| Pharmaceutical Information |
| Drug Name |
Omalizumab |
| Drug ID |
BADD_D01610 |
| Description |
Omalizumab, manufactured by _Genentech_, was first FDA approved in 2003 to treat adults and children 12 years of age and older with moderate to severe persistent allergic asthma which is not controlled by inhaled steroids [L4670]. Since its U.S. approval, more than 200,000 patients older than 12 with allergic asthma have been treated [L4670]. In September 2018, a new prefilled syringe formulation of this drug was approved by the FDA [L4671]. |
| Indications and Usage |
This drug is an anti-IgE antibody indicated for:
1. Moderate to severe persistent asthma in patients 6 years of age and older
with a positive skin test or in vitro reactivity to a perennial aeroallergen and symptoms that are inadequately controlled with inhaled corticosteroids [FDA label]
2. Chronic idiopathic urticaria in adults and adolescents 12 years of age and older who remain symptomatic despite H1 antihistamine treatment [FDA label] |
| Marketing Status |
approved; investigational |
| ATC Code |
R03DX05 |
| DrugBank ID |
DB00043
|
| KEGG ID |
D05251
|
| MeSH ID |
D000069444
|
| PubChem ID |
Not Available
|
| TTD Drug ID |
D02GEC
|
| NDC Product Code |
50242-040; 50242-215; 50242-214 |
| UNII |
2P471X1Z11
|
| Synonyms |
Omalizumab | Xolair |
|
| Chemical Information |
| Molecular Formula |
Not Available |
| CAS Registry Number |
242138-07-4 |
| SMILES |
Not Available |
| Chemical Structure |
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| ADRs Induced by Drug |
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*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
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