Xolair is a brand-name prescription drug. It’s used to treat the following conditions:

  • Asthma. Xolair is used to treat moderate to severe asthma that’s persistent (long-lasting). For this condition, Xolair is prescribed for people ages 6 years and older who have both:
  • Hives. Xolair is used to treat long-lasting hives with an unknown cause. (This condition is called chronic spontaneous urticaria, which used to be called chronic idiopathic urticaria.) For this use, Xolair is prescribed for people ages 12 years and older who continue to have hives even after they’ve used certain antihistamines.
  • Nasal polyps. Xolair is used to treat nasal polyps in adults whose condition hasn’t improved with nasal corticosteroids. It’s given in combination with other treatments for this condition.

This drug has certain limitations of use. For more information about Xolair’s uses and its limitations, see the following sections:

Drug details

Xolair contains the drug omalizumab. It’s a monoclonal antibody, which is a biologic drug that’s made from immune system cells. Xolair works with your body’s immune system to treat the conditions listed above.

Xolair is given by subcutaneous injection (an injection under your skin) at a healthcare facility. After a Xolair injection, your doctor or nurse will monitor you for a while. This allows them to manage any side effects that you may have, including allergic reaction to the drug.

If your doctor recommends it, you may be able to give Xolair injections to yourself at home. But you’ll receive at least your first three Xolair injections at a healthcare facility.

Xolair is available in two strengths:

  • 75 milligrams (mg)/0.5 milliliters (mL) and 150 mg/1 mL. These strengths each come as a liquid solution inside prefilled single-dose syringes.
  • 150 mg. This strength comes as a powder that’s mixed with liquid to form a solution. It comes in single-dose vials.

Effectiveness

In clinical studies, Xolair was effective at treating allergic asthma, chronic hives, and nasal polyps. To learn how the drug performed in these studies, see the following sections:

Xolair contains the active drug omalizumab, which is a biologic medication. It’s available only as a brand-name medication. Xolair isn’t currently available in biosimilar form.

Biologic medications are made from living cells. A biosimilar medication is a drug that’s similar to a brand-name biologic drug (the parent drug).

It’s not possible to make an exact copy of a biologic. A generic, on the other hand, refers to a drug made from chemicals. A generic is an exact copy of the active drug in a brand-name medication.

Biosimilars are considered just as safe and effective as their parent drugs. And like generics, biosimilars tend to cost less than brand-name medications.

Xolair can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Xolair. These lists do not include all possible side effects.

For more information on the possible side effects of Xolair, talk with your doctor or pharmacist. They can give you tips on how to deal with any side effects that may be bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs they have approved. If you would like to report to the FDA a side effect you’ve had with Xolair, you can do so through MedWatch.

Side effects of Xolair can vary depending on the condition you’re using the drug to treat. The more common side effects seen in Xolair’s clinical studies are described below.

More common side effects

The more common side effects of Xolair in people ages 12 years and older with asthma can include:

  • pain, which can be throughout your body, including in your joints, legs, and arms
  • reactions near the site of your Xolair injections, which may cause redness or pain
  • dizziness
  • tiredness
  • itchy skin
  • skin rash
  • bone fractures
  • earache

The more common side effects of Xolair in people ages 12 years and older with chronic hives can include:

The more common side effects of Xolair in adults with nasal polyps can include:

  • headache
  • reactions near the site of your Xolair injections, which may cause pain or discoloration, such as redness
  • pain in your joints or upper abdomen
  • dizziness

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

Serious side effects

Serious side effects from Xolair aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 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:

  • Parasitic (worm) infection. Symptoms can include:
    • pain in your abdomen
    • diarrhea
  • Heart and blood circulation problems, such as heart attack, stroke, and blood clots. Symptoms can include:
    • pain in your chest
    • being unable to speak clearly, for example due to slurring
    • feeling weak on one side of your body
    • having changes in your vision
  • Bone fractures.

Other serious side effects, which are discussed in more detail below, include:

* Xolair has a boxed warning from the Food and Drug Administration (FDA) regarding the risk of anaphylaxis (a severe allergic reaction). A boxed warning is the strongest warning the FDA requires. It alerts doctors and patients about drug effects that may be dangerous.

Side effects in children

The safety of Xolair in children (ages 6 to less than 12 years) was reported from clinical studies of children with asthma. At least 3% of children using Xolair had one or more of the following side effects:

These side effects occurred more often in children using Xolair than in those using a placebo. (A placebo is a treatment with no active drug).

If you’re concerned about side effects in a child using Xolair, talk with the child’s doctor. They can recommend ways to help improve these side effects during treatment.

Side effect details

You may wonder how often certain side effects occur with this drug, or whether certain side effects pertain to it. Here’s some detail on several of the side effects this drug may or may not cause.

Cancer

Some people have developed cancer while using Xolair. In clinical studies of people ages 12 years and older, some people using Xolair developed breast, skin, or prostate cancer. Cancer development wasn’t seen in people ages 6 to 12 years who took Xolair.

In the studies, of the people taking Xolair, 0.5% developed cancer. In comparison, 0.2% of people taking a placebo (treatment with no active drug) developed cancer.

However, in another study of people with asthma, those who were taking Xolair had similar rates of cancer development as those who either took other asthma drugs or didn’t take any treatment at all.

Symptoms of cancer can vary depending on what type of cancer you have. If you have concerns about your risk of developing cancer while using Xolair, talk with your doctor.

Allergic reaction, including anaphylaxis

As with most drugs, some people can have an allergic reaction after taking Xolair.

Symptoms of a mild allergic reaction can include:

  • skin rash
  • itchiness
  • flushing (warmth and redness in your skin)

A more severe allergic reaction, called anaphylaxis, is rare but possible. In fact, Xolair has a boxed warning from the Food and Drug Administration (FDA) regarding the risk of anaphylaxis. A boxed warning is the strongest warning the FDA requires. It alerts doctors and patients about possible side effects that may be dangerous.

