Prescribing information

 

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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.2

CSU is a disabling condition that can have a devastating impact on patients’ quality of life and a considerable impact on healthcare resources.1,3,4 The 2021 international EAACI/GA²LEN/EuroGuiDerm/APAAACI guidelines state that the "goal of treatment is to treat the disease until it is gone and as efficiently and safely as possible aiming at a continuous UAS7 = 0, complete control and a normalisation of quality of life."1

It is imperative that patients are monitored regularly from diagnosis to establish their level of disease control, so that treatment can be optimised accordingly. Find out more and download monitoring tools here.

Xolair (omalizumab) is widely recognised in key guidelines/recommendations relevant to the UK and internationally.1,5,6

Use the links below to jump to the summarised treatment guidelines from national and international bodies:

 

Summary of CSU patient management pathway in adults and new positioning of Xolair (omalizumab)

 

Image showing the summary of CSU patient management pathway in adults

Adapted from Sabroe RA, et al. 20217

To download a simplified PDF summary of the BAD recommended CSU patient management algorithm, please click the link below.

Click to view

This 2021 update and revision of the international guideline for urticaria was developed following the methods recommended by Cochrane and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) working group.

It is a joint initiative of the Dermatology Section of the European Academy of Allergology and Clinical Immunology (EAACI), the Global Allergy and Asthma European Network (GA²LEN) and its Urticaria and Angioedema Centers of Reference and Excellence (UCAREs and ACAREs), the European Dermatology Forum (EDF; EuroGuiDerm), and the Asia Pacific Association of Allergy, Asthma and Clinical Immunology (APAAACI) with the participation of 64 delegates of 50 national and international societies and from 31 countries.

 

Image showing the treatment algorithm for urticaria

NOTE: At any time, short course (max. 10 days) of corticosteroids may be considered in case of severe exacerbation.

To read the full guidelines, please click the link below (the link will take you to the Wiley Online Library, a non-Novartis website).

Click to view

Adapted from the 2021 EAACI/GA²LEN/EuroGuiDerm/APAAACI guideline (Zuberbier T, et al. Allergy. 2021),1 and according to the Xolair Summary of Product Characteristics.2 Considering potential off-label uses of products mentioned in this treatment guideline, the SmPC of individual products should be consulted for further information. Complete information about the CSU International Guideline is available in the full publication.

Image showing the treatment algorithm for urticaria

Adapted from Powell RJ et al. 2015.6

A short course of corticosteroids may be appropriate in severe episodes at any stage (e.g. prednisolone up to 40 mg daily for 7 days).

*Post hoc analysis of phase 3 studies8, omalizumab 300 mg significantly improved total DLQI scores vs placebo: - ASTERIA I : mean decrease from baseline to week 12 of -10.3 vs -6.1 (p<0.0001) – ASTERIA II : -10.2 vs -6.1 (p=0.0004) - GLACIAL : -9.7 vs -5.1 (p<0.0001)
Not licensed for treatment in CSU.1,9,10
Lacks high quality evidence.7
§Total IgE levels and BHRAs are only indicative and may not reflect actual clinical responsiveness in all patients.7

AAS, angio-oedema activity score; ACAREs, Angioedema Centers of Reference and Excellence; ACEi, angiotensin-converting enzyme inhibitors; AH, H-1 antihistamine; APAAACI, Asia Pacific Association of Allergy, Asthma and Clinical Immunology; BAD, British Association of Dermatologists; BHRA, basophil histamine release assay; BSACI, British Society for Allergy & Clinical Immunology; CSU, chronic spontaneous urticaria; DLQI, Dermatology Life Quality Index; EAACI, European Academy of Allergy and Clinical Immunology; EDF, European Dermatology Forum; GA2LEN, Global Allergy and Asthma European Network; IgE, immunoglobulin E; LTRA, leukotriene receptor antagonist; UAS7, urticaria activity score at seven days; UCAREs, Urticaria Centers of Reference and Excellence; UCT, urticaria control test.

References

  1. Zuberbier T et al. Allergy 2021;00:1–33.
  2. Xolair®(omalizumab) 150 mg Summary of Product Characteristics.
  3. Kolkhir P et al. World Allergy Organ J 2018;11(1):14.
  4. Maurer M et al. Allergy 2017;72(12):2005–2016.
  5. British Association of Dermatologists. Guidance for managing urticaria patients on omalizumab during the Coronavirus pandemic. Available at: https://www.bad.org.uk/shared/get-file.ashx?itemtype=document&id=6659 [Accessed March 2022].
  6. Powell RJ et al. Clin Exp Allergy 2015;45(3):547–565.
  7. Sabroe RA et al. Br J Dermatol 2022;186(3):398–413.
  8. Finlay AY et al. J Eur Acad Dermatol Venereol 2017;31(10):1715–1721.
  9. Montelukast Summary of Product Characteristics. November 2020.
  10. Capimune (ciclosporin) Summary of Product Characteristics. December 2021.
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UK | April 2022 | 164030
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Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Novartis via [email protected] or online through the pharmacovigilance intake (PVI) tool at www.report.novartis.com
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