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10265 details
Primary information
ID10265
Therapeutic IDTh1038
Protein NameOmalizumab
Sequence>Th1038_Omalizumab EVQLVESGGGLVQPGGSLRLSCAVSGYSITSGYSWNWIRQAPGKGLEWVASITYDGSTNYADSVKGRFTISRDDSKNTFYLQMNSLRAEDTAVYYCARGSHYFGHWHFAVWGQGTLVTVSSGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKAEPKSCDKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRDELTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK
Molecular Weight149000
Chemical FormulaC6450H9916N1714O2023S38
Isoelectric Point6.6 - 7.2
Hydrophobicity-0.432
Melting point61(FAB fra
Half-life624 hours
DescriptionA recombinant DNA-derived humanized IgG1k monoclonal antibody that selectively binds to human immunoglobulin E. Xolair is produced by a Chinese hamster ovary cell suspension culture in a nutrient medium containing the antibiotic gentamicin.
Indication/DiseaseFor treatment of asthma caused by allergies
PharmacodynamicsXolair inhibits the binding of IgE to the high-affinity IgE receptor (FceRI) on the surface of mast cells and basophils. Reduction in surface-bound IgE on FceRI-bearing cells limits the degree of release of mediators of the allergic response. Xolair is used to treat severe, persisten asthma.
Mechanism of ActionXolair binds to IgE (a class of antibodies normally secreted in allergic responses), which prevents their binding to mast cells and basophils.
ToxicityAnaphylaxis may occur rarely with this agent, either after the first dose or multiple doses
MetabolismMost likely removed by opsonization via the reticuloendothelial system.
Absorptionbioavailability of 62%
78 ± 32 mL/kg
ClearanceLiver elimination of IgG includes degradation in the liver reticuloendothelial system (RES) and endothelial cells. Intact IgG is also excreted in bile.
CategoriesAgents to Treat Airway Disease, Amino Acids, Peptides, and Proteins, Anti-Allergic Agents, Anti-Asthmatic Agents, Anti-IgE, Antibodies, Antibodies, Monoclonal, Antibodies, Monoclonal, Humanized, Blood Proteins, Decreased IgE Activity, Globulins, IgE-directed Antibody Interactions, Immunoglobulins, Immunoproteins, Proteins, Respiratory Agents, Miscellaneous, Respiratory System Agents, Serum Globulins
Patents NumberCA2113813
Date of Issue12-Apr-2005
Date of Expiry14-Aug-2012
Drug InteractionNA
TargetHigh affinity immunoglobulin epsilon receptor subunit alpha and beta
Brand NameXolair
CompanyGenentech Inc, Novartis Europharm Limited
Brand DescriptionGenentech Inc, Novartis Europharm Limited
Prescribed ForXolair is used to treat moderate to severe asthma that is caused by allergies, and chronic idiopathic urticaria (a form of chronic hives) in adults and children who are at least 12 years old. Xolair is usually given after other asthma medications have bee
Chemical NameNA
FormulationFormulated in a single use vial that is reconstituted with sterile water for injection (SWFI), USP, and administered as a subcutaneous (SC) injection. Each 202.5 mg vial of omalizumab also contains L-histidine (1.8 mg), L-histidine hydrochloride monohydra
Physical Appearance Sterile, white, preservative free, lyophilized powder
Route of AdministrationSubcutaneous Injection
Recommended DosageXolair is administered at 150 to 375 mg by subcutaneous injection every 2 or 4 weeks. Determine doses (mg) and dosing frequency by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg) as if serum IgE is less than 30-or >700 IU/mL and <66 or >330 lb, respectively) should not be dosed.
ContraindicationSevere hypersensitivity
Side EffectsWheezing, tightness in your chest, trouble breathing; hives or skin rash; feeling anxious or light-headed, fainting; warmth or tingling under your skin; or swelling of your face, lips, tongue, or throat.
Useful Link 1Link
Useful Link 2NA
RemarksNA