US Healthcare Professionals

For people 12 years of age and older with chronic spontaneous urticaria (CSU) not controlled by H1 antihistamines.

FAQs

Frequently asked questions about XOLAIR and CSU

XOLAIR and CSU
Administering XOLAIR in office
Administering XOLAIR at home

XOLAIR and CSU

The symptoms of chronic hives are similar to other types of hives.

  • Hives can be red, white, or flesh-colored bumps that itch
  • Hives can often occur on the chest, back, arms, or legs, but can appear anywhere on the body
  • The location where hives appear may move around. They may show up on your hand, disappear, then show up later on your shoulder
  • A red hive will turn pale when pressed in the center

Read more about CSU

XOLAIR is an injectable prescription medicine used to treat chronic spontaneous urticaria (CSU, previously referred to as chronic idiopathic urticaria (CIU), chronic hives without a cause) in people 12 years of age and older who continue to have hives that are not controlled with H1 antihistamine treatment. It is not known if XOLAIR is safe and effective in people with CSU under 12 years of age.

XOLAIR is not used to treat other allergic conditions, other forms of hives, or sudden breathing problems.

Learn how XOLAIR can help

Read the Full Medication Guide for more information

XOLAIR® (omalizumab) 75mg and 150mg syringe

Not actual size

In two studies, XOLAIR helped reduce the severity of itch and number of hives in people who had symptoms that were not controlled by H1 antihistamines. Individual results may vary. View the full XOLAIR CSU clinical study results to learn more.

Learn more about XOLAIR results

Do not decrease the dose of or stop taking any other CSU medications unless otherwise instructed by your doctor. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Medication Guide

XOLAIR became the first FDA-approved biologic for chronic hives in 2014. Since then, over 380,000 CSU patients have been prescribed XOLAIR.*  

*Data on file (December 2024). Genentech USA, Inc. South San Francisco, CA.

Learn more about XOLAIR

XOLAIR is given by an injection just under the skin (subcutaneous injection) every 4 weeks.

  • XOLAIR is given in 1 or more subcutaneous injections, depending on the dose your doctor has prescribed
  • Each injection takes about 5-10 seconds to administer
  • Your healthcare provider will monitor you closely for symptoms of an allergic reaction while you are receiving XOLAIR and for a period of time after treatment is initiated. Your healthcare provider should talk to you about getting medical treatment if you have symptoms of an allergic reaction
  • You may not see improvement in your symptoms right after XOLAIR treatment
  • Do not decrease or stop taking any of your other medicines unless your healthcare providers tell you to
  • After you've established treatment in a doctor's office or infusion center, your doctor will determine if you or your caregiver may inject XOLAIR. If your doctor decides that you or a caregiver may be able to give your own XOLAIR prefilled syringe or autoinjector injections, you should receive training right way to prepare and inject XOLAIR. Do not try to inject your XOLAIR prefilled syringe or autoinjector until you have been shown the right way to give XOLAIR injections by your doctor

Learn more about XOLAIR injection

Severe allergic reaction. A severe allergic reaction called anaphylaxis can happen when you receive XOLAIR. The reaction can occur after the first dose, or after many doses. It may also occur right after a XOLAIR injection or days later. Anaphylaxis is a life-threatening condition and can lead to death. Go to the nearest emergency room right away if you have any of these symptoms of an allergic reaction:

  • Wheezing, shortness of breath, cough, chest tightness, or trouble breathing
  • Low blood pressure, dizziness, fainting, rapid or weak heartbeat, anxiety, or feeling of “impending doom”
  • Flushing, itching, hives, or feeling warm
  • Swelling of the throat or tongue, tightness of the throat, hoarse voice, or trouble swallowing

Your healthcare provider will monitor you closely for symptoms of an allergic reaction while you are receiving XOLAIR and for a period of time after treatment is initiated. Your healthcare provider should talk to you about getting medical treatment if you have symptoms of an allergic reaction.

Do not receive XOLAIR if you are allergic to omalizumab or any of the ingredients in XOLAIR.

Click below for more Important Safety Information regarding XOLAIR.

