- An Immunoglobulin Request Form must be completed for all patients starting on Intravenous Immunoglobulin (IVIg).
- Indications that are categorised as GREY on the forms will require an Individual Patient Treatment Request (IPTR) Form to be submitted and approved by the clinical director.
- Kiovig®10%, Panzyga®10%, Gamunex®10% and Gamten®10% are the current contractual products within NHS GGC but availability may vary. If a lower strength product is clinically indicated, Octagam®5% is available.
- Long-term patients stabilised on a brand should continue on the same brand.
- Please note in situations of shortages it may be necessary to switch patients to an alternative brand. Dosing rates for IVIg products are not interchangeable and there is a risk of adverse events with a new brand even if a previous brand has been well tolerated.
Intravenous Immunoglobulin (IVIg) - use in Paediatric Patients
Objectives
There has historically been global supply issues with Intravenous Immunoglobulin (IVIg) as well as cost effectiveness in some indications. Use of IVIg is therefore subject to a National Demand Management Plan and in Scotland this is managed through the National Plasma Product Expert Advisory Group (NPPEAG).
Use should be reserved for indications that are commissioned and any use out with the reserved indications require Individual Patient Treatment Request forms (IPTR) to be submitted and approved.
This short guideline is intended to aid healthcare professionals in requesting, prescribing, administration and monitoring of IVIg. It is to be noted that this guidance does not replace the detailed information found for each IVIg product in the Summary of Product Characteristics on the EMC website.
Audience
This guideline is for use within the paediatric wards at the Royal Hospital for Children, NHS Greater Glasgow & Clyde.
- Patient’s urine output and serum creatinine levels must be monitored and they must be adequately hydrated prior to initiation of infusion of IVIg.
- Patients must be monitored for signs and symptoms of thrombosis and blood viscosity assessed in patients at risk for hyperviscosity.
- Concomitant use of loop diuretics must be avoided.
- For patients at risk of thromboembolic events (including deep vein thrombosis, pulmonary embolism, myocardial infarction and stroke) or acute kidney injury, maintain at the minimum practical infusion rate.
- Rarely hypersensitivity reactions, neutropenia/leukopenia, transfusion related acute lung injury (TRALI), cutaneous skin reactions, aseptic meningitis syndrome (AMS), haemolytic anaemia and acute renal failure can develop.
- Adverse events are more likely to occur in patients receiving IVIg for the first time, following a prolonged period between treatments, or when a different brand of IVIg is administered. Adverse events are also more likely to occur in high infusion rates and in patients with an untreated infection or underlying chronic inflammation.
- Management of infusion-related adverse events should include lowering the infusion rate or stopping the infusion. The treatment required depends on the nature and severity of the adverse reaction. **The infusion must be STOPPED and medical advice sought if a severe adverse reaction occurs**
- Further information for adverse events, cautions and contra-indications for each IVIg product will be found in the in the Summary of Product Characteristics on the EMC website.
- Due to the maltose content of Gamten®10% and Octagam®5% (90mg per ml and 100mg per ml retrospectively) consider alternative products in patients with renal dysfunction, use with CAUTION in infants and diabetic patients & AVOID in patients with corn allergies. See Summary of Product characteristics on EMC website for further information before use in these patients.
- The maltose content of Gamten®10% and Octagam®5% may result in falsely elevated glucose readings, both during the infusion and for a period of ~15 hours after the end of the infusion, if a non-glucose-specific blood testing system is used including that of test strips. To avoid serious clinical consequences the measurement of blood glucose should be done with a glucose-specific method. The diabetes team must be contacted before use for advice on appropriate blood glucose testing systems.
- Refer to the Summary of Product Characteristics on the EMC website for advice on scheduling live attenuated virus vaccines after a patient has received IVIg.
- As IVIg is a blood product, consent must be taken beforehand.
- The dose and regimen of IVIg given will be dependent on the indication. Dosing information can be found on the Immunoglobulin Request Form and on local speciality guidelines.
- Updated advice from Clinical Commissioning Policy for the use of therapeutic immunoglobulin (Ig) England (2025) recommends that in all paediatric patients, IVIg dosing should be based on Ideal Body Weight (IBW).
