GUIDELINES FOR BLOOD GROUP / ABO INCOMPATIBLE RENAL TRANSPLANTATION

Transcription

1 GUIDELINES FOR BLOOD GROUP / ABO INCOMPATIBLE RENAL TRANSPLANTATION Author: Contact Name and Job Title Dr Gavin McHaffie (Consultant Nephrologist) Ext Dr Alastair Ferraro (Consultant Nephrologist) Mr Keith Rigg (Consultant Transplant Surgeon) Directorate & Speciality Cancer and Associated Specialties (Renal/Transplant) Date of submission October 2016 Explicit definition of patient group to which it applies (e.g. inclusion and exclusion criteria, diagnosis) Adult Patients undergoing blood group/ ABO incompatible transplantation Version If this version supersedes another clinical guideline please be explicit about which guideline it replaces including version number. Statement of the evidence base of the guideline has the guideline been peer reviewed by colleagues? Evidence base: (1-6) 1 NICE Guidance, Royal College Guideline, SIGN (please state which source). Adapted from ABOi protocol from Cardiff (Author : Rommel Ravanan) and ABOi protocol from Birmingham Evidence level 5 2a 2b 3a 3b meta analysis of randomised controlled trials at least one randomised controlled trial at least one well-designed controlled study without randomisation at least one other type of well-designed quasiexperimental study 4 well designed non-experimental descriptive studies (ie comparative / correlation and case studies) 5 expert committee reports or opinions and / or clinical experiences of respected authorities 6 recommended best practise based on the clinical experience of the guideline developer Consultation Process Ratified by: Date: These guidelines were developed in conjunction with medical and nursing staff within the renal unit and the East Midlands Renal Network. Renal Unit Senior Staff Meeting

2 Target audience Review Date: (to be applied by the Integrated Governance Team) A review date of 5 years will be applied by the Trust. Directorates can choose to apply a shorter review date; however this must be managed through Directorate Governance processes. Renal and Transplant Unit Medical and Nursing Staff 1 st February 2019 This guideline has been registered with the trust. However, clinical guidelines are guidelines only. The interpretation and application of clinical guidelines will remain the responsibility of the individual clinician. If in doubt contact a senior colleague or expert. Caution is advised when using guidelines after the review date.

3 Contents Page number 1. Introduction 2 2. Summary ABOi protocol 3 3. Recipient selection 4 4. Transplant assessment and planning - Roles & Responsibilities to discharge 6 6. Appendix 1 Immunosuppression Appendix 2 Blood test protocol Appendix 3 Rituximab prescription and administration Appendix 4 Immunoabsorption protocol 17 1

4 Introduction The number of patients with end stage renal failure continues to increase and a kidney transplant is considered to be the optimum form of renal replacement therapy for the majority of individuals. Unfortunately the number of donor organs is not able to match the demand and therefore a variety of strategies have been developed to try and increase the number of kidneys available. ABO incompatible (ABOi) transplantation is one such strategy. Transplantation has traditionally not been performed between individuals who are blood group incompatible because they developed a rapid antibody mediated rejection. About one third of potential live donors are ABO incompatible with the potential recipient. Techniques are now available to lower the antibody level in the recipient before they receive the transplant, thereby permitting safe transplantation. The protocol below has been developed based on published evidence and experience obtained from other transplant centres. It details the assessment of the donor and recipient pair, the individual responsibilities of the transplant team, the immunosuppression protocol, the techniques to perform the immunoabsorption process and the subsequent followup of the patient s clinical parameters. It should be used along side the standard transplant protocol although additional therapies and monitoring will be necessary for these patients and there will be variance in the immunosuppressive regimen used. 2