Symptoms of anaphylaxis can include:

  • swelling under your skin, typically in your eyelids, lips, hands, or feet
  • swelling of your tongue, mouth, or throat
  • trouble breathing
  • cough
  • tightness in your chest
  • flushing
  • hives and itchiness

It’s possible to have anaphylaxis right after your Xolair injection, or days after your injection. This reaction can occur after just one dose of the drug or after many doses.

In clinical trials of people with asthma who took Xolair, 0.1% had anaphylaxis. Once Xolair was on the market and available by prescription, anaphylaxis was reported in 0.2% of people using the drug. (This percentage was based on an estimated number of 57,300 people using Xolair over a 3-year period.)

After you’re given Xolair, you’ll be monitored closely for this reaction by your healthcare professional.

If your doctor has you administer Xolair injections yourself, they’ll first consider your risk of anaphylaxis. And they’ll make sure you’re able to identify anaphylaxis and treat it right away.

Call your doctor right away if you have a severe allergic reaction to Xolair. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency.

If you’ve had a severe allergic reaction to Xolair, you shouldn’t continue using the drug. Your doctor will recommend a different medication for you to use instead of Xolair.

Injection site reactions

Injection site reactions are possible while you’re using Xolair. These reactions occur at or near the area where the drug was injected under your skin.

Symptoms of injection site reactions can include the following problems near your injection site:

  • burning
  • stinging
  • pain
  • bruising
  • itchiness
  • redness

In clinical studies, 45% of people taking Xolair for asthma had an injection site reaction. Of those with asthma who took a placebo (treatment with no active drug), 43% had an injection site reaction.

Of people taking Xolair for chronic hives, 0.6% to 2.7% of people had injection site reactions. This is compared to 0.8% of people with chronic hives who took a placebo.

In people taking Xolair for nasal polyps, 5.2% had injection site reactions. In comparison, 1.5% of people taking a placebo reported this side effect.

During studies, some people who took Xolair for asthma also had severe injection risk reactions. Of people using Xolair, 12% had a severe injection site reaction. Of people using a placebo, 9% had the same result.

If you have an injection site reaction while you’re using Xolair, talk with your doctor. They can recommend ways to help manage this side effect.

Hair loss

You may have hair loss, which is also called alopecia, while you’re using Xolair.

In clinical studies of people with chronic hives, hair loss occured in at least 2% of people taking Xolair. Hair loss was seen in a lower percentage of people taking a placebo (tretment with no active drug).

If you have concerns about hair loss while you’re using Xolair, talk with your doctor. They can recommend ways to help manage this condition.

Joint pain

You may have joint pain (arthralgia) while you’re using Xolair.

In clinical studies of people with asthma, joint pain occurred in 8% of those taking Xolair. In comparison, joint pain occurred in 6% of people taking a placebo (treatment with no active drug).

In clinical studies of people with chronic hives, joint pain occurred in 2.9% of those taking Xolair. Of people taking a placebo, only 0.4% had joint pain.

In studies of people with nasal polyps, joint pain was reported in 3% of those taking Xolair. In people taking a placebo, 1.5% reported joint pain.

If you have joint pain while you’re using Xolair, talk with your doctor. They can recommend ways to help relieve your discomfort.

Fever, rash, and joint pain

After Xolair became available by prescription, fever, rash, and joint pain have been reported in people using the drug. These symptoms are similar to those caused by a condition called serum sickness (an immune response that’s similar to an allergic reaction).

Fever, rash, and joint pain can occur 1 to 5 days after you’ve received Xolair. These symptoms may happen after your first dose of Xolair or after you’ve had multiple doses of the drug.

If you have a fever, skin rash, and joint pain while you’re using Xolair, call your doctor right away. They may recommend that you stop using Xolair.

Skin rash

Dermatitis (inflammation in your skin that may cause a rash) has occurred in some people taking Xolair.

In clinical studies of people with asthma, dermatitis was reported in 2% of those taking Xolair. In people taking a placebo (treatment with no active drug), 1% had dermatitis.

If you develop a skin rash while using Xolair, talk with your doctor. They can recommend ways to help manage this condition.

Weight gain or weight loss (not a side effect)

There weren’t any reports of weight loss or weight gain in people using Xolair during clinical studies.

If you’re concerned about changes in your weight while you’re using Xolair, talk with your doctor. They can recommend diet and exercise tips to encourage a healthy weight.

Your healthcare professional will give you injections of Xolair in their office or clinic. If your doctor recommends it, you may be able to give yourself Xolair injections at home.

If you and your doctor agree that you’ll give yourself Xolair injections, you’ll have to get Xolair at a specialty pharmacy. This type of pharmacy is authorized to carry specialty medications. These are drugs that may be expensive or may require help from healthcare professionals to be used safely and effectively.

The price you’ll pay for Xolair depends on your insurance plan and your dosage of the drug. If you have any questions about the cost of Xolair, call your doctor’s office or your insurance company.

Before approving coverage for Xolair, your insurance company may require you to get prior authorization. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the prior authorization request and decide if the drug will be covered.

If you’re not sure whether you’ll need to get prior authorization for Xolair, contact your insurance company.

Financial assistance

If you need financial support to pay for Xolair, help is available. Genentech, Inc., the manufacturer of Xolair, offers a number of programs and services, including the Xolair Co-pay Program and Xolair Access Solutions.

For more information about insurance coverage for Xolair and to see if you’re eligible for financial support, call Xolair Access Solutions at 866-422-2377. If you’d like more information about the Xolair Co-pay Program, call 855-965-2472. You can also visit the manufacturer’s website for information about cost assistance.

