Prescribing information

 

Dosing and administration instructions for Xolair in CSU.

  • Recommended dose is 300 mg by subcutaneous injection every 4 weeks1
  • Xolair 300 mg comes as two pre-filled syringes (2 x 150 mg solution)1

Treatment should be initiated by physicians experienced in the diagnosis and treatment of CSU. Prescribers are advised to periodically reassess the need for continued therapy. Clinical trial experience of long-term treatment beyond 6 months in this indication is limited.

Retreatment guidance

NICE states that treatment is only restarted if the condition comes back.2 It is important to monitor patients post treatment to identify and restart those who are relapsing.

In the original model, before consultation ‘relapse’ was defined as moderate or severe urticaria (UAS7 of 16 or more) after a previous response.2

Self-administration1

Xolair can be self-administered by the patient (or injected by a caregiver) with no known history of anaphylaxis from the fourth dose onwards, if a physician determines this is appropriate.

First 3 doses must be administered by or under the supervision of a healthcare professional.

Patient or caregiver must be trained in correct injection technique and recognition of early signs and symptoms of serious allergic reactions.

This guidance has been co-created by an expert steering committee and funded by Novartis to help you select and train appropriate CSU patients and establish a working self-administration protocol for your clinic.

Dr Sinisa Savic
Consultant in Clinical Immunology and Allergy, Leeds Teaching Hospitals

Dr Chris Rutkowski
Clinical & Service Lead for Adult Allergy, Guy’s and St Thomas’ NHS Foundation Trust

Dr Tariq El-Shanawany
Consultant in Clinical Immunology, Cardiff & Vale University Health Board

Alison Donnelly
Specialist Allergy Nurse, Belfast Health & Social Care Trust

Jeanette Brooks
Lead Nurse, Department of Clinical Immunology, Oxford University Hospitals

Emily Carne
Advanced Nurse Practitioner, Cardiff & Vale University Health Board

 

 

 

Additional considerations for self-administration

Transport and storage

Xolair should be stored in a refrigerator between 2°C and 8°C and may be kept at a maximum of 25°C for a total of 4 hours (e.g. during transportation), but this must not be done more than once. Alternative provisions may need to be made if patients are travelling long distances after collection of Xolair, for example:

  • Collection from a hospital/pharmacy closer to home
  • Delivery to patient’s home (if available at the hospital)
  • Use of provisions to ensure that the medicine remains within 2–8°C during transportation

Xolair should be stored in the original package to protect from light.

Blood tests

  • Routine blood tests are NOT required for Xolair patients.

Anaphylaxis

  • Patients should be informed that anaphylactic reactions are possible and prompt medical attention should be sought if allergic reactions occur
  • If you are unsure about a patient’s current symptoms or any previous possible anaphylaxis, consult with a specialist healthcare professional before deciding if suitable for Xolair  
  • The rate of anaphylaxis in Xolair clinical trials was rare (≥1/10,000 to <1/1,000) and the post-marketing reporting rate for anaphylaxis is approximately 0.2%1 
  • There is NO requirement to supply an adrenaline auto-injector to Xolair patients who are self-injecting

Administration by a caregiver

If a patient is unwilling or unable to inject themselves it is possible for a caregiver such as a partner, relative or friend to administer their injections for them providing:

  • They are comfortable doing so
  • They receive training as outlined in the summary of product characteristics and any local protocols you have in place

 

*Post hoc analysis of phase 3 studies (ASTERIA I & II, and GLACIAL), demonstrated clinically meaningful improvements in quality of life (measured using DLQI) in patients with CSU.3

Indication: Xolair is indicated as add-on therapy for the treatment of chronic spontaneous urticaria in adult and adolescent (12 years and above) patients with inadequate response to H1-antihistamine treatment.1

CSU, chronic spontaneous urticaria; DLQI, Dermatology Life Quality Index; IgE, immunoglobulin E; UAS7, urticaria activity score at seven days; UCT, urticaria control test.

References

  1. Xolair® (omalizumab) 150 mg Summary of Product Characteristics.
  2. NICE Technology Appraisal Guidance 339. Omalizumab for previously treated chronic spontaneous urticaria. June 2015.
  3. Finlay AY et al. J Eur Acad Dermatol Venereol 2017;31(10):1715–1721.
XSU20-C013 July 2020.
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Adverse events should be reported. Reporting forms and information can be found at yellowcard.mhra.gov.uk. Adverse events should also be reported to Novartis via [email protected] or online through the pharmacovigilance intake (PVI) tool at http://www.report.novartis.com/
If you have a question about the product, please contact Medical Information on 01276 698370 or by email at [email protected]