CHHS18/032

Canberra Hospital and Health ServicesClinical ProcedureImmunoglobulin Authorisation and Administration – Adults, Paediatrics and NeonatesContents

Contents...................................................................................................................................1

Purpose.................................................................................................................................... 2

Criteria......................................................................................................................................2

Alerts........................................................................................................................................2

Scope........................................................................................................................................3

Section 1 –Authorisation / approval of Immunoglobulin (IVIg, SCIg, NIg)................................3

Section 2 – Urgent requests for IVIg (submitting an emergency Authorisation request in BloodSTAR)...............................................................................................................................6

Section 3 – Ordering product from transfusion laboratory once approval obtained (IVIg, SCIg, NIg) 7

Section 4 – What to do if the patient does not meet the Criteria............................................8

Section 5 – Normal human immunoglobulin NHIg...................................................................8

Section 6 – Patient Information and Consent...........................................................................9

Section 7 – Administration of IVIg..........................................................................................10

Section 8 – SCIg program for home based care......................................................................11

Section 9 – Administration of SCIg/NHIg................................................................................13

Section 10 – Patient Monitoring and Adverse Reaction Management...................................15

Section 11 – Maximum Infusion Rates All 10% IVIg Products.................................................17

Section 12 – Product Storage Conditions...............................................................................18

Section 13 – Contact Phone List.............................................................................................18

Implementation......................................................................................................................18

Related Policies, Procedures and Legislation.........................................................................19

References..............................................................................................................................19

Search Terms..........................................................................................................................20

Attachments...........................................................................................................................20

Attachment A – A Training Checklist...................................................................................22

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Purpose

The purpose of this document is to provide a systematic and consistent approach for the safe and appropriate administration of Intravenous Immunoglobulin (IVIg) or subcutaneous immunoglobulin (SCIg) across ACT Health. All staff involved in transfusion of IVIg and or SCIg are responsible for maintaining and updating their knowledge and practices.

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Criteria

IVIg and SCIg are used in the management of an increasingly wide range of diseases. IVIg and SCIg are used mainly as a source of antibody replacement in primary immunodeficiency (PID) and to modulate the immune system in autoimmune and inflammatory diseases. Access to IVIG and SCIg in Australia is approved by the Australian Red Cross Blood Service (Blood Service). In order for patients to gain approval through the Blood Service, the patients must also meet conditions outlined in the Criteria for the Clinical Use of Intravenous Immunoglobulin in Australia edition 2012 (the Criteria)

BloodSTAR. BloodSTAR is an online system that facilitates authorisations, dispensing and reviews of immunoglobulin products such as IVIg and SCIg in Australia in line with the Criteria.

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Scope

Alerts

Avoid starting infusion overnight in non urgent cases; IVIg can be administered through a vented giving set.

(E.g. B|Braun Infusomat Space line ref: 8700110SP) IVIg will be given where resuscitation equipment is available, in an area where the

patient can be easily observed and monitored; IVIg contains no antimicrobial additives or agents therefore should be infused

immediately after opening; A Medical Officer should be accessible (easily reached by phone) at all times during IVIg

transfusion.

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Scope

This procedure pertains to Medical and Nursing staff ordering and/or administering IVIg/SCIg across ACT Health.

Products currently approved under the National Blood Arrangements: IVIg SCIg

Intragam 10% Evogam NF Privigen 10% Hizentra 20% Flebogamma 10 %

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Section 1 –Authorisation / approval of Immunoglobulin (IVIg, SCIg, NIg)

IVIg, SCIg and NHIg are issued in accordance with the Criteria. Authorisation for Ig under the National Blood Arrangements must be obtained via BloodSTAR available at www.blood.gov.au

SCIg is only approved for patients with a medical condition where there is support for use cited in the Criteria for the Clinical use of Intravenous Immunoglobulin in Australia, namely: Primary immunodeficiency diseases with antibody deficiency Specific antibody deficiency; Acquired hypogammaglobulinaemia secondary to haematological malignancies (chronic

lymphocytic leukaemia, multiple myeloma, non-hodgkin lymphoma and other relevant malignancies, and post-haemopoietic stem cell transplantation) secondary hypogammaglobulinaemia (including iatrogenic immunodeficiency);

Being treated by a clinical specialist within a hospital based SCIg program (see below); Where the hospital provides access to all resources and takes full accountability for the

management and use of the SCIg product, at no additional cost to patients; and Following a patient-specific SCIg request submitted to, and authorised by, the Australian

Red Cross Blood Service (Blood Service).