- Calculating IBW: If height is able to be measured use Moore’s method to calculate IBW (see example calculation below). IBW is calculated by measuring weight at corresponding height centile using RCPCH-WHO growth chart. If height is not available, use the patient’s age and refer to the BNFc section tilted ‘Approximate conversions and units’ to determine the patients mean weight and use this instead of IBW.
- Calculate total treatment course and round to the nearest dose which can be administered using whole vials (contact pharmacy to confirm vial size if needed).
- Where the dose is split over multiple days, the daily dose may differ.
- IVIg should be prescribed on HEPMA/Kardex as ‘Immunoglobulin Injection for Infusion PAEDIATRIC AS CHARTED’ for the duration of treatment. The brand given must be added as an ‘Order Note’ on HEPMA (or handwritten if using a Kardex).
- Individual Prescribing, Administration and Monitoring (PAM) charts are available for each product and must be fully completed. Note infusion rates for each immunoglobulin brand differs and it is therefore important that the correct PAM chart is selected.
- Prescribers must print the appropriate PAM chart for nursing staff according to the brand of IVIg prescribed.
- IVIg must always be prescribed at the initial infusion rate for all doses and be increased as described on each individual PAM chart. Except as follows:
- Alternative lower infusion rates should be prescribed in patients with previous infusion related adverse event and in patients at risk of thromboembolic events or acute kidney injury. For patients at risk of thromboembolic events or acute kidney injury, IVIg must be given at the minimum infusion rate practical.
- Alternative higher infusion rates must only be prescribed for long-term immunology patients with no previous infusion related reactions and are deemed suitable by the patient’s immunology consultant. Further information on infusion rates for each brand may be found in Summary of Product Characteristics on the EMC website. The decision to prescribe a higher infusion rate must be clearly documented by the patient’s immunology consultant. This would be considered off-label use and should be guided by clinical judgement and individual patient response. Higher infusion rates must NOT be prescribed for any acute patient or other long-term patient not under an immunology consultant.
- Where possible IVIg should be given during daytime hours.
- Each infusion should be started at the initial recommended infusion rate (See Prescribing section for more details). Recommended initial infusion rates vary between brands and are described in each individual PAM chart.
- Patient’s urine output and serum creatinine levels must be monitored and they must be adequately hydrated prior to initiation of infusion of IVIg.
- Patients must be monitored for signs and symptoms of thrombosis and blood viscosity assessed in patients at risk for hyperviscosity.
- Nursing staff must complete infusion rates, batch number and expiry dates on the PAM chart and record on the PEWS chart the patients temperature, blood pressure, pulse and respiratory rate before starting the infusion, prior to increasing the infusion rate and for 1 hour after completion of the first infusion or 20 minutes after subsequent infusions.
- Management of infusion-related adverse events should include lowering the infusion rate or stopping the infusion. The treatment required depends on the nature and severity of the adverse reaction. **The infusion must be STOPPED and medical advice sought if a severe adverse reaction occurs**
- All IVIg adverse events must be documented in the patient’s notes.
- Refer to each IVIg PAM chart for adverse effects, specialist monitoring, administration and drug interactions as these may differ. Further information for each product will be found in the in the Summary of Product Characteristics on the EMC website.
A 7 year old girl who is 121cm tall and weighs 32kg (ABW)
- Diagnosed with Guillain-Barre syndrome and meets criteria for IVIg
- Plan to receive 2g/kg IVIg based on IBW to be given over 5 days as per guidelines.
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Calculation of IBW |
Using Moore’s Method Step 1: Identify the height centile using RCPCH-WHO growth charts. The height is around the 50th centile. Step 2: Identify the weight at the 50th centile using the UK WHO growth charts. 50th centile weight for a 7 year old girl is 23kg. IBW is 23kgs |
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Calculation of total dose |
2 x 23kg = 46g → rounded to dose which can be administered using whole vials → 45g |
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Split total dose over 5 days |
Day 1: 10g Day 2: 10g Day 3: 10g Day 4: 10g Day 5: 5g IVIg should be prescribed on HEPMA/Kardex as ‘Immunoglobulin Injection for infusion PAEDIATRIC AS CHARTED’ for the duration of treatment. The brand given must be added as an ‘Order Note’ on HEPMA (or handwritten if using a Kardex). The correct PAM chart must be completed including dose and infusion rate. |