Shared Care Policy and Prescribing Information for General Practitioners for Mycophenolate mofetil (Adults only, non-renal patients) Publish public Applies to: NHS Grampian Coordinator Medicines Information pharmacist Signature: I Mweemba Authorised for issue by Medicines Guidelines and Policies Group Signature: C Hind Version 2 Document no: NHSG/SCPa/Myc/MGPG422 Effective date: August 2010 Review Date: August 2012 Supersedes: Version 1 Please keep this document in the patients notes PATIENT NAME UNIT NUMBER CHI NUMBER HOSPITAL WARD TELEPHONE NO CONSULTANT (print name) ADDRESS DATE OF BIRTH Insert patient sticker here THERAPEUTIC INDICATION FOR THIS PATIENT: DATE SIGNATURE (to be completed by consultant) DOSAGE/PREPARATION/ROUTE/FREQUENCY OF ADMINISTRATION: (to be completed by consultant) SAFE PRACTICE IS THAT THE CLINICIAN WHO ORDERS THE TEST MUST ACT ON THE RESULT CARE WHICH IS THE RESPONSIBILITY OF THE HOSPITAL CONSULTANT 1. Baseline: Full blood count (FBC); urea, creatinine and electrolytes (U&E); liver function tests (LFTs); blood pressure (BP) and lipids. 2. Copy of results to be sent to GP. 3. Exclude pregnancy before starting therapy. Give advice on contraception and tell patient to use contraception for at least 6 weeks after discontinuation of treatment. Advise patient to contact their physician immediately should pregnancy occur. 4. Initiation of therapy and recommendations for dose increments. 5. Decision on final dose required for patient. 6. Monitoring clinical response to treatment. 7. Advise patients to immediately report any signs or symptoms of bone marrow suppression, e.g. inexplicable bruising infection, or bleeding. CARE WHICH IS THE RESPONSIBILITY OF THE GENERAL PRACTITIONER 2. Prescribing of medication under guidance of consultant 3. Check before prescribing medication that the monitoring is up to date and that results are within the normal range 4. The GP should be aware that the drug can cause bone marrow suppression, raised blood pressure, dyslipidaemia, and increased susceptibility to skin cancer. Patients should be asked about the presence of sore throat, abnormal bruising or bleeding at each visit. Check for development of lymphomas and other malignancies particularly of the skin. When the patient has an intercurrent illness a FBC, U&E and LFTs should be done and any abnormal results including those noted above should be reported to the consultant. 5. The General Practitioner has primary responsibility for monitoring therapy according to the schedule below: FBC weekly until dose stable for four weeks, then twice a month for the second and third months, then monthly in the first year even if patient is stabilized on treatment. Thereafter monitoring every two to three months may be adequate. To be confirmed by consultant. Also U&E (incl.creatinine), LFTs and blood pressure. When writing laboratory request forms always include details of the patient’s medication NOTE: in addition to absolute values for haematological indices a rapid fall or a consistent downward trend in any value should prompt caution and extra vigilance. If something unexpected occurs contact consultant. Notify the consultant if the drug is stopped. UNCONTROLLED WHEN PRINTED Review Date August 2012 (sooner if recommendations change) SCP and Prescribing Information for GPs for MYCOPHENOLATE MOFETIL - Version 2, August 2010 NHSG/SCPa/Myc/MGPG422 -1- Shared Care Policy and Prescribing Information for General Practitioners for Mycophenolate mofetil (Adults only, non-renal patients) ABNORMAL MONITORING RESULT ACTION TO BE TAKEN WBC <4.0 x 10 /L Withhold until discussed with consultant 9 Neutrophils <2.0 x 109/L Withhold until discussed with consultant Platelets <150 x 10 /L Withhold until discussed with consultant >2-fold rise in ALT or Alk Phos (from upper limit of reference range) Withhold until discussed with consultant MCV >105fl Investigate and if B12 or folate low start appropriate supplementation Abnormal bruising, sore throat, rash, oral ulceration Withhold until discussed with consultant Unexplained fever Withhold until discussed with consultant Malignancies Withhold until discussed with consultant 9 For specific product information please consult the current summary of product characteristics (http://emc.medicines.org.uk/) and the BNF (http://www.bnf.org/bnf/) Other information Live vaccines should be avoided in patients taking mycophenolate mofetil. Single pneumococcal vaccination and annual influenza vaccine should be given. Common side-effects include moniliasis, vomiting, diarrhoea, nausea, abdominal pain and GI ulceration. Seek advice if haematemesis, coffee ground vomit or melaena occurs. There are a number of drug interactions that must be considered. When a new drug is prescribed please refer to Summary of Product Characteristics, BNF or contact Medicines Information. Some important interactions to consider include the following: Aciclovir administered concurrently with mycophenolate mofetil increases concentration levels for both. Interaction only significant in renal impairment. Mycophenolate mofetil absorption is reduced by antacids, colestyramine or iron. Avoid concomitant administration of drugs that increase the risk of agranulocytosis, e.g. clozapine. Do not give concomitantly with azathioprine as combination has not been studied. To minimize the risk of skin cancer, exposure to sunlight and Ultra Violet light should be limited by wearing protective clothing and using sunscreen with a high protection factor. Pregnancy Discuss with consultant. Contra-indicated in pregnancy. Effective contraception required during and for 6 weeks after discontinuation of treatment. Advise to contact their physician immediately should pregnancy occur. Breast-feeding Discuss with Aberdeen Maternity Hospital. Manufacturer advises avoid. Responsibilities of GPs undertaking monitoring A GP agreeing to monitor mycophenolate mofetil should: Ensure that the relevant monitoring requirements are undertaken at the correct frequency. Ensure that the test results are checked for any abnormality as soon as the results are available. Ensure abnormal results are acted upon. Only continue to prescribe mycophenolate mofetil if it is being satisfactorily monitored. Contact the consultant in the event of a drug reaction or monitoring abnormality or anything you are unhappy about. Be alert for any of the known adverse reactions. ** The patient should be encouraged to ensure blood tests are taken at the correct intervals. ** UNCONTROLLED WHEN PRINTED Review Date August 2012 (sooner if recommendations change) SCP and Prescribing Information for GPs for MYCOPHENOLATE MOFETIL - Version 2, August 2010 NHSG/SCPa/Myc/MGPG422 -2-