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Xolair is the brand name for omalizumab subcutaneous injection.

Xolair is available as a 75 mg/0.5 mL, 150 mg/mL, and 300 mg/2 mL single-dose prefilled syringe and autoinjector.

Xolair is an immunoglobulin E (IgE) monoclonal antibody and is used for the following:

• Moderate-to-severe allergic asthma
• Chronic rhinosinusitis with nasal polyps
• Chronic spontaneous urticaria (CSU) (chronic hives of unknown cause)
• Lower risk of severe allergic reactions after accidental exposure to food triggers

Xolair is a monoclonal antibody. It targets a specific protein in the immune system called immunoglobulin E (IgE). This protein is typically involved in ramping up your immune system’s allergic response to something, like certain food. Xolair stops IgE from releasing histamine and other chemicals that cause symptoms of allergic asthma, nasal polyps, hives, and allergic reactions from food.

Xolair is dosed as follows:

• Your allergist will determine and adjust your dose of Xolair based on different factors like body weight, serum IgE level, and how well the medication is working for you
• Xolair is given as an injection under the skin (subcutaneous or SC) in either the front and middle of your thigh, stomach area (2 inches away from your belly button), or in the back of the upper arm (if given by a caregiver)

Allergic asthma

• Adults and children ages 6 years and older: The typical dose ranges from 75 mg to 375 mg injected SC every 2 or 4 weeks.

Chronic rhinosinusitis with nasal polyps

• Adults: The typical dose ranges from 75 mg to 600 mg injected SC every 2 or 4 weeks

Chronic idiopathic urticaria (hives)

• Adults and children ages 12 years and older: The typical dose ranges from 150 mg or 300 mg SC every 4 weeks
• Prevention of severe food allergy reactions
• Adults and children ages 1 year and older: The typical dose ranges from 75 mg to 600 mg injected SC every 2 or 4 weeks

Xolair is a safe and effective treatment when used for FDA licensed indications. However, like all medications, they may give you unwanted side effects. You should always discuss potential side effects with your physician to ensure the medication is suitable and right for you.

Common side effects of Xolair:

• Injection site reaction
• Common cold symptoms
• Joint pain
• Body pain
• Leg pain
• Dizziness
• Fatigue
• Headache

Serious side effects are rare with Xolair. Contact your healthcare provider immediately if you experience any of the following.

• Serious allergic reactions: hives, wheezing, difficulty breathing, swelling of face, mouth, tongue, or throat
• Inflammation of blood vessels: rash, difficulty breathing, tingling or numbness in arms or legs, chest pain
• Heart and blood circulation problems: chest pain, heart attack, blood clots, stroke
• Fever, joint pain, or rash after an injection
• Parasitic infections

• No formal drug-drug interaction studies with Xolair have been conducted. However, always let your physician and pharmacist know about any other medications or supplements (including prescribed and over-the-counter medications, vitamins, and dietary or herbal supplements) that you are currently taking

Genentech, Inc.

It is not known if Xolair will harm your unborn baby. Tell your healthcare provider if you are pregnant or plan to become pregnant while using Xolair.

• Omalizumab