Prescribing information

 

Key safety data for Xolair in CSU.

___________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

Xolair has an established safety profile in CSU since 2014 and severe allergic asthma since 20051–4

Common reported side effects are headache, sinusitis, upper respiratory tract infection, arthralgia and injection-site reaction.2

 

Incidence of adverse events

  ASTERIA I5,6† ASTERIA II7,8‡ GLACIAL9†
  Placebo 300 mg Placebo 300 mg Placebo 300 mg
Number of patients 80 81 79 79 83 252
Any AE 53

(66.3%)
57

(70.4%)
51

(64.6%)
52

(65.8%)
65

(78.3%)
211

(83.7)
Severe AE 8

(10.0%)
13

(16.0%)
7

(8.9%)
6

(7.6%)
NR NR
Serious AE (SAE) 5

(6.3%)
2

(2.5%)
2

(2.5%)
5

(6.3%)
5

(6.0%)
18

(7.1%)
AE leading to treatment withdrawal 7

(8.8%)
2

(2.5%)
1

(1.2%)
3

(1.2%)
AE suspected to be caused by drug study 4

(5.0%)
14

(17.3%)
3

(3.8%)
7

(8.9%)
11

(13.3%)
28

(11.1%)
Deaths 0 0 0 0 0 0
Anaphylaxis 0 0 0 0 0 0

 

*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.10
Incidence of AEs observed across duration of study including treatment period and follow-up = 40 weeks.
Incidence of AEs observed across duration of study including treatment period and follow-up = 28 weeks. 

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.2

AE, adverse event; CSU, chronic spontaneous urticaria; DLQI, Dermatology Life Quality Index; IgE, immunoglobulin E; NR, not reported.

References

  1. Zuberbier T et al. Allergy 2018;73(7):1393–1414.
  2. Xolair® (omalizumab) 150 mg Summary of Product Characteristics. 
  3. Novartis, data on file XSU15-C006. Patient treatment years and clinical subjects in Xolair studies.
  4. EMA Xolair CSU 2014; EMA/CHMP/20684/2014; Committee for Medicinal Products for Human Use (CHMP) January 2014.  
  5. Saini S et al. J Invest Dermatol 2015;135(1):67–75.
  6. Saini S et al. J Invest Dermatol 2015;135(1):67–75 (supplementary information).
  7. Maurer M et al. N Engl J Med 2013;368(10):924–935.
  8. Maurer M et al. N Engl J Med 2013;368(10):924–935 (supplementary information). 
  9. Kaplan A et al. J Allergy Clin Immunol 2013;132(1):101–109. 
  10. Finlay AY et al. J Eur Acad Dermatol Venereol 2017;31(10):1715–1721.
XSU20-C012 July 2020.
×

Ask Speakers

×

Medical Information Request

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]