Description
Indication & Scope
Xolair® Omalizumab for Injection treats moderate to severe uncontrolled allergic asthma; treatment of chronic spontaneous urticaria resistant to antihistamines.
- Mechanism: Monoclonal antibody that specifically binds free IgE, reduces IgE concentration in blood, inhibits mast cell and basophil degranulation to block allergic cascade reactions.
- Drug class: Anti-IgE monoclonal antibody, biological anti-allergic agent.
- Clinical use: Long-term add-on therapy for refractory allergic asthma; second-line treatment for chronic spontaneous urticaria.
| Generic Name | Omalizumab for Injection |
| Brand Name | Xolair |
| Ingredient | Omalizumab |
| Dosage Form | Injection |
| Package | [Omalizumab 150mg*1 vial + injection water 2ml*1 vial]/box;
[Omalizumab 150mg*4 vial + injection water 2ml*4 vial]/box; [Omalizumab 150mg*10 vial + injection water 2ml*10 vial]/box |
| Conditions Treated | IgE-mediated moderate-severe allergic asthma, antihistamine-resistant chronic spontaneous urticaria |
| Taboos | Severe hypersensitivity to omalizumab or excipients; acute severe asthma attack requiring emergency rescue |
| Place of origin | Schaffhauserstrasse, 4332 Stein, Switzerland |
| Prescription type | Prescription-only |
| Storage Conditions | Store refrigerated at 2°C – 8°C, do not freeze; protect from light during transportation and storage |
| Manufacturer | Novartis Pharma Stein AG |
| Registration Authority | National Medical Products Administration (NMPA), China |
| Approval number | SJ20170042 |
| Approval Date | Jan 27, 2022 |
| Shelf Life | 24 months |
How to use ?
Recommended Dose: Dose is calculated strictly based on body weight and baseline total IgE level, administered subcutaneously every 2 or 4 weeks.
Time: Fixed subcutaneous injection every 2 or 4 weeks at the same interval.
Instructions for use: Reconstitute lyophilized powder strictly per specification before injection; administer subcutaneously in upper arm, thigh or abdomen; monitor for hypersensitivity for at least 2 hours after injection.
Interaction: No direct drug-drug interactions reported; dosage adjustment is not needed with inhaled steroids, antihistamines or bronchodilators.
Side effects:
1. Common: injection site redness, swelling, fatigue, headache, joint pain.
2. Rare: anaphylaxis, parasitic infection risk, mild fever.
Important Notice
This product should be administered only by qualified healthcare professionals in accordance with the approved prescribing information and local clinical guidelines. Dosage and administration may vary depending on patient condition, indicatiaon, and regional regulatory requirements.
Packaging & Shipping
Packaging
Original manufacturer’s packaging with secure export carton. Customized export packaging is available upon request.
Shipping Methods
Express Courier (EMS, DHL, FedEx, UPS), Air Freight, and Sea Freight. Cold-chain transportation is available for products requiring temperature-controlled logistics.
Export Support
Certificate of Analysis
GMP Certificate
Commercial Invoice
Packing List & CPP
Cold Chain Logistics
Customs Documentation
Scientific and regulatory sources
FAQ
What two main allergic diseases are covered by the indications of Omalizumab for Injection?
Moderate-severe uncontrolled allergic asthma and chronic spontaneous urticaria unresponsive to antihistamines.
What factor determines the specific dosage and injection interval of Omalizumab for Injection?
Dosage and interval depend on body weight and pretreatment total serum IgE concentration.
What mandatory monitoring is required right after each injection of Omalizumab for Injection?
Continuous observation for allergic reactions for no less than two hours after subcutaneous injection.
Can Omalizumab for Injection be used to relieve sudden severe asthma attacks?
No, it is forbidden for emergency rescue of acute severe asthma exacerbations.
Xolair® | Omalizumab for Injection | Allergic Asthma/Urticaria | DengYueRX
INN: Omalizumab for Injection
Indications: Allergic asthma and urticaria
Dosage Form: Injection
Strength: 150mg/vial
Original price was: $302.02.$256.71Current price is: $256.71.
