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DOCUMENT TITLE: CYCLOPHOSPHAMIDE INTRAVENOUS INJECTION RHEUMATOLOGY GP INFORMATION FILENAME PHA_Medicines Management_Shared care Guideline_Cyclophosphamide Intravenous Injection Rheumatology GP information VERSION № 6 DATE OF ISSUE 26/10/2007 REVIEW INTERVAL 2 Years AUTHORISED BY Drug and Therapeutics Committee AUTHOR Dr Shabina Sultan –Consultant Rheumatologist Linda Stewart – Pharmacist Linda Sigsworth – Rheumatology Nurse Specialist EMAIL ADDRESS OF AUTHOR [email protected] COPY № 2 LOCATION OF COPIES 1. SHAREPOINT 2. AIREDALE NHS TRUST WEBSITE ASSOCIATED WORKING INSTRUCTIONS N/A LOCATION OF WORKING INSTRUCTIONS N/A TO BE VIEWED TRUST WIDE X PHARMACY ONLY DOCUMENT REVIEW HISTORY REVIEW DATE REVIEWED BY CHANGES 26/10/2007 Karen Lindsay Rheumatology Nurse and Linda Stewart Pharmacist Live vaccines to be avoided Contact details 17/12/2009 Linda Stewart – Pharmacist Dr S Sultan – Consultant Rheumatologist Live vaccine, screening and monitoring information updated 31/01/2011 Linda Stewart and Dr Sultan Expiry date extended whilst document being reformatted 31/05/2011 Linda Stewart – Pharmacist Dr Reddy – Consultant Rheumatologist Dr Sultan – Consultant Rheumatologist Document reformatted and responsibilities of GP and consultant added 31/5/2013 Linda Stewart Review date extended. Sent to consultants 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 NB: ONLY SHAREPOINT VERSION OR NUMBERED COPIES IN STATED LOCATIONS ARE VALID FOR OPERATIONAL USE 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 5 CYCLOPHOSPHAMIDE INTRAVENOUS INJECTION RHEUMATOLOGY GP INFORMATION GENERAL STATEMENTS Cyclophosphamide should be initiated in secondary care under specialist supervision. Prescribing, administration and monitoring will be carried out by the Rheumatology Department throughout the course of treatment. The full summary of product characteristics (SPC) should be read before prescribing. Baxter UK - IV Solutions & Medication Delivery Systems PHARMACOLOGIC AL SUMMARY INDICATIONS FOR THERAPY CONTRAINDICATIONS PREGNANCY AND BREASTFEEDING Cyclophosphamide is an antineoplastic agent which is converted in the body to an active alkylating metabolite. It also possesses marked immunosuppressant properties. Cyclophosphamide is used in the treatment of systemic vasculitis and in certain organ or life threatening manifestations of other rheumatological conditions such as SLE, Scleroderma. Hypersensitivity and haemorrhagic cystitis Porphyria 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 Share Care Guideline The Rheumatologist will discuss with the patient the potential effects on fertility before commencing therapy. Pregnancy should be avoided during treatment and for 3 months after discontinuation of treatment. Breastfeeding not recommended Contraception should be used for at least 3 months after treatment in both sexes. May affect sperm count in males. 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: 2 of 5 CYCLOPHOSPHAMIDE INTRAVENOUS INJECTION RHEUMATOLOGY GP INFORMATION CAUTIONS POTENTIAL DRUG INTERACTIONS INITIAL SCREENING PRESCRIBING Can cause infertility in women of childbearing age with the younger persons at higher risk Hepatic and renal impairment 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 Contact the rheumatology consultant urgently if any queries about a patient on regular IV cyclophosphamide. In the presence of significant infection, treatment should be withheld, FBC, U&E, LFTs and CRP sent, and prompt therapy instituted. and inform specialist team Oral hypoglycaemic agents may be potentiated by cyclophosphamide. See BNF for full list of interactions FBC, LFT's, CRP, U&E, urinalysis, eGFR checked in Rheumatology clinic, dose reduced if reduced eGFR Consider hepatitis B and C in high risk groups Administration, and monitoring will be carried out by Rheumatology Department. The decision to use cyclophosphamide should be made by the Consultant Rheumatologist responsible for the patient’s care and its planned use should be outlined in the management plan and filed in the patient’s case notes. Patients typically have severe connective tissue disease with organ involvement, resistant rheumatoid arthritis or vasculitides. Pulsed therapy on Surgical Day Ward 10 -15mg/kg plus 10mg/kg methylprednisolone. Usual dose of 3 pulses every 2 weeks, then 3 pulses every 3 weeks and then reassess. Oral Mesna (or iv mesna) should be given to protect the bladder from cystitis. A high fluid intake is encouraged throughout treatment day. Pneumovax and annual ‘flu vaccine should be given 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: 3 of 5 CYCLOPHOSPHAMIDE INTRAVENOUS INJECTION RHEUMATOLOGY GP INFORMATION MONITORING FBC U&E LFT CRP and ESR/ CRP 7-10 days after each pulse Urinalysis: each visit, with all results reviewed prior to administering the drug 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 Neutrophils Platelets AST/ALT/AlkPhos <3.0 x 109/l <1.5 x 109/l <100 x 109/l >2 x upper limit of normal 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 Bone marrow depression, neutropenia and lymphopenia more likely than anaemia and thrombocytopaenia Amenorrhoea and azoospermia during treatment, usually reversible on stopping treatment Can induce permanent sterility in children Haematuria (haemorrhagic cystitis) Hair loss, which may be total, although generally reversible; Mucosal ulceration; Anorexia, nausea and vomiting (may need to consider ondansetron or equivalent) Increased risk of certain malignancies on prolonged use. See BNF or SPC for full details 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: 4 of 5 CYCLOPHOSPHAMIDE INTRAVENOUS INJECTION RHEUMATOLOGY GP INFORMATION RESPONSIBILITY OF THE SPECIALIST INITIATING TREATMENT SUMMARY RESPONSIBILITY OF OTHER PRESCRIBERS SUMMARY To monitor the patients overall health and wellbeing. 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 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 To assess the suitability of the patient for this treatment To perform the baseline tests To inform the patient of the side effects of cyclophosphamide and long term monitoring required before initiating treatment To initiate treatment and provide 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). A patient information leaflet has been issued to your patient If any problems occur please contact: Dr Sultan, Consultant rheumatologist’s secretary: Dr Reddy, Consultant rheumatologist’s secretary: Rheumatology Nurse specialist/ advice line: Pharmacy: 01535 292067 01535 292080 01535 292084 01535 293503 Access to shared care guidelines is available via the internet at Airedale NHS Trust: http://www.airedale-trustformulary.nhs.uk/default.asp 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: 5 of 5