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Articles

Safety in Lactation: Drugs for obstructive airways disease

25 September 2020Additional information relating to breastfeeding To be used in conjunction with individual drug entries for specific information and guidance. Bronchodilators Most bronchodilators are considered to…
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Refrigerated Storage

XolairNovartis Pharmaceuticals UK Ltd

Novartis Pharmaceuticals UK Ltd
Xolair
Solution for injection, 75mg and 100mg

In the event of an inadvertent temperature excursion the following data may be used: Xolair shelf life includes potential temperature excursions. The product may be kept for a total of 4 hours at 25°C. If necessary, the product may be returned to the refrigerator for later use, but this must not be done more than once.

Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk.

Contact Novartis in all cases where a deviation from the recommended storage conditions has occurred.

Refer to the current BNF for company contact details.

No
Yes, but this must not be done more than once.
15 May 2020
London MI Service

Lactation Safety Information

Corticosteroids
Monoclonal antibody used for IgE-mediated allergic asthma
No published evidence of safety
Low levels anticipated in milk due to the drug’s properties and likely to be degraded in infant’s GI tract, although long half-life increases risk of accumulation in breastfed infant
Although large protein molecules may appear in colostrum, risk to preterm infants and neonates is considered to be small and unproven
21 April 2017

New Medicines

XolairChronic sinusitis with nasal polyps

Information

Xolair
Licence extension / variation
Novartis
Novartis

Development and Regulatory status

Launched
Launched
Launched
July 2020
Dec 20Approved in US [12].
Jul 20Approved in EU [11]
Jun 20Recommended for EU approval by CHMP - the additional indication is "as an add-on therapy with intranasal corticosteroids (INC) for the treatment of adults (18 years and above) with severe CRSwNP [Chronic rhinosinusitis with nasal polyps] for whom therapy with INC does not provide adequate disease control" [10].
Dec 19The FDA has accepted a supplemental Biologics License Application (sBLA) for omalizumab for the treatment of nasal polyps in adult patients 18 years of age and older with inadequate response to intranasal corticosteroids [8].
Nov 19Novartis submitted to the European Medicines Agency a Type II variation application for Xolair for the treatment of nasal polyps. A decision is expected in 2020 [9].
Oct 18EU & US filings now planned for 2019 [5].
Mar 18Filings planned for 2020 [4].

Category

Monoclonal antibody that binds specifically to the Cε3 domain of immunoglobulin E (IgE). Cε3 is the site of high-affinity IgE receptor binding. IgE plays a major role in allergic disease by causing the release of histamine and other inflammatory mediators.
Nasal polyps are lesions arising from the nasal mucosa, occurring at any site in the nasal cavity or paranasal sinuses but most frequently seen in the clefts of the middle meatus. Nasal polyps can be considered as part of the spectrum of chronic rhinosinusitis. The population prevalence is reported as around 4%, with no racial predilection. The male-to-female ratio is approximately 2:1 [1].
Chronic sinusitis with nasal polyps
Subcutaneous

Further information

Yes
Terminated

Trial or other data

Feb 21POLYP 1 and 2 published in J Allergy Clin Immunol 2020; 146(3): 595-605 [13].
Jun 19Competing with dupilumab for nasal polyps. Xolair is also being investigated as a treatment for food allergies (US Breakthrough Therapy designation) and seasonal allergic rhinitis [7]
Jun 19Positive topline data announced from two PIII trials of Xolair (omalizumab) for adults with chronic rhinosinusitis with nasal polyps. The POLYP 1 and 2 trials both met co-primary endpoints and key secondary endpoints.[6]
Dec 18Recruitment complete in PIII trials, POLYP 1 and POLYP 2 [5].
Dec 17Roche initiates two PIII trials to evaluate the efficacy and safety of omalizumab compared with a placebo each in 120 patients with chronic rhinosinusitis with nasal polyps (POLYP 1, NCT03280550; POLYP 2, NCT03280537) who have had an inadequate response to standard of care treatments. Sites include the US & EU and collection of primary outcome data (change from baseline in average daily nasal congestion score at 24 weeks, and in nasal polyp score at 24 weeks) should complete May 19 [2,3].

Evidence based evaluations

XolairFood allergy - in patients with multiple food allergies

Information

Xolair
Licence extension / variation
Novartis
Novartis

Development and Regulatory status

None
None
Phase III Clinical Trials

Category

Monoclonal antibody that binds specifically to the Cε3 domain of immunoglobulin E (IgE). Cε3 is the site of high-affinity IgE receptor binding. IgE plays a major role in allergic disease by causing the release of histamine and other inflammatory
Food allergy is thought to affect 5 in 100 young children and 3-4 in 100 adults in westernised countries. Levels of food allergy seem to be rising. Reasons for this are unclear but it may be connected with the processed nature of the western diet and its effects on the gut microbiome. It is difficult to find accurate numbers for prevalence of food intolerance or allergy [1].
Food allergy - in patients with multiple food allergies
Subcutaneous