Departments of Haematology, Nephrology and Pharmacy Care Pathway for the Administration of Intravenous Iron Sucrose (Venofer ) [Care Pathway Review Date] Guidance for use This Care Pathway is intended as a guide to treatment and an aid to documenting patient progress. Of course practitioners are free to exercise their own professional judgement, however, any alteration to the practice identified within this care Pathway must be noted as a variance on the sheet at the back of the Pathway. (Please record alteration to practice and action taken as a result.) Name Consultant Case note number Ward Date of Admission Named Nurse Date commended on pathway Date of Discharge For information relating to the care outlined on this Pathway, please contact: Anne Waddington Pharmacy Dept Ext 3987 If you require clarification on Care Pathways in general, please contact: Clinical Governance Department Ext 6475 Iron Sucrose (Venofer) Care Pathway Page 1 of 11
Section 1 Assessment (to be completed by prescriber) 1. Patient Details (attach addressograph label) Name Unit number Date of Birth 2. Indications for the Use of Venofer (select indication by ticking box) Table 1. Indication Yes No 1. Does the patient have anaemia of Chronic Kidney disease with ferritin <200 mcg/l or total iron saturation (TSAT) <20%? 2. Is the patient intolerant or resistant to oral iron therapy? 3. Is oral iron therapy unsuitable or contraindicated? Other indication:.. Signature of prescriber Iron Sucrose (Venofer) Care Pathway Page 2 of 11
3. Cautions and Contraindications to the use of Venofer (to be completed by the prescriber) Venofer must not be given if the patient has any of the following contraindications. Please complete the table below stating yes or no as appropriate. Table 2 Contraindications to Venofer Yes No Non iron deficient anaemia (e.g. haemolytic anaemia) Iron overload or disturbance of iron utilisation History of asthma, eczema or atopic allergy Drug hypersensitivity to parenteral iron preparations Decompensated liver cirrhosis or hepatitis Acute/chronic infection of any type Pregnancy first trimester Occasionally iron infusion may be given with steroid cover for patients who have shown a mild reaction to the infusion in the past. This should be requested by the referring consultant. Cautions Parenterally administered iron preparations can cause allergic or anaphylactoid reactions, which may be potentially fatal. Therefore, treatment for serious allergic reactions and facilities with the established cardiopulmonary resuscitation procedures should be available. In patients with liver dysfunction, parenteral iron should only be administered after careful risk/benefit assessment. Parenteral iron administration should be avoided in patients with hepatic dysfunction where iron overload is a precipitating factor, in particular Porphyria Cutanea Tarda (PCT). Careful monitoring of iron status is recommended to avoid iron overload. Parenteral iron must be used with caution in case of acute or chronic infection. It is recommended that the administration of iron sucrose is stopped in patients with ongoing bacteraemia. In patients with chronic infection a risk/benefit evaluation has to be performed, taking into account the suppression of erythropoiesis. Hypotensive episodes may occur if the injection is administered too rapidly. Allergic reactions, sometimes involving arthralgia, have been more commonly observed when the recommended dose is exceeded. Paravenous leakage must be avoided because leakage of Venofer at the injection site may lead to pain, inflammation, tissue necrosis and brown discoloration of the skin Iron Sucrose (Venofer) Care Pathway Page 3 of 11