The Xolair dosage your doctor prescribes will depend on several factors. These include:

  • the type and severity of the condition you’re using Xolair to treat
  • your age
  • your weight
  • other medical conditions you may have

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to suit your needs.

Drug forms and strengths

Xolair is available in two strengths:

  • 75 milligrams (mg)/0.5 milliliters (mL) and 150 mg/1 mL. These strengths each come as a liquid solution inside prefilled single-dose syringes.
  • 150 mg. This strength comes as a powder that’s mixed with liquid to form a solution. It comes in single-dose vials.

Both forms of Xolair are given by subcutaneous injection (an injection under your skin). You’ll receive Xolair injections at your healthcare professional’s office.

If your doctor recommends it, you may be able to give yourself Xolair injections at home. But you’ll receive at least your first three Xolair injections at a healthcare facility.

The maximum dose of Xolair that can be injected into one area of your body is 150 mg. If your dose of Xolair is greater than 150 mg, you’ll get more than one injection, in different areas of your body. (For more information about injection sites, see the “How Xolair is given” section below.)

Dosage for chronic hives

The typical dosage of Xolair for chronic (long-lasting) hives with an unknown cause is either:

  • 150 mg once every 4 weeks, or
  • 300 mg once every 4 weeks

This is the recommended dosage for this condition in adults and children ages 12 years and older.

Dosage for allergic asthma

The typical dosage of Xolair for persistent (long-lasting) allergic asthma is 75 mg to 375 mg once every 2 or 4 weeks.

Your exact dosage will be based on your body weight and the results of a certain blood test that checks for an allergy marker called immunoglobulin E (IgE). Your doctor will order this test for you before you start taking Xolair.

This is the recommended dosage for this condition in adults and children ages 12 years and older.

Dosage for nasal polyps

The typical dosage of Xolair for nasal polyps is 75 mg to 600 mg once every 2 or 4 weeks.

Your exact dosage will be based on your body weight and the results of a blood test that checks for an allergy marker called immunoglobulin E (IgE). Your doctor will order this test for you before you start taking Xolair.

This is the recommended dosage for this condition in adults.

Pediatric dosage

Pediatric dosages of Xolair vary, depending on the condition treated.

Children’s dosage for hives

For chronic hives, the typical dosage of Xolair is the same in children (ages 12 years and older) as it is in adults. For dosage information, see the section above called “Dosage for chronic hives.”

Children’s dosage for asthma

For persistent allergic asthma, children’s dosages vary, as shown in the following chart:

For children ages 6 years to less than 12 years:Xolair is typically given once every 2 to 4 weeks. Their Xolair dosage will be based on their body weight and the results of a certain blood test that checks for an allergy marker called immunoglobulin E (IgE).
For children ages 12 years and older:Xolair is given in the same dosages as for adults. For this information, see the section above called “Dosage for allergic asthma.”

What if I miss a dose?

If you miss an appointment for your dose of Xolair, call your healthcare professional’s office right away to schedule another injection.

If you give Xolair injections at home, call your doctor and ask how you should handle the missed injection.

To help you avoid missing a dose, try setting a reminder on your phone or leaving a note for yourself on your calendar.

Will I need to use this drug long term?

Xolair is meant to be used as a long-term treatment. If you and your doctor determine that Xolair is safe and effective for you, you’ll likely take it long term. You doctor will monitor your symptoms and recommend if you should continue treatment with Xolair.

The Food and Drug Administration (FDA) has approved Xolair to treat a type of hives called chronic spontaneous urticaria in adults and children ages 12 years and older. It’s used in people whose hives aren’t controlled with certain antihistamines.

Chronic spontaneous urticaria used to be called chronic idiopathic urticaria (CIU). It’s a condition that has all of these characteristics:

  • It’s chronic (lasts a long time). It may occur every day, and it lasts for 6 weeks or longer.
  • It has no known cause (called spontaneous or idiopathic). With this condition, certain blood or skin tests haven’t shown the cause for your hives. (If the cause of your hives is found, you may be prescribed a medication other than Xolair for treatment.)
  • It results in hives (urticaria). Hives are small bumps on your skin that usually feel itchy. They’re sometimes called wheals or welts.

When certain antihistamines (called H1 antihistamines) no longer work to treat your hives, Xolair may be an option for you. This drug helps to relieve itchiness and reduce your number of hives.

It’s important to note that Xolair should not be used to treat other forms of hives.

In addition to treating chronic spontaneous urticaria, Xolair is also approved to treat asthma. For more details, see the “Xolair for asthma” section below. Additionally, it’s approved to treat nasal polyps, which is described below in “Xolair for nasal polyps.”

Effectiveness

One clinical study looked at people ages 12 years and older with chronic hives. Xolair was given to people in a dosage of either 150 mg or 300 mg every 4 weeks. Some people in the study were given a placebo (treatment with no active drug) instead of Xolair. All of the people were given an antihistamine.

After 12 weeks of treatment:

  • People who took 300 mg of Xolair had a 67% fewer hives each week than they had prior to treatment.
  • People who took 150 mg of the drug had a 50.2% fewer hives each week than they had prior to treatment.
  • People who took the placebo had 25% fewer hives each week.

Also after 12 weeks:

  • People who took the 300 mg dosage of Xolair had about 66.6% less itching each week than they had prior to treatment.
  • People taking the 150 mg dosage of Xolair had about 47.7% less itching each week than they had prior to treatment.
  • People taking the placebo had 25.5% less itching each week.

The Food and Drug Administration (FDA) has also approved Xolair to treat a certain type of asthma in adults and children ages 6 years and older.

Xolair is used to treat asthma that has all of these characteristics:

  • It causes moderate to severe symptoms.
  • It’s persistent (long-lasting).
  • It’s considered “allergic asthma,” which is diagnosed by having a positive skin or blood test for allergens that are present year-round.
  • It didn’t improve after treatment with other drugs called inhaled corticosteroids.

