GUIDELINES FOR ADMINISTRATION OF INTRAVENOUS IRON IN ADULTS WITH CHRONIC KIDNEY DISEASE

Transcription

1 GUIDELINES FOR ADMINISTRATION OF INTRAVENOUS IRON IN ADULTS WITH CHRONIC KIDNEY DISEASE Full Title of Guideline: Author (include and role): Division & Speciality: Scope (Target audience, state if Trust wide): Review date (when this version goes out of date): Explicit definition of patient group to which it applies (e.g. inclusion and exclusion criteria, diagnosis): Changes from previous version (not applicable if this is a new guideline, enter below if extensive): Summary of evidence base this guideline has been created from: Guidelines for administration of intravenous iron in adults with chronic kidney disease Diane O Donnell and Kate Taylor Anaemia Nurse Specialists and Leads for Anaemia Management Cancer and Associated Specialties Renal Trust Wide October 2020 All patients under the care of the Nottingham Renal and Transplant Unit including patients at the Lings Bar Dialysis Unit; Cassidy Renal Unit, Kings Mill Hospital and Shipley Dialysis Unit, Ilkeston All patients with an AdjCKD EPI <60mls/min/1.73m 2 ; excluding patients with Haemoglobin (Hb) >110g/l not prescribed an erythropoietin stimulating agent (ESA). Patients with a serum ferritin >800µg/l Inclusion of administration of Monofer and Diafer. National Institute for Health and Care Excellence (2015) Chronic kidney disease: managing anaemia. National Institute for Health and Clinical Excellence (NICE):9-29. Kidney Disease Improving Global Outcomes (KDIGO) (2012) Clinical Practice Guideline for Anaemia in Chronic Kidney Disease. Kidney International Supplements (2012); Moore, R.A., Gaskell, H., Rose, P. and Allan, J. (2011) Meta-analysis of efficacy and safety of intravenous ferric carboxymaltose (Ferinject) from clinical trial reports and published trial data. BMC Blood Disorders; 11:4. Drug Safety Update MHRA; Volume 7, Issue 1; August 2013 SPC for Ferinject (Ferric Carboxymaltose) last updated 19/07/16; accessed via accessed on 21/02/17 SPC for Venofer (Iron Sucrose) last updated 09/11/16; 1 of 9

2 accessed via accessed on 21/02/17 SPC for Monofer (Ferric Isomaltoside) last updated 23/11/15; accessed via accessed on 21/02/17 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 or outside of the Trust. 1. Introduction The investigation and management of anaemia should be considered in people with anaemia of chronic kidney disease (CKD) if: their haemoglobin (Hb) level falls to 110 g/l or less or they develop symptoms attributable to anaemia (such as tiredness, shortness of breath, lethargy and palpitations) When determining individual aspirational Hb ranges for people with anaemia of CKD, take into account: patient preferences symptoms and comorbidities the required treatment The correction to normal levels of Hb with ESAs is not usually recommended in people with anaemia of CKD. - Typically maintain the aspirational Hb range between 100 and 120g/l To keep the Hb level within aspirational range, do not wait until Hb levels are outside the aspirational range before adjusting treatment (for 2 of 9

3 example, take action when Hb levels are within 5g/l of the range s limits; 105g/l and 115g/l) Age alone should not be a determinant for treatment of anaemia of CKD. Erythropoietin stimulating agent (ESA) therapy should not be initiated in the presence of absolute iron deficiency without also managing the iron deficiency. In people with functional iron deficiency, iron supplements should be given concurrently when initiating ESA therapy. In non-dialysis patients with anaemia of CKD in whom there is evidence of absolute or functional iron deficiency, this should be corrected before deciding whether ESA therapy is necessary. 2. Diagnosing Iron Deficiency Do not request transferrin saturation or serum ferritin measurement alone to assess iron deficiency status in people with anaemia of chronic kidney disease. Because serum ferritin is an acute-phase reactant and frequently raised in CKD, the diagnostic cut-off value should be interpreted differently to non-ckd patients. Iron deficiency anaemia should be: diagnosed in people with stage 5 CKD with a ferritin of less than 100 micrograms/l (absolute iron deficiency) considered in people with stage 3 and 4 CKD if the ferritin is less than 100 micrograms/l. transferrin saturation of less than 20%. 4. Intravenous Iron Preparations Iron Sucrose 20mg/ml (Venofer) 100mg/5ml vial. Administered by intravenous injection using undiluted solution of up to 200mg at a rate of 1 ml/minute IV iron preparation for haemodialysis patients Maximum single dose of 200mg (100mg if patient weighs < 45kg) Maximum dose 600mg/week Ferric carboxymaltose 50mg/ml (Ferinject) 500mg/10ml vial. Administered by intravenous injection using undiluted solution up to 1000mg iron (up to a maximum of 15mg/kg body weight- 67kg) Maximum dose 1000mg/week mg doses should be administered at a rate of 100mg/min (2-5 minutes) 3 of 9

