clinical guideline use of biologic agents for the

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Clinical Guideline Use of biologic agents for the treatment of severe asthma in adult patients Version Number 1.0 Date written: 31 st March 2021 Date approved: 27 th April 20201 Date of next review: 31 st March 2023 Authors: Joanna Hutchison - Senior Respiratory Pharmacist Dr Devesh Dhasmana - Consultant Respiratory Physician Dr Patrick Liu - Consultant Respiratory Physician Lindsay Simmons - Respiratory Nurse Specialist Approval Group: Managed Service Drug and Therapeutics Committee

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Page 1: Clinical Guideline Use of biologic agents for the

Clinical Guideline

Use of biologic agents for the treatment of severe asthma in adult

patients

Version Number 1.0

Date written: 31st March 2021

Date approved: 27th April 20201

Date of next review: 31st March 2023

Authors: Joanna Hutchison - Senior Respiratory Pharmacist Dr Devesh Dhasmana - Consultant Respiratory Physician Dr Patrick Liu - Consultant Respiratory Physician Lindsay Simmons - Respiratory Nurse Specialist

Approval Group: Managed Service Drug and Therapeutics Committee

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Contents 1. Introduction ................................................................................................................................ 3

2. Biologics for severe asthma ........................................................................................................ 3

3. Biologics for the treatment of asthma in adults: treatment algorithm ...................................... 5

4. Cautions and contraindications .................................................................................................. 5

5. Adverse effects ........................................................................................................................... 6

6. Pregnancy .................................................................................................................................... 6

7. Breastfeeding .............................................................................................................................. 6

8. Immunisations............................................................................................................................. 7

9. Approval process ......................................................................................................................... 7

10. Prescribing (initial 16 weeks within secondary care outpatient setting) ................................ 7

11. Administration ........................................................................................................................ 8

12. Monitoring and management of allergic reactions ................................................................ 8

13. Clinical assessment ................................................................................................................. 8

14. References .............................................................................................................................. 9

Appendix 1-NHS Fife Severe Asthma Biologics Proforma ................................................................. 10

Appendix 2-NHS Fife Severe Asthma Biologics Pathway .................................................................. 12

Appendix 3- Mepolizumab self-administration training checklist .................................................... 13

Appendix 4- Omalizumab self-administration training checklist ...................................................... 14

Appendix 5-Benralizumab self-administration training checklist ..................................................... 15

Appendix 6-Mepolizumab self-administration patient information leaflet ..................................... 16

Appendix 7-Omalizumab self-administration patient information leaflet ....................................... 18

Appendix 8-Benralizumab self-administration patient information leaflet ..................................... 20

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1. Introduction The term severe asthma generally refers to a clinical situation where a prior diagnosis of asthma

exists, and asthma-like symptoms and asthma attacks persist despite prescription of high-dose

asthma therapy. In line with SIGN 158, for the purposes of this guidance difficult asthma in

adults is defined as persistent symptoms and/or frequent asthma attacks despite treatment with

high-dose inhaled corticosteroids (ICS) plus a long-acting beta-2-agonist (LABA) or leukotriene

receptor antagonist (LTRA); or medium-dose ICS plus a LABA or LTRA and an appropriate

additional therapy or continuous or frequent use of oral steroids1.

Patients with severe asthma should be assessed by a dedicated multidisciplinary severe asthma

service, by a team experienced in the assessment and management of severe asthma.

2. Biologics for severe asthma Several monoclonal antibodies or biologics are licensed for the treatment of severe asthma and

approved for use within NHS Fife.

Biologics for IgE-mediated severe allergic asthma

Omalizumab is a recombinant DNA-derived humanised monoclonal antibody that selectively

binds to human immunoglobulin E (IgE). Omalizumab prevents binding of IgE to receptors on

basophils and mast cells, thereby reducing the amount of free IgE that is available to trigger the

allergic cascade. Treatment with Xolair inhibits IgE-mediated inflammation, as evidenced by

reduced blood and tissue eosinophils and reduced inflammatory mediators, including IL-4, IL-5,

and IL-132,3.