IVIg can be obtained under National Blood Arrangements or Direct Order arrangements (see section 4)

Patients travelling overseasProvision for the supply of product for patients temporarily travelling or studying overseas may be granted in accordance with the Policy for Issuing Blood Products and Blood Related Products in Australia for Use Overseas. For more information, please refer to the NBA website at www.blood.gov.au/supply-australians-overseas.

Dosage

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Dosage of Immunoglobulin (Ig) is dependent on the condition for which it is being administered; with the aim of using the lowest possible dosage that achieves an appropriate clinical outcome for each patient. Please refer to the Criteria.

Equipment BloodSTAR registration portal; Blood Transfusion Request form.

Procedure for authorisation of IgRegister with BloodSTAR Treating clinicians must seek approval for Ig via BloodSTAR. If approval has already been granted go directly to section 3 -Ordering product from transfusion laboratory.

Alert BloodSTAR User Registration is a two part process comprised of: a. BloodPortal User Registration – Creating a single username and password for all NBA

systems, and b. B. BloodSTAR Role Request – Requesting a role and location for access to your facility

1. Access www.blood.gov.au2. Select BloodPortal 3. Login with your BloodPortal User Name and Password.4. If you do not have an account already, please select “New User? Create an account” link

next to the login button.

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5. Once you have Blood Portal access select the BloodStar tile :

For BloodSTAR prescriber tip sheet see https://www.blood.gov.au/medical-officer

6. Request access in the My Account drop down menu

7. Select “add role to access request”, complete all mandatory fields and save.8. Accept terms and conditions and ‘Submit’.9. A CHHS systems administrator will accept your request allowing access to request for Ig.

Request authorisation1. Make new authorisation request by selecting the Authorisation Requests tab at the top

of the BloodStar home page and click New Initial Authorisation Request. A patient search window will appear. Enter the full name and date of birth of the patient, and click Search. If there is an exact match, the patient will appear for you to select and continue with

a patient already in BloodSTAR; a partial match will not return results. If there is no match, select Create New Patient to progress with an authorisation

request after entering the extra required details for that patient. 2. Enter patient details and obtain consent to store patient data in BloodSTAR

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Alert Patients must consent to having their details stored in BloodSTAR. Copies of the consent form and information for patients as to what details are recorded and why are available on the consent page in BloodSTAR. Enter in your patient’s consent status, Select whether the consent granted was verbal or written, who granted the

consent and the date it was obtained. You can nominate if the consent status is recorded in the medical record and also

upload a scanned copy of any consent you have received in writing. If this form is used it should be uploaded into BloodSTAR as it has not been

approved for use by CHHS

3. Add treating administering facility details.4. Add diagnosis.5. Add patient weight.6. Add dose required.7. The product type and dosage per kilogram will be pre-populated and is determined by

the entered diagnosis. 8. Enter the details of the treatment, including frequency, date required and any notes.9. If you need to select a different product, tick the box marked Request a different product.

A field will appear for you to select an alternate product and to provide a reason for the change. This reason is mandatory.

10. Treatment duration and amount per kilogram is calculated automatically off the weight entered for the patient. If you need to prescribe more than the recommended maximum of product per kilogram, enter this under Dose/Kg. If the Dose/Kg is higher than the recommended amount under the criteria you must enter a reason.

11. When all details are completed, select Save and Continue.12. Confirm all details and check the box Accepting Terms and Conditions. Click Submit to

complete the request.13. All requests will be reviewed by the Blood Service and prescribers will be notified ( by

email) dispensing facilities will also be notified via BloodNET.