4 >500mg-1000mg doses should be administered as an infusion over 15 minutes (80 mls/hr) 1000mg Ferinject can be diluted in 250mls 0.9%saline infused over 15 minutes(up to a maximum of 20mg/kg body weight - 50kg or over) Iron Isomaltoside % 50mg/ml (Diafer) 100mg/2ml vial Administered by intravenous injection using undiluted solution of up to 200mg at a rate of 1 ml/minute IV iron preparation only for haemodialysis patients Maximum single dose of 200mg Maximum dose 1000mg/week Iron Isomaltoside1000 (MonoFer) 500mg/5ml vial The maximum single dose of Monofer should not exceed 20mg iron/kg, if more than 20 mg/kg required it must be split in to 2 doses 1 week apart mg doses should be administered at a rate of 250mg/min (1-2 minutes) Doses 500mg-1000mg must be diluted in 0.9% saline up to a total volume of 20mls and infused over 20 minutes (60mls/hr), (up to a maximum of 20mg/kg body weight - 50kg or over for 1000mg doses) Doses above 1000mg must be diluted in 250mls 0.9% saline and infused over 30 minutes Currently only used for Kings Mill Hospital inpatients. Contraindications hypersensitivity to iron sucrose/ ferric carboxymaltose/ Iron isomaloside or its excipients anaemias not attributable to iron deficiency iron overload/disturbances in iron utilisation (e.g. acute infection) first trimester (0-12 weeks) of pregnancy (unlicensed indication) The risk of hypersensitivity is increased in patients with: known allergies (including drug allergies); immune or inflammatory conditions (eg, systemic lupus erythematosus, rheumatoid arthritis); or those with a history of severe asthma, eczema, or other atopic allergy. In these patients, IV iron products should only be used if the benefits are clearly judged to outweigh the potential risks. 4 of 9

5 5. General Information 1. All registered nurses who have been assessed as being competent in the administration of intravenous medications at Nottingham University Hospitals can administrator intravenous iron. 2. The nurse must complete the allergy box and ask the patient prior to administration whether they have any allergy or sensitivity to the drug(s) prescribed and must sign and date the allergy box. 3. All female patients under the age of 50yrs should be asked if they might be pregnant (outcome documented on renal computer system) and if there is any possibility of pregnancy, a pregnancy test should be performed. Intravenous iron should not be administered in the first trimester of pregnancy. 4. Caution is needed with every dose of intravenous iron even if it has been well tolerated previously. There is no need for test doses. 5. Patients should be closely monitored for signs of hypersensitivity during and for at least 30 minutes after every administration of an intravenous iron product. 6. In addition to the patient s drug card/prescription, the prescription and administration of intravenous iron should be documented on the renal computer system. 7. Iron sucrose can be administered to both non-haemodialysis and haemodialysis patients in the community setting if they have received at least 2 doses of iron sucrose in a hospital setting with no side effects/ adverse reaction. 8. In the community setting 2 EPIPEN s should always be available and in the hospital setting there must always be access to anaphylaxis drugs and cardiopulmonary resuscitation facilities. 9. Iron isomaltoside and Ferric carboxymaltose cannot be administered in the community setting at present, however it is envisaged that Ferric carboxymaltose will possible be once risk assessed and approved by the drugs and therapeutics committee. 5 of 9