Symptoms of allergic asthma can occur when you breathe in allergens, such as pet dander or dust mites. Some allergens are around all throughout the year. Sometimes allergens can trigger your asthma symptoms to flare up (also called an asthma attack).

Symptoms of asthma that may occur include:

  • trouble breathing
  • tightening in your chest
  • coughing
  • wheezing

It’s important to note that Xolair shouldn’t be used to treat sudden asthma symptoms, such as shortness of breath. Instead, you should use a rescue inhaler for these symptoms. To learn more, see the “Xolair use with other drugs” section below.

In addition to treating asthma, Xolair is also approved to treat hives. For more details, see the “Xolair for hives (urticaria)” section above. Additionally, it’s approved to treat nasal polyps, which is described below in “Xolair for nasal polyps.”

Effectiveness

Xolair has been found effective to treat allergic asthma when it’s used with other asthma medications called inhaled corticosteroids (ICS).

A clinical study included people ages 12 years and older with allergic asthma. Some of the people were given Xolair, while others were given a placebo (treatment with no active drug). Everyone in the study was also given an ICS.

After 16 weeks of treatment, 85.8% of people using the Xolair combination had no asthma attacks. Of those taking the placebo combination, 76.7% had the same result.

Over the next 12 weeks of the study, the dosage of ICS was lowered. (This was done to see if people taking Xolair could safely decrease the amount of steroid that they were taking.)Of those using the Xolair combination, 78.7% had no asthma attacks. Of those taking the placebo combination, 67.7% had no asthma attacks.

The Food and Drug Administration (FDA) has also approved Xolair to treat nasal polyps in adults.

The drug is used in adults whose condition hasn’t improved with nasal corticosteroids. And it’s given in combination with other treatments for this condition.

Nasal polyps are noncancerous growths that form inside the nose or sinuses. These growths may not cause symptoms in some people. But possible symptoms of nasal polyps include:

  • stuffy or runny nose
  • altered sense of smell or taste
  • facial pain
  • breathing problems

In addition to treating nasal polyps, Xolair is also approved to treat hives. For more details, see the “Xolair for hives (urticaria)” section above. Additionally, it’s approved to treat asthma, which is described above in “Xolair for asthma.”

Effectiveness

In clinical studies, Xolair was effective at treating nasal polyps in certain people. To learn how the drug performed in these studies, check out Xolair’s prescribing information.

The Food and Drug Administration (FDA) approves prescription drugs such as Xolair to treat certain conditions. To learn about Xolair’s approved uses, see the following sections above:

Xolair may also be used off-label for other conditions. Off-label use is when a drug that’s approved to treat one condition is used to treat a different condition.

Xolair for allergies (off-label use)

Xolair isn’t approved to treat allergic rhinitis (a type of allergy that’s also called hay fever). But sometimes it’s used off-label to treat this condition. Allergic rhinitis causes symptoms such as:

  • congestion (stuffy nose)
  • runny nose
  • sneezing
  • itchy eyes, nose, and throat
  • watery eyes

Effectiveness for allergies

Clinical studies have looked at using Xolair to treat both perennial (lasts all year) allergic rhinitis and seasonal (occurs only at certain times of the year) allergic rhinitis.

In one study, Xolair was given to people with moderate to severe perennial allergic rhinitis. After 16 weeks of treatment, Xolair was more effective than a placebo in reducing people’s daily allergy symptoms. (A placebo is a treatment with no active drug.)

A review of studies found that omalizumab helped manage symptoms in people with moderate to severe allergic rhinitis. (Omalizumab is the active drug in Xolair.)

If you’re interested in using Xolair to treat allergies, talk with your doctor. They can discuss all of your treatment options with you.

Xolair for eczema (off-label use)

Xolair isn’t approved to treat eczema (atopic dermatitis). But sometimes it’s used off-label for this condition. Eczema causes your skin to feel dry and itchy.

A review of several clinical studies that tested the use of Xolair for eczema found that the drug may be helpful for some people. But the results are inconsistent at this time. More studies are needed to know how safe and effective Xolair is for treating eczema.

If you’re interested in using Xolair to treat eczema, talk with your doctor. They can discuss all of your treatment options with you.

Here are answers to some frequently asked questions about Xolair.

Is Xolair an immunosuppressant? Will it weaken my immune system?

Xolair isn’t classified as an immunosuppressant, and it isn’t believed to weaken your immune system.

Infections were reported as a side effect by some people taking Xolair in clinical studies. This may make it seem like the drug weakens the immune system’s ability to fight off infection. However, it’s important to keep in mind that people with asthma and nasal polyps have a higher risk of infection. (These are two of the conditions that Xolair is used to treat.)

Based on studies of omalizumab, it’s not believed that Xolair weakens your immune system. (Omalizumab is the active drug in Xolair.)

If you’re concerned about how Xolair may affect your immune system, talk with your doctor. They can discuss with you the risks and benefits of using this drug.

Will I have withdrawal symptoms if I stop taking Xolair?

Stopping Xolair isn’t known to cause withdrawal symptoms. These are symptoms that can occur if you stop taking a drug that your body has become dependent on. (With dependence, your body needs the drug in order to function like usual.)

However, stopping Xolair can cause symptoms of your condition to return. Because of this, you should talk with your doctor before stopping Xolair or any other medications. Your doctor can recommend if it’s safe to do so.

Can I take Xolair for angioedema?

No, you shouldn’t take Xolair to treat angioedema (swelling caused by a severe allergic reaction). This drug isn’t approved to treat angioedema.

In fact, angioedema has been reported as a serious side effect of Xolair. And there haven’t been any studies done to look at using Xolair to treat the condition.

If you have questions about how to treat angioedema, talk with your doctor.

Is Xolair a type of chemotherapy?