5 Summary ABOi protocol ABO incompatible transplant is intended as a treatment strategy for patients with no other alternative live donor option. The donor / recipient pair should be offered the opportunity to participate in national paired exchange scheme. All patients need to be counselled about additional treatments and risks involved. All patients, but particularly those with high anti-a or anti B titres (=/> 1 in 256), need to be counselled that transplantation may not be possible if antibody titre does not reach target. Protocol Low titre - Anti-A or Anti-B IgG =/< 1:16 Immunoabsorption only. Target titre =/< 1 :4 High titre - Anti-A or Anti-B titre > 1:16 Rituximab 375mg/kg day -14 Immunoabsorption. Target titre =/< 1:4 Baseline immunosuppression Adoport (Tacrolimus) Myfenax (Mycophenolate Mofetil ) } started pre-transplant } started pre-transplant Basiliximab Corticosteroids (higher dosing regimen than standard transplant see appendix) Post transplant Target Tacrolimus level 8-11 ng/ml - first month 5-8 ng/ml - after first month No routine post transplant immunoabsorption. Monitor transplant function and Anti-A / B antibody titre. Consider immunoabsorption if concern about transplant function particularly if Anti-A / B antibody titre rising. The Nottingham Renal and Transplant unit has links with the transplant unit based at the Queen Elizabeth Hospital, Birmingham, UK. Advice and guidance may be sought from this unit where there is clinical uncertainty or the case is complex. 3

6 Full ABOi Protocol Recipient selection: Inclusion: [1] Medically fit to undergo renal transplantation [2] Active on the deceased donor waiting list or patient being considered for pre-emptive transplant with egfr <15 mls/min (or likely to be <15mls/min within 180 days). [3] Able to provide full informed consent or consent provided by person with legitimate legal authority. [4] Medically fit blood group in-compatible Living Kidney Donor only available. Exclusion: [1] Previous intolerance to monoclonal or polyclonal anti-t/b cell antibodies. [2] Previous intolerance to Plasma Exchange. [3] Native kidney disease of either MPGN type II or primary FSGS [with evidence of graft loss due to recurrence in previous transplant]. Relative contra-indications: [1] Blood stream or systemic infection within 60 days of planned operation date. [2] Patients in-tolerant of blood products for medical or religious reasons. [3] Native kidney disease atypical Haemolytic Uraemic Syndrome. To proceed would need Eculizumab therapy and careful consideration about immunosuppression plan. Donor selection: Donor selection will be considered with reference to the UK Renal Association guidelines (Assessment of the Potential Kidney Transplant Recipient UK Renal Association 5th Edition, 2010 Final Version ) and the Recipient Workup for Kidney Transplantation - East Midlands protocol. Other than ensuring that there are no other ABO compatible potential donors available for the intended recipient, there will be no change to the process of the donor s medical evaluation. All further steps in this protocol will refer only to the recipient unless specified otherwise. 4

