Subcutaneous and sublingual immunotherapy in adults and ...



Canberra Hospital and Health ServicesClinical ProcedureSubcutaneous and sublingual immunotherapy in adults and childrenContents TOC \h \z \t "Heading 1,1,Heading 2,2" Contents PAGEREF _Toc506453761 \h 1Purpose PAGEREF _Toc506453762 \h 2Alerts PAGEREF _Toc506453763 \h 2Scope PAGEREF _Toc506453764 \h 2Section 1 – Subcutaneous Bee Venom Immunotherapy – Rush Protocol PAGEREF _Toc506453765 \h 2Section 2 – Subcutaneous Bee Venom Immunotherapy – Weekly Protocol PAGEREF _Toc506453766 \h 7Section 3 – Subcutaneous Aeroallergen Immunotherapy – Initiation and Maintenance PAGEREF _Toc506453767 \h 8Section 4– Sublingual Aeroallergen Immunotherapy - Initiation PAGEREF _Toc506453768 \h 11Implementation PAGEREF _Toc506453769 \h 13Related Policies, Procedures, Guidelines and Legislation PAGEREF _Toc506453770 \h 13References PAGEREF _Toc506453771 \h 14Search Terms PAGEREF _Toc506453772 \h 14Attachments PAGEREF _Toc506453773 \h 14Attachment 1: Immunology Department guidelines for treatment of allergy and anaphylaxis during immunological testing and procedures. PAGEREF _Toc506453774 \h 15PurposeThe purpose of this document is to describe the procedures for safe and effective administration of subcutaneous and sublingual immunotherapy within Canberra Hospital and Health Services (CHHS).Back to Table of ContentsAlertsAdministration of subcutaneous and sublingual immunotherapy should only be done by trained staff. It can be administered by trained nursing staff under medical supervision.In Canberra Region Cancer Centre (CRCC) for Levels 2 and 4, nebulisation therapy should be undertaken in a negative pressure room to prevent the spread of airborne infection to hospital staff and patients. If a negative pressure room is unavailable a single room should be used. Back to Table of ContentsScopeThis document pertains to:Initiation and maintenance of subcutaneous immunotherapy for aeroallergens and venom in both children and adults at CHHSInitiation of sublingual immunotherapy (both as drops or tablets) in both children and adults at Canberra HospitalThis document applies to staff working within their scope of practice:Clinical Immunologists and Clinical Immunology registrarsClinical Immunology nurses and Student Nurses working under direct supervisionNurses in the paediatric day stay area and supervised by the Clinical Immunologists or their registrarsBack to Table of ContentsSection 1 – Subcutaneous Bee Venom Immunotherapy – Rush ProtocolPatient selection:Patient selection is determined by the Immunology Consultants and is based upon:The nature of the reaction to venomAny concurrent medical problems, andThe results of blood or skin tests to venom.Patients need to be advised of the need for regular visits, the possible side effects of the treatment and how to recognise these symptoms so that the most appropriate help can be sought if any side effects occur. Patients will usually have a basal serum tryptase measured during their initial evaluation. Patients with clonal mast cell disease are more likely to have venom anaphylaxis and patients with elevated basal mast cell tryptase are more likely to have reactions while receiving specific immunotherapy to bee venom, with the potential for more severe reactions (1).Despite this, venom immunotherapy is highly recommended for patients with mastocytosis or isolated elevation of their tryptase, as they are at higher risk if immunotherapy is not performed. While on immunotherapy most are protected from further sting reactions and it is recommended that venom immunotherapy continue for life in these patients (2).Contraindications:There are no absolute contraindications to venom immunotherapy. It is preferable to switch patients on beta-blockers or ACE inhibitors to alternate antihypertensive agents, but studies have shown that even in patients in which this switch cannot occur, in some cases the risk benefit ratio to the patient is in favour of immunotherapy with these concurrent medications (1).There is no evidence that angiotensin receptor blockers are associated with greater risk of anaphylaxis during immunotherapy (1).Pregnancy – immunotherapy is not commenced in patients who are pregnant, but it can be continued in patients who fall pregnant as long as no further dose escalation is carried out. Some patients may decide to stop their immunotherapy when they fall pregnant and will then need to start again from the beginning at a later date. Current recommendations are that immunotherapy which is still in the up-dosing phase and therefore unlikely to be efficacious if continued at the