Omalizumab 150mg/1ml solution for injection pre-filled disposable devices
Requires a prescription from a doctor or prescriber
Omalizumab is a recombinant DNA-derived humanized monoclonal antibody directed against human immunoglobulin E (IgE).[L50482] IgE promotes the release of inflammatory mediators from mast cells and basophils during allergic and inflammatory reactions.
Official documents, adverse reaction reporting, and safety monitoring
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Official medicine documents
Safety monitoring data
Yellow Card reports
The MHRA Yellow Card scheme collects reports of suspected side effects from healthcare professionals and patients. View the Drug Analysis Profile (iDAP) for real-world adverse reaction data.
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Suspected adverse reactions reported for Omalizumab
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Submit a Yellow Card report to the MHRA
Data from the MHRA Yellow Card scheme. A reported reaction does not necessarily mean the medicine caused it. Contains public sector information licensed under the Open Government Licence v3.0.
EudraVigilance
The European Medicines Agency (EMA) collects suspected adverse reaction reports from across the EU/EEA through the EudraVigilance system. Search for safety data on this medicine.
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Suspected adverse reactions reported for Omalizumab
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EudraVigilance data is published by the European Medicines Agency (EMA). A suspected adverse reaction is not necessarily caused by the medicine.
2 branded products available
MHRA licensed products
View all licensed products for Omalizumab on the MHRA register
Omlyclo 150mg/1ml solution for injection pre-filled pens
Xolair 150mg/1ml solution for injection pre-filled pens
WHO defined daily dose (DDD)
16 mg
Not a recommended dose. The DDD is the assumed average maintenance dose per day for a drug used for its main indication in adults. It is a statistical measure used for research and comparison purposes only.
Source: WHO Collaborating Centre for Drug Statistics Methodology, distributed via NHS dm+d BNF mapping files. Contains public sector information licensed under the Open Government Licence v3.0.
Therapeutically similar medicines
Similarity based on WHO Anatomical Therapeutic Chemical (ATC) classification and NHS BNF section grouping. Source data: NHS dm+d via TRUD (OGL v3.0), WHO ATC/DDD Index.
NHS prescribing volume and spending trends
Clinical guidelines and formulary information
British National Formulary
Omalizumab
Source: British National Formulary, NICE. Joint Formulary Committee. Contains public sector information licensed under the Open Government Licence v3.0.
NICE clinical guidance(11)
Omalizumab for previously treated chronic spontaneous urticaria (TA339)
Omalizumab for treating severe persistent allergic asthma (TA278)
Omalizumab for treating chronic rhinosinusitis with nasal polyps (terminated appraisal) (TA678)
Reslizumab for treating severe eosinophilic asthma (TA479)
Asthma pathway (BTS, NICE, SIGN) (NG244)
Tezepelumab for treating severe asthma (TA880)
The Airsonett temperature-controlled laminar airflow device for persistent allergic asthma (MIB8)
Alair bronchial thermoplasty system for adults with severe difficult to control asthma (MIB71)
Rituximab in combination with glucocorticoids for treating anti-neutrophil cytoplasmic antibody-associated vasculitis (TA308)
Dupilumab for treating severe asthma with type 2 inflammation (TA751)
Benralizumab for treating severe eosinophilic asthma (TA565)
Source: National Institute for Health and Care Excellence (NICE). Contains public sector information licensed under the Open Government Licence v3.0.
Check stock at pharmacies and supply information
Pharmacy stock checkers
Search for this medicine at major UK pharmacy chains. These links open the retailer's own website — results depend on their current online catalogue.
Supply & product information
Official product databases and supply status monitoring
Pharmacy links redirect to the retailer's own search and do not represent real-time stock levels. emc (electronic medicines compendium) is operated by Datapharm Ltd. Shortage information sourced from NHS Specialist Pharmacy Service (SPS), sps.nhs.uk.
Codes for healthcare professionals and prescribing systems
These codes are used by healthcare IT systems and prescribers to identify this medicine.
NHS UK identifiers
Browse tools
SNOMED CT and dm+d codes from NHS TRUD (Technology Reference data Update Distribution), licensed under the Open Government Licence v3.0. BNF codes from NHS Business Services Authority (NHSBSA). ATC codes from the WHO Collaborating Centre for Drug Statistics Methodology (whocc.no).
Active and completed clinical studies from ClinicalTrials.gov
Source: ClinicalTrials.gov, a database of the U.S. National Library of Medicine (NLM), National Institutes of Health (NIH). Data accessed via ClinicalTrials.gov API v2. Trial information is provided for research purposes and does not constitute medical advice.