Important Safety Information

In people with chronic spontaneous urticaria: nausea, headaches, swelling of the inside of your nose, throat or sinuses, cough, joint pain, and upper respiratory tract infection.

These are not all the possible side effects of XOLAIR. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555 or Novartis Pharmaceuticals Corporation at (888) 669-6682.

Please see full Prescribing Information, including Medication Guide, for additional Important Safety Information.

Read more Important Safety Information regarding XOLAIR.

Learn about XOLAIR side effects

Administering XOLAIR in the doctor's office

When starting treatment, XOLAIR should be given by your healthcare provider in a healthcare setting. If your healthcare provider decides that you or a caregiver may be able to give your own XOLAIR prefilled syringe or autoinjector injections, you should receive training on the right way to prepare and inject XOLAIR. Do not try to inject XOLAIR until you have been shown the right way to give XOLAIR prefilled syringe or autoinjector injections by a healthcare provider.

Learn more about XOLAIR injections

Self-injecting XOLAIR at home

Your doctor will determine if you or a caregiver may inject XOLAIR.

A subcutaneous injection means an injection that is given under the skin, into a person’s fatty tissue. In the doctor’s office, your doctor or nurse will inject XOLAIR into your upper arm, front of thigh, or abdomen. After you've established your XOLAIR treatment in a doctor's office or infusion center, your doctor may determine that self-injection is right for you. Your doctor may ask you about your confidence with self-injection and about your at-home support team, if you require injection assistance.

Learn more about XOLAIR injections

If you are giving the injection to your child (or another adult), you can use:

  • Front of thighs
  • Middle of thighs
  • Stomach area (abdomen). Do not inject within the 2-inch area directly around your belly button (navel)
  • Outer area of the upper arms (Do not use this area if you are giving the injection to yourself)

Learn more about XOLAIR injections

Injection self-administration site map.
Injection administration site map.

If you are giving yourself the injection, you can inject into any of these sites:

  • Front of thighs
  • Middle of thighs
  • Stomach area (abdomen). Do not inject within the 2-inch area around your belly button (navel)

Learn more about XOLAIR injections

Injection self-administration site map.

Call your doctor’s office and ask for another training session. You can also call 1-866-4XOLAIR (1-866-496-5247) if you have any questions, or click the button below.

Learn more about how to inject XOLAIR

Do not use XOLAIR if the packaging is damaged. It might not be safe to use. Call your doctor’s office for guidance. For additional information, you can also call 1-866-4XOLAIR (1-866-496-5247).

Learn more about how to inject XOLAIR

Safely throw away the prefilled syringe or autoinjector in a sharps disposal container and contact your healthcare provider.

Learn more about how to inject XOLAIR

DO NOT USE the prefilled syringe or autoinjector if the medicine is cloudy, discolored/brown, or contains particles. The medicine should be clear and colorless to pale brownish-yellow. You may see an air bubble, which is normal. If the medicine does not look as described or if the expiration date has passed, safely throw away the prefilled syringe or autoinjector in a sharps disposal container and contact your healthcare provider. For more information, call 1-866-4XOLAIR (1-866-496-5247).

Learn more about XOLAIR injections

If the prefilled syringe or autoinjector does not reach room temperature, this could cause the injection to feel uncomfortable.

Learn more about how to inject XOLAIR

On the 75 mg and 150 mg prefilled syringes, activating the syringe needle-shield too early could cause that dose of XOLAIR to no longer work. The needle-shield will totally cover the needle. It is there to prevent accidental needle sticks after use. Once the needle-shield is activated, even if the dose has not been administered, the prefilled syringe should be properly disposed of in a sharps container. If this happens, talk to your healthcare provider.

Learn more about how to inject XOLAIR

Call your doctor to discuss when you should inject the next dose.

Learn more about how to inject XOLAIR

Dispose of used prefilled syringes or autoinjectors immediately in a sharps disposal container.

Learn more about how to inject XOLAIR

Prefilled syringe disposal

Store XOLAIR in your refrigerator between 36 °F and 46 °F. DO NOT FREEZE. (Do not use if the prefilled syringe or autoinjector has been frozen.) Store it in the original packaging to protect it from light.