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Section 2 – Urgent requests for IVIg (submitting an emergency Authorisation request in BloodSTAR)

An important function in BloodSTAR is the ability for a Medical Officer who does not yet have full access to be able to place an Emergency Authorisation Request.

You must submit an access request but do not have to have the access approved before you can lodge an emergency request for a patient. You will only be able to place one emergency authorisation request before you are fully approved as a Medical Officer by the facility administrator.

1. Complete Blood Portal registration www.blood.gov.au (see section 1)

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2. Request BloodSTAR access as per section 1 (point 5-6)3. For BloodSTAR prescriber tip sheet see https://www.blood.gov.au/medical-officer4. Once your access request has been submitted, you will be navigated to the Access

Request History Page. You can submit an emergency request by clicking the link + Emergency Authorisation Request

5. A warning will appear, specifying that you may only complete this function for an emergency and that you will be notified by email of the outcome, as well as informing you that you are able to search for a direct match for an existing patient but will not be able to see all patients for the site, as that access is restricted to approved users. Your provisional access will be removed after 48 hours if not approved by the facility administration.

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Section 3 – Ordering product from transfusion laboratory once approval obtained (IVIg, SCIg, NIg)

All approved requests for supply of IVIg/ SCIg to the clinical area must be written on a Blood Transfusion Request form and signed by the requesting Medical Officer or Nurse Practitioner. Documentation must be legible and include: Patient surname, full given name, date of birth and the medical record number (MRN); Gender; Name and signature of requesting doctor; Product to be transfused; Date and time the product is required; Relevant clinical history; Dose required in grams.

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Section 4 – What to do if the patient does not meet the Criteria

Where the patient does not meet the Criteria:Patients that do not meet the Criteria can, in some instances receive Ig under the Jurisdictional Direct Order (JDO), where imported Ig is available to approved recipients. In these circumstances the treating clinician must submit a request to the hospital Drug Therapeutics Committee (DTC) for approval.

Contact details for DTC: Email: email dtc@act.gov.auSecretariat ext. 42121

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Section 5 – Normal human immunoglobulin NHIg

NHIg, a scarce resource produced from the same plasma pool as domestically produced IVIg and SCIg, may be supplied under the national blood arrangements for two purposes, as follows:1. NHIg may be supplied for public health disease control activities, to treat susceptible

contacts of an indicated infectious disease (hepatitis A, measles, poliomyelitis or rubella), where directed by the public health physicians, infectious disease consultants or clinical microbiologists. Advice and guidance to public health units in responding to a notifiable disease event can be found in the Series of National Guidelines (SoNGs) at:www.health.gov.au/internet/main/publishing.nsf/Content/cdnasongs.htm

2. NHIg may be supplied for the treatment of immunodeficiency conditions for which the product is indicated, for patients for whom treatment with IVIg and SCIg (where available) are both contraindicated, provided that: The diagnosis and written prescription is provided by a relevant medical specialist; The same diagnostic, qualifying, exclusion and review criteria and authorisation

process for the relevant conditions are used to authorise the supply of NHIg, as would apply for the supply of IVIg or SCIg for those conditions;

At the time of seeking authorisation, the prescribing specialist clinician confirms in writing the specific clinical reason why treatment with IVIg and SCIg are both contraindicated;

The governing requirements for SCIg are applied where NHIg is proposed to be used outside of the hospital setting;

Ongoing access to supply of NHIg may cease if the required review and supporting documentation demonstrating clinical effectiveness against the review criteria have not been met.

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Section 6 – Patient Information and Consent

Documented consent for Blood and Blood Products is required under National Safety and Quality Health Care Standard - Standard 7. Significant risks, benefits and alternatives to IVIg/SCIg including the patient’s right to refuse should be discussed and documented in the patient progress notes in accordance with ACT Consent to Treatment Policy and Procedures (Including sections: Consent and Treatment: Blood and Blood Products; Consent and Treatment : Children or Young People; and Consent to treatment : Capacity and Substitute Decision maker) .

Consent for IVIg/ SCIg should also be documented on the Blood and Blood Products Prescription and Checklist document, available on the clinical forms register.