Pharmacology and chemical data from DrugBank
Key facts
Drug status
Approved
Major interactions
None known
Half-life
26 days
Mechanism
IgE antibodies have been implicated in several immune-mediated diseases, includi…
Food interactions
None known
Human targets
2 targets
Data: DrugBank · CC BY-NC 4.0
Pharmacokinetics at a glance
Absorption
62%
Half-life
26 days
Volume of distribution
32 mL
[L50477]
Metabolism
[A263507]
Elimination
Clearance
1.1 mL
Pharmacokinetic data: DrugBank · CC BY-NC 4.0
Omalizumab was first approved in the US in 2003 [A263507] and in Europe in 2005.[L50482] It is used to treat a range of immune and inflammatory conditions, including allergies, urticaria, and asthma.[A263507]
- the treatment of patients six years of age and older with moderate to severe persistent asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids.
[L50477][L50482]
- add-on maintenance treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adults with inadequate response to nasal corticosteroids.
[L50477][L50482]
- the reduction of allergic reactions (Type I), including anaphylaxis, that may occur with accidental exposure to one or more foods in patients aged one year and older with IgE-mediated food allergy. Omalizumab is to be used in conjunction with food allergen avoidance.
[L50477]
- the treatment of adults and adolescents 12 years of age and older with chronic spontaneous urticaria (CSU) who remain symptomatic despite H1 antihistamine treatment.
[L50477]
Known interactions with other medications. Always consult a healthcare professional.
Showing 50 of 380 interactions
[L50487]
Maximum tolerated dose of omalizumab has not been determined. Single intravenous doses up to 4000 mg have been administered to patients without evidence of dose-limiting toxicities. The highest cumulative dose administered to patients was 44,000 mg over a 20-week period and this dose did not result in any untoward acute effects.
If an overdose is suspected, the patient should be monitored for any abnormal signs or symptoms. Medical treatment should be sought and instituted appropriately.
[L50482]
Omalizumab is an IgE-neutralizing antibody: It selectively binds to the C-epsilon-3 locus of IgE, the domain at which IgE binds to Fc-epsilon-RI to mediate its actions. Omalizumab works to lower circulating free IgE levels and prevent IgE from interacting with Fc-epsilon-RI,[A263507] which can also lead to the reduced expression of Fc-epsilon-RI.[A263532]
How the body processes this drug — absorption, distribution, metabolism, and elimination
[L50477]
The pharmacokinetics of omalizumab were linear at doses which were higher than 0.5 mg/kg. In patients with asthma, after several doses of omalizumab, areas under the serum concentration-time curve from Day 0 to Day 14 at steady state were up to 6-fold of those after one dose.
After repeated dosing from 75mg-300 mg every 4 weeks, trough serum concentrations of omalizumab increased proportionally with the dose.
[L50477]
[L50477]
[L50477]
[A263507]
[L50477]
[L50482]
Proteins and enzymes this drug interacts with in the body
Secreted immunoglobulins mediate the effector phase of humoral immunity, which results in the elimination of bound antigens .
PMID:20176268 PMID:22158414
The antigen binding site is formed by the variable domain of one heavy chain, together with that of its associated light chain. Thus, each immunoglobulin has two antigen binding sites with remarkable affinity for a particular antigen. The variable domains are assembled by a process called V-(D)-J rearrangement and can then be subjected to somatic hypermutations which, after exposure to antigen and selection, allow affinity maturation for a particular antigen PMID:17576170 PMID:20176268
Associates with pattern recognition receptors CLEC4D and CLEC4E to form a functional signaling complex in myeloid cells. Binding of mycobacterial trehalose 6,6'-dimycolate (TDM) to this receptor complex leads to phosphorylation of ITAM, triggering activation of SYK, CARD9 and NF-kappa-B, consequently driving maturation of antigen-presenting cells and shaping antigen-specific priming of T-cells toward effector T-helper 1 and T-helper 17 cell subtypes. May function cooperatively with other activating receptors.
Functionally linked to integrin beta-2/ITGB2-mediated neutrophil activation. Also involved in integrin alpha-2/ITGA2-mediated platelet activation
ATC R03DX05
Chemical identifiers
CAS, UNII, InChI Key and database cross-references
Show
Chemical identifiers
CAS, UNII, InChI Key and database cross-references
Linked compound data from DrugBank Open Data (CC BY-NC 4.0)
Omalizumab
Additional database identifiers
Drugs Product Database (DPD)
13365
HUGO Gene Nomenclature Committee (HGNC)
HGNC:5522
GeneCards
IGHE
Guide to Pharmacology
2741
UniProt Accession
IGHE_HUMAN
HUGO Gene Nomenclature Committee (HGNC)
HGNC:3611
GenAtlas
FCER1G
GeneCards
FCER1G
GenBank Gene Database
M33195
GenBank Protein Database
182488
UniProt Accession
FCERG_HUMAN
International reference pricing
Reference pricing from DrugBank. Prices are indicative and may not reflect current UK costs.
Source: DrugBank. Used under CC BY-NC 4.0 academic licence for non-commercial purposes.
Patent information
All patents expired, 2 expired
Source: DrugBank · CC BY-NC 4.0. Patent data sourced from national patent offices. Expiry dates may not reflect extensions, regulatory exclusivity periods, or legal challenges.
DrugBank citations
If you use DrugBank data in your research, please cite the following publications: