Prescribing information

 

Dosing and administration instructions for Xolair in SAA.

Dosing

Appropriate dose and dosing frequency with Xolair is determined by baseline IgE (IU/ml), measured before the start of treatment, and body weight (kg). Patients whose baseline IgE and body weight are outside the limits of the dosing table should not be given Xolair.1

Xolair is administered by subcutaneous injection every 2 or 4 weeks dependent on dose. Maximum recommended dose is 600 mg every two weeks.1

 

Table showing the recommended dose and dosing schedule of Xolair according to patients' body weight and baseline IgE

Adapted from Xolair® (omalizumab)  Summary of Product Characteristics.1

 

Table showing the number of injections required for each dose of Xolair

Adapted from Xolair® (omalizumab) Instructions for Use.2

 

 

There’s no place like home

Following 15 years and 1.3 million patient-years of treatment experience,3 and supported by evidence from randomised clinical trials and the real world,4–7 Xolair is now licensed for self-administration.1

  • Self-administration gives patients the freedom to fit their treatment around their lives, reducing time spent travelling to and from the clinic and meaning less disruption to work or school.
  • It also increases clinic capacity, giving you more time to see more patients.
 Illustration of a house
 

This guidance has been co-created by an expert steering committee and funded by Novartis.

Members of the steering committee:

Professor Dominick Shaw (Chair)
University of Nottingham.

Dr Rob Niven
Clinical Lead for the Asthma Service, Manchester University NHS Foundation Trust.

Dr Tom Fardon
Consultant Physician in Respiratory and General Internal Medicine, NHS Tayside.

Professor Andrew Menzies-Gow
Consultant Respiratory Physician and Director of Lung Division, Royal Brompton Hospital.

Dr James Calvert
Consultant Respiratory Physician, North Bristol NHS Trust.

Professor Anna Murphy
Consultant Respiratory Pharmacist, University Hospitals of Leicester.

Rachel Stead
Lead Asthma Nurse, Royal Brompton Hospital.

Sam Prigmore
Consultant Nurse and Lead Asthma Nurse, St George’s London.

 

Algorithm showing the process of initiating Xolair self-administration

Transport and storage:

  • Xolair should be stored in a refrigerator between 2°C and 8°C, it should not be kept outside of the fridge for more than 4 hours at room temperature (25°C). If necessary, the product may be returned to the refrigerator for later use, 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 or considering holidays, e.g.     
    • Collection from a hospital/pharmacy closer to home     
    • Use of provisions to ensure that medicine remains within 2-8°C during transportation     
    • Delivery via a hospital trust homecare company if available

Latex allergy:

  • The removable needle cap of the pre-filled syringe contains a derivative of natural rubber latex. No natural rubber latex has to date been detected in the removable needle cap, however the Xolair pre-filled syringe has not been tested on latex-sensitive individuals so there is a potential risk for hypersensitivity reactions which cannot be completely ruled out

Pregnancy:

  • There are limited data from the use of Xolair in pregnant women and it should not be used in pregnancy without consideration of the risks and benefits (see SmPC for further information)

There is little potential for drug interactions (see SmPC for further information)

Other concurrent injections:

  • Avoid concurrent injections on the same day where possible (e.g. flu vaccine). If not possible (e.g. daily insulin injections) then rotate injection sites

Concurrent illnesses (e.g. exacerbation/infection):

  • Oral corticosteroids and/or antibiotics may be considered, if necessary, as per normal asthma management

Patients already using Xolair:

  • Existing Xolair patients who meet the eligibility criteria for self-administration can be trained and assessed at their routine injection appointments and should not have to wait for a 16-week review before being allowed to inject at home

Xolair is not licensed for acute asthma exacerbations.

We have produced a range of resources to help you identify patients suitable for self-administration and train these patients on the injection procedure.

Click here to visit the Resources page.

*Xolair provides clinically meaningful improvements in quality of life for patients with severe allergic asthma.8

Indication1: Xolair should only be considered for patients with convincing IgE (immunoglobulin E) mediated asthma. In adults and adolescents (12 years of age and older): Xolair is indicated as add-on therapy to improve asthma control in patients with severe persistent allergic asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and who have reduced lung function (FEV1 <80%) as well as frequent daytime symptoms or night-time awakenings and who have had multiple documented severe asthma exacerbations despite daily high-dose inhaled corticosteroids, plus a long-acting inhaled beta2-agonist. In children (6 to <12 years of age): Xolair is indicated as add-on therapy to improve asthma control in patients with severe persistent allergic asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and frequent daytime symptoms or night-time awakenings and who have had multiple documented severe asthma exacerbations despite daily high-dose inhaled corticosteroids, plus a long-acting inhaled beta2-agonist.

FEV1, forced expiratory volume in 1 second; IgE, immunoglobulin E; IgG, immunoglobulin G; SAA, severe allergic asthma.

References

  1. Xolair® (omalizumab) Summary of Product Characteristics.
  2. Xolair® (omalizumab) Instructions for Use.
  3. Novartis data on file. Periodic Safety Update Report (PSUR) 2019.
  4. Brusselle G et al. Respir Med 2009;103(11):1633–1642.
  5. Kulus M et al. Curr Med Res Opin 2010;26(6):1285–1293.
  6. Humbert M et al. Allergy 2005;60(3):309–316.
  7. Barnes N et al. J Asthma 2013;50(5):529–536.
  8. Braunstahl GJ et al. Resp Med 2013;107(8):1141–1151.
XSA20-C017 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 patient safety information (PSI) tool at https://psi.novartis.com
If you have a question about the product, please contact Medical Information on 01276 692255 or by email at [email protected]