Monitoring requirements Consultant. specialist responsibilities Best practice recommends the following precautions for specialists before commencing immunosuppressant therapy: • Record patient’s blood pressure, weight and height if clinically indicated. • Screening for lung disease should be undertaken at clinician discretion on a case- by-case basis. The extent of screening should be influenced more by a patient’s clinical features and risk factors for lung disease (e.g. underlying autoimmune disease or smoking history) rather than subsequent immunomodulating choice. Pre-existing lung disease should not be considered an absolute contraindication to any immunomodulating medication. • Consultant to consider ECG where appropriate especially when commencing medications associated with hypertension • Screen for viral hepatitis B&C and HIV in all patients • Investigate patient medical history including co-morbidities and previous immunomodulating medication use. For rheumatic patients CRP/ESR may be done every 3 months. These tests are part of the assessment of the underlying rheumatic disease rather than a requirement for monitoring of immunomodulating therapy. The monitoring CRP/ESR may be coordinated between secondary and primary care on an individual basis. Pregnancy must be excluded before starting treatment Consultant/specialist monitoring schedule Baseline and 2 weekly until on a stable dose for at least 6 weeks • FBC • ALT and/or AST and albumin • U&E including creatinine/calculated GFR • Blood pressure • Patient is asked to report any unexplained weight loss (>10%) Annually review the patient and advise the GP promptly on when to adjust the dose, stop treatment or consult with the specialist. GP responsibility monitoring schedule In patients following the 6 weeks of dose stability conduct monthly monitoring as above for three months followed by three monthly monitoring thereafter of: • FBC • ALT and/or AST and albumin • U&E including creatinine/eGFR • Blood pressure • Patient asked to report any unexplained weight loss (>10%) See advice below on pregnancy and breastfeeding in section (Caution and contraindication) Leflunomide in combination with MTX requires extended monthly monitoring for at least 12 months. Patients who have been stable for 12 months can be considered for reduced frequency of monitoring on an individual patient basis. Dosage increase For dose increase, monitor 2 weekly until stable for 6 weeks. Dose and monitoring to be agreed with consultant. • FBC • ALT and/or AST and albumin • U&E including creatinine/eGFR • Blood pressure • Patient is asked to report and unexplained weight loss (>10%) Monitoring to then continue at 3 monthly intervals. When restarting treatment after an abnormality has been detected, repeat bloods in 2 weeks and then monthly for 3 months. Following this resume monitoring frequency to what it was prior to the abnormality. Actions to be taken NB – a rapidly increasing or decreasing trend in any value should prompt caution irrespective of actual value. Note: specific monitoring of eosinophil counts has been removed, as historically eosinophilia was an important marker for identifying toxicity from only gold therapy. This has been agreed with local specialists. **Wash out procedure with cholestyramine Wash out should only be carried out after discussion with the consultant/ specialist 8 grams TDS for 11 days or activated Charcoal 50grams QDS for 11 days. Concentration of active metabolite should be < 20 micrograms /l (measured on 2 occasions 14 days apart) in men & women before conception after a further, but shorter period. It is worth nothing that both agents will reduce absorption and therefore effectiveness of oral contraception.
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Sources: Shared Care Agreement, Shared Care Agreement