current dose, be stopped and immunotherapy reconsidered after pregnancy (1).EquipmentAdrenaline injection 1mg/1mL ampoules Oxygen and maskCetirizine 10mg tablets or Fexofenadine 180mg tabletsIntravenous and topical preparations of hydrocortisone (hydrocortisone cream (1%), vials (100mg for Intravenous use))Intravenous fluids – Sodium Chloride 0.9% normal saline and giving setNebulising mask2 boxes of appropriate venom should be available for the patientProcedure Subcutaneous rush venom desensitisation takes place in the High Dependency Unit (HDU) with emergency resuscitation equipment available. The patient should be advised to start a daily non-sedating anti-histamine 3 days prior to rush immunotherapy and to take a dose each morning before coming to the hospital.The use of non-sedating antihistamines has been shown to decrease the side effects of venom immunotherapy particularly the number of cutaneous side effects (3), without changing the efficacy of immunotherapy. This advice is sent to the patient in our information and booking time notification letter.Reconstitution of Albey Venom Immunotherapy KitReconstitution should be performed by the registrar and a registered nurse on the day immunotherapy is due to take place. Instructions for reconstitution are given below:Add 5.5mL of diluent to the large vial containing the freeze dried venom, to make a concentration of 100 microgram/mL. Label this vial “Vial 4 -100 microgram/mL”.Take 0.2mL from Vial 4 and dilute in a new vial with 1.8mL of diluent, to make a concentration of 10 microgram/mL. Label this vial “Vial 3 – 10 microgram/mL”.Take 0.2mL from Vial 3 and dilute in a new vial with 1.8mL of diluent, to make a concentration of 1 microgram/mL. Label this vial “Vial 2 – 1 microgram/mL”.Take 0.2mL from Vial 2 and dilute in a new vial with 1.8mL of diluent to make a concentration of 0.1 microgram/mL. Label this vial “Vial 1 – 0.1 microgram/mL”.Label each vial with the appropriate use by date. Further dilutions can be made as needed for skin prick testing or intradermal testing after consultation with the admitting Consultant. The final reconstituted vials are therefore as follows: (the appropriate venom name can be inserted in the table below)Rush Venom Dosing ProtocolDosing: Dosing will be performed over three consecutive days unless specified otherwise by the Consultant and is given as per the protocol below taken directly from reference (4).AdministrationThe appropriate dose is drawn up (usually by the nursing staff), after gently inverting the bottle to ensure equal distribution of venom, using a 1mL disposable graduated syringe with a 26 gauge needle.The dose must be checked with another member of the nursing staff or attending doctor.The injection is given subcutaneously in the posterior aspect of the middle third of the arm (in the fat pad between the deltoid and triceps). First clean the area with an alcohol swab.The plunger is withdrawn prior to injection.If blood appears, a new injection site must be found.If no blood appears, slowly inject the antigen, withdraw the needle and apply pressure to the area for 15-20 seconds. Do not massage the area. Injection sites are alternated between arms from dose to dose. The injection must be given subcutaneously, and not intramuscularly.At 20 minutes, the injection site is checked and the size of any local reaction noted. If the previous does is tolerated, sequential doses are administered every 20 minutes. Subsequent doses may be modified by the presence of local reactions – a wheal greater than 5 mm and a flare greater than 5cm should be discussed with the consultant before further doses are given. Large local reactions may require cessation of immunotherapy. Treatment of large localised reactions should include application of a cold pack to the area in addition to pharmacological measures such as antihistamine treatment.Systemic reactions require treatment as per Section 3 in the Management of Anaphylaxis in Adults and Children Clinical Guideline located on the Policy Register, and Immunology Department Guidelines for treatment of Allergic reactions and Anaphylaxis (Attachment 1).No further venom desensitization is given on this day. Further desensitization for this patient will be decided by the consultant. All systemic reactions should be documented in the patient file. Prior to DischargeThe patient should be advised about the possibility of a delayed hypersensitivity reaction and given instructions to follow (including a person to contact) should they experience a reaction. Patients should be picked up by, and stay with an adult after each day of rush venom