7 Transplant assessment and planning - Roles & Responsibilities Live Donor co-ordinator will: [1] Ensure no other blood group compatible potential live donor available for the intended recipient. [2] Provide recipient with information leaflet for ABOi transplantation. [3] Liaise with recipient co-ordinator and ensure recipient is either active on the deceased donor list or is in the process of being assessed to be declared medically fit for transplantation. [4] Ensure blood from recipient is made available for anti-a/b titre estimation. [5] Ensure that donor and recipient nephrologists, and donor and recipient surgeons, are aware of the planned ABO incompatible transplantation. [6] Co-ordinate review of the recipient by lead nephrologist & surgeon for the ABOi program before invasive investigations are completed for the donor. [7] Ensure donor and recipient details are discussed at the relevant transplant MDT prior to the second crossmatch. [8] Ensure an Estimated Date of Operation (EDO) decision is made at MDT in liaison with donor & recipient surgeons. EDO to be communicated to donor + recipient s nephrologists + surgeons, live donor co-ordinator, and independent assessor as appropriate and documented in the clinical notes of the recipient. Lead Nephrologist for ABOi program will: [1] Ensure no other blood group compatible potential live donor available for the intended recipient [2] Ensure intended recipient is medically fit to undertake ABOi transplantation. If necessary, he/she will arrange for appropriate investigations to prove fitness in liaison with the recipient s nephrologist. [3] Ensure recipient is aware of potential transplant choices and is aware of risks of each option. [4] Ensure recipient is aware of logistics of pre-operative conditioning including need for central venous access to enable immunoabsorption [if usable AVF/permacath not already available]. Lead transplant surgeon for ABOi program will: [1] Ensure no other blood group compatible potential live donor available for the intended recipient. [2] Ensure recipient is surgically fit to undergo transplantation and arrange appropriate investigations if necessary in liaison with the recipient s nephrologist. [3] Ensure recipient is aware of potential transplant choices and is aware of risks of each option. Live donor co-ordinator will: [1] Attend the Live Donor Transplant MDT meetings. [2] Liaise with lead ABOi nephrologist/surgeon plus patient to plan for day case administration of pre-operative IV Rituximab as per protocol. [3] Liaise with patient to plan schedule for immunoabsorption. [4] Co-ordinate with ward staff for bed availability in case patient requires admission for pre-operative immunoabsorption or co-ordinate with ward clerk for patient transport to enable pre-operative immunoabsorption as an out-patient. [5] Liaise with lead ABOi nephrologist for securing appropriate venous access to enable immunoabsorption. [6] In conjunction with ward staff ensure immunoabsorption performed as per protocol [7] Ensure pre immunoabsorption blood samples to estimate anti-a/b titres are sent as per protocol*. [8] Liaise with the ABOi titre laboratory to ensure anti-a/b titre results are made available to lead nephrologist/surgeon. [9] Liaise with ward/capd/hd unit staff to ensure patient undergoes regular PD/HD in-between immunoabsorption sessions. *Unless stated otherwise to estimate anti-a/b titres, 6mls of blood collected in an EDTA tube will be required from recipient. 5

8 -21 to discharge : -21 will normally be 21 days prior to Expected date of operation Live donor co-ordinator will: [1] Arrange for formal HLA cross match between donor and recipient and ensure result reviewed before Rituximab administration on -14. This will also assist in the interpretation of the final cross match results done the week before transplantation. [2] Obtain recipient anti A/B titres and send for up to date assay. [3] Liaise with Carrel nursing staff to schedule the patient for day case admission to Carrel Ward for Rituximab on day -14 [4] Obtain patient specific prescription for Rituximab signed by lead ABOi nephrologist/surgeon and deliver to renal pharmacist [5] Ensure independent assessor process completed and approved before administration of Rituximab on day -14. [6] Ensure arrangements made for the donor and recipient to have an anaesthetic review 1-2 weeks before EDO. -14: Renal Transplant Registrar will: [1] Ascertain any history of acute medical illness during the 6 weeks preceding day -14 and if positive history obtained to discuss with lead ABOi nephrologist/surgeon. [2] Record basic clinical observations [Temperature, pulse and blood pressure]. [3] Obtain peripheral venous access. [4] Obtain blood for a Rituximab panel before the Rituximab infusion is commenced [5] Arrange for Rituximab infusion as detailed in Rituximab for ABOi transplant prescription [Appendix 1]. [Ideally this prescription should have been obtained and delivered to the renal pharmacist by day-21.] [6] If basic observations normal at the end of the infusion patient can be discharged home. Arrangements to be made to admit or review the patient on day -7 [see below]. [7] If patient is currently prescribed ACEI, to discuss with ABOi nephrologist with a view to discontinuing drug prior to admission on day -7 [see below]. [8] Confirm history of drug allergies and requirements for drugs (e.g. immunosuppression preferred in syrup form as compared to tablets) If issues are identified discuss with renal pharmacist. NO BLOOD PRODUCTS SHOULD BE ADMINISTERED TO THE PATIENT UNLESS AUTHORISED BY THE TRANSPLANT NEPHROLOGIST OR SURGEON 6

