Shared Care Policy and Prescribing Information for General Practitioners for oral Cyclophosphamide (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/Cyc/MGPG419 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); urinalysis; urea, creatinine and electrolytes (U&E); liver function tests (LFTs). 2. Copy of results to be sent to GP. 3. Exclude pregnancy before starting therapy Advise effective contraception essential during treatment and for at least 3 months after discontinuation in women or men. 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. sore throat, fever, infection, inexplicable bruising or bleeding, mouth ulcers or rash, haemorrhagic cystitis. CARE WHICH IS THE RESPONSIBILITY OF THE GENERAL PRACTITIONER (GP) 1. Prescribing of medication under guidance of consultant. 2. The GP should check before prescribing medication that the monitoring is up to date and that results are within the normal range. 3. The GP should be aware that the drug can cause bone marrow suppression. Patients should be asked about the presence of sore throat, rash, abnormal bruising or bleeding, oral ulceration, or taste disturbances at each visit. 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. 4. The General Practitioner has primary responsibility for monitoring therapy according to the schedule below: FBC, LFTs (incl. ALT and Alk Phos), U&E and urinalysis weekly for the first month then fortnightly for the second and third month. FBC, LFTs, U&E and urinalysis 4 weekly thereafter. Patients should be asked about the presence of sore throat, rash, haemorrhagic cystitis, abnormal bruising or oral ulceration at each visit. 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 CYCLOPHOSPHAMIDE - Version 2, August 2010 NHSG/SCPa/Cyc/MGPG419 -1- Shared Care Policy and Prescribing Information for General Practitioners for oral Cyclophosphamide (Adults only, non-renal patients) Abnormal Monitoring Results 9 WBC <4.0 x 10 /L Neutrophils <2.0 x 109/L Action To Be Taken Withhold until discussed with consultant 9 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 Rash, oral ulceration, unexplained fever Withhold until discussed with consultant Abnormal bruising or sore throat Withhold until FBC result available Dipstick heamaturia Advise increased fluid intake and discuss with consultant. Monitor closely. Macroscopic haematuria or haematuria with dysuria Withhold until discussed with consultant 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 cyclophosphamide. Single pneumococcal vaccination and annual influenza vaccine should be given. A high fluid intake should be encouraged to reduce the risk of haemorrhagic cystitis. Cyclophosphamide tablets should be swallowed whole, preferably on an empty stomach, if gastric irritation is severe, they may be taken with meals. Oral tablets are only available in strengths of 50mg. These are sugar coated and cannot be divided. 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: Interactions have been reported with allopurinol (increased bone marrow depression), sulphonylureas (enhanced hypoglycaemia) and suxamethonium (prolonged apnoea). Pregnancy Discuss with consultant. Pregnancy should be avoided during and for three months after stopping therapy. Advise to contact their physician immediately should pregnancy occur. Breast-feeding Discuss with Aberdeen Maternity Hospital. Discontinue breast-feeding during and for 36 hours after stopping treatment. Responsibilities of GPs undertaking monitoring A GP agreeing to monitor cyclophosphamide 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 cyclophosphamide 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 CYCLOPHOSPHAMIDE - Version 2, August 2010 NHSG/SCPa/Cyc/MGPG419 -2-