therapy.If the patient reaches a maintenance dose of venom during the three day rush protocol, they should be booked in for a further maintenance dose of 100 microgram of venom on level 4 of Building 19 the following week. If this is tolerated, they are booked in with 2 weeks, 3 weeks and 4 weeks between injections.If these doses are tolerated the patient will be discharged to the GP for the following maintenance doses:Year 1100g (micrograms) every 4 weeksYear 2100g (micrograms) every 6 weeksYear 3100g (micrograms) every 8 weeksYear 4100g (micrograms) every 12 weeksYear 5 100g (micrograms) every 12 weeksWhile the patient continues on immunotherapy they should be reviewed at the hospital clinic at least every 12 months.If the patient does not reach a maintenance dose of venom during the three day rush protocol they should be booked in for further weekly doses of venom in the level 4 treatment area of Building 19 and doses administered as per “Section 2- Subcutaneous bee venom immunotherapy – weekly protocol.”Back to Table of Contents Section 2 – Subcutaneous Bee Venom Immunotherapy – Weekly ProtocolSee Section 1 – Subcutaneous Bee Venom Immunotherapy – Rush Protocol for Patient Selection, Contraindications and EquipmentProcedure Subcutaneous weekly venom desensitisation takes place in the treatment area on level 4 of Building 19 with emergency resuscitation equipment available. Procedure for subcutaneous injection is as per Section 1. The patient is asked to take a non-sedating antihistamine 30 minutes prior to their injection appointment.Reconstitution of Albey Venom Immunotherapy KitReconstitution should be performed as outline in Section 1 aboveDosing: Dosing will be performed weekly unless specified otherwise by the Consultant and is given as per the protocol below (4)Weekly Venom Dosing ProtocolWeekDose microgramVialVial concentration microgram/mLVolume mLSite10.0110.10.120.1210.130.3210.3413100.1513100.1633100.3753100.581041000.192041000.2103541000.35115041000.5126541000.65138041000.814100410011510041001171004100120100410012410041001Administration: See Section 1 above.Any systemic side effects and large local reactions will be treated as per Section 3 in the Management of Anaphylaxis in Adults and Children Clinical Guideline located on the Policy Register and Immunology Department Guidelines for treatment of Allergic reactions and Anaphylaxis (Attachment 1)Prior to DischargeThe patient should be advised about the possibility of a delayed hypersensitivity reaction and given instructions to follow (including a person to contact) should they experience a reaction. Patients should be picked up by, and stay with an adult after each day of rush venom therapy.If these doses are tolerated the patient will be discharged to the GP for the following maintenance doses:Year 1 100g (micrograms) every 4 weeksYear 2100g (micrograms) every 6 weeksYear 3100g (micrograms) every 8 weeksYear 4100g (micrograms) every 12 weeksYear 5 100g (micrograms) every 12 weeksWhile the patient continues on immunotherapy they should be reviewed at the hospital clinic at least every 12 months.Back to Table of Contents Section 3 – Subcutaneous Aeroallergen Immunotherapy – Initiation and MaintenancePatient selection:Patient selection is determined by the Immunology Consultants and is based upon (1):the duration and severity of symptomsthe number of sensitisationsany concurrent medical problemsthe outcome of any allergen avoidance measuresthe (lack of) benefit of any medical therapiesPatients need to be advised of the cost of the treatment (not PBS funded), and the requirement for regular visits and need to understand the possible side effects of the treatment, and how to access appropriate help if any side effects occur.Contraindications:Patients on beta-blockers: these medications should ideally be switched to another class of antihypertensive medications prior to commencement of immunotherapy (1).Concomitant severe medical conditions such as coronary artery disease or severe asthma that may reduce the patient’s ability to survive a serious allergic reaction (1).Pregnancy: immunotherapy is not commenced in patients who are pregnant, but it can be continued in patients who fall pregnant as long as no further dose escalation is carried out. Some patients may decide to stop their immunotherapy when they fall pregnant and will then need to start again from the beginning at a later date (1).Allergen orders:Allergens for subcutaneous immunotherapy can take up to 3 months to arrive after the order has been placed. Allergen orders for initiation (completed by consultant or advanced trainee registrar) are