AZATHIOPRINE TABLETS RHEUMATOLOGY SHARED CARE GUIDELINE

Title: Azathioprine tablets Rheumatology Shared Care Guideline
Filename / PHA_Medicines management_Shared care guideline_Azathioprine Rheumatology Shared Care Guideline
Version № / 6
Date of Issue / 01/09/2004
Review Interval / 2 Years
Authorised By / Drug and Therapeutics Committee
Author / Dr Shabina Sultan – Consultant Rheumatologist
Dr Hanu Reddy – Consultant Rheumatologist
Linda Stewart – Pharmacist
Linda Sigsworth – Rheumatology Nurse Specialist
Email Address of Author /
Copy № / 1
Location of Copies /
  1. SharePoint

Associated Working Instructions / N/A
Location of Working Instructions / N/A
To Be Viewed / Trust Wide / Pharmacy Only
Document Review History
Review Date / Reviewed By / Changes
26/10/07 / Sue Carr Rheumatology Nurse and Linda Stewart Pharmacist / Live vaccines to be avoided
June 2008 / Dr K. Lindsay – Consultant Rheumatologist
Linda Stewart - Pharmacist
Sarah Redfern - Riley Rheumatology Nurse
20/07/09 / Linda Stewart / Expiry date extended as we are waiting for the New Yorkshire Guidelines to come out later this year
17/12/2009 / Linda Stewart – Pharmacist
Dr S Sultan – Consultant Rheumatologist / Prescribing, monitoring and live vaccine information updated
31/01/2011 / Linda Stewart and Dr Sultan / Review date extended whilst they are being reformatted.
31/03/2011 / Linda Stewart – Pharmacist
Dr Sultan – Consultant Rheumatologist
Dr Reddy – Consultant Rheumatologist and DTC March 2011 / Document reformatted and responsibilities of consultant and GP added
31/3/2013 / Linda Stewart – Pharmacist / Expiry date extended. Document out for consultation.
30/9/2013 / Linda Stewart – Pharmacist
Dr Sultan – Consultant Rheumatologist
DTC September 2013 / Shingles vaccine added to the ‘avoid live vaccine’ section.
30/9/2015 / Linda Stewart – Pharmacist
Dr Sultan – Consultant Rheumatologist
APC – 17th December 2015 / Monitoring section reviewed in line with Yorkshire Rheumatology Guidelines for monitoring DMARDs (May 2014) and SPC
Pregnancy and breastfeeding moved to a separate new section
17/12/2017
19/07/2018 / Expiry date extended until 30th September 2018

NB: Only SharePoint Version or Numbered Copies in Stated Locations Are Valid for Operational Use

AZATHIOPRINE TABLETS RHEUMATOLOGY SHARED CARE GUIDELINE

General Statements /
  • Azathioprine should be initiated in secondary care under specialist supervision. Once the patient’s dose has been titrated to the optimum dose they may be considered suitable for shared care between the consultant and the GP.
  • Patient’s clinical condition is to be stable or predictable before contacting the GP to arrange shared care.
  • The specialist should write to the GP to request the GP to participate in shared care.
  • Patients receive supplies of drug from hospital until shared care is agreed.
The full summary of product characteristics (SPC) should be read before prescribing.
SPC Azathioprine
Pharmacological Summary / Azathioprine is thought to affect purine nucleotide synthesis and metabolism and is used in cases of severe rheumatoid arthritis as an immunosuppressant antimetabolite. Its therapeutic effect may be evident only after weeks or months and can include a steroid-sparing effect, thereby reducing the toxicity associated with high dosage and prolonged usage of corticosteroids..
Indications for therapy / Rheumatoid arthritis, systemic lupus erythematosus, dermatomyositis,polymyositis, vasculitis and as a steroid sparing agent
Contra-Indications /
  • Hypersensitivity to azathioprine
  • Caution if hypersensitivity to 6 mercaptopurine
  • TPMT deficiency, Lesch-Nyhan Syndrome

Pregnancy and Breastfeeding / Please contact the Rheumatologist if patient considering conceiving or in case of pregnancy.
  • Azathioprine may be continued during pregnancy and when breastfeeding where the benefit is deemed to outweigh potential risk e.g. in SLE or colitis

Cautions /

Renal and or hepatic impairment

  • Exposure to sunlight / UV radiation
  • Chicken pox/varicella zoster can be fatal in immunosuppresed patients: varicella zoster immunoglobulin should be given to susceptible patients (not known to be immune to chicken pox) where contact occurs, preferably within 3 days but up to 10 days after exposure. Systemic antivirals should be given if infection is suspected

Avoid live vaccinations (BCG, MMR, Poliomyelitis (live oral vaccine), Rotavirus (live oral vaccine), Typhoid (live oral vaccine), Varicella-Zoster vaccine, Shingles and Yellow Fever)

  • For more detail see Vaccinations Rheumatology Shared Care Guideline
  • In the presence of significant infection and or those requiring antibiotics DMARD’s should be stopped. They can be restarted when clear of infection and /or the antibiotic course has been completed.

