Xolair
Xolair (omalizumab) is an immunoglobulin E (IgE) monoclonal antibody. It's used to treat allergic asthma, chronic urticaria (hives), and nasal polyps when first-choice options aren't enough to control the symptoms. This medication is also approved to lower the risk of severe food allergy reactions after accidental exposure to triggers. For most conditions, Xolair (omalizumab) can be used by both adults and children. It's given as an injection under the skin, typically every 2 or 4 weeks. Side effects of this medication include headache, stomach pain, and dizziness.
What is Xolair (omalizumab)?
What is Xolair (omalizumab) used for?
Moderate-to-severe allergic asthma
Chronic spontaneous urticaria (CSU) (chronic hives of unknown cause)
Lower risk of severe allergic reactions after accidental exposure to food triggers
How Xolair (omalizumab) works
Xolair (omalizumab) 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 (omalizumab) stops IgE from releasing histamine and other chemicals that cause symptoms of allergic asthma, nasal polyps, hives, and allergic reactions from food.
Drug Facts
More on Xolair (omalizumab) essentials
What are the side effects of Xolair (omalizumab)?
Common Side Effects
- Injection site reaction (45%)
- Joint pain (8%)
- Body pain (7%)
- Leg pain (4%)
- Dizziness (3%)
- Fatigue (3%)
- Headache (8%)
- Injection site reactions (5%)
- Headache (up to 12%)
- Common cold symptoms (up to 9%)
- Joint pain (3%)
- Injection-site reactions (16%)
- Fever (6%)
Other Side Effects
- Fracture
- Arm pain
- Itching
- Ear ache
- Rash
- Stomach pain
- Joint pain
- Dizziness
- Nausea
- Sinus infection
- Cough
Serious Side Effects
- 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
Source: Prescribing information
More on Xolair (omalizumab) side effects
The following side effects have also been reported
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
Less common
Blistering, crusting, irritation, itching, or reddening of the skin
body produces substance that can bind to drug making it less effective or cause side effects
difficulty in moving
muscle pain or stiffness
pain in the joints
stomach pain
Rare
difficulty with swallowing
dizziness
fast heartbeat
malignant tumor
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
tightness in the chest
unusual tiredness or weakness
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
body aches or pain
congestion
dryness or soreness of the throat
headache
hoarseness
leg pain
lumps
pain or tenderness around the eyes and cheekbones
stuffy or runny nose
voice changes
Incidence not known
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Pros and cons of Xolair (omalizumab)
Pros
Helps to prevent allergies from many different foods such as cashews, milk, and wheat
Helps people who didn't get relief from other treatments for asthma, nasal polyps, or hives
Only given once every 2 or 4 weeks
Possible to give yourself injection at home
Cons
Only given as an injection under the skin
Has a risk of severe and life-threatening allergic reactions that can happen at any time during treatment
Not a good choice if you have a history of cancer or have had parasitic infections
Contains latex, which can be a problem with a latex allergy
Pharmacist tips for Xolair (omalizumab)
Xolair (omalizumab) can cause injection-site reactions, such as pain, bruising, itchiness, and redness at the injection site. They typically happen within an hour of the dose, are mild-to-moderate, and should go away within a few days. But if they don't, contact your allergist.
Xolair (omalizumab) can help control your asthma or severity of food allergy in the long-term. It's not meant to stop an asthma attack or allergic reaction once one has started. Make sure to always have the proper rescue medication, such as a rescue inhaler (albuterol (Ventolin)) or epinephrine (Epipen), with you at all times.
Tell your allergist if you have any changes in body weight. This is very important because the dose of Xolair (omalizumab) is adjusted depending on your weight if it's for asthma, food allergies, or nasal polyps.
If you're taking oral or inhaled corticosteroids for your asthma or nasal polyps, don't stop taking them suddenly when switching to Xolair (omalizumab). Doing so can worsen your symptoms and raise your risk for steroid withdrawal symptoms. If needed, your healthcare team will work with you to lower the dosage of the corticosteroids slowly over time.
If you're pregnant or breastfeeding, avoid using Xolair (omalizumab) without talking to your allergist first. It's unknown if Xolair (omalizumab) might harm your unborn baby and it's unknown if this medication passes into breast milk.
How to inject Xolair (omalizumab) at home
If your provider says it's safe for you to administer Xolair (omalizumab) at home, follow their directions carefully to inject the medication safely. Depending on which Xolair (omalizumab) product you have, review the prefilled autoinjector instructions for use or the prefilled syringe instructions for use. Contact your pharmacist or allergist if you have any questions on how to use Xolair (omalizumab).
Keep Xolair (omalizumab) in the original carton to protect it from light and store it in the refrigerator.
When you're ready to give yourself the injection, take the carton from the refrigerator and lay it on a flat surface to warm up. This will take about 15 to 30 minutes (for the syringe) or 30 to 45 minutes (for the autoinjector). Don't try to warm up the medication any other way.
If you're traveling or don't have access to a refrigerator, you can keep Xolair (omalizumab) at room temperature for up to 2 days.
Always check the medication solution to make sure it's clear and colorless to a pale brownish yellow before using it. If it's cloudy, discolored, or has particles (solid parts), don't use it. Contact your allergist or pharmacist about giving you a replacement.