All patients should be routinely provided with written information prior to commencement of the IVIg/ SCIg.

Equipment Blood and Blood Products Prescription and Checklist document For Consumer information IVIg (select appropriate Hyperlink):

Intragam® 10% Human Normal Immunoglobulin Privigen® Normal immunoglobulin (Human) 10% (100 g/L)Flebogamma 10%

For Consumer information SCIg (select appropriate Hyperlink):Evogam® Human Normal Immunoglobulin 16% (16 g/100 mL)Hizentra® Human Normal Immunoglobulin 20% (20 g per 100 mL)

Procedure Treating medical officer to:1. Discuss clinical decision to administer IVIg/SCIg with patient or authorised patient

advocate.2. Discuss risks, benefits with patient or authorised patient advocate.3. Provide appropriate consumer information.4. Document consent on the Blood and Blood Products Prescription and Check list

document 5. If patient or authorised patient advocate is unable to consent, or refuses consent, this

must also be documented in clinical record.

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Section 7 – Administration of IVIg

Alert precautions IVIg must only be administered intravenously. IVIg contains traces of IgA which may provoke anaphylaxis in patients with IgA

antibodies. IVIg must be administered separately from other IV fluids or medications -administer via

a dedicated line or lumen

Equipment IVIg Product Blood and Blood Product Prescription and Checklist Vented IV giving set Braun Infusomat Space line ref: 8700110SP Infusion Pump MEWS Observation Chart

Procedure1. Ensure consistent practice with ACT Health Hand Hygiene practices.2. Ensure there is a current medical order written up on Blood and Blood Products

Prescription and Checklist.3. Ensure that the patient has received adequate education and has had the opportunity to

ask questions about blood product transfusions.4. Ensure the patient has given informed consent to receiving the transfusion and this is

documented in the clinical record.5. Order trough IgG levels prior to infusion where appropriate.6. Allow IVIg to reach room temperature before opening.7. Check IVIg against transfusion sheet with two nursing staff, one of which must be a

Registered Nurse, AT THE PATIENTS BEDSIDE in line with standard IV management: Check correct IVIg product and concentration of product; Correct Dosage; Expiry date; and Batch number (attach batch number sticker to transfusion document supplied by the

laboratory).8. Patient must be wearing an identification wristband.9. Ask patient to state and spell their given name, surname and date of birth.10. Check full name, MRN and date of birth exactly match written orders, Patient ID band

and Transfusion Sheet.11. Record baseline vital signs (temperature, heart rate, blood pressure, respirations/SaO2

and LOC).12. Give premedication if indicated. See Section 7 -Adverse Reactions13. Remove plastic cover from the seal on the vial and wipe the exposed rubber stopper with

an alcohol swab and allow to dry.14. Use a vented giving set e.g. B|Braun Infusomat Space line ref: 8700110SP;15. Ensure IV Cannula (IVC) is patent by flushing with 5-10mL Normal Saline.

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16. IVIg must be administered separately from other IV fluids or medications -administer via a dedicated line or lumen.

17. Prime the IV line with the Ig product.18. Program infusion pump using appropriate guard rails.19. Commence infusion.20. Continue observation and titrate infusion via appropriate protocol see Section 10

Infusion Rates.21. When infusion complete document completion time, flush and remove cannula if no

further IV treatment is required.

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Section 8 – SCIg program for home based care

Referral to SCIg ProgramAll referrals to the SCIg home based program from the treating consultant must be directed to the SCIg Nurse and the Haematology/ Oncology Outpatient CNC. See contact phone list Section 13 Pg 15

Patients must meet the clinical authorisation criteria outlined in Section 1In addition, patients must undergo a nursing assessment to establish their suitability for the program i.e. Patients/carer understanding of the responsibilities of home based care Psychosocial status Cognitive status Suitable home environment to safely administer at home

Patients will be triaged by the SCIg Nurse and referring consultant according to need.

