Omalizumab
- Atc Codes:R03DX05
- CAS Codes:242138-07-4
- PHARMGKB ID:242138-07-4
Table of contents
- Brand Names
- Chemistry
- Pharmacologic Category
- Mechanism of Action
- Therapeutic Use
- Pregnancy and Lactation Implications
- Contraindications
- Warnings and Precautions
- Adverse Reactions
- Genes that may be involved
- Drug Interactions
- Dosage
- Pharmacokinetics and Pharmacodynamics
- Special Considerations
Brand Names
Europe
Austria: Xolair; Belgium: Xolair; Bulgaria: Xolair; Cyprus: Xolair; Czech Republic: Xolair; Denmark: Xolair; Estonia: Xolair; Finland: Xolair; France: Xolair; Germany: Xolair; Greece: Xolair; Hungary: Xolair; Ireland: Xolair; Italy: Xolair; Latvia: Xolair; Lithuania: Xolair; Luxembourg: Xolair; Malta: Xolair; Netherlands: Xolair; Poland: Xolair; Portugal: Xolair; Romania: Xolair; Slovakia: Xolair; Slovenia: Xolair; Spain: Xolair; Sweden: Xolair; UK: Xolair.
North America
Canada: Xolair; USA: Xolair.
Latin America
Argentina: Xolair; Brazil: Xolair.
Drug combinations
Chemistry
Omalizumab: Mw: approx. 150000.01. (1) Immunoglobulin G, anti-(human immunoglobulin E Fc region)(human-mouse monoclonal E25 clone pSVIE26 γ-chain), disulfide with human-mouse monoclonal E25 clone pSVIE26 κ-chain, dimer; (2) Immunoglobulin G (human-mouse monoclonal E25 clone pSV1E26 γ-chain anti-human immunoglobulin E Fc region), disulfide with human-mouse monoclonal E25 clone pSVIE126 κ-chain, dimer. CAS-242138-07-4 (2002).
Pharmacologic Category
Respiratory Agents, Miscellaneous. Anti-Asthmatic Monoclonal Antibody. (ATC-Code: R03DX05).
Mechanism of action
An IgG monoclonal antibody (recombinant DNA-derived) which inhibits IgE binding to high-affinity IgE receptor on mast cells and basophils. By decreasing bound IgE, activation and release of mediators in allergic response (early and late phase) is limited. Long-term treatment in allergic asthma showed decrease in asthma exacerbations and corticosteroid usage.
Therapeutic use
Moderate-to-severe, persistent allergic asthma not adequately controlled with inhaled corticosteroids.
Pregnancy and lactiation implications
Teratogenic effects not observed in animals. There are no adequate studies in pregnant women. IgG molecules known to cross placenta. Use during pregnancy only if clearly needed. Excretion in breast milk unknown (use caution).
Unlabeled use
Contraindications
Hypersensitivity to omalizumab or any component of the formulation. Acute bronchospasm, status asthmaticus.
Warnings and precautions
Anaphylaxis, including delayed-onset anaphylaxis, reported following administration. Malignant neoplasms reported in short-term studies. Use with caution in risk for parasitic (helminth) infections (risk of infection may be increased). Gradually taper corticosteroid therapy, do not discontinue abruptly. For use in documented reactivity to a perennial aeroallergen and with symptoms uncontrolled using inhaled corticosteroids (not used to control acute asthma symptoms). Dosing based on pre-treatment IgE serum levels and body weight.