"The U.S. Food and Drug Administration today approved Cinqair (reslizumab) for use with other asthma medicines for the maintenance treatment of severe asthma in patients aged 18 years and older. Cinqair is approved for patients who have a hi"...
(omalizumab) or Injection, for Subcutaneous Use
Anaphylaxis presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of Xolair. Anaphylaxis has occurred as early as after the first dose of Xolair, but also has occurred beyond 1 year after beginning regularly administered treatment. Because of the risk of anaphylaxis, observe patients closely for an appropriate period of time after Xolair administration. Health care providers administering Xolair should be prepared to manage anaphylaxis that can be life-threatening. Inform patients of the signs and symptoms of anaphylaxis and instruct them to seek immediate medical care should symptoms occur [see WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS].
Xolair 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 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 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. Each 202.5 mg vial of omalizumab also contains L-histidine (1.8 mg), L-histidine hydrochloride monohydrate (2.8 mg), polysorbate 20 (0.5 mg) and sucrose (145.5 mg) 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: 10/26/2016
This monograph has been modified to include the generic and brand name in many instances.
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