Contraindications discussed with referring consultant Yes No Date Name of consultant Time Signature Outcome: To be completed by prescriber 4. Dose of Intravenous Iron Please tick Yes No Does the patient have anaemia of Chronic Kidney disease with ferritin <200 mcg/l or total iron saturation (TSAT) <20% but is not dialysis dependent? If yes, use table 3 (on page 5) to calculate dose of Venofer. Is the patient dialysis dependent with ferritin <200 mcg/l or total iron saturation (TSAT) <20%? If yes use table 4 (on page 5) to calculate dose of Venofer Is patient iron deficient with Haemoglobin < 11 g/dl and either a) intolerant or resistant to oral iron therapy or b) oral iron therapy is unsuitable or contraindicated? If yes, see table 5 (on page 6) for dose of Venofer. For other indications consult product literature and discuss dosage with pharmacy. Please tick Yes No Dosage discussed with pharmacy Name of Pharmacist Date: Time: Signature: Iron Sucrose (Venofer) Care Pathway Page 4 of 11
Venofer may be administered up to maximum of 200mg three times weekly. If a less rapid correction is required Venofer may be given as 200mg weekly for the required number of doses. Table 3 Total Number of doses of Venofer for non dialysis patients with anaemia of Chronic Kidney Disease Patient Weight Number of doses of Venofer (kg) 30-39 200mg up to a maximum of three times weekly for 3 doses 40-49 200mg up to a maximum of three times weekly for 4 doses >50 200mg up to a maximum of three times weekly for 5 doses Consider prescribing a maintenance regime for replacement of iron in patients with anaemia of chronic kidney disease, particularly if they are receiving an Erythropoeisis Stimulating Agent e.g. Aranesp. Table 4 Total Number of doses of Venofer for haemodialysis patients with anaemia of Chronic Kidney Disease Patient Weight Dose of Venofer Haemodialysis patients (kg) Induction Maintenance dose 30-39 200mg three times weekly for 3 doses 100mg monthly 40-49 200mg three times weekly for 4 doses 100mg fortnightly >50 200mg three times weekly for 5 doses 100mg weekly Dialysis patients often require intravenous iron supplementation to be continued after the initial replacement dose. The maintenance dose schedule in Table 4 above may be used and modified as appropriate based on patient s Haematinics. Iron Sucrose (Venofer) Care Pathway Page 5 of 11
Table 5 Total Dose of Venofer for patients with haemoglobin < 11 g/dl who do not have anaemia of chronic kidney disease and in whom oral iron is unsuitable. How to use table 5 to select the correct dose of Venofer In the left hand column, find the body weight that most closely matches the patient s bodyweight. Read across this row to the column headed by the haemoglobin concentration that matches the patient s current state. The reading at this point gives the total dose Venofer that the patient should receive to correct their iron stores. Divide the total dose by 200 to give the number of doses of 200mg of Venofer that the patient requires to complete their treatment. For example an 80kg patient with a haemoglobin of 7g/dL would require 1200mg of Venofer. This could be given as a 2 week course of 200mg three times per week. Haemoglobin Concentration g/dl) Body Weight (Kg) 35 40 45 50 55 60 65 70 75 80 85 90 5 g/dl 6 g/dl 7 g/dl 8 g/dl 9 g/dl 10 g/dl 1000 1000 800 800 600 600 1000 1000 800 800 600 600 1200 1000 1000 800 800 600 1200 1000 1000 800 800 600 1200 1200 1000 800 800 600 1400 1200 1000 1000 800 600 1400 1200 1200 1000 800 600 1600 1400 1200 1000 800 600 1600 1400 1200 1000 800 600 1600 1400 1200 1000 800 600 1800 1600 1400 1200 1000 800 1800 1600 1400 1200 1000 800 NB This is the total dose of Venofer needed. It is not the dose to be given in one treatment. The maximum dose of Venofer that can be given in one week is 200mg three times weekly. Iron Sucrose (Venofer) Care Pathway Page 6 of 11