organised by the nurses and delivered to Level 2 of Building 19. The initial immunotherapy kit is usually funded by the hospital. The responsibility for the ordering is transferred to the GP and patient, when the patient is on maintenance dosing and receives the immunotherapy with their GP, and funded by the patient. The GP and patient will receive a copy of the standard order form and the kits will be delivered to the GP practice.The total cost of the immunotherapy is discussed with the patient (and provided to the patient in the form of an information sheet), and the patient agrees to fund their treatment before the first kit is ordered. The supervising Immunologist will review stable patients on a yearly basis while they continue with specific mencement:Immunotherapy for some aeroallergens can be started at any time of the year while others need to start at specific times. Patients having desensitisation for grass pollens need to start approximately three months before the next grass pollen season in September. To start immunotherapy, patients need to be booked into the Friday morning Immunotherapy clinic. This is organised at the monthly Allergy Challenge meetings. Patients will then be notified of their appointment time and told to take an antihistamine prior to coming to the clinic (see Injections, below). Aeroallergen immunotherapy patients have their immunotherapy in the clinic area on Level 2 of Building 19.Consent to commence immunotherapy must be obtained from the patient at the first visit and the patient reviewed with respect to suitability – see notes about circumstances in which immunotherapy should not be given (section on Patient selection). Patient education is given at this time to explain the importance of maintaining the schedule of injections and what they should do if they are ill. Education is also given about recognition of possible side effects of therapy.Administration:Subcutaneous aeroallergen desensitisation takes place in the clinic area of Level 2 of Building 19 or in the Paediatric Day Stay area (Building 11) with emergency resuscitation equipment available. The following equipment should be available:Equipment Adrenaline injection 1mg/1mL ampoules Oxygen and maskCetirizine 10mg tablets/ Fexofenadine 180mg tablets (or suitable forms of paediatric non-sedating antihistamine)Intravenous and topical preparations of hydrocortisone (hydrocortisone cream (1%), vials (100mg for Intravenous use))Intravenous fluids – normal saline and giving setNebulising maskAn initiation kit of subcutaneous immunotherapyProcedure InjectionsAllergy injections are initiated at a very low dose. The dose is gradually increased on a weekly basis until a maintenance dose is reached according to the manufacturer’s protocol. Patients will be reviewed by the Immunology Consultant or Senior Registrar at each visit to determine the safety of immunotherapy being given on this day and to chart the appropriate immunotherapy dose on a hospital medication chart. The dose depends upon the patient’s response to the previous dose, and any illness or delay to previous doses. Prior to this review, the patient’s observations, peak flow and weight will be recorded in their notes.Patients should take a non-sedating antihistamine on the day of their immunotherapy injection 20-30 min before they are due to have their injection. If they have not done so, an antihistamine is given at the clinic and their therapy delayed for 30 min. DosingDoses of subcutaneous immunotherapy are usually increased according to the protocol but a number of things are taken into consideration by the prescribing doctor when deciding on the next dose. The size of the local reaction after the last doseAny recent illnesses or increase in allergic symptomsCommencement of a new bottle of immunotherapy – this may be accompanied by a dose reductionOnce the appropriate dose is charted:The allergen extract is checked. Allergen extracts should be kept at 4°C and the expiry date should be checked. They should be inverted before use to ensure even distribution of antigen.the appropriate dose is then drawn up (usually by the nursing staff) in a 1mL disposable graduated syringe with a 26-29 gauge needle (preferably a BD Safety glide insulin syringe) and checked with another member of the nursing staff or attending doctorthe injection is given subcutaneously in the posterior aspect of the middle third of the arm after the area is cleaned with an alcohol swabThe plunger is withdrawn prior to injection. If blood appears a new injection site must be found. If no blood appears, slowly inject the antigen, withdraw the