No, Xolair isn’t chemotherapy (traditional drugs used to treat cancer). It works differently in your body than chemotherapy does.

Chemotherapy drugs use powerful chemicals to kill cells that are multiplying (making more cells) quickly in your body. Chemotherapy is effective for cancer treatment because cancer cells multiply more quickly than most other cells in your body.

Xolair is a monoclonal antibody drug. These drugs are made in a lab using immune system cells. Monoclonal antibodies are used to treat various conditions. And some monoclonal antibodies are used to treat certain forms of cancer. However, Xolair is not approved to treat cancer.

If you have questions about cancer treatment options, talk with your doctor.

Does Xolair contain steroids?

No, Xolair isn’t a steroid and it’s not made from steroids. Xolair is a monoclonal antibody. These drugs are made in a lab from immune system cells. They work differently in your body than steroids do.

Your doctor may recommend that you use a corticosteroid) along with Xolair. (This could be a corticosteroid that’s either inhaled, taken by mouth, or given through your nose.) This combination of drugs is sometimes used to better treat your condition.

Can Xolair cause depression?

Studies haven’t shown that Xolair causes or leads to depression. However, you may have a higher risk of depression if you have persistent asthma or chronic hives. And Xolair is used to treat both of these conditions.

Living with these long-term conditions may lead to changes in your emotions. If you feel depressed while you’re using Xolair, talk with your doctor. They’ll recommend ways to improve your mood and help you decide if you need treatment for your symptoms.

Other drugs are available that can treat your condition. Some may be better suited for you than others. If you’re interested in finding an alternative to Xolair, talk with your doctor. They can tell you about other medications that may work well for you.

Note: Some of the drugs listed below are used off-label to treat these specific conditions. Off-label use is when a drug that’s approved to treat one condition is used to treat a different condition.

Alternatives for allergic asthma

Examples of other drugs that may be used to treat moderate to severe allergic asthma that’s persistent (long-lasting) include:

  • certain oral corticosteroids, such as:
    • prednisone (Rayos)
    • methylprednisolone (Medrol)
  • leukotriene modifiers, such as:
    • montelukast (Singulair)
    • zafirlukast (Accolate)
    • zileuton (Zyflo)
  • other biologic medications, such as:
    • benralizumab (Fasenra)

Alternatives for chronic hives

Examples of other drugs that may be used to treat long-lasting hives with an unknown cause (called chronic idiopathic urticaria) include:

  • certain oral corticosteroids that are used for a short time to reduce symptoms, such as:
    • prednisone (Rayos)
    • methylprednisolone (Medrol)
  • doxepin (Zonalon), which is a tricyclic antidepressant drug that comes as a topical cream
  • certain immunosuppressants (drugs that suppress your immune system), such as:
    • cyclosporine (Neoral, Gengraf)
    • tacrolimus (Prograf)

Alternatives for nasal polyps

Examples of other drugs that may be used to treat nasal polyps include:

  • corticosteroid nasal sprays, such as:
    • triamcinolone (Nasacort)
  • leukotriene modifiers, such as:
    • montelukast (Singulair)
    • zafirlukast (Accolate)
    • zileuton (Zyflo)

You should take Xolair according to your doctor’s or another healthcare professional’s instructions.

When to take

Xolair is given as a subcutaneous (under your skin) injection. Your doctor or another healthcare professional will administer Xolair doses when you first start treatment.

In some cases, your doctor may recommend that you self-inject doses of the drug at home. But you’ll receive at least your first three Xolair doses at a healthcare facility.

If you’re receiving doses at your doctor’s office, you’ll need to schedule appointments to receive Xolair.

In either case, your doctor will recommend how often you need to have Xolair injections, depending on the condition you’re treating.

Xolair injection sites

Xolair can be injected into the following areas:

  • thighs
  • belly, avoiding the 2-inch area around the belly button

If a healthcare professional or caregiver injects Xolair, it can also be given into the outer side of the upper arms.

You may wonder how Xolair compares to other medications that are prescribed for similar uses. Here we look at how Xolair and Dupixent are alike and different.

About

Xolair contains omalizumab, while Dupixent contains the drug dupilumab. Both drugs are monoclonal antibodies, which means they’re made in a lab from immune system cells. However, Xolair and Dupixent each work differently inside your body.

Uses

Xolair and Dupixent are both approved to treat asthma.

Xolair is used to treat moderate to severe asthma that’s persistent (long-lasting). For this condition, Xolair is used in people ages 6 years and older who have both:

  • allergic asthma, which is diagnosed by having a positive skin or blood test for allergens that are present year-round, and
  • asthma symptoms that aren’t controlled by other medications called inhaled corticosteroids

Dupixent is also used to treat moderate to severe asthma. It’s used as a maintenance (long-term) treatment in combination with another asthma treatment. Dupixent is used in adults and children ages 12 years and older who:

  • need to use drugs called oral (taken by mouth) corticosteroids for their asthma, or
  • have a certain type of asthma called eosinophilic asthma

In addition to treating asthma, Dupixent is also used to treat moderate to severe atopic dermatitis (eczema) in people ages 12 years and older. It’s used to treat eczema that’s not controlled with topical skin treatments.

Dupixent is also approved to treat chronic (long-lasting) rhinosinusitis with nasal polyps in adults. With this condition, you have ongoing swelling in your sinuses and growths on the lining inside your sinuses. For this use, Dupixent is given in combination with other medications.

Xolair is also used to treat a certain type of hives and nasal polyps, in certain situations. To learn more, see the following sections:

Drug forms and administration

Both Xolair and Dupixent are given by subcutaneous injection (an injection under your skin). Xolair and Dupixent injections may be given by a healthcare professional or self-injected at home. Your doctor will recommend how you should receive either drug.

Xolair is given once every 2 to 4 weeks. Dupixent is given once every other week or once every 4 weeks.

Side effects and risks

Xolair and Dupixent both contain monoclonal antibodies. Therefore, these medications can cause very similar side effects.

Below are examples of these side effects in people with asthma who are ages 12 years and older. Side effects in children less than 12 years of age may differ from those listed here. For more information about side effects in such children, see the “Xolair side effects” section above.

More common side effects

These lists contain examples of more common side effects that can occur with Xolair, with Dupixent, or with both drugs (when taken individually).

  • Can occur with Xolair:
    • tiredness
    • itchy skin
    • skin rash
    • bone fractures
    • earache
    • pain throughout your body, including in your joints, legs, and arms
  • Can occur with Dupixent:
    • increased level of eosinophils (a type of white blood cell) in your blood
    • pain in your mouth and throat
  • Can occur with both Xolair and Dupixent:
    • reactions at the site of your injection, which may cause redness or pain

Serious side effects

These lists contain examples of serious side effects that can occur with Xolair, with Dupixent, or with both drugs (when taken individually).

  • Can occur with Xolair:
    • problems with your heart and blood circulation, such as heart attack, stroke, and blood clots
    • immune system reactions, which may cause fever, rash, and joint pain
  • Can occur with Dupixent:
    • inflammation in certain parts of your eye, such as your conjunctiva (clear covering over the white of your eye) or cornea (clear covering over your iris and pupil)
  • Can occur with both Xolair and Dupixent:
    • severe allergic reaction*
    • inflammation in your blood vessels

* Xolair has a boxed warning from the Food and Drug Administration (FDA) regarding the risk of anaphylaxis (a severe allergic reaction). A boxed warning is the strongest warning the FDA requires. It alerts doctors and patients about drug effects that may be dangerous.

Effectiveness

Xolair and Dupixent have different FDA-approved uses, but they’re both used to treat certain types of moderate to severe asthma.

These drugs haven’t been directly compared in clinical studies. But separate studies have found both Xolair and Dupixent to be effective for treating moderate to severe asthma.

Costs

Xolair and Dupixent are both brand-name drugs. There are currently no generic or biosimilar forms of either drug. Brand-name medications usually cost more than generics. To learn more about generics and biosimilars, see the “Xolair generic or biosimilar” section above.

According to estimates on WellRx.com, Dupixent generally costs more than Xolair. The actual price you’ll pay for either drug depends on your insurance plan, your location, and the pharmacy you use.

While there aren’t any known interactions between Xolair and alcohol, you should talk with your doctor before drinking alcohol while you’re using this medication.

Alcohol can have various effects on your health. For example, alcohol can affect the way your immune system works. This can increase your risk of developing certain types of cancer or infections. Alcohol may also increase your risk of certain side effects of Xolair, such as dizziness, because both Xolair and alcohol can cause this.

If you drink alcohol, talk with your doctor about whether it is safe to drink while you’re using Xolair.

You may wonder how Xolair compares to other medications that are prescribed for similar uses. Here we look at how Xolair and Nucala are alike and different.

About

Xolair contains the drug omalizumab, while Nucala contains the drug mepolizumab. Both drugs are monoclonal antibodies, which means they’re made in a lab from immune system cells. However, Xolair and Nucala each work differently inside your body.

Uses

Xolair and Nucala are both approved to treat asthma.

Xolair is used to treat moderate to severe asthma that’s persistent (long-lasting). For this condition, Xolair is used in people ages 6 years and older who have both:

  • allergic asthma, which is diagnosed by having a positive skin or blood test for allergens that are present year-round, and
  • asthma symptoms that aren’t controlled by other medications called inhaled corticosteroids

Nucala is used to treat severe forms of eosinophilic asthma. For this condition, it’s used in combination with other asthma treatments. It’s approved for this use in people ages 6 years and older.

Additionally, Nucala may be used to treat:

Xolair is also used to treat a certain type of hives and nasal polyps, in certain situations. To learn more, see the following sections:

Drug forms and administration

Both Xolair and Nucala are given by subcutaneous injection (an injection under your skin). Xolair and Nucala injections may be given by a healthcare professional or self-injected at home. Your doctor will recommend how you should receive either drug.

Xolair is given once every 2 to 4 weeks, while Nucala is given once every 4 weeks.

Side effects and risks

Xolair and Dupixent both contain monoclonal antibodies . Therefore, these medications can cause very similar side effects. Below are examples of these side effects in people with asthma who are ages 12 years and older.

Side effects in children less than 12 years of age may differ from those listed here. For more information about side effects in children, see the “Xolair side effects” section above.

More common side effects

These lists contain examples of more common side effects that can occur with Xolair, with Nucala, or with both drugs (when taken individually).

  • Can occur with Xolair:
    • itchy skin
    • skin rash
    • bone fractures
    • earache
    • pain throughout your body, including in your joints, arms, and legs
  • Can occur with Nucala:
    • headache
    • back pain
  • Can occur with both Xolair and Nucala:
    • reactions at the site your injection, which may cause redness or pain
    • tiredness

Serious side effects

These lists contain examples of serious side effects that can occur with Xolair, with Nucala, or with both drugs (when taken individually).

  • Can occur with Xolair:
    • inflammation in your blood vessels
    • problems with your heart and blood circulation, such as heart attack, stroke, and blood clots
    • immune system reaction, which may cause fever, rash, and joint pain
  • Can occur with Nucala:
  • Can occur with both Xolair and Nucala:
    • severe allergic reaction*

* Xolair has a boxed warning from the Food and Drug Administration (FDA) regarding the risk of anaphylaxis (a severe allergic reaction). A boxed warning is the strongest warning the FDA requires. It alerts doctors and patients about drug effects that may be dangerous.

Effectiveness

Xolair and Nucala have different FDA-approved uses, but they’re both used to treat severe asthma.

These drugs haven’t been directly compared in clinical studies. But separate studies have found both Xolair and Nucala to be effective for treating severe asthma.