Biologics for severe eosinophilic asthma

Mepolizumab and Benralizumab are humanised monoclonal antibodies. Interleukin-5 (IL-5) is

the main cytokine responsible for the growth and differentiation of eosinophils. Benralizumab

binds directly to IL-5 receptors expressed on the surface of eosinophils, resulting in apoptosis

and reducing eosinophilic inflammation4-5. Mepolizumab inhibits the bioactivity of IL-5 by

blocking the binding of IL-5 to the alpha chain of the IL-5 receptor complex expressed on the

eosinophil cell surface, thereby inhibiting IL-5 signalling and reducing the production and survival

of eosinophils6-7.

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Table 1: Summary of eligibility criteria (from product license, NHS Fife Formulary,

Scottish Medicines Consortium and NICE technology appraisal2-7

)

Omalizumab Mepolizumab Benralizumab

≥4 courses of prednisolone in the previous 12 months

OR

chronic daily OCS for previous 3-6months *

*6 months

continuous OCS

Serum eosinophils ≥150cells/microlitre

Total IgE between 30-1500 IU/L

Evidence of specific allergy (either positive skin prick test or raised specific-IgE to perennial allergen)

FEV1 < 80%

Frequent daytime symptoms or night time awakenings

High dose ICS +LABA (or alternative controller*)

*

Full trial of (and documented compliance with) high dose ICS, LABA, LRTA, theophyllines, oral corticosteroids and smoking cessation

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3. Biologics for the treatment of asthma in adults: treatment algorithm

4. Cautions and contraindications

The use of Omalizumab, Mepolizumab and Benralizumab is contraindicated in patients with

known hypersensitivity to active substance or any excipients.

Biologics should not be used to treat an acute asthma exacerbation

Abrupt discontinuation of corticosteroids after initiation of biologic therapy is not

recommended. Reduction in corticosteroid doses, if appropriate, should be gradual and

under medical supervision.

Patients with pre-existing helminth infections should be treated before initiating therapy

with a biologic. If patients become infected, while receiving treatment with a biologic and do

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not respond to anti-helminth treatment, biologic treatment should be discontinued until

infection resolves.

5. Adverse effects Common side effects include headache, pharyngitis, pyrexia, abdominal pain and local injection site

reactions eg. pain, erythema.

Hypersensitivity and anaphylactic reactions have been reported (refer to section 12).

Refer to the BNF or product summary of characteristics (available from: www.medicines.org.uk) for

a full list of adverse effects for each medication.

6. Pregnancy Mepolizumab and Benralizumab: There is a limited amount of data on use during pregnancy. Animal

studies do not indicate harmful effects. It is preferable to avoid treatment during pregnancy.

Administration should only be considered if the expected benefit for the mother is greater than any

possible risk to the foetus5,7.

Omalizumab: There is a moderate amount of data on use of Omalizumab in pregnant women which

indicates no malformative or foetal/neonatal toxicity. Animal studies indicate that omalizumab

crosses the placental barrier but there is no indication of direct or indirect harmful effects. If

clinically needed, the use of omalizumab can be considered in pregnancy2.

7. Breastfeeding Benralizumab: It is unknown whether Benralizumab or its metabolites are excreted in human or

animal milk. Risk to the breast-fed child cannot be excluded5,8.

Mepolizumab: There are no data regarding the excretion of Mepolizumab in human milk. However,

animal studies showed that mepolizumab was excreted into the milk at concentrations of less than

0.5% of those detected in plasma. A decision must be made whether to discontinue breast-feeding

or to discontinue mepolizumab therapy taking into account the benefit of breast-feeding for the

child and the benefit of therapy for the woman7,9.