Induction programInduction and assessment of competency will be determined by the SCIg Nurse utilising the A Training Checklist. Example at Attachment A

Completed check list is to be scanned and recorded in CHARMTM by the SCIg Nurse.

Session 1:Orientation to the SCIg support network and facilities. Establishment of a ‘buddy system’ (i.e. having a support person at home while they are infusing the product). SCIg Nurse demonstrates nominated procedure (push/ pump) and associated safety criteria to patient /carer. Nurse proceeds with administration of product.

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Session 2:Patient/carer sets up and administers SCIg with prompts from SCIg Nurse.

Session 3:Patient/ Carer self –administers product without cues from SCIg Nurse. Competency based assessment by SCIg nurse to ascertain if patient/carer is competent to perform the procedure unaided at home.

Session 4:If required to reinforce learning and gauge patient competency.

Once found to be competent the patient will transition to self –administration at home. Follow up will be provided through the Immunology/Haematology Clinic specialist appointments and phone calls / emails from the SCIg Nurse (weekly for first month, then monthly for 3 months or as required). It is expected the patient will remain within the Canberra Region for this period.

SCIg Product Issue Product will be issued to patients on a month basis during induction and 2 monthly with

SCIg nurse approval Requests for products must be documented on the ACT Pathology Blood Transfusion

Request form Requests for issue must be provided to the transfusion laboratory at least 1 week prior

to patient collecting product from transfusion laboratory

SCIg Consumables Consumable of SCIg infusion will be patient specific but at a minimum the following

items will be supplied by Haematology/ oncology out patientso 19 gauge bevelled edge needle or interlink to draw up the solution;o 10 / 20mL Syringe/s;o Infusion set;o Infusion device ( if required);o Alcohol wipes;o Occlusive dressing e.g. IV tegaderm/opsite (to secure the cannula)o Retractable butterfly +/- extension

Patient Diary Patients are required to document the following information in the patient diary and

present the diary to the SCIg Nurse on request:o Infusion dateo Batch Numbero Volume infusedo Infusion siteo Total infusion time

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o Any adverse events /Symptoms noted prior to / during and after infusiono Medications taken for symptomso Other comments

Charm DocumentationThe SCIg Nurse will enter all encounters and supporting documentation including phone call into CHARM

Ongoing Support During business hours, the SCIg Nurse will manage notifications from patients of

infection and illness and refer them to the appropriate registrar or consultant for follow up. Outside of business hours, the patient will attend the emergency department if the condition needs management that cannot wait to the next working day.

The SCIg Nurse will coordinate supply of product with the transfusion laboratory/blood service for patients travelling overseas.

The SCIg Nurse will manage changes in regime for patients requiring change in product

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Section 9 – Administration of SCIg/NHIg

The advantages of SCIg over IVIg include: ease of administration, fewer side effects, reduced administration time, although the frequency of infusions is greater. SCIg also results in steady plasma IgG levels, whereas IVIg is associated with peaks and

troughs.

SCIg must only be administered subcutaneously.

SCIg requires initial training/induction program by qualified health care professional, after which patient can self-infuse.

Equipment Local anaesthetic cream e.g. EMLA (Only for paediatric patients, or, special

circumstances); 19 gauge bevelled edge needle or interlink to draw up the solution; 10 / 20mL Syringe/s; Infusion set; Infusion device ( if required); Alcohol wipes; Occlusive dressing e.g. IV tegaderm/opsite (to secure the cannula ) Retractable butterfly +/- extension

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Procedure1. Ensure that the patient has received adequate education and has had the

opportunity to ask questions about SCIg administration.2. If patient has already been inducted into the SCIg program and has been deemed

competent ask patient if they would like to give their infusion.3. If the patient is not competent/or prefers not to give the SCIg themselves follow

steps 4 to 22.4. Ensure consistent practice with ACT Health Hand Hygiene practices.5. Ensure the patient has given informed consent to receiving SCIg.6. If using EMLA Cream apply 1 hour prior to infusion.7. Give pre-med if indicated.8. Allow SCIg to reach room temperature before opening.9. Check