Costs

Xolair and Nucala are both brand-name drugs. There are currently no generic or biosimilar forms of either drug. Brand-name medications usually cost more than generics. To learn more about generics and biosimilars, see the “Xolair generic or biosimilar” section above.

The actual price you’ll pay for either drug depends on your dosage, your insurance plan, your location, and the pharmacy you use. To find price estimates for your prescription, visit WellRx.com.

It’s not known for sure if Xolair is safe to use during pregnancy. However, Xolair is known to pass across the placenta during pregnancy. (The placenta is the organ that passes nutrients to a developing fetus.) This means that the drug is passed to a developing fetus if it’s taken by a pregnant person.

A clinical study that included 250 pregnant females* with asthma was done to monitor the effects of Xolair during and after pregnancy. Most of the people in the study used Xolair at least once during all three trimesters of pregnancy. There was no increase in major problems with fetal development or miscarriage in people who took Xolair, compared with those who didn’t.

In the study, more infants exposed to Xolair during pregnancy had lower birth weights than infants who weren’t exposed to it. However, having asthma that’s not controlled with treatment can also increase the risk of pregnancy-related problems. These problems include premature birth and a low birth weight.

If you’re pregnant or may become pregnant, talk with your doctor about whether Xolair is safe for you to use.

* Sex and gender exist on spectrums. Use of the term “female” and “male” below refers to sex assigned at birth.

It’s not known for sure if Xolair passes into breast milk, or if it affects how your body makes breast milk.

In the pregnancy studies of Xolair, most of the infants included were breastfed after birth by people who were using Xolair. There was no difference in the rate of side effects or harmful outcomes in these infants compared to infants who weren’t breastfed or who were breastfed by people who didn’t take Xolair.

For more information about the risks and benefits of breastfeeding while you’re using Xolair, talk with your doctor.

Xolair works with your immune system to treat:

With these conditions, your body has increased levels of a certain immune system protein called immunoglobulin E (IgE).

What is immunoglobulin E and what does it do?

IgE is an immune system protein that causes inflammation in your body.

If you have allergic asthma, IgE levels increase when you inhale allergens such as pet dander or dust mites. (Allergens are substances that cause allergies.) When IgE attaches to allergens, it causes other substances to be released inside your body. This leads to inflammation, which can narrow your airways and make it hard for you to breathe.

If you have chronic hives, IgE binds to mast cells (a type of white blood cell) in your skin. Once IgE attaches to mast cells, the cells cause other substances (such as histamine) to be released in your body. This leads to hives and itchy skin.

It’s not exactly known what causes nasal polyps. It’s thought that, similar to IgE, eosinophils cause inflammation in the body. (Eosinophils are a type of white blood cell.) This includes inflammation inside the nose. And this inflammation plays a role in nasal polyps forming.

What Xolair does

Xolair contains the drug omalizumab. It’s both a biologic drug and a monoclonal antibody drug. Biologics are drugs that are made from living cells, while monoclonal antibodies are drugs that are made from immune system cells.

Xolair works by blocking IgE from binding to its receptors (attachment sites).

In people with asthma, Xolair decreases the amount of certain substances in their body that cause inflammation and asthma symptom flare-ups.

In people with chronic hives, Xolair lowers their levels of IgE. This decreases the amount of IgE that can attach to mast cells in their skin and cause inflammation.

In people with nasal polyps, Xolair lowers IgE levels. This decreases inflammation, which is thought to help treat nasal polyps.

How long does it take to work?

It takes a little while for Xolair to begin to work in your body. You might not notice an improvement in your symptoms until you’ve used the drug for several months.

There haven’t been any studies done to look at whether Xolair interacts with any other drugs.

However, before taking Xolair, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Xolair and herbs and supplements

There aren’t any herbs or supplements that have been specifically reported to interact with Xolair. However, you should still check with your doctor or pharmacist before using any of these products while taking Xolair.

Xolair and foods

There aren’t any foods that are known to interact with Xolair. However, if you have concerns about food interactions with this medication, talk with your doctor or pharmacist.

Xolair and lab tests

Xolair may increase your level of immunoglobulin E (IgE), which is an immune system protein. And this level can stay elevated for up to a year after you’ve stopped taking Xolair.

If you’re having blood tests done to check your IgE level, be sure that your doctor knows whether you’ve taken Xolair.

Xolair may be used with other drugs to treat your condition. Depending on the condition you’re using Xolair to treat, your doctor will recommend which medications you’ll need to use with Xolair.

Drugs used with Xolair for allergic asthma

If you have moderate to severe allergic asthma that’s persistent (long-lasting), you may be taking other drugs with Xolair. Some drugs are used for quick relief of symptoms (called rescue medications), while other drugs are used for long-term symptom control.

Rescue medications for allergic asthma

Xolair is not a rescue medication. It’s not meant to be used to treat sudden breathing problems or asthma flare-ups. You’ll still need to use your rescue medication for quick relief of asthma symptoms while you’re taking Xolair.

Examples of rescue medications that are used to quickly relieve asthma symptoms include:

Long-term medications for allergic asthma

Xolair may be used with other asthma medications for long-term control of asthma symptoms. Examples of these medications include:

  • inhaled corticosteroids, such as:
    • fluticasone (Flovent HFA)
    • budesonide (Pulmicort Flexhaler)
    • mometasone (Asmanex Twisthaler)
    • beclomethasone (Qvar RediHaler)
    • ciclesonide (Alvesco)
  • long-acting beta-agonists (LABAs), such as:
    • salmeterol (Serevent)
  • combination medications (contain both a corticosteroid and LABA), such as:
  • leukotriene modifiers, such as:
    • zafirlukast (Accolate)
    • zileuton (Zyflo)

Drugs used with Xolair for chronic hives

If you have chronic (long-lasting) hives, you’ll most likely take an antihistamine with Xolair. Examples of nondrowsy and less-drowsy antihistamines include:

  • loratadine (Claritin)
  • desloratadine (Clarinex)
  • fexofenadine (Allegra)
  • cetirizine (Zyrtec)

If your hives don’t improve after using one these antihistamines with Xolair, your doctor may increase your dosage of the antihistamine. Or your doctor may recommend that you use a different type of antihistamine that may cause drowsiness, such as diphenhydramine (Benadryl).