Omalizumab: Immunoglobulins G (IgG) are present in human milk and therefore it is expected that

Omalizumab will be present in human milk. The EXPECT study, with 154 infants who had been

exposed to Xolair during pregnancy and through breast-feeding did not indicate adverse effects on

the breast-fed infant. The interpretation of data may be impacted due to methodological limitations

of the study, including small sample size and non-randomised design. Given orally, immunoglobulin

G proteins undergo intestinal proteolysis and have poor bioavailability. No effects on the breast-fed

newborns/infants are anticipated. Consequently, if clinically needed, the use of Xolair may be

considered during breast-feeding2,10

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8. Immunisations Patients with severe asthma are recommended to get the annual influenza vaccination. Patients

with severe asthma requiring continuous or multiple courses of corticosteroids (more than a month

at a dose equivalent to prednisolone at 20mg or more per day) should also considered

pneumococcal immunisation11.

Patients who have had a previous systemic allergic reaction to a biologic should not receive the

Pfizer COVID-19 vaccine due to the presence of polyethylene glycol which is a common component

and allergen in biologics12.

No additional immunisations are required due to use of biologic therapy in asthma.

9. Approval process Patients being considered for treatment with a biologic should be referred to the Severe Asthma

Multidisciplinary Team for review. The NHS Fife Severe Asthma MDT assessment proforma

(appendix 1) should be completed and submitted by email to [email protected].

Patients undergoing monoclonal antibody treatment should have their details entered onto the UK

Severe Asthma Registry. Local registers are kept of all patients started on treatment and of those

continuing treatment after 16 weeks; please contact Dr Dhasmana or Lindsay Simmonds for further

details.

10. Prescribing (initial 16 weeks within secondary care outpatient

setting) For patients receiving Omalizumab, the dose should be calculated based on weight and IgE in

accordance with the dosing table in the summary of product characteristics.

Mepolizumab and Benralizumab are fixed dose preparations.

Medication Route of

administration

Dose Frequency

Omalizumab Subcutaneous Dose based on IgE and weight. Refer to dosing table in summary of product characteristics

Every 2-4 weeks. Frequency based on IgE and weight. Refer dosing table in summary of product characteristics.

Mepolizumab Subcutaneous 100mg Every 4 weeks

Benralizumab Subcutaneous 30mg Every 4 weeks for the first 12 weeks then 8 weekly thereafter.

The biologic should be prescribed on a drug chart (kardex) via subcutaneous route on the once only

section for one dose and then the regular medication section thereafter.

The following as required medications should be prescribed on the chart in the event of allergic

reaction

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Paracetamol 1g oral 4-6 hourly max 4g/24 hours

Salbutamol 5mg nebulised

Ondansetron oral 4mg up to three times daily

Chlorphenamine 10mg IV stat max 40mg/24 hours

Hydrocortisone IV 100mg stat. Max 300mg/24 hours

11. Administration Patients considered eligible for treatment with a biologic by the MDT will be referred by the

respiratory nurse specialist (RNS) to an outpatient setting for administration for the first 16 weeks of

treatment initially. The initial appointment will be made by RNS but organised by the clinic

thereafter.

Patients should be encouraged, where possible, to complete self-administration training. This will

enable patients to continue to administer the biologic in the own home. The relevant self-

administration checklist (appendix 3 and 4) should be completed and filed in the patient’s notes.

Patients prescribed Mepolizumab and Omalizumab can be considered for medication supply via a

homecare company following the 16-week review. This service is not currently available for

Benralizumab within NHS Fife.

12. Monitoring and management of allergic reactions Facilities for the treatment of allergic reactions including anaphylaxis must be available for

immediate use. Type 1 local or systemic allergic reactions may occur. These reactions usually occur

within two hours of administration. Please refer to the NHS Fife Policy on Management of

Anaphylaxis for further details.

For patients with no previous history of anaphylaxis, the minimum waiting time after the first

injection should be two hours, after the second injection it should be 1 hour, and if no side effects

have been observed, the waiting time could be reduced to 30 minutes thereafter.

