For Subcutaneous Use
Xolair (Omalizumab) is a recombinant DNA-derived humanized IgG1κ monoclonal antibody that selectively binds to human immunoglobulin E (IgE). The antibody has a molecular weight of approximately 149 kilodaltons. Xolair (omalizumab) is produced by a Chinese hamster ovary cell suspension culture in a nutrient medium containing the antibiotic gentamicin. Gentamicin is not detectable in the final product.
Xolair (omalizumab) is a sterile, white, preservative-free, lyophilized powder contained in a single-use vial that is reconstituted with Sterile Water for Injection (SWFI), USP, and administered as a subcutaneous (SC) injection. A Xolair vial contains 202.5 mg of Omalizumab, 145.5 mg sucrose, 2.8 mg L-histidine hydrochloride monohydrate, 1.8 mg L-histidine, and 0.5 mg polysorbate 20, and is designed to deliver 150 mg of Omalizumab in 1.2 mL after reconstitution with 1.4 mL SWFI, USP.
What are the possible side effects of omalizumab (Xolair)?
Some people using omalizumab have had a severe, life-threatening allergic reaction to this medication, either right after the injection or hours later. Allergic reaction may occur even after using the medication regularly for a year or longer.
Get emergency medical help if you have any of these signs of an allergic reaction:
- wheezing, 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...
What are the precautions when taking omalizumab (Xolair)?
Before using omalizumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history.
This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.
It is not known whether this drug passes into breast milk. Consult your doctor before...
Last reviewed on RxList: 7/24/2007
This monograph has been modified to include the generic and brand name in many instances.
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