Potential Drug Interactions /
  • Allopurinol, oxipurinol and/or thiopurinol - when these are given concomitantly with 6mercaptopurine or azathioprine, the dose of 6-mercaptopurine or azathioprine should be reduced to one-quarter of the original dose.
  • Sulfasalazine – risk of leucopenia
  • Inhibition of the anticoagulant effect of warfarin
  • Co-administration of ribavirin and azathioprine is not advised. Ribavirin may reduce efficacy and increase toxicity of azathioprine.
See BNF for full list of interactions
Initial Screening / Baseline:
TPMT, FBC, LFTs, ESR, CRP, U&E checked in Rheumatology clinic
Consider hepatitis B and C in high risk groups
Prescribing / Initial prescribing and monitoring will be carried out by Rheumatology Department for the first three months. Thereafter if the patient is on a stable dose the GP will continue prescribing and monitoring
Dose: Azathioprine 50mg/day, if no problems increase by 50mg increments every 1-2 weeks to a maximum of 2 - 3mg/kg
Take with/after food in divided doses if preferred
Continue NSAIDs or analgesics at least until response
Pneumovax and annual ‘flu vaccine should be given
Monitoring / FBC, LFT’s every 2 weeks for 2 months then monthly for 4 months, then three monthly (assuming dose stable)
ESR every 3 months
U&E’s and creatinine every 6 months
If any increase in dose monitor FBC and LFT’s every 2 weeks for 2 months then revert to patient’s usual monitoring arrangements
Ask about presence of rash or oral ulceration each time
If the bloods are abnormal BUT ABOVE the specified values below, consider the trend. If the patient is well, simply repeat count in one week but continue DMARD.If persistently low CONTACT AGH as dose adjustment may be required
If any of the following apply please contact AGH urgently and withhold DMARDs
WCC <3.0 x 109/l
Neutrophils <1.5 x 109/l
Platelets <100 x 109/l
AST/ALT/AlkPhos >2 x upper limit of normal
MCV > 105fl - check folate, B12 and TSH
Unusual bruising, fever, sore throat (check FBC first and if the above apply: contact AGH)
Breathlessness and/ or cough unexplained by infection or persistent despite antibiotics
Significant deterioration in renal function or if GFR falls below 30ml/min
Adverse Events /
  • Depression of bone marrow function; leucopenia, thrombocytopenia and in rare cases agranulocytosis, pancytopenia, aplastic anaemia, megaloblastic anaemia, erythriod hypoplasia.
  • Nausea
  • Rash, hypersensitivity reactions
  • Abnormal liver function tests
  • For a full list of potential side effects please consult SPC
    SPC Azathioprine

Responsibility of the Specialist Initiating Treatment /

Summary

  • To assess the suitability of the patient for this treatment
  • To perform the baseline tests
  • To inform the patient of the side effects of azathioprine and long term monitoring required before initiating treatment
  • To initiate treatment and supply a DMARD monitoring booklet and patient information leaflet.
  • To assess and monitor the patient’s response to treatment
  • To adjust treatment as clinically necessary.
  • Supporting and advising GPs
  • To monitor the patient for adverse events and report to the GP, and where appropriate, the Commission on Human Medicines / MHRA (Yellow card scheme).

Responsibility of other Prescribers /

Summary

  • To inform the specialist in writing if they are not willing to participate in Shared care
  • To continue prescribing and monitoring after 3 months or once the patient is on a stable dose
  • To ensure that there are no interactions with any other medications initiated
  • To refer back to the hospital specialist if the patient’s condition deteriorates.
  • To stop treatment on the advice of the hospital specialist or if the GP feels it is clinically indicated.
  • To identify adverse events if the patient presents with any signs and liaise with the hospital specialist where necessary. To report adverse events to the specialist and where appropriate the Commission on Human Medicines/MHRA (Yellow card scheme).

Contacts / A patient information leaflet has been issued to your patient
If any problems occur please contact:
Dr Sultan - Consultant Rheumatologist’s secretary: / 01535 292067
Dr Reddy - Consultant Rheumatologist’s secretary: / 01535 292080
Rheumatology Nurse Specialist / advice line: / 01535 292084
Pharmacy: / 01535 293503
Access to shared care guidelines is available via the internet at Airedale NHS Trustat:

In keeping with Yorkshire Rheumatology Guidelines May 2014

In accordance with BSR/BHPR guidelines 2008

Revised December 2015 Review date December 2017

Agreed by DTC September 2013 Page: 1 of 4