For the first dose, temperature, blood pressure, oxygen saturations should be recorded prior to

administration then every 15 minutes for one hour then half hourly for the second hour. This should

be recorded half hourly in further visits up to week 16 and any visits following this should the patient

not opt for self administration.

For patients with a history of anaphylaxis, the monitoring schedule should be adjusted for the

individual and specified by the responsible consultant.

13. Clinical assessment Patients will be assessed at the intervals specified in the severe asthma biologics pathway (appendix

2). Patients will be asked to complete Asthma Control Test (ACT) and Mini Asthma Quality of Life

Questionnaire (MiniAQLQ). Response to biologic treatment will be reviewed on an annual basis by

the severe asthma multidisciplinary team.

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14. References 1. SIGN 158 (2019). British guideline on management of asthma. Available at

https://www.sign.ac.uk/media/1773/sign158-updated.pdf

2. ELECTRONIC MEDICINES COMPENDIUM (EMC), 2020. Xolair 150 mg solution for injection in

pre-filled syringe– Summary of Product Characteristics. [online]. Available from:

https://www.medicines.org.uk/emc/product/4725/smpc [Accessed 10 February 2021].

3. NICE TA278 (2013). Omalizumab for treating severe persistent allergic asthma. Available at

https://www.nice.org.uk/guidance/ta278

4. SMC (2019). SMC medicines advice- benralizumab. Available at

https://www.scottishmedicines.org.uk/medicines-advice/benralizumab-fasenra-

fullsubmission-smc2155/

5. ELECTRONIC MEDICINES COMPENDIUM (EMC), 2019. Fasenra 30 mg solution for injection in

pre-filled pen– Summary of Product Characteristics. [online]. Available from:

https://www.medicines.org.uk/emc/product/10559/smpc [Accessed 10 February 2021].

6. SMC (2016). SMC medicines advice- mepolizumab. Available at

https://www.scottishmedicines.org.uk/medicines-advice/mepolizumab-nucala-

fullsubmission-114916/

7. ELECTRONIC MEDICINES COMPENDIUM (EMC), 2020. Nucala 100 mg solution for injection in

pre-filled pen– Summary of Product Characteristics. [online]. Available from:

https://www.medicines.org.uk/emc/product/10564/smpc [Accessed 10 February 2021].

8. Drug and Lactation Database (LACTMED). Benralizumab. Available at:

http://toxnet.nlm.nih.gov. Accessed Feb 2021.

9. Drug and Lactation Database (LACTMED). Mepolizumab. Available at:

http://toxnet.nlm.nih.gov. Accessed Feb 2021

10. Drug and Lactation Database (LACTMED). Omalizumab. Available at:

http://toxnet.nlm.nih.gov. Accessed Feb 2021.

11. Pneumococcal. Green Book Chapter 25: 2020. Available at:

https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/263318/G

reen-Book-Chapter-25-v5_2.pdf

12. Specialist Pharmacy Service (2021). Advising individuals with allergies on their suitability for

Pfizer-BioNTech COVID-19 Vaccine. Available at: https://www.sps.nhs.uk/articles/advising-

individuals-with-allergies-on-their-suitability-for-pfizer-biontech-covid-19-vaccine/ [Accessed

11/2/21]

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Appendix 1-NHS Fife Severe Asthma Biologics Proforma

NHS Fife Severe Asthma Biologics Proforma

Date of MDT:

Consultant:

Smoking: Never Ex- Current Weight: BMI:

Clinical History

Significant Co-morbidities:

Medications: Drug Route Dose Frequency

Drug / food allergies:

Any previous biologic for severe asthma:

Compliance satisfactory

Weight advice given

Good inhaler technique

Allergen exposure advice given

Self-management plan

Smoking cessation advice

Standard therapy optimised Hyperventilation /vocal cord dysfunction considered

Peak flow diary reviewed Psychological & social factors considered

PATIENT DETAILS / STICKER

Name:

CHI:

Age:

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Baseline Measurements

Mini-AQLQ (date)

Overall: Symptoms: Activities: Emotions: Environment:

Hospital admissions in previous year:

ACT No. of OCS courses in previous year

FEV1 (% pred) (date)

L (%) GP/OOH/A+E attendance in previous 3 months

FVC (% pred) (date)

L (%) Eosinophils (x109/L) (date)

FeNO Total IgE (Ku/L) (date) (omalizumab patients only)

ANCA

List of RAST (specific IgE) results

HRCT Thorax

MDT Outcome Record: Summary: Decision:

MDT Form completed by:

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Appendix 2-NHS Fife Severe Asthma Biologics Pathway

Pre-treatment

MDT discussion to start biologic therapy

Patient contacted post MDT by RNS

Severe asthma registry complete

Clinic date planned for first injection

Letter sent to patient’s GP

Week 1 First dose given in hospital, schedule next for fortnightly or 4 weekly depending on

dosage for weeks 4-16

Week 4 RNS review

Week 8 RNS review, patient starts self administration training

Week 12 RNS review, patient completes self administration training

Week 16 RNS review & discussion about homecare

QOL questionnaires (ACT and mini-AQLQ) completed by patient

Consultant review-to continue or cease treatment

Patients continuing via homecare:

Homecare registration form and 6 month prescription completed

Hospital outpatient prescription written for four week supply

Homecare charter and patient information leaflet sent to patient

Patients continuing via hospital outpatient

Hospital outpatient prescription written for 3 months duration dispense

monthly

Patients continuing via secondary care clinic

Ensure drug chart available

Week 26 6-month medical review

Week 39 RNS review. Ensure new homecare prescription is written

Week 52 12-month consultant medical review

MDT annual review for continuation or re-evaluation

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Appendix 3- Mepolizumab self-administration training checklist

Training Checklist for self injection of Mepolizumab

(Nucala®)

Patient’s name: ..........................................................................................................................

Trainer’s name: ..........................................................................................................................

Date Patient’s

Initials

Trainer’s

Initials

Has read and understands all information (Fife Self Administration of mepolizumab information leaflet, www.nucalapatient.co.uk, provide GSK

mepolizumab starter pack)

Discussion of potential side effects: headache, local injection site reactions, , hypersensitivity reactions, back pain abdominal pain, nasal congestion, lower respiratory tract infections

Understands mepolizumab storage information

Collecting and assembling of equipment

Preparation of work area

Hand washing

Checking and opening equipment

Rotation of injection site

Administration of Mepolizumab (see training video on www.nucalapatient.co.uk)

Disposal of injection and waste

Knows arrangements for future prescriptions

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Appendix 4- Omalizumab self-administration training checklist

Training Checklist for Self Injection of Omalizumab (Xolair®) Patient’s name: .......................................................................................................................... Trainer’s name: ..........................................................................................................................

Date Patient’s

Initials Trainer’s Initials

Has read and understands all information (Fife Self Administration of omalizumab information leaflet, Asthma UK website and Xolair® My Therapy application)

Discussion of potential side effects: anaphylaxis, injection site reaction, sinusitis, upper respiratory tract infection, headache, arthralgia

Understands omalizumab storage information

Collecting and assembling of equipment

Preparation of work area

Hand washing

Checking and opening equipment

Rotation of injection site

Administration of omalizumab (see Xolair® PIL or training video on My Therapy)

Disposal of injection and waste

Knows arrangements for future prescriptions

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Appendix 5-Benralizumab self-administration training checklist

Training checklist for self injection of benralizumab (Frasenra®) for severe asthma Patient’s name: .......................................................................................................................... Trainer’s name: ..........................................................................................................................