9 -7: -7 will normally be 7 days prior to Expected date of operation. For most patients with average antibody titres [=/< 1:128], admission on day -7 will be appropriate. If titres are significantly higher or lower than the average, then date of admission will be modified as necessary and decision on the exact date of admission confirmed by the ABOi nephrologist and live donor co-ordinator. If it has been decided that the patient can be managed as an out-patient the live donor co-ordinator needs to ensure that a bed for immunoabsorption is available during the scheduled immunoabsorption dates/times. The target anti-a/b IgG titre is =/< 1:4 prior to transplantation. Renal Transplant Registrar will: [1] Clerk patient. If new/active medical symptoms or signs are elicited on history/examination, to discuss with consultant transplant surgeon and nephrologists urgently. [2] Ensure local blood tests are ordered electronically for the following week and appropriate blood forms are completed for blood test which will be sent to external labs. This should include FBC & Renal profile on admission. Anti-A/B titres should be collected pre and post immunoabsorption therapy. [3] Continue with patient s current prescribed medication including alfacalcidol/erythropoietin stimulating agent. Discuss with ABOi nephrologist regarding ACE/ARB therapy and discuss with transplant surgeon regarding clopidogrel. [4] Check if useable AVF/permacath available for performing immunoabsorption. If none available, in liaison with lead ABOi nephrologist, arrange for appropriate central venous access. This will normally be a triple lumen vascath inserted into the jugular vein. The central lumen can be used for CVP measurement, IV drug administration if required etc. The dialysis lumens are to be used exclusively for the purpose of immunoabsorption. Lead Nephrologist for the ABOi program will: [1] Review patient and ensure no active/current medical history to preclude commencing immunoabsorption. [2] Prescribe immunoabsorption. [3] Follow up serial anti-a/b titre results and alter immunoabsorption plan as appropriate. Carrel Ward nurse will: [1] If patient is on CAPD liaise with CAPD nursing staff to ensure prescribed dialysis regimen is followed. If on HD ensure prescribed HD sessions are provided (on non-immunoabsorption days where possible). [2] Ensure anti-a/b titre blood sample obtained. [3] Commence first session of immunoabsorption. Drugs to be prescribed and commenced on day -7 [1] Adoport (Tacrolimus) 0.2mg/kg daily in two divided PO. [2] Myfenax (Mycophenylate Mofetil) 500mg PO twice daily. [3] Co-trimoxazole 480mg PO once daily. Note if patient is not staying as in-patient, drugs need to be prescribed on an outpatient prescription. NO BLOOD PRODUCTS SHOULD BE ADMINISTERED TO THE PATIENT UNLESS AUTHORISED BY THE TRANSPLANT NEPHROLOGIST OR SURGEON 7

10 -7 to -2 Where the patient has not already been admitted on day-7, he/she will be admitted on day -3 prior to Expected date of operation. This will usually be on Sunday before the planned operation on the following Wednesday. ABOi lead nephrologist/surgeon will: [1] Review the patient to ensure tolerating immunoabsorption and oral immunosuppression. [2] Review immunoabsorption prescription according to titre values. [3] Discuss any planned change in date of operation if appropriate. Ward nursing staff will: [1] Ensure anti-a/b titre blood sample obtained and sent by 9am. [2] Complete prescribed immunoabsorption sessions. [3] Liaise with lead ABOi nephrologist and surgeon with results of anti-a/b titres to ensure no contraindication for proceeding to transplantation on day 0. Live donor co-ordinator will: [1] Inform donor of any change to Expected date of operation. NO BLOOD PRODUCTS SHOULD BE ADMINISTERED TO THE PATIENT UNLESS AUTHORISED BY THE TRANSPLANT NEPHROLOGIST OR SURGEON 8

