Immunosuppressants (Formulary)

TAM (Treatments and Medicines) NHS Highland
NHS Highland

Patients uncontrolled on standard therapy may be prescribed azathioprine or other disease modifying agents, initiated by hospital specialists. Regular monitoring is required for all drugs listed, refer to DMARD monitoring.

ADALIMUMAB

Therapy notes

  • Amgevita brand is first-line
  • Humira brand is second-line.
  • See monitoring advice in DMARD monitoring.

Formulation and dosage details

Formulation:

Solution for injection, pre-filled pen (Amgevita) 40mg/0·8mL (hospital use only)

Dosage:

Homecare is the preferred option - contact nhsh.homecare@nhs.scot

Formulation and dosage details

Formulation:

Solution for injection, pre-filled pen (Humira) 40mg/0·4mL (hospital use only)

Dosage:

Homecare is the preferred option - contact nhsh.homecare@nhs.scot

Formulation and dosage details

Formulation:

Solution for injection, pre-filled syringe (Amgevita) 20mg/0·4mL, 40mg/0·8mL (hospital use only)

Dosage:

Homecare is the preferred option - contact nhsh.homecare@nhs.scot

Formulation and dosage details

Formulation:

Solution for injection, pre-filled syringe (Humira) 40mg/0·4mL (hospital use only)

Dosage:

Homecare is the preferred option - contact nhsh.homecare@nhs.scot

AZATHIOPRINE

Therapy notes

  • Azathioprine should only be used in combination with allopurinol on Gastroenterology advice.
  • Allopurinol blocks the metabolism of azathioprine leading to increased levels of the active metabolite and potential drug toxicity.
  • Monitor in accordance with DMARD monitoring.

Formulation and dosage details

Formulation:

Tablets 25mg, 50mg (s)

Dosage:

2 to 2·5mg/kg daily.

CICLOSPORIN

Therapy notes

  • Usually only used in acute colitis for 3 months as a bridge to maintenance therapy.
  • Monitor ciclosporin trough blood concentrations (EDTA tube), serum creatinine and blood pressure, especially when the patient is changed to a different formulation or brand.
  • Monitor in accordance with DMARD monitoring.

Formulation and dosage details

Formulation:

Capsules (Neoral®) 25mg, 50mg, 100mg (s)

Dosage:

By mouth, 7mg/kg daily, usual maximum dose for 70kg patient 250mg twice daily off-label. 

Formulation and dosage details

Formulation:

Oral solution (Neoral®) 100mg/mL (s)

Dosage:

By mouth, 7mg/kg daily, usual maximum dose for 70kg patient 250mg twice daily off-label. 

Formulation and dosage details

Formulation:

Concentrate for intravenous infusion (oily) (Sandimmun®) 50mg/mL (s)

FILGOTINIB

Therapy notes

MHRA advice: Janus kinase (JAK) inhibitors: new measures to reduce risks of major cardiovascular events, malignancy, venous thromboembolism, serious infections and increased mortality (April 2023) (www.gov.uk).

Risk minimisation materials

Formulation and dosage details

Formulation:

Tablets 200mg film-coated (hospital use only)

Dosage:

As per SMC 2467: for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic agent. 

Homecare is the preferred option - contact nhsh.homecare@nhs.scot

 

INFLIXIMAB

Therapy notes


  • Prescribe infliximab by brand name.
  • Give patients the infliximab patient information leaflet and the special Patient Alert Card, and advise them appropriately when treatment is administered.

Formulation and dosage details

Formulation:

Powder for concentrate for solution for infusion (Inflectra®, Remsima®, Zessly®) 100mg (s)

Dosage:

For initiation and maintenance therapy.

Formulation and dosage details

Formulation:

Solution for injection, pre-filled pen (Remsima®) 120mg (s)

Dosage:

For maintenance therapy.

Formulation and dosage details

Formulation:

Solution for injection, pre-filled syringe (Remsima®) 120mg (s)

Dosage:

For maintenance therapy.

MERCAPTOPURINE

Therapy notes

Formulation and dosage details

Formulation:

Tablets 50mg (s)

Dosage:

Inflammatory bowel disease when azathioprine is not tolerated (off label) 1 to 1.5mg/kg daily.

METHOTREXATE

Therapy notes

MHRA advice: Methotrexate: advise patients to take precautions in the sun to avoid photosensitivity reactions (August 2023) (www.gov.uk).  