Date Patient’s

Initials Trainer’s Initials

Has read and understands all information (NHS Fife self administration of benralizumab information leaflet, provide AstraZeneca Benralizumab starter pack)

Discussion of potential side effects: headache, local injection site reactions, , hypersensitivity reactions, back pain abdominal pain, nasal congestion, lower respiratory tract infections

Understands benralizumab storage information

Collecting and assembling of equipment

Preparation of work area

Hand washing

Checking and opening equipment

Rotation of injection site

Administration of benralizumab (see training video on

https://www.connect360asthma.co.uk/360/help-with-self-injection

Disposal of injection and waste

Knows arrangements for future prescriptions Signature of patient / caregiver .......................................................................... Signature of trainer .............................................................................................. Date..................

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Appendix 6-Mepolizumab self-administration patient information leaflet

Self-injecting Mepolizumab at Home

About Mepolizumab injections

Mepolizumab is a monoclonal antibody, a type of protein designed to recognise a specific target substance in the body. It is used to treat severe asthma in adults, adolescents and children aged 6 years and older.

Some people with severe asthma have too many eosinophils (a type of white blood cell) in the blood and lungs. This condition is called eosinophilic asthma – the type of asthma mepolizumab can treat.

Mepolizumab can reduce your number of asthma attacks and can also help reduce the daily dose of oral corticosteroid you need to control your asthma. Many people who take mepolizumab for asthma are helped by it and have few side-effects.

This leaflet will tell you about injecting Mepolizumab at home. When injecting Mepolizumab there are certain rules regarding how to inject and how to deal with waste. This leaflet tells you the:

• procedure for injecting Mepolizumab

• arrangements for supply and storage of the pre-filled pen

• disposal of waste.

Learning to self-inject

The respiratory nurse specialists at the Victoria Hospital will teach you the procedure for injecting mepolizumab and will watch you self-injecting until you feel confident and happy to do this at home. There is a patient information leaflet provided with each pre-filled pen, detailing the steps to follow to administer mepolizumab. Additional information including training videos can also be found at www.nucalapatient.co.uk How to obtain your medication

Mepolizumab injections are supplied in a ‘pre-loaded form’ which means the solution is already in the pen. The Respiratory Department will prescribe these injections. Initially you will pick them up from hospital pharmacy. Following your 16-week review, you can chose to register with a homecare company who deliver the omalizumab directly to your home or chosen address.

Storing your Mepolizumab

All medications should be kept out of reach of children. You should store mepolizumab pre-filled pens in a fridge at a temperature of 2-8°C and in the original packaging to protect from light. Once the pre-filled pen is removed from the original pack, it must be administered within eight hours.

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If necessary, the mepolizumab pre-filled pen can be removed from the refrigerator and kept in the unopened pack for up to seven days at room temperature, but any longer than this and you need to dispose of the medication. Obtaining other supplies

Please contact your community pharmacy to arrange exchange of a sharps bin for used pens. Each pre-filled pen should only be used once and then discarded. When these are ¾ full, return to the community pharmacy and exchange for a replacement. When homecare is in place your sharps bin will be supplied and picked up by the homecare company. Used pens should be kept out of reach of children.

Further Information If you have any questions please contact your respiratory nurse specialist via telephone (01592 643355 ext: 24237).

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Appendix 7-Omalizumab self-administration patient information leaflet

Self-injecting Omalizumab at Home

(Xolair®)

About Omalizumab injections

Omalizumab is a monoclonal antibody, a type of protein designed to recognise a specific target substance in the body. It is used to treat severe allergic asthma in adults, adolescents and children aged 6 years and older.

Omalizumab works by blocking a substance called immunoglobulin E (IgE), which is produced by the body. IgE plays a key role in causing allergic asthma.

Omalizumab can reduce your number of asthma attacks and can also help reduce the daily dose of oral corticosteroid you need to control your asthma. Many people who take omalizumab for asthma are helped by it and have few side-effects.

