Fumarate capsules – see NICE TA 320 & note below
Fingolimod capsule - see NICE TA 254 & note below. Protocol available here.
Natalizumab infusion - see notes and  NICE TA 127; see note
Lenalidomide capsules - see NICE TA 171; see notes below
Teriflunomide tablets - see NICE TA 303
Thalidomide capsules - see NICE TA 228 - thalidomide in combination with an alkylating agent and steroid is an option for first-line treatment of multiple myeloma; see notes below

Notes:

1. Use of interferon beta 1a, interferon beta 1b, glatiramer acetate and natalizumab for Multiple Sclerosis is in accordance with EMSCG commissioning policy. Supplies of all (apart from natalizumab) via home care deilvery services. The Department of Health has agreed with the industry a risk-sharing scheme for the supply of interferon beta and glatiramer.

Beta interferon has also been associated with reports of thrombotic microangiopathy. See Drug Safety Update October 2014

2. The risk of developing progressive multifocal leukoencephalopathy (PML) with natalizumab increases after 2 years of therapy, especially in patients who have had previous immunosuppressant treatment. Patients with multiple sclerosis should be informed of the risk before treatment, and again after 2 years. The risk of developing PML beyond 3 years of treatment is currently unknown. See the Drug Safety Update March 2011 and Drug Safety Update April 2016; also PRAC guidance

3. Thalidomide has been associated with an increased risk of secondary primary malignancies (acute myeloid leukaemia and myelodysplastic syndromes). See Drug Safety Update May 2013. There is also a recommendation for a reduced starting dose in patients older than 75 years (100mg) / day to reduce side effects – See Drug Safety Update December 2015

4. Lenalidomide is used in the management of multiple myeloma.

See the following advice from the February 2011 issue of the MHRA Drug Safety update:

  • Patients receiving lenalidomide for the management of multiple myeloma should be closely monitored for evidence of arterial and venous thromboembolic events.
  • Modifiable risk factors for thromboembolic events should be managed wherever possible (e.g. smoking cessation, control of hyperlipidaemia).
  • Medicines that may increase the risk of thromboembolism, such as oestrogens and erythropoietic agents, should be used with caution during lenalidomide treatment.
  • Appropriate thrombotic prophylaxis medication should be considered during lenalidomide treatment, particularly in patients with multiple thrombotic risk factors, after careful assessment of the balance of risks and benefits in individual patients.
  • Treatment with lenalidomide must be discontinued and anticoagulation therapy started in patients who experience thromboembolic events. Once the patient has been stabilised on on anticoagulation treatment and any complications of the thromboembolic event have been managed, lenalidomide may be restarted at the original dose, after reassessment of risks and benefits of treatment. Anticoagulation should then be continued throughout the course of lenalidomide treatment.

 

5. Lenalidomide: Drug Safety Update November 2011:

Data from three large controlled clinical trials investigating use in patients with newly diagnosed multiple myeloma have recently shown a signal of an apparent excess of second primary malignancies in patients treated with lenalidomide. Use of lenalidomide in this or other unlicensed indications is not recommended. Healthcare professionals should be vigilant for the occurrence of second primary malignancies, and should report such events promptly.

Risk of serious hepatic reactions has been associated with a transient reduction in heart rate and decreased atrioventricular conduction.

6. Fingolimod: First dose to be administered in cardiac catheter suite. All patients should be monitored (ECG &  BP) before, during and immediately after the first 6 hours of treatment. This may also be necessary in the event of treatment interruption. See the SPC for details. The immunomodulatory effects of fingolimod increase the risk of progressive multifocal leukoencephalopathy and opportunistic infections see DSU April 2016. Fingolimod may be associated with a rebound effect (clinical and radiological signs of severe exacerbation beyond that expected) after stopping or switching therapy – see DSU.

 7. Dimethyl fumarate: Check full blood counts before prescribing dimethyl fumarate and then every 6 to 12 months. Stop treatment immediately if you suspect progressive multifocal leukoencephalopathy. See MHRA Drug Safety Update and Drug Safety Update for more information..

 

For link to BNF section: 8.2 Drugs affecting the immune response