a. Correct positive patient identification ( i.e. Ensure full name, DOB and Medical Record Number match the patient details on the product, Identification band and any accompanying documentation) ;

b. Ig solution is clear;c. Expiry date; andd. Batch number (attach batch number sticker to transfusion document supplied by

the laboratory or in patient diary).10. Remove plastic cover from the seal on the vial and wipe the exposed rubber stopper

with an alcohol swab and allow to dry.11. Draw up product using an interlink “needle” or a 19g bevelled edged needle into 10

or 20mL syringe/s depending on dose and number of infusion sites. 12. Connect syringe to infusion set/s, protecting any remaining filled syringes with red

combi stoppers.13. Prime line. (Keep 2cm air lock at end of line – dry needle insertion is optimal)14. If using an infusion pump –Load syringe into Pump Program Pump, connect to

infusion set and commence infusion. Check infusion set frequently through the infusion to see if it is still in place and the SCIg is being delivered.

15. If using slow manual push – connect to infusion set.16. Remove EMLA cream if applicable.17. Swab injection site on skin and allow to dry.18. Insert infusion set (“Butterfly”) Insert needle at 45° or 90° angle depending on body

size of client: 90° if obese; 45° if average weight (See figure 1), suitable Subcutaneous infusion sites can be seen at Figure 2.

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Figure 1 Figure 2

19. Pull back on syringe to ensure that you are not in a blood vessel, then detach butterfly from syringe and check for backflow, if blood appears in the device you must remove and replace the butterfly and reinsert.

20. If using an infusion pump –Load syringe into Pump. Program Pump and Connect to infusion set and commence infusion

21. If using slow manual push –commence infusion.22. Check infusion set frequently through the infusion to see if it is still in place and that

the SCIg is being delivered.23. When infusion complete remove infusion set and apply pressure with a cotton ball. 24. Dispose of infusion set in sharps container.25. Record infusion details in medical records and/or patient diary.

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Section 10 – Patient Monitoring and Adverse Reaction Management

ObservationsClose observation is required and the patient’s general status should be monitored regularly throughout the infusion. Observations must be recorded on the appropriate Modified Early Warning Score observation chart. Refer to Vital Signs and Early Warning Scores procedure.

Patient observations temperature, pulse, respiratory rate SpO2 Level of consciousness blood pressure and Observe cannulation site ( document in progress notes if any concerns)

Observation Frequency IVIg prior to infusion commencing 15 minutes for the first hour or prior to adjusting the rate of infusion hourly once maximum rate is achieved on completion of the infusion

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if patient experiences any new or increased symptoms

Observation Frequency SCIg (inpatients) prior to commencing infusion on completion of infusion

Management of adverse reactionSometimes adverse reactions occur to IVIg/SCIg. These can be dealt with in several ways, depending on the nature and severity of the reaction.

Options can include: No action. Mild reactions occur from time to time and seem to be batch specific. Change to another IVIg preparation. Premedicate, usually with a combination of antihistamines and/or glucocorticosteroids. The decision about the most appropriate course of action should be made based on the

individual patient, after discussions between nursing and medical staff in charge.

Adverse reactions may be caused by high infusion rates and can be minimised by slowing down the infusion rate or temporarily interrupting the infusion. These events usually occur during the first hour of infusion. Sometimes a premedication may be ordered prior to the commencement of the infusion.

Procedure Recognise React Report

Mild Document in patients clinical records

Notify ACT Pathology Transfusion Laboratory(02) 6244 2918 Canberra Hospital

(02) 6201 6270 Calvary HealthCare

Notify Transfusion NursePhone: (02) 6244 4092 business hoursOr email maria.burgess@act.gov.au

Report to Riskman

Complete product specific adverse reaction form

Malaise Monitor patient , reduce rateModerate Abdominal pain Headache Facial flushing or pallor Erythema Hot sensations Skin rash Pompholyx on hands and

palms (vesicular eczema) Nausea and vomiting

Stop infusion- assess patient

Check vital signs Medical officer review

Severe Dyspnoea Change in blood pressure Chest tightness

Aseptic meningitis syndrome

Thromboembolic events

Cease infusion- assess patient

Check vital signs MET

Note: HeadachesThe patient’s hydration status may affect the development of headaches; the patient should make sure he/she is adequately hydrated on the day of the infusion.