Inject Xolair (omalizumab) under the skin in your thigh, stomach, or back of the upper arms. Avoid injecting the medication within 2 inches of your belly button. Don't inject into skin that has bruises, scars, or moles, or skin that's tender, red, or hard to avoid pain or skin damage.
After your injection, place your used Xolair (omalizumab) in a sharps container or a heavy-duty plastic container (e.g., empty milk carton, laundry detergent bottle) to lower the risk of needlestick injuries.
More on Xolair (omalizumab) tips
Frequently asked questions about Xolair (omalizumab)
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What are the risks and warnings for Xolair (omalizumab)?
Xolair (omalizumab) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Severe allergic reactions
Risk factors: Latex allergy
It's possible to experience a life-threatening allergic reaction from Xolair (omalizumab) called anaphylaxis. Symptoms include difficulty breathing, dizziness, itchy skin, and swelling of the throat or tongue. The serious allergic reaction is most likely to happen after the first few doses of Xolair (omalizumab), but have been reported up to a year after starting treatment.
To be safe, your allergist will ask you to receive your first few doses of Xolair (omalizumab) in a clinic or hospital that is equipped to treat a serious allergic reaction. They might ask you to stay a few hours after your dose to be observed. If you don't have any problems, your care team might train you to give yourself Xolair (omalizumab) at home for future doses. If you experience anaphylaxis at home, call 911 immediately for medical attention.
In addition, tell your allergist if you're allergic to latex because the needle cap on the Xolair (omalizumab) prefilled syringe can contain latex or latex materials.
Not for an asthma attack
Xolair (omalizumab) is meant to be used for asthma as an add-on maintenance medication only. This means it's added to other asthma medications to help control your symptoms in the long term. Don't use Xolair (omalizumab) to treat an asthma attack because it isn't a rescue medication like albuterol (ProAir, Ventolin) inhaler. If you experience difficulty breathing from an asthma attack, use your albuterol inhaler.
Not for emergency treatment of severe allergic reactions
Xolair (omalizumab) is meant to be used to help prevent serious allergic reactions from certain foods. It should never be used as emergency treatment for an allergic reaction. It's still important to avoid foods you're allergic to while taking this medication. If you develop symptoms of a serious allergic reaction, use your prescribed emergency allergy treatments (i.e., epinephrine) if you have it and get medical attention right away.
Fever, joint pain, or rash after injection
People who receive Xolair (omalizumab) sometimes develop fever, joint pain, or rash after receiving a dose. These symptoms generally occur 1 to 5 days following the first few doses of Xolair (omalizumab) and ease overtime. You're less likely to experience these side effects after you've been taking this medication for a while. Let your care team know if you experience these side effects. They might ask you to stop Xolair (omalizumab), depending on your symptoms.
Cancer risk
Though rare, there have been reports of cancer among people who received Xolair (omalizumab) during clinical studies. It's unclear whether the cancers were caused by Xolair (omalizumab). If you have a personal or family history of cancer, tell your allergist before starting Xolair (omalizumab). You can discuss the risks and benefits of this medication with your allergist before beginning treatment.
Inflammation of blood vessels (vasculitis)
Very rarely, people who took Xolair (omalizumab) reported symptoms related to blood vessel problems (called vasculitis), such as intense itching, rash, difficulty breathing, tingling or numbness in hands or feet, and pain and swelling of your sinuses. If you notice any of these symptoms, tell your allergist right away.
Parasitic infections
If you're at a high risk for parasitic infections (e.g., roundworm or hookworm), or have had a parasitic infection in the past, your allergist will need to know to do proper testing and follow-up before starting you on Xolair (omalizumab). Taking Xolair (omalizumab) might raise your risk of a parasitic infection. You can discuss the risks and benefits of this medication with your allergist before beginning treatment.
Xolair (omalizumab) dosage forms
Typical dosing for Xolair (omalizumab)
Your allergist will determine and adjust your dose of Xolair (omalizumab) based on different factors like body weight, serum IgE level, and how well the medication is working for you.
Xolair (omalizumab) 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.
Interactions between Xolair (omalizumab) and other drugs
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Tofacitinib
What are alternatives to Xolair (omalizumab)?
Moderate-to-severe allergic asthma
Chronic spontaneous urticaria (CSU) (chronic hives of unknown cause)
Lower risk of severe allergic reactions after accidental exposure to food triggers
Moderate-to-severe eczema that isn't well-controlled by other topical medications - adults and children 6 months and older
Add-on treatment for moderate-to-severe asthma - adults and children 6 years and older
Long-term sinus congestion with nasal polyps - adults only
Swollen esophagus (eosinophilic esophagitis) - adults and children 1 year and older
Long-term itchy skin bumps (prurigo nodularis) - adults
What is the latest news about Xolair (omalizumab)?
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References
Best studies we foundAmerican College of Allergy, Asthma, & Immunology. (n.d.). Chronic rhinosinusitis with nasal polyps.
Genentech, Inc. (2024). Xolair® (omalizumab) injection, for subcutaneous use; Xolair® (omalixumab) for injection, for subcutaneous use [package insert]. DailyMed.
Genentech, Inc. (2024). Xolair- omalizumab injection, solution; Xolair PFS- omalizumab injection, solution; Xolair- omalizumab injection, solution [package insert]. DailyMed.
Van Herck, M., et al. (2018). Fatigue is highly prevalent in patients with asthma and contributes to the burden of disease. Journal of Clinical Medicine.
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