11 -1: This will usually be the Tuesday before the planned operation on Wednesday / day 0 Live donor co-ordinator nurse will: [1] Ensure anti-a/b titre blood sample obtained and sent off by 9am. [2] Liaise with ward staff to arrange final immunoabsorption session. [3] Liaise with ward staff to arrange for HD session later the same day if patient on HD or continue on CAPD as per prescribed regimen. [4] Obtain the final anti-a/b titre result from ABOi titre laboratory and liaise with lead ABOi nephrologist/surgeon before 5pm. Renal Transplant Registrar will: [1] Ensure immunosuppression drugs prescribed as detailed in appendix 1. Note Myfenax (Mycophenylate Mofetil) dose to increase to 1g bd. [2] Ensure the following additional drugs are prescribed Induction therapy with IL-2 receptor antagonist : Basiliximab 20mg iv, in anaesthetic room. Basiliximab 20mg iv, on day four. TED stockings unless peripheral vascular disease. Enoxaparin 20mg prescribed at 1800 until the patient is fully mobile. Co-amoxiclav 1.2g IV at induction (then 600mg at 8 and 16 hours post operatively). If penicillin allergic prescribe cefuroxime 750mg IV, unless anaphylactic reaction when further advice should be sought from microbiology. Aspirin 75 mg od (to commence post operatively). Ranitidine 300 mg nocte (omeprazole 20mg in patients with dyspepsia). Isoniazid 300mg daily for patients with a history or evidence of previous TB. Valganciclovir tablets 450mg oral if CMV-ve recipient receiving CMV+ve kidney, but only give once Cockcroft and Gault egfr >10ml/min. If the patient has prolonged DGF consider giving liquid at dose tabled below.[see separate CMV protocol for further details]. [3] Stop unnecessary dialysis drugs. Also stop anti-hypertensive medications (except ß-blockers used for ischaemic heart disease). Continue alfacalcidol or calcium supplements if the patient has had a previous parathyroidectomy. [4] Ensure two units of recipient specific packed red cells is cross matched for use intra-operatively if required. ABOi lead nephrologist will: [1] Review patient with results of anti-a/b titres by 5pm and confirm final decision to proceed to transplantation the following day. [2] Ensure patient is well and no medical contra-indication to transplantation [3] Ensure all drugs are correctly prescribed. NO BLOOD PRODUCTS SHOULD BE ADMINISTERED TO THE PATIENT UNLESS AUTHORISED BY THE TRANSPLANT NEPHROLOGIST OR SURGEON 9

12 0: Ward nursing staff will: [1] Ensure pre-operative anti-a/b titre sample has been obtained. [2] Ensure necessary arrangements in place for urgent immunoabsorption if required in the immediate postoperative period. Renal/ Surgical Transplant Registrar will: [1] Ensure early morning blood results available and discuss with transplant surgeon if any abnormal results. [2] Ensure that patient has FBC, renal profile blood tests sent off within 2 hours of returning to the ward postoperation. [3] Ensure routine post transplant tests are requested including daily FBC, Renal profile and 3x / week tacrolimus level. Transplant surgeon will: [1] If required intra-operatively will only use donor specific or AB negative FFP for the recipient. [2] If required intra-operatively will use recipient blood group specific packed RBCs. Transplant nephrologist will: [1] Review the patient post-operatively and arrange for HD/CAPD if necessary for standard biochemical / clinical indications. NO BLOOD TRANSFUSIONS SHOULD BE ADMINISTERED TO THE PATIENT UNLESS AUTHORISED BY THE TRANSPLANT NEPHROLOGIST OR SURGEON 10

13 +1 Renal Transplant Registrar will: [1] Arrange for ultrasound scan of the transplant kidney if indicated. [2] If immediate and good graft function commence patient on Valganciclovir if indicated as per unit CMV prophylaxis protocol. Live Donor Co-ordinator will: [1] Ensure anti-a/b titre blood sample obtained and sent by 9am. [2] Plan to arrange for immunoabsorption depending on titre results & graft function. [3] Once titre result available later in the day, discuss the same with transplant nephrologist/surgeon. Transplant nephrologist/surgeon will: [1] Review the patient. [2] Decide frequency / timing of further immunoabsorption sessions*. +2 Transplant nephrologist/surgeon will: [1] Review the patient. [2] Decide on frequency / timing of further immunoabsorption sessions*. +3 Live Donor Co-ordinator will: [1] Ensure anti-a/b titre blood sample obtained and sent by 9am. [2] Arrange for immunoabsorption session if indicated by transplant nephrologist/surgeon. [3] Once titre result available later in the day, discuss the same with transplant nephrologist/surgeon. Transplant nephrologist/surgeon will: [1] Review the patient. [2] Decide on frequency / timing of further immunoabsorption sessions*. *Post transplant Immunoabsorption The need for post transplant immunoabsorption will be decided on an individual patient basis. Any rise in antibody titre should be interpreted in the context of the patient s kidney function. If the titre rises =/> 1:16 and there is concern about the patient s kidney function then immunoabsorption should be instituted. A biopsy should be performed at an early stage to check whether there is any evidence of rejection. If the titre rises =/> 1:16 but the kidney function is very good then the titre should simply be monitored. If the titre remains low but there is concern about the patient s kidney function then a biopsy should be performed at an early stage. Donor specific antibody (DSA) levels should also be checked urgently. NO BLOOD PRODUCTS SHOULD BE ADMINISTERED TO THE PATIENT UNLESS AUTHORISED BY THE TRANSPLANT NEPHROLOGIST OR SURGEON 11