Your doctor may also suggest that you use corticosteroid creams with Xolair. These could include creams such as betamethasone valerate (Dermabet).

Drugs used with Xolair for nasal polyps

If you have nasal polyps, you’ll take Xolair in combination with another treatment. These may include:

  • corticosteroid nasal sprays, such as:
    • triamcinolone (Nasacort)
  • leukotriene modifiers, such as:
    • zafirlukast (Accolate)
    • zileuton (Zyflo)

This drug comes with several warnings.

FDA warning: anaphylaxis (severe allergic reaction)

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

Using Xolair can lead to a dangerous condition called anaphylaxis. This condition may occur after just one dose, or after many doses of Xolair. It may also occur right away after your dose or days later. After you’re given Xolair, you’ll be monitored closely for this reaction by your healthcare professional.

Your doctor may have you administer Xolair injections to yourself. They’ll consider your risk of anaphylaxis when determining whether this is safe. And they’ll make sure you’re able to identify anaphylaxis and treat it right away.

Anaphylaxis can include symptoms such as swelling of your tongue and throat, trouble breathing, tightening in your chest, and low blood pressure. Anaphylaxis can also cause you to feel warm and itchy, or to have hives. If you have any of these symptoms, you need medical attention right away.

Other warnings

Before taking Xolair, talk with your doctor about your health history. Xolair may not be right for you if you have certain medical conditions. These include:

  • Cancer. Taking Xolair may cause new cancer development or worsen your cancer if you’re already affected by this condition. Some people using Xolair have developed breast, skin, or prostate cancer. Talk with doctor about your risk of developing cancer before you start using Xolair.
  • Steroid treatment. If you’re taking steroid medications for asthma or nasal polyps, your doctor will recommend that you don’t suddenly stop the steroids when starting Xolair. Instead, if you need to stop taking the steroids, your doctor will have you slowly taper them off.
  • Parasitic infection. If you have a high risk of parasitic (worm) infections, using Xolair may increase this risk. Tell your doctor if you’ve traveled to or are living in an area where parasitic infections occur. Your doctor can check to see if you have a parasitic infection by testing your stool. Talk with your doctor about your risk of parasitic infections before you start using Xolair.
  • Acute asthma symptoms. Xolair should not be used to treat acute (sudden) asthma symptoms. Xolair hasn’t been shown effective to treat asthma attacks (flare-ups) or sudden breathing problems. Talk with your doctor about which medications you should use to treat sudden asthma symptoms while you’re taking Xolair.
  • Latex allergy. If you’re allergic to latex, you shouldn’t use prefilled syringes of Xolair. The needle cap on these syringes contain a form of latex. However, you may be able to use the powered form of Xolair, which comes in glass vials. Talk with your doctor about any allergies you have before you start using Xolair.
  • Pregnancy. It’s not known if Xolair is safe to take during pregnancy. See the “Xolair and Pregnancy” section above for more details.
  • Breastfeeding. It’s not known if Xolair is safe to take while you’re breastfeeding. See the “Xolair and Breastfeeding” section above for more information.
  • Severe allergic reactions. You shouldn’t take Xolair if you’ve had a severe allergic reaction (including anaphylaxis) to Xolair or any of its ingredients. If you’re not sure if you’ve had an allergic reaction to Xolair in the past, talk with your doctor before starting treatment.

Note: For more information about the potential negative effects of Xolair, see the “Xolair side effects” section above.

The following information is provided for clinicians and other healthcare professionals.

Indications

Xolair is approved to treat:

  • moderate to severe persistent asthma that is not controlled with inhaled corticosteroids in adults and children ages 6 years and older. Xolair is used in people who have had a positive skin test or reactivity through a blood test to year-round aeroallergens.
  • chronic idiopathic urticaria in adults and children ages 12 years and older who continue to experience symptoms despite using H1 antihistamines.
  • nasal polyps that are not managed with nasal corticosteroids, in combination with another therapy.

Mechanism of action

Xolair is considered a monoclonal antibody and an anti-IgE therapy. It contains the drug omalizumab, which blocks the binding of immunoglobulin E (IgE) to its receptors on mast cells and basophils.

In people with asthma, omalizumab limits the release of substances that lead to an allergic response.

In people with chronic idiopathic urticaria, omalizumab lowers levels of free IgE by binding to IgE. This causes IgE receptors to down-regulate.

In people with nasal polyps, omalizumab limits the release of substances thought to contribute to nasal polyp formation.

Pharmacokinetics and metabolism

The average absolute bioavailability of Xolair after subcutaneous administration is 62%. After the first dose of Xolair in people with either asthma or urticaria, peak serum concentrations occurred in approximately 7 to 8 days.

Omalizumab clearance is through the liver and can also be excreted in the bile. The serum elimination half-life of omalizumab was about 26 days in people with asthma and 24 days in people with urticaria.

Contraindications

Xolair is contraindicated in people with a history of severe allergic reaction to its active ingredient, omalizumab, or any of its inactive ingredients.

Storage

Xolair vials and prefilled syringes should be stored in the refrigerator at a temperature of 36˚F to 46˚F (2˚C to 8˚C). Syringes and vials should be kept in their original carton and protected from light. The syringes should never be frozen; if they’ve been frozen, they cannot be used.

Disclaimer: Medical News Today 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 another 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.