Xolair
Xolair (omalizumab) is a prescription injection used to treat allergic asthma, chronic hives, and nasal polyps. It's also approved to help lower the risk of food allergy reactions if you or your child are accidentally exposed to a trigger. Xolair (omalizumab) is a monoclonal antibody that works by calming your immune system to reduce inflammation and allergy symptoms. You'll get it as a shot under the skin the every 2 or 4 weeks. Common side effects include headache, stomach pain, and dizziness.
What is Xolair (omalizumab)?
What is Xolair (omalizumab) used for?
- Moderate-to-severe allergic asthma - people 6 years and older
- Chronic rhinosinusitis (sinus inflammation) with nasal polyps - adults only
- To prevent food allergy reactions after accidental exposure - people 1 year and older
- Chronic hives - people 12 years and older
How Xolair (omalizumab) works
Xolair (omalizumab) is a monoclonal antibody. It blocks immunoglobulin E (IgE), an antibody that causes allergic reactions. By stopping IgE from working, Xolair (omalizumab) helps calm your immune system so you have fewer allergy symptoms and flare-ups.
Drug facts
Side effects of Xolair (omalizumab)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
Allergic asthma:
- Joint pain (8%)
- Body pain (7%)
- Leg pain (4%)
- Dizziness (3%)
- Tiredness (3%)
Chronic rhinosinusitis with nasal polyps:
- Headache (8%)
- Injection site reactions (5%)
Chronic hives:
- Headache (up to 12%)
- Common cold symptoms (up to 9%)
- Sinus inflammation (up to 5%)
Prevention of food allergy reactions:
- Injection-site reactions (16%)
- Fever (6%)
Less Common Side Effects
Allergic asthma:
- Fracture
- Arm pain
- Itching
- Ear ache
- Rash
Chronic rhinosinusitis with nasal polyps:
- Stomach pain
- Joint pain
- Dizziness
Chronic idiopathic urticaria (hives):
- Nausea
- Cough
- Joint pain
Xolair (omalizumab) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Severe allergic reactions: shortness of breath, wheezing, swelling of the face or throat, dizziness, itching, hives, flushing
- Inflammation of your blood vessels: rash, shortness of breath, tingling or numbness in arms or legs, chest pain
- Heart and circulation problems: chest pain, heart attack, blood clots, stroke
- Parasitic infections: fever, stomach pain, rash, diarrhea, bloating, itching
- Fever, muscle aches, and rash: fever, muscle or joint pain, rash, swollen lymph nodes
More on Xolair (omalizumab) side effects
The following Xolair (omalizumab) 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
- Injected once every 2 or 4 weeks
- Can be given at home for some people
- Helps to prevent allergies from many different foods
Cons
- Commonly causes headache, joint pain, and infections
- Risk of severe allergic reactions
- Can take months to see the full effects
Pharmacist tips for Xolair (omalizumab)
- You’ll usually inject Xolair (omalizumab)] every 2 or 4 weeks. If you need more than one injection for your dose, give yourself all the injections one after another in the same sitting.
- Xolair (omalizumab) can cause injection-site reactions, like pain, bruising, itchiness, and redness. These are usually mild and go away in a few days, but contact your allergist if they don’t.
- Xolair (omalizumab) helps control allergic asthma and food allergy symptoms over time. But it won’t stop an asthma attack or allergic reaction once it starts, so always carry a rescue inhaler or epinephrine with you at all times.
- Tell your allergist about any changes in body weight while using Xolair (omalizumab). Your dose depends on body weight, so it might need to be adjusted.
- Don’t lower the dose or stop taking any of your other medications for asthma, nasal polyps, chronic hives, food allergies, or allergy shots unless your prescriber tells you to. When you start Xolair (omalizumab), you might not notice improvement in your symptoms right away, so it's important to keep taking your other treatments.
- If you're pregnant or breastfeeding, don't use Xolair (omalizumab) without talking to your allergist first. It isn’t known if this medication harms an unborn baby or passes into breast milk.
- Store Xolair (omalizumab) in the original carton in the refrigerator to protect it from light. If needed, you can keep it at room temperature for up to 2 days total.
How to inject Xolair (omalizumab) at home:
- If your allergist says it's safe for you to use Xolair (omalizumab) at home, follow their directions carefully whether you're using the syringe or autoinjector. Contact your pharmacist or allergist if you have any questions.
- Before injecting Xolair (omalizumab)], take the carton from the fridge and place it on a flat surface to warm up. This takes about 15–30 minutes for the syringe or 30–45 minutes for the autoinjector. Don’t try to warm it any other way.
- Inject Xolair (omalizumab) under the skin in your thigh, stomach, or back of your upper arm. Avoid areas within 2 inches of your belly button and don’t inject into bruised, scarred, or tender skin.
- After your injection, place the needle in a sharps container or a sturdy plastic container like an empty detergent bottle to avoid needlestick injuries.
Common questions about Xolair (omalizumab)
Xolair (omalizumab) can be helpful, but it also has risks. Most people only get mild side effects like headache, stomach pain, or dizziness. But in rare cases it can cause severe allergic reactions, including anaphylaxis, which can be life-threatening. Because of this, you might need to stay at your allergist’s office for a short time after your shot so they can watch for any reaction. Your allergist will decide if the benefits of this medication outweigh the risks.
You'll inject Xolair (omalizumab) every 2 or 4 weeks if you're using it for allergic asthma, nasal polyps, and to help prevent food allergy reactions. For chronic hives, you'll inject it every 4 weeks. Your prescriber will tell you the exact dose and how often you should take it.