14 s +4 to discharge: Transplant nephrologist/surgeon will: [1] Review the patient daily. [2] Review medications and adjust according to clinical need. [3] Decide on frequency / timing of further immunoabsorption sessions. If immunoabsorption session required, nephrologist/surgeon will liaise with ward nursing staff. [4] Ensure anti-a/b titre obtained as necessary. Post transplant follow up arrangements: 1 st month reviewed 3x / week Weekly anti-a/b titres At least once/week the patients results will be reviewed by the transplant nephrologist/surgeon at the weekly MDT meeting. The transplant nephrologist/surgeon will co-ordinate removal of central venous access if placed for the purpose of immunoabsorption once immunoabsorption no longer required. 2 nd month reviewed 2x / week 3 rd and 4 th month reviewed 1x / week 5 th and 6 th month reviewed 1x / two weeks If the patient s progress is uncomplicated they will continue with routine transplant surgical / medical follow up. NO BLOOD PRODUCTS SHOULD BE ADMINISTERED TO THE PATIENT UNLESS AUTHORISED BY THE TRANSPLANT NEPHROLOGIST OR SURGEON 12

15 Appendix 1. Immunosuppression protocol for ABOi transplantation: Rituximab Basiliximab Adoport (Tacrolimus) Target conc (ng/l) -14 As per protocol -7 to day mg/kg/day in two divided doses Target 8-11 Myfenax (Mycophenylate Mofetil) Prednisolone ImmAb 500 mg bd As indicated by antibody titre 0 20mg 1g bd 1g Methypred mg PO Prednisolone +2 60mg PO Prednisolone +3 60mg PO Prednisolone +4 20mg 60mg PO Prednisolone +5 60mg PO Prednisolone +6 60mg PO Prednisolone +7 30mg PO Prednisolone mg mg mg Target mg/kg +120 >12 As clinically As clinically As clinically months indicated indicated indicated PRN PRN PRN PRN PRN PRN PRN Prednisolone dose: Regimen given above is appropriate for patients with rejection free post transplant course. If one or more episodes of cellular rejection occur steroid dose reduction should be delayed and discuss with transplant nephrologist/surgeon before altering dose. If one or more episodes of vascular rejection occur, the maintenance dose should be 20mg/day and any dose changes should only be initiated by following discussion at the transplant MDT meeting. 13

16 Appendix 2. Blood test protocol for patients undergoing ABOi transplantation Test required / day FBC X X X X X X X X X X U&E X X X X X X X X X X Bone, LFTs X X X X X X Clotting X X screen G&S X Anti-A/B titre As indicated by immunoabsorption therapy X X X Tacrolimus level X X X +3 Test required / day FBC X X X X X X X X X X U&Es X X X X X X X X X X Bone, LFTs X X X X Anti-A/B X X X X X titre Tacrolimus level X X X X X X X +28 If there is an episode of acute transplant dysfunction within 3 months of transplantation and the patient is due to be admitted please arrange for urgent Anti-A/B titres* estimation along with FBC, clotting screen, Tacrolimus level, DSA levels, MSU and US transplant before admission. *6mls EDTA blood sample labelled Blood group antibody titre estimation. If sample needs to be processed urgently please arrange for Taxi through live donor co-ordinator or OP staff. Samples should be sent to the transfusion laboratory in Birmingham which has the expertise and accreditation to perform a validated haemagglutination assay. Where necessary results should be discussed with the responsible laboratory haematologist or MLSO. RCI Department National Blood Service Vincent Drive Edgbaston Birmingham B15 2SG 14