MHRA advice: Methotrexate once-weekly for autoimmune diseases: new measures to reduce risk of fatal overdose due to inadvertent daily instead of weekly dosing (September 2020) (www.gov.uk).

Risk minimisation materials

  • Note: Pay attention to the strength of methotrexate tablets prescribed and the frequency of dosing; methotrexate is always given weekly. Prescribing and dispensing errors have caused fatalities.

  • Give methotrexate on day 1 then give folic acid 5mg on day 2 of the same week to reduce some of the side-effects such as nausea and mouth ulcers off-label. If necessary the dose of folic acid can be increased to 5 days per week avoiding the day methotrexate is given.
  • See BNF for updated recommendations for conception and contraception.
  • See the NPSA leaflet on methotrexate
  • Monitor in accordance with DMARD monitoring.

Formulation and dosage details

Formulation:

Tablets 2·5mg (s)

Dosage:

Maximum dose, 25mg once weekly off-label.

Formulation and dosage details

Formulation:

Injection pre-filled syringe 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 (s)

Dosage:

Maximum dose, 25mg once weekly off-label.

OZANIMOD

Therapy notes

Risk minimisation materials

Formulation and dosage details

Formulation:

Capsules 0.23mg, 0.46mg and 0.92mg

Dosage:

As per SMC2478: for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent.

Homecare is the preferred option - contact nhsh.homecare@nhs.scot.

RISANKIZUMAB

Therapy notes

 

Formulation and dosage details

Formulation:

Concentrate for solution for infusion 600mg

Dosage:

As per SMC 2534: for the treatment of patients 16 years and older with moderately to severely active Crohn's disease who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or a biologic therapy, or if such therapies are not advisable.

Homecare is the preferred option - contact nhsh.homecare@nhs.scot.

Formulation and dosage details

Formulation:

Solution for injection 360mg

Dosage:

As per SMC 2534: for the treatment of patients 16 years and older with moderately to severely active Crohn's disease who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or a biologic therapy, or if such therapies are not advisable.

Homecare is the preferred option - contact nhsh.homecare@nhs.scot.

TOFACITINIB

Therapy notes

MHRA advice: Tofacitinib (Xeljanz): new measures to minimise risk of major adverse cardiovascular events and malignancies (October 2021) (www.gov.uk).
MHRA advice: Tofacitinib (Xeljanz) - new measures to minimise risk of venous thromboembolism and of serious and fatal infections (March 2020) (www.gov.uk).
MHRA advice: Tofacitinib (Xeljanz) - restriction of 10mg twice-daily dose in patients at high risk of pulmonary embolism while safety review is ongoing  (May 2019) (www.gov.uk).


Risk minimisation materials

  • For severe ulcerative colitis by Clinicians expert in its management and after discussion at the IBD MDT, and as per SMC advice.

Formulation and dosage details

Formulation:

Tablets 5mg, 10mg

Dosage:

As per SMC 2122: For the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent.

Homecare is the preferred option - contact nhsh.homecare@nhs.scot

UPADACITINIB

Therapy notes

Formulation and dosage details

Formulation:

Tablets prolonged-release 15mg, 30mg, 45mg (hospital use only)

Dosage:

As per SMC 2510: for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.

and SMC 2575: for the treatment of adult patients with moderately to severely active Crohn’s disease (CD) who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent, or for whom such therapies are not advisable.

Homecare is the preferred option - contact nhsh.homecare@nhs.scot

USTEKINUMAB

Therapy notes

Formulation and dosage details

Formulation:

Infusion 130mg/26mL

Dosage:

For the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor-alpha (TNFα) antagonist or have medical contraindications to such therapies.

Notes:

As per SMC 1250/17: for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor-alpha (TNFα) antagonist or have medical contraindications to such therapies. 

Homecare is the preferred option - contact nhsh.homecare@nhs.scot

Formulation and dosage details

Formulation:

Injection 90mg/mL

Dosage:

As per SMC 1250/17: for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor-alpha (TNFα) antagonist or have medical contraindications to such therapies. 

Notes:

Homecare is the preferred option - contact nhsh.homecare@nhs.scot

VEDOLIZUMAB

Therapy notes


Risk minimisation materials

Formulation and dosage details

Formulation:

Powder for concentrate for solution for infusion 300mg (s)

Dosage:

Homecare is the preferred option - contact nhsh.homecare@nhs.scot

Editorial Information

Document Id: F227