This leaflet will tell you about injecting omalizumab at home. When injecting omalizumab there are certain rules regarding how to inject and how to deal with waste. This leaflet tells you the:

• procedure for injecting omalizumab

• arrangements for supply and storage of the pre-filled syringe.

• disposal of waste.

Learning to self-inject

The respiratory nurse specialists at the Victoria Hospital will teach you the procedure for injecting omalizumab and will watch you self-injecting until you feel confident and happy to do this at home. There is a patient information leaflet provided with each pre-filled syringe, detailing the steps to follow to administer omalizumab. A training video is also available on the Xolair® My Therapy app. How to obtain your medication

Omalizumab injections are supplied in a ‘pre-loaded form’ which means the solution is already in the syringe. The Respiratory Department will prescribe these injections. Initially you will pick them up from hospital pharmacy. Following your 16-week review, you can chose to register with a homecare company who deliver the omalizumab directly to your home or chosen address.

Storing your omalizumab

All medicines should be kept out of reach from children. You should store omalizumab syringes in a fridge at a temperature of 2-8°C. You can keep omalizumab for a total of four hours at 25°C but any longer and you need to throw it away. Please store the omalizumab in the original package to protect it from light.

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Obtaining other supplies

Please contact your community pharmacy to arrange exchange of a sharps bin for used syringes. Each pre-filled syringe should only be used once and then discarded. When these are ¾ full, return to the community pharmacy and exchange for a replacement. When homecare is in place your sharps bin will be supplied and picked up by the homecare company. Used syringes should be kept out of reach of children.

Further Information If you have any questions please contact your respiratory nurse specialist via telephone (01592 643355 ext: 24237).

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Appendix 8-Benralizumab self-administration patient information leaflet

Self-injecting Benralizumab at Home

About Benralizumab injections

Benralizumab is a monoclonal antibody, a type of protein designed to recognise a specific target substance in the body. It is used to treat severe asthma in adults.

Some people with severe asthma have too many eosinophils (a type of white blood cell) in the blood and lungs. This condition is called eosinophilic asthma – the type of asthma benralizumab can treat.

Benralizumab can reduce your number of asthma attacks and can also help reduce the daily dose of oral corticosteroid you need to control your asthma. Many people who take benralizumab for asthma are helped by it and have few side-effects.

This leaflet will tell you about injecting benralizumab at home. When injecting benralizumab there are certain rules regarding how to inject and how to deal with waste. This leaflet tells you the:

• procedure for injecting benralizumab

• arrangements for supply and storage of the pre-filled pen or pre-filled syringe

• disposal of waste.

Learning to self-inject

The respiratory nurse specialists at the Victoria Hospital will teach you the procedure for injecting benralizumab and will watch you self-injecting until you feel confident and happy to do this at home. There is a patient information leaflet provided with each pre-filled pen, detailing the steps to follow to administer benralizumab. Additional information including

training videos can also be found at https://www.connect360asthma.co.uk/360/help-with-self-injection

How to obtain your medication

Benralizumab injections are supplied in a ‘pre-loaded form’ which means the solution is already in the pen or syringe. The Respiratory Department will prescribe these injections. Initially you will pick them up from hospital pharmacy.

Storing your benralizumab

All medications should be kept out of reach of children. You should store benralizumab pre-filled pens in a fridge at a temperature of 2-8°C and in the original packaging to protect from light.

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If necessary, the benralizumab pre-filled pen can be removed from the refrigerator and kept in the unopened pack for up to fourteen days at room temperature, but any longer than this and you need to dispose of the medication. Obtaining other supplies

Please contact your community pharmacy to arrange exchange of a sharps bin for used injections. Each pre-filled device should only be used once and then discarded. When these are ¾ full, return to the community pharmacy and exchange for a replacement. Used pens should be kept out of reach of children.

Further Information If you have any questions please contact your respiratory nurse specialist via telephone (01592 643355 ext: 24237).