Though very rare, some people in clinical studies who took Xolair (omalizumab)] developed different types of cancer. But newer studies haven't shown a clear link between this medication and cancer. If you or someone in your family has a history of cancer, be sure to tell your allergist before starting treatment so you can talk together about the possible risks and benefits.
Being sick usually won't stop you from getting your dose of Xolair (omalizumab). But it's always best to check with your prescriber since it can depend on the type of illness. Xolair (omalizumab) can raise your risk of infections, including common colds and upper respiratory infections. If you have a serious infection or feel very sick, your prescriber might recommend waiting to take your next dose.
It's best to keep Xolair (omalizumab) in the refrigerator, but you can leave it out at room temperature if needed. Once the medication reaches room temperature, you can put it back in the fridge, but the total time it can stay out of the fridge is for up to 2 days. To help you keep track, write the date on the box when you first take it out.
No, Xolair (omalizumab) isn't a steroid. Instead, it's a biologic medication, meaning it's made from living sources in a lab. Xolair (omalizumab) is a monoclonal antibody, or a lab-made protein, that works by reducing inflammation. It does this by stopping immunoglobulin E (IgE), an antibody that triggers allergic reactions, which helps treat certain allergic conditions and their symptoms.
It takes about 3 to 4 months for most of Xolair (omalizumab) to fully leave your body after just one dose. This time frame is estimated based on its half-life. Even though it can last that long, you still need to take it every 2 or 4 weeks as prescribed. This keeps enough medication in your system so it works properly to manage your condition.
How long it takes for Xolair (omalizumab) to work depends on the condition you're being treated with. It might start helping in as little as 4 weeks, but for some people it can take up to 4 months to feel the full effects. Everyone responds differently, so if you’re worried about how well the medication is working for you, check in with your allergist.
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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 reaction
- Risk factors: History of severe allergic reaction
It's possible to have a life-threatening allergic reaction to Xolair (omalizumab) called anaphylaxis. Symptoms can include trouble breathing, dizziness, itchy skin, and swelling of your throat or tongue. This reaction is most likely to happen within the first few doses, but it has also been reported up to a year after starting treatment.
To be safe, your allergist will give you your first few doses of Xolair (omalizumab) in a clinic or hospital that is equipped to treat a serious allergic reaction. You may be asked to stay for a few hours after each dose so you can be monitored. If you don’t have any problems, your care team might train you to give future doses at home. If you ever have anaphylaxis at home, call 911 right away.
Cancer risk
Though rare, some people who took Xolair (omalizumab)] in clinical studies developed different types of cancer, but it’s not clear if the medication was the cause. If you or someone in your family has a history of cancer, let your allergist know before starting treatment. Together, you can weigh the possible risks and benefits of using this medication.
Not for an asthma attack
Xolair (omalizumab) doesn’t work right away to stop asthma attacks. Don’t use it to treat sudden breathing problems or severe asthma attacks. If you have an asthma attack, use your rescue inhaler like albuterol. If your asthma gets worse after starting this medication, contact your allergist for guidance.
Don't stop corticosteroids suddenly
Don’t stop oral or inhaled steroids suddenly when switching to Xolair (omalizumab)]. This can worsen symptoms and raise your risk for steroid withdrawal. Your allergist will taper your dose slowly if needed.
Inflammation of blood vessels
- Risk factors: Tapering off oral steroids
Very rarely, people taking Xolair (omalizumab) have had symptoms related to blood vessel problems. Symptoms can include rash, shortness of breath, tingling or numbness in arms or legs, chest pain. If you notice any of these symptoms, contact your allergist right away.
Fever, muscle pain, and rash
Some people who get Xolair (omalizumab)] may have fever, muscle aches, rash, or swollen lymph nodes within 1 to 5 days after a shot. Tell your care team right away if you notice these side effects. Since these symptoms can look like a condition called serum sickness, your allergist will stop Xolair (omalizumab) if they happen.
Parasitic infections
If you're at a high risk for parasitic infections, like roundworm or hookworm, tell your allergist before starting Xolair (omalizumab). This medication might raise your risk of getting a parasitic infection. Talk to your allergist about the possible risks and benefits before you begin treatment.
Not for emergency treatment
You shouldn't use Xolair (omalizumab) to treat an allergic reaction in an emergency. This medication is meant for long-term use to help lower your risk of allergic reactions, including anaphylaxis. It's still important to avoid foods you're allergic to while taking this medication. If you ever develop symptoms of a serious allergic reaction, use your prescribed emergency treatments, such as epinephrine, and get medical attention right away.
Xolair (omalizumab) dosage
Typical dosage for Xolair (omalizumab)
Your allergist will decide your dose of Xolair (omalizumab) and might adjust it over time. The dose depends on things like your body weight, your serum IgE level, and how well the medication is working for you.
Xolair (omalizumab) is injected under the skin, usually in the front and middle of your thigh or in your stomach area (at least 2 inches away from your belly button).If a caregiver gives the shot, it can also go in the back of your upper arm.
- Allergic asthma: The typical dose ranges from 75 mg to 375 mg injected under the skin every 2 or 4 weeks.
- Chronic rhinosinusitis with nasal polyps: The typical dose ranges from 75 mg to 600 mg injected under the skin every 2 or 4 weeks.
- Prevention of food allergy reactions: The typical dose ranges from 75 mg to 600 mg injected under the skin every 2 or 4 weeks.
- Chronic hives: The typical dose ranges from 150 mg or 300 mg injected under the skin every 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
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