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Severe, persistent posterior occipital headaches may be a sign of aseptic meningitis, which has been reported in some patients after IVIG infusion. The symptoms may occur during the infusion, but more typically they usually develop within 24 hours of the infusion.

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Section 11 – Maximum Infusion Rates All 10% IVIg Products

The infusion calculator below is provided as a guide.

Note: The infusion rate needs to be individualised to the patient’s risk factors, co morbidities and tolerability.

It should be noted that when setting the initial infusion rate and the incremental rate escalations it is always important to consider a patients existing risk factors co morbidities, medical history (e.g. renal status, thromboembolic risk) and thus tolerability to receive a given volume load.

Where a patient has had prior adverse reactions to IVIg the prescriber may indicate a different infusion rate slower than these guidelines, on a patient specific basis. Where a decision has been made for a slower infusion rate this must be used in preference to the maximum rates in this procedure.

Patients Less than 10kg Note: In Paediatrics <10 kg, a weight-based formula should be used to determine the rate of administration.

Note: Subsequent bottles for all products can be administered at the rate of the previous bottle for the same admission.

0.5 or 1.0mL/kg for the first 30 minutes Check Vital Signsas a base line prior to commencing infusion Every 15 mins for the first hour then Hourly and at completion of dose

2mL/kg for the next 15 minutes4mL/kg for the next 15 minutes6mL/kg for the next 30 minutes7mL/kg for the remainder of the dose

Monitor the patient’s vital signs throughout the infusion. Slow or stop the infusion if adverse reactions occur. If symptoms subside promptly, the infusion may be resumed at a lower rate that is comfortable for the patient.

Titrate based on patient tolerability.

Patients >10kgInfusion Rate of Weight in Kg Observations

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Time (mins)

infusion(mL/Kg/hr) 10 15 20 25 30 35 40 50 60 70 80 90 100 Base line prior to

commencing infusionEvery 15 mins for the first hour then Hourlyand at completion of dose

First 30min0.5or 5 7.5 10 12.5 15 17.5 20 25 30 35 40 45 50

1.0 10 15 20 25 30 35 40 50 60 70 80 90 10030 - 45 2 20 30 40 50 60 70 80 100 120 140 160 180 20045 - 60 4 40 60 80 100 120 140 160 200 240 280 320 360 40060 - 90 6 60 90 120 150 180 210 240 300 360 420 480 540 60090 to remainder 7 70 105 140 175 210 245 280 350 420 490 560 630 700

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Section 12 – Product Storage Conditions

Product Storage Conditions IVIg Product Storage Conditions SCIg Privigen 10% CSL Behring

Flebogamma 10 %

(Lateral Grifols)

Intragam 10% CSL Behring Hizentra 20% Evogam 16%

Store below 25°C

Store below 30°C

Store at 2°C -8°C

Do not freeze.Once removed from refrigeration, store

below 25°C and use within 3 months.

Store below 25°C

Store at 2°C to 8°C.

Do not freeze.Once removed from refrigeration, store below 25°C and use

within 2 weeks.

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Section 13 – Contact Phone List

PHONE LISTHaematology Out Patient CNC 02 6244 48458Oncology Out Patient CNC 02 6244 8457SCIg Nurse 0466 487 701Transfusion Laboratory ACT Pathology The Canberra Hospital

02 6244 2918

Transfusion Laboratory ACT Pathology Calvary Hospital 02 6201 6274ARCBS Medical Officer Business Hours (BH) 02 9234 2262ARCBS Medical Officer After Hours (AH) 07 3838 9010Transfusion CNC CHHS 02 6244 4092

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Implementation

Local ward/ Unit Orientation Communication through ACT Health News HUB

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National Safety and Quality Health Service (NSQHS) CHHS SCOOP In-services to Clinical areas by Transfusion CNC/SCIg Nurse

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Related Policies, Procedures and Legislation

