Omalizumab | Side Effects, Dosage, Uses & More
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Generic Name:

omalizumab, Injectable solution

All Brands

  • Xolair
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Highlights for omalizumab

Injectable solution
1

Omalizumab is used for moderate to severe allergic asthma for people who aren’t responding to their current asthma medications.

2

It may also be used for hives that occur without a known cause (chronic idiopathic urticarial).

3

Omalizumab is only administered in a clinic setting by a healthcare professional. You cannot give this drug to yourself.

4

Omalizumab is available as the brand Xolair.

5

Common side effects of omalizumab are injection site reactions. These may include redness, swelling, itching, and warmth at the site where omalizumab is injected.

IMPORTANT INFORMATION

FDA warning

This drug has a black box warning. This is the most serious warning from the Food and Drug Administration (FDA). A black box warning alerts doctors and patients about drug effects that may be dangerous.

Anaphylaxis warning. Anaphylaxis is a severe and sometimes life-threatening reaction that can occur after you receive omalizumab. You will only be able to receive omalizumab in a healthcare setting where you will be monitored for these types of reactions. This reaction can occur right after you first dose. Or it may happen more than a year after you start treatment with this drug.

Not for asthma attacks

Do not use this drug to treat asthma attacks. Talk to your doctor about what medications can be used for treating asthma attacks.

Steroid discontinuation

Do not stop using oral corticosteroid tablets, such as prednisone, or your maintenance steroid inhaler without talking with your doctor first.

What is omalizumab?

Your healthcare provider will inject this drug under your skin (subcutaneous injection). Only a healthcare provider can give you this drug. You can’t give it to yourself.

Why it's used

This drug helps to decrease the number of asthma attacks you have. It is given to people aged 12 years and older who have moderate to severe allergic asthma that is not controlled by corticosteroid inhalers.

More Details

How it works

This drug injection belongs to a class of drugs called anti-IgE monoclonal antibodies. A class of drugs is a group of medications that work in a similar way. These drugs are often used to treat similar conditions. 

More Details

Why it's used

This drug helps to decrease the number of asthma attacks you have. It is given to people aged 12 years and older who have moderate to severe allergic asthma that is not controlled by corticosteroid inhalers. Allergic asthma is caused by substances in the air, such as pollen, dust mites, and dander.

This drug is also used to treat chronic hives that occur with no known cause and cannot be controlled by drugs called antihistamines.

How it works

This drug injection belongs to a class of drugs called anti-IgE monoclonal antibodies. A class of drugs is a group of medications that work in a similar way. These drugs are often used to treat similar conditions. 

This drug works by binding to and lowering amounts of an antibody called immunoglobulin E (IgE).  

In people with mild to severe allergic asthma, IgE is believed to help increase the allergic response and inflammation. By lowering your amounts of IgE, you are less likely to have an asthma attack. 

In people with hives that occur with no known cause, IgE is thought to be involved, but it is not known exactly how.

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omalizumab Side Effects

Injectable solution

More Common Side Effects

Some of the more common side effects that can occur with use of omalizumab include:

  • reactions at the injection site

  • pain in your joints, arms, and legs

  • tiredness

  • ear pain

  • headache

  • nausea

  • swelling of the nose, throat, or sinuses

If these effects are mild, they may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk to your doctor or pharmacist.

Serious Side Effects

Call your doctor right away if you have serious side effects. Call 9-1-1 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:

  • Allergic reaction. Symptoms may include:

    • fever
    • muscle aches
    • rash
    • hives
    • trouble breathing
    • swelling of your tongue, lips, face, and throat
    • low blood pressure
    • fainting
  • Shortness of breath

  • Coughing up blood

  • Skin sores

  • Severe pain and numbness or tingling in hands or feet

  • Certain types of cancer. Symptoms may include:

    • Change in bladder or bowel habits
    • Persistent cough or hoarseness
    • Sores that don’t heal
    • Unusual bleeding or discharge
    • Change in the size or color of a mole or wart
    • Persistent upset stomach or difficulty swallowing
    • Lumps or thickened areas on your body
  • Infection from parasites. You may be at higher risk of infection from parasites, such as roundworm, hookworm, whipworm, or threadworm, after receiving this drug. Symptoms may include:

    • diarrhea
    • blood or worms or both in your stool
    • persistent upset stomach
    • nausea and vomiting
    • loss of appetite
    • rash contained to a specific area on your body
    • weight loss
    • insomnia
Pharmacist's Advice
Healthline Pharmacist Editorial Team

This drug can cause tiredness.

You may have the following reactions at the injection site:

  • pain
  • swelling
  • warmth
  • bruising
  • burning
  • itching
  • hardness
Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this information includes all possible side effects. This information is not a substitute for medical advice. Always discuss possible side effects with a healthcare provider who knows your medical history.
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omalizumab May Interact with Other Medications

Injectable solution

An interaction is when a substance changes the way a drug works. This can be harmful or prevent the drug from working well. To help prevent interactions, your doctor should manage all of your medications carefully. Be sure to tell your doctor about all medications, vitamins, or herbs you’re taking. 

To find out how this drug might interact with something else you’re taking, talk to your doctor or pharmacist.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs interact differently in each person, we cannot guarantee that this information includes all possible interactions. This information is not a substitute for medical advice. Always speak with your healthcare provider about possible interactions with all prescription drugs, vitamins, herbs and supplements, and over-the-counter drugs that you are taking.
Drug warnings
Pregnant women
Pregnant women

This drug is a category B pregnancy drug. That means two things: 

  1. Studies of the drug in pregnant animals have not shown a risk to the fetus.
  2. There aren’t enough studies done in pregnant women to show if the drug poses a risk to the fetus.

Talk to your doctor if you’re pregnant or planning to become pregnant. This drug should be used only if the potential benefit justifies the potential risk to the fetus.

breast-feeding
Women who are breast-feeding

This drug may pass into breast milk and may cause side effects in a child who is breast-fed.

Talk to your doctor if you breast-feed your baby. You may need to decide whether to stop breast-feeding or stop taking this medication.

children
For children

This drug has not been approved for children younger than 12 years.

allergies
Allergies

This drug can cause a severe allergic reaction. Symptoms can include: 

  • Wheezing, coughing, tightness in the chest, difficulty breathing
  • Dizziness, feeling faint, rapid or weak heartbeat
  • Hives, flushing, itching
  • Difficulty swallowing, swelling of the throat or tongue 

Call 9-1-1 or go to the nearest emergency room if you develop these symptoms.

Don’t take this drug again if you’ve ever had an allergic reaction to it. Taking it again could be fatal (cause death).

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How to Take omalizumab (Dosage)

Injectable solution

Your doctor will determine a dosage that’s right for you based on your individual needs. Your general health may affect your dosage. Tell your doctor about all health conditions you have before your healthcare provider administers the drug to you.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this list includes all possible dosages. This information is not a substitute for medical advice. Always to speak with your doctor or pharmacist about dosages that are right for you.
Pharmacist's Advice
Healthline Pharmacist Editorial Team

This drug comes with risks if you don’t take it as prescribed.

If you stop taking the drug or don’t take it at all

Your condition may not improve and it may worsen.

If you miss doses or don’t take the drug on schedule

Your medication may not work as well. Keep all appointments you have with your doctor and laboratory.

If you take too much

You could have dangerous levels of the drug in your body. If you think you’ve taken too much of the drug, act right away. Call your doctor or local poison control center, or go to the nearest emergency room.

What to do if you miss a dose

Call your doctor as soon as you realize you have to miss an appointment to receive an injection.

How to tell if the drug is working

Your asthma symptoms will improve and you will experience fewer asthma attacks.

This drug is used for long-term treatment.

How long does it take?

Your doctor will decide how long you need to stay after the injection in order to make sure you are not experiencing any serious side effects.

Travel

Talk to your doctor about any travel plans you have that may overlap when you are due to receive your next injection. In order to avoid missing an injection, you may have to schedule your injection at a different office in advance while you are traveling.

Clinical monitoring

Your doctor will test your blood. This will be done to check your levels of Immunoglobulin E. Your doctor will also test your lung function.

Insurance

Many insurance companies require a prior authorization for this drug. This means your doctor will need to get approval from your insurance company before your insurance company will pay for the prescription.

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How Much Does omalizumab Cost?

Injectable solution

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Lowest price for omalizumab

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These prices represent the lowest priced national pharmacies for omalizumab on GoodRx. They may be lower than your insurance.

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Content developed in collaboration with University of Illinois-Chicago, Drug Information Group

Medically reviewed by Creighton University, Center for Drug Information and Evidence-Based Practice on January 21, 2016

Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up-to-date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.
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