needle and apply pressure to the area for 15-20 seconds. Do not massage the area. Injection sites are usually alternated between arms from week to week. The patient is then observed in the immunotherapy patient waiting area opposite the nurses’ room on Level 2 of Building 19 (or in the Paediatric Day Stay area, Building 11) for at least 30 minutes after their injection. Some patients may need to stay for an hour or longer, if they have had delayed reactions to injections in the past. The requirement for the patient to stay for longer is at the discretion of the treating doctor and should be recorded in the notes.At 30 minutes, the injection site is checked and the size of any local reaction noted. A distinction needs to be made between an erythematous lump and a wheal. A local reaction with a wheal is more significant. If the wheal has pseudopods or surrounding hives, the prescribing doctor needs to be informed. Patients with asthma may need to be observed for up to 60 minutes after administration of their immunotherapy.Any systemic side effects and large local reactions will be treated as per Section 3 in the Management of Anaphylaxis in Adults and Children Clinical Guideline located on the Policy Register and Immunology Department Guidelines for treatment of Allergic reactions and Anaphylaxis (Attachment 1)Discharge to GPOnce the patient reaches maintenance dosing, they will be discharged to their GP for further injections.The following information is given to their GP at discharge:ASCIA Immunotherapy information sheet – which outlines contraindications to immunotherapy and guidelines for dose reduction if required – taken to the GP by the patient together with any therapy.A letter specifying the allergen and dose and instructions about obtaining further allergen – taken to the GP by the patient and also sent directly.Back to Table of ContentsSection 4– Sublingual Aeroallergen Immunotherapy - InitiationPatient selection:See Section 3 aboveContraindications:See Section 3 aboveAllergen orders:Sublingual immunotherapy can be given in the form of drops or dispersible tablets. Tablet immunotherapy is TGA registered and should be obtained by the patient at a community pharmacy using a script provided by the Clinical immunologist or immunology registrar.To obtain “Drop” immunotherapy an order form is sent to the relevant company (organised by the immunology nursing staff) and it will be delivered to Level 2 of Building 19. Please note this form of sublingual immunotherapy can take up to 3 months to arrive after it is ordered. After the first kit has been ordered and tolerated, the patient will be responsible for ordering all further kits at their own expense.Stable patients are reviewed on a 3-6 monthly basis by the supervising Immunologist while they continue with specific immunotherapy to obtain further scripts (for tablet immunotherapy) and for review.Sublingual immunotherapy is self-administered by the patient or family/carer in the home environment. However, the first dose of immunotherapy must be given in hospital and the procedure of initial of sublingual immunotherapy is outlined here.Patients will be notified of their appointment time and told to take a non-sedating antihistamine 20-30 min prior to coming to the clinic. This is usually done by the nursing staff or supervising immunologist).Consent to commence immunotherapy is obtained from the patient (or parent/guardian) at this visit and the patient reviewed with respect to ongoing suitability for immunotherapy – see notes about circumstances in which immunotherapy should not be given (Patient selection).Patient education is given at this time to explain the importance of maintaining the schedule of doses and what they should do if they are ill. Education is also given about recognition of possible side effects of therapy and what to do in such cases.Administration:Sublingual immunotherapy is commenced in the clinic area on Level 2 of Building 19 or in the paediatric immunology clinic (Building 11) with emergency resuscitation equipment available. The following equipment should be available:Equipment Adrenaline injection 1mg/1mL ampoules Oxygen and maskCetirizine 10mg tablets/ Fexofenadine 180mg tablets/ Suitable paediatric formulations of non-sedating anti-histaminesIntravenous and topical preparations of hydrocortisone (hydrocortisone cream (1%), vials (100mg for Intravenous use))Intravenous fluids – normal saline and giving setNebulising maskAn initiation kit of subcutaneous immunotherapyThe patient administers the sublingual immunotherapy under the supervision of the Immunology nurses. The patient