6 10. Side-effects to both preparations are mainly anaphylactoid reactions such as: headache; hypotension; metallic taste (iron sucrose); nausea and vomiting. Patients should be informed of the possibility of reactions and advised to notify the nurse if they occur. If a patient suffers side-effects consider reducing the dose and/or rate of administration and discuss with the Renal Anaemia Nurse Specialists, Renal Doctors or Renal Pharmacist. 11. In the event of an anaphylactic reaction administer EPIPEN and ring 999 immediately if no improvement after 5-15 minutes administer second EPIPEN if in the community or follow hospital policy for anaphylaxis. Do not administer the medication that caused the reaction again and ensure clear documentation in patient records of allergy. 6. Treating Iron Deficiency People with anaemia of CKD who are receiving ESAs should be given iron therapy to maintain: serum ferritin level > 100micrograms/l transferrin saturation level > 20% (unless ferritin > 800 micrograms/l) Most adult patients will require mg in single or divided doses depending on the preparation. Patients with functional iron deficiency should be treated with intravenous iron. Peritoneal dialysis and non-dialysis patients who do not respond to oral iron will require intravenous iron. People receiving ESA maintenance therapy should be given iron supplements to keep their: serum ferritin levels between 100 and 500 micrograms/l in both haemodialysis patients and non-haemodialysis patients, and the transferrin saturation (TSAT) level above 20% (unless ferritin >800 micrograms/l) In practice it is likely that this will require intravenous iron. Review iron dose when serum ferritin reaches 500micrograms/l (should not rise > 800micrograms/l) 6 of 9

7 Haemodialysis patients In haemodialysis, where frequent administration of intravenous iron is made feasible through the use of dialysis vascular access, the following algorithm is used for dosing iron sucrose and ferric carboxymaltose. Patients are initially prescribed intravenous iron sucrose, however, if this is not tolerated they will be prescribed ferric carbyoxmaltose. Both preparations should be administered undiluted into the venous port of the extracorporeal circuit. Ferritin (micrograms/l) Transferrin saturation (%) Iron Sucrose (Venofer) and Iron Isomaltoside %(Diafer) dose Ferric carboxymaltose (Ferinject) dose <200 ANY 100mg 500mg/fortnight x2/week <20 100mg 500mg/fortnight x2/week mg 500mg/month x1/week >40 100mg 500mg/month x1/fortnight <20 Discuss with Discuss with consultant consultant >20 No iron No iron >800 ANY No iron No iron Table 1 The above dosing regimen should be reviewed according to clinical indication in patients with a Hb >120g/l. Iron sucrose (Venofer) Administered by slow injection at a rate of 1 ml-undiluted solution per minute (i.e. 5 minutes per 100mg vial) Iron Isomaltoside %(Diafer) Administered at a rate of 1 ml-undiluted solution per minute (i.e. 2 minutes per 100mg vial) Ferric carboxymaltose (Ferinject) Administered by slow injection at a rate of 100mg/min (500mg in 5 minutes). 7 of 9

8 Non-haemodialysis patients In non-haemodialysis patients i.e. pre-dialysis, transplant and peritoneal dialysis patients intravenous iron is given in absolute and functional iron deficiency anaemia and in cases where the patient either does not tolerate or respond adequately to oral iron supplements. Both preparations can be given via a peripheral vein (preferably in the patient s dominant arm). Transferrin saturation (%) Iron Sucrose (Venofer) dose Ferric carboxymaltose (Ferinject) dose <100 <40 5 x 200mg* 1000mg** <30 5 x 200mg* 1000mg** >30 3 x 200mg* 500mg <30 3 x 200mg* 500mg >30 3 x 200mg* 500mg <20 1 x 200mg* Discuss with consultant >20 No iron No iron >800 ANY No iron No iron Table 2 * 100mg if patient weighs <45kg ** 2 x 500mg if patient weighs <67kg The above dosing regimen should be reviewed according to clinical indication in patients with a Hb >120g/l. Iron sucrose (Venofer ) Administered by slow injection at a rate of 1 ml-undiluted solution per minute (200mg in 10minutes) Ferric carboxymaltose (Ferinject ) Administered by slow injection at a rate of 100mg/min (500mg in 5 minutes). For doses greater than mg, infuse undiluted over 15minutes. 6. Monitoring iron status Patients with anaemia of CKD should not have iron levels checked earlier than 1 week after receiving intravenous iron. The length of time to monitoring of iron status is dependent on the product used and the amount of iron given. 8 of 9

9 Routine monitoring of iron stores should be at intervals of 4 weeks to 3 months. Haemodialysis patients All haemodialysis patients have their haemoglobin levels; ferritin and TSAT levels measured monthly, these results are then used to dose the patients (table 1). Non-haemodialysis patients At the time of giving the first dose of intravenous iron the patient will be requested to stop taking any oral iron preparations. This may be recommenced if necessary 1 week after completion of the course. 4 weeks after completion of the prescribed intravenous iron course (Venofer or Ferinject) the patient will have their haemoglobin, ferritin and transferrin saturation checked to review the effectiveness of iron replacement and determine whether further treatment further treatment (iron and/or ESA) is required. 9 of 9