To be completed by prescriber 5. Prescription of Venofer Venofer should be prescribed on the patient s drug Kardex or outpatient prescription. The required dose of Venofer is given in 100 ml Sodium Chloride 0.9%. Give the first 25mg of the infusion as a test dose over 15 minutes. If no adverse reactions the remainder of the infusion should be given over 30 minutes. Venofer may also be given undiluted into the venous limb of the dialyser. In this case the first 1mL (20mg) of Venofer should be given as a test dose over 1 to 2 minutes. If there is no reaction in the 15 minutes after the test dose the remaining portion of the dose may be given over 5 minutes. 6. Monitoring 6.1 Haematinics. Record patients blood results pre-treatment. Ensure patient is given 2 blood test forms when they receive Venofer infusion so that their haematinics can be rechecked as an Outpatient at week 4 and week 12. Correct B 12 and folate as appropriate. Ferritin Normal Ferritin range is 14-330 mcg/l. For anaemia management in Chronic Kidney disease aim for ferritin 200-500 mcg/l. Iron infusion must not be given if Ferritin>800 mcg/l unless discussed with referring consultant. Date Hb B 12 211-911 Week 0 (baseline) nanogram/l Serum Folate 5.4-24 mcg/l Ferritin Iron 10-30 µmol/l Iron Saturation % Week 4 Week 12 Repeat test not Required if normal at baseline Iron Sucrose (Venofer) Care Pathway Page 7 of 11
7. Administration (To be completed by person administering the Venofer ) Add the prescribed amount of Venofer to 100mL of sterile normal sodium chloride using aseptic technique. Prescribed amount of Venofer added to 100ml of sterile normal sodium chloride using aseptic technique. 8. Observations during Venofer Infusion Anaphylactoid reactions Yes No Signature and Print Name Anaphylactoid reactions to Venofer are usually evident within a few minutes, and close observation is necessary to ensure recognition. If no adverse reactions are seen after 15 minutes, give the remaining portion of the infusion over at least 30 minutes. Observe patient every 5 minutes whilst the test dose is being given and then every 15 minutes until infusion is completed. Complete the observations chart below (on page 9), recording Heart Rate, Blood Pressure, Respiratory Rate and Temperature. If at any time during the intravenous administration of Venofer, any signs of a hypersensitivity reaction or intolerance are detected, administration must be stopped immediately. Facilities for cardio-pulmonary resuscitation including adrenaline (1:1000) must be available when administering Venofer Iron Sucrose (Venofer) Care Pathway Page 8 of 11
Record of Venofer Administration (To be completed by person administering Venofer ) Attach Cannulation Sticker here Verbal consent for treatment given Venofer Batch Number: Venofer Expiry Date./... 0.9% Saline Batch Number. 0.9% Saline Expiry Date./ Yes No Test dose started Signature Test dose stopped Signature Time Time Observations Chart to be used During Venofer Infusion Date Time Heart Rate Blood Pressure Respiratory Rate Temperature Free from side effects Yes *No * If no, record in variance section and follow Section 9 management of side effects of intravenous iron Iron Sucrose (Venofer) Care Pathway Page 9 of 11
To be completed by attending medic 9. Management of Side Effects of Intravenous Iron Side Effect Action Required Action Taken Date / Time Anaphylaxis Stop infusion. Yes No Signature Give Hydrocortisone 100mg iv. Give Chlorphenamine 10mg iv. Consider also giving 1mg of Intramuscular adrenaline (1:1000) if the patient shows signs of cardiovascular compromise. Mild allergic reaction Hypotension * May be as a result of administering intravenous iron too quickly. Injection Site Pain * Extravasation Record Anaphylactic reaction in case notes and do not use intravenous iron again in this patient. Stop intravenous infusion. Administer Chlorphenamine 10mg iv. Stop infusion. Lay patient flat. Recommence infusion at half of previous rate when systolic BP has recovered to >100mmHg. Stop infusion. Confirm venflon is sited correctly. Emergency Drugs Hydrocortisone 100mg i.v. Time: Signature: Chlorphenamine 10mg i.v. Time: Signature: Adrenaline (1:1000) 1mg i.m. Time: Signature Iron Sucrose (Venofer) Care Pathway Page 10 of 11
Venofer Variance Sheet All Staff Patient ID Label Reference Variance Iron Sucrose (Venofer) Care Pathway Page 11 of 11