administers the sublingual immunotherapy according to the manufacturer’s instructions and is directly observed for 5-10 minutes. The patient then waits for a further 20-25 minutes in the Immunotherapy waiting area.After 30 minutes the patient is formally reviewed and asked about any side effects. If there are none, they are discharged home to continue their immunotherapy. If there have been side effects noted, the patient is reviewed by the Clinical Immunologist to decide if sublingual immunotherapy should proceed.Any systemic side effects and large local reactions will be treated as per Section 3 in the Management of Anaphylaxis in Adults and Children Clinical Guideline located on the Policy Register and Immunology Department Guidelines for treatment of Allergic reactions and Anaphylaxis (Attachment 1)A letter is prepared for the patient’s GP to outline the treatment they have commenced.Back to Table of ContentsImplementation This procedure outlines the procedures already occurring for the safe administration of Immunotherapy. The updated guidelines will be distributed to all staff it pertains to and will be discussed at the weekly Immunology Department meeting as well as the monthly Allergy meeting.Back to Table of ContentsRelated Policies, Procedures, Guidelines and LegislationPoliciesHealth Directorate Nursing and Midwifery Continuing Competence PolicyConsent and TreatmentProceduresCHHS Healthcare Associated Infections Clinical ProcedureCHHS Patient Identification and Procedure Matching PolicyCHHS Management of Anaphylaxis in Adults and Children Clinical GuidelineCHHS Adult Nebulisation TherapyGuidelines LegislationHealth Records (Privacy and Access) Act 1997Human Rights Act 2004Work Health and Safety Act 2011Back to Table of ContentsReferencesCox L et al, (2011) Allergen immunotherapy: A practice parameter third update, JACI, 127:S1-S55Bonadonna P et al (2010) Mastocytosis and insect venom allergy. Current Opinion in Allergy and Clinical Immunology, 10:347-353Mueller et al (2008) Clinical and immunological effects of H1 antihistamine preventative medication during honeybee venom immunotherapy. JACI, 122:1001-1007Patterson’s allergic diseases, 2009, 7th Edition, Leslie C Grammar and Paul A Greenberger, page 225Back to Table of ContentsSearch Terms Immunotherapy, Desensitisation, Aeroallergen, Venom, Desensitization, AllergenBack to Table of ContentsAttachmentsAttachment 1: Immunology Department guidelines for treatment of allergy and anaphylaxis during immunological testing and procedures.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 AmendedSection AmendedDivisional ApprovalFinal Approval 24/01/2018Complete ReviewED CACHSCHHS Policy CommitteeThis document supersedes the following: Document NumberDocument NameCHHS13/290Allergen desensitisation - rush venom ( Adult )CHHS13/290Allergen desensitisation - subcutaneous aeroallergens ( Adult )CHHS13/290Allergen desensitisation - weekly venom ( Adult )Attachment 1: Immunology Department guidelines for treatment of allergy and anaphylaxis during immunological testing and procedures.Criteria for termination of the procedure:Patient develops urticaria OR oromucosal angioedema OR generalised erythema OR persistent cough OR wheeze OR rhinorrhoea and nasal stuffiness OR ocular tearing and conjunctival erythemaPeak expiratory flow rate (PEFR; best of three attempts) drops by ≥ 20%Systolic OR diastolic blood pressure drops by ≥15-20mmHgReaction GradeDefined byTreatment GuideS SubjectiveSymptoms only – lack of objective featuresObserve. Check all vital signs including blood pressure, peak flow.1 MildAny of urticaria, periorbital oedema, rhinorrhoea, nasal stuffiness.Observe, give antihistamine as charted and call Medical Officer (MO).1 + AAs above plus tongue/throat angioedema (AE)Give IM adrenaline, call MET, call MO2 ModerateAs above PLUS ANY OF :difficulty talkinghoarse voicedyspnoea,stridor,wheeze,persistent cough,nausea,vomiting,dizziness (pre-syncope),diaphoresis,chest or throat tightness orabdominal pain.Give IM adrenaline, call MET, call MO, add salbutamol if wheeze, plus adrenaline nebuliser if stridor. LIE FLAT, if tolerated and check/secure iv access3 SevereUNDER ANY CIRCUMSTANCES:PEFR drops ≥ 20% from baseline ORSp02 ≤ 92% at any stage ORcyanosis ORhypotension (BP drop > 15-20mmHg from baseline) WHETHER OR NOT there are any of the above skin features.Hypotension and/or hypoxia may be manifested as a pale/floppy child, confusion, collapse, unconsciousness or incontinence.As above, + 20mL/kg normal saline stat (under pressure) if hypotensive. ................
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