17 Appendix 3 ADULT NEPHROLOGY INTRAVENOUS RITUXIMAB INFUSION Stick patient s printed label here WARD DRUG ALLERGIES If none known tick box Patient Name: CONSULTANT Medicine/Other Effect DOB: Hospital Number: K NHS Number: CYCLE No: HEIGHT(cm): WEIGHT(kg): BODY SURFACE Signature... Date... This section must be completed and signed by a prescriber or Pharmacist before a drug is administered. AREA (m 2 ): BSA = (Height (cm) x Weight (kg) / 3600 ADMINISTRATION SCHEDULE Premedication with paracetamol, chlorphenamine and methylprednisolone should always be given: usually at least minutes before the Rituximab infusion is started. DATE DRUG ROUTE DOSE ADDITIONAL INSTRUCTIONS BATCH NO TIME STARTED GIVEN/ CHECKED BY PHARM Screen Supply Paracetamol PO 1g Maximum 4 doses in 24hrs Dose interval 6 hourly Chlorphenamine IV 10mg Maximum 4 doses in 24hrs Give over 3-5 mins Methylprednisolone IV 100mg Give over 3-5 mins Rituximab 375mg/m 2 (round to nearest 50mg) IV In 250ml Sodium Chloride 0.9% See overleaf for administration rate See overleaf PRESCRIBER S SIGNATURE PRINT NAME AND BLEEP NUMBER DATE PRESCRIBED PRESCRIBING INFORMATION 1. Dose of Rituximab: 375mg / m 2 given as an intravenous infusion (Round dose to nearest 50mg) 2. Dilute Rituximab dose in 250ml 0.9% sodium chloride. 15

18 BLOOD MONITORING Pre-Rituximab : FBC (EDTA sample), Lymphocyte markers (EDTA sample); Immunoglobulins levels, Functional antibody levels, Hepatitis B and C serology (serum sample). Results need to be reviewed prior to Rituximab infusion. Monthly FBC following infusion. RITUXIMAB INFUSION RATES Start at 50mg/hr escalated, if tolerated every 30 minutes by 50mg/hr, to a maximum rate of 300mg/hr. Rituximab Infusion Rate (mls/hr) = Total Infusion Volume (mls) x Required Infusion Rate (mg/hr) B n Total Drug Dose (mg) Time (Min) Rituximab infusion rate (ml/hr) Nurse comment regarding patient reaction and rate changes Nurse/ Nurse check Time (hh:mm) Start Monitor blood pressure, pulse, respiration, oxygen saturations and temperature every 15 minutes for the first hour and then if stable, hourly until infusion stops. If patient experiences an infusion reaction, the infusion should be stopped or the rate decreased. If the patient s symptoms then improve, the infusion can be continued at 50% of the rate prior to the reaction and accelerated as tolerated. Version 1,1 Revised January MMC Ref: 01k/11, do not use after Jan

19 Appendix 4 Protocol for Immunoabsorption for ABOi transplantation Choice of Glycosorb column Donor A Donor B Donor AB Donor O Recipient A Column B Column B Recipient B Column A Column A Recipient AB Recipient O Column A Column B Column A and Column B Volume of plasma to be treated per immunoabsorption 90mls x weight =. (Maximum 9l per treatment) Also prescribe the following to be given as required Hydrocortisone 100mg PRN for allergic reactions Chlorpheniramine 10mg IV PRN for allergic reactions Calcichew 1g PRN (for mild hypocalcaemia) Calcium Gluconate 10%, 10mls slow IV over 5minutes (for severe hypocalcaemia) The protocol for completing the immunoabsorption therapy is detailed in the ABOi Immunoabsorption Treatment Sheet. 17