Procedures Healthcare Associated Infections Nursing and Midwifery Continuing Competence Procedure Vital Signs and Early Warning Scores Patient Identification and Procedure Matching Procedure

Policies Nursing and Midwifery Continuing Competence Policy Consent to Treatment Policy Patient Identification and Procedure Matching Policy

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References

1. CHHS Consent and Treatment Policy and Procedure 2. National Policy: Access to Government Funded Immunoglobulin Products in Australia

July 2016. Available at:https://www.blood.gov.au/system/files/2016-immunoglobulin-governance-national-policy-website.pdf Accessed 29/11/2017

3. Royal Children’s Hospital, Melbourne, Australia, Clinical Practice Guideline on Intravenous Immunoglobulin Guideline. Available at https://www.rch.org.au/bloodtrans/about_blood_products/Intravenous_Immunoglobulin_Guideline/ Accessed 29/11/2017

4. Intragam® 10 product informationhttps://www.blood.gov.au/system/files/Intragam10PI.v7-CMI.v7.PDF Accessed 29/11/2017

5. TGA Product and Consumer Medicine Information https://tga-search.clients.funnelback.com/s/search.html?query=&collection=tga-artg Accessed 29/11/2017

6. National Blood Authority. (Australia) Website: Available at http://www.nba.gov.au/Accessed 29/11/2017

7. Criteria for the Clinical Use of Intravenous Immunoglobulin in Australia edition 2012 Accessed 29/11/2017

8. Arch Dis Child Fetal Neonatal Ed 2003; 88:F6-F10 doi:10.1136/fn.88.1.F6: 9. Systematic review of intravenous immunoglobulin in haemolytic disease of the newborn,

2003, R Gottstein, R W I Cooke, and Alcock Gary S, Liley Helen.10. Immunoglobulin infusion for isoimmune haemolytic jaundice in neonates. Cochrane

Database of Systematic Reviews, 2002 NO: 3.

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11. Privigen Product informationhttps://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2014-PI-03170-1&d=2017112816114622483 Accessed 29/11/2017

12. BloodSTAR portal. Available at: https://auth.blood.gov.au/NBASTS/NBAFormsSignIn.aspx?ReturnUrl=%2fnbasts%2f%3fwa%3dwsignin1.0%26wtrealm%3dhttp%253a%252f%252fauth.blood.gov.au%252fadfs%252fservices%252ftrust%26wctx%3dd2081e17-af16-4a1d-a8e2-d34d037dca68%26wct%3d2017-03-21T13%253a02%253a08 Accessed 29/11/2017

13. IDF Guide for Nurses. Immunoglobulin Therapy for Primary Immunodeficiency Diseases Third Editionhttp://primaryimmune.org/wp-content/uploads/2015/11/IDF-Guide-for-Nurses-2013.pdf Accessed 29/11/2017

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Search Terms

Immunoglobulin, Intravenous Immunoglobulin, Subcutaneous Immunoglobulin, Normal Human Immunoglobulin, IVIg, SCIg, NHIg, IVIg Infusion Rates, Blood and Blood Products, Transfusion, BloodSTAR

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Attachments

Attachment A – A Training Checklist

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Disclaimer: This document has been developed by ACT Health, Canberra Hospital and Health Services specifically for its own use. Use of this document and any reliance on the information contained therein by any third party is at his or her own risk and Health Directorate assumes no responsibility whatsoever.

Policy Team ONLY to complete the following:Date Amended Section Amended Divisional Approval Final Approval 24/01/2018 Complete Review Jeffery Fletcher, CMA CHHS Policy Committee

This document supersedes the following: Document Number Document NameCHHS15/083 Immunoglobulin Authorisation and Administration Adults, Paediatrics and

Neonates

Doc Number Version Issued Review Date Area Responsible PageCHHS18/032 1 30/01/2018 01/02/2022 CMO 21 of 22

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Attachment A – A Training Checklist

Doc Number Version Issued Review Date Area Responsible PageCHHS18/032 1 30/01/2018 01/02/2022 CMO 22 of 22

Sample