Learn more about how to inject XOLAIR

Temperature change may affect the medicine. The prefilled syringe or autoinjector should not be stored out of the refrigerator for more than 48 hours and should not be exposed to temperatures above 77 °F. If either of these situations happen, do not use the prefilled syringe or autoinjector, and call your doctor’s office.

Learn more about how to inject XOLAIR

Allow time for the prefilled syringe or autoinjector to warm up to room temperature:

  • For the 75 mg and 150 mg prefilled syringes, allow 15 to 30 minutes
  • For the 300 mg prefilled syringe, allow 30 to 45 minutes
  • For the autoinjector, allow 30 to 45 minutes

Leave the syringe or autoinjector in the box to protect it from the light during this time.

Learn more about how to inject XOLAIR

If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:

  • Made of a heavy-duty plastic
  • Can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out
  • Upright and stable during use
  • Leak-resistant, and
  • Properly labeled: Hazardous waste inside the container

Learn more about how to inject XOLAIR

No, XOLAIR should never be put in the freezer. It should always stay in the refrigerator until ready for use.

No, in addition to self-injection, you can have XOLAIR administered by your healthcare provider in a healthcare setting.

Learn more about XOLAIR injections

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IMPORTANT SAFETY INFORMATION & INDICATION

What is XOLAIR?

XOLAIR® (omalizumab) for subcutaneous use is an injectable prescription medicine used to treat chronic spontaneous urticaria (CSU, previously referred to as chronic idiopathic urticaria (CIU), chronic hives without a known cause) in people 12 years of age and older who continue to have hives that are not controlled with H1 antihistamine treatment. It is not known if XOLAIR is safe and effective in people with CSU under 12 years of age.

XOLAIR is not used to treat other forms of hives.

What is the most important information I should know about XOLAIR?

Severe allergic reaction. A severe allergic reaction called anaphylaxis can happen when you receive XOLAIR. The reaction can occur after the first dose, or after many doses. It may also occur right after a XOLAIR injection or days later. Anaphylaxis is a life-threatening condition and can lead to death. Go to the nearest emergency room right away if you have any of these symptoms of an allergic reaction:

  • wheezing, shortness of breath, cough, chest tightness, or trouble breathing
  • low blood pressure, dizziness, fainting, rapid or weak heartbeat, anxiety, or feeling of “impending doom”
  • flushing, itching, hives, or feeling warm
  • swelling of the throat or tongue, throat tightness, hoarse voice, or trouble swallowing

Your healthcare provider will monitor you closely for symptoms of an allergic reaction while you are receiving XOLAIR and for a period of time after treatment is initiated. Your healthcare provider should talk to you about getting medical treatment if you have symptoms of an allergic reaction.

Do not receive and use XOLAIR if you are allergic to omalizumab or any of the ingredients in XOLAIR.

Before receiving XOLAIR, tell your healthcare provider about all of your medical conditions, including if you:
  • have a latex allergy or any other allergies (such as food allergy or seasonal allergies). The needle cap on the XOLAIR prefilled syringe contains a type of natural rubber latex.
  • have ever had a severe allergic reaction called anaphylaxis
  • have or have had a parasitic infection
  • have or have had cancer
  • are pregnant or plan to become pregnant. It is not known if XOLAIR may harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if XOLAIR passes into your breast milk. Talk with your healthcare provider about the best way to feed your baby while you receive and use XOLAIR.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I receive and use XOLAIR?
  • When starting treatment, XOLAIR should be given by your healthcare provider in a healthcare setting.
  • Do not try to inject XOLAIR until you have been shown the right way to give XOLAIR prefilled syringe or autoinjector injections by a healthcare provider. Use XOLAIR exactly as prescribed by your healthcare provider.
  • The XOLAIR autoinjector (all doses) is intended for use only in adults and adolescents aged 12 years and older. For children 12 years of age and older, XOLAIR prefilled syringe or autoinjector may be self-injected under adult supervision.
  • See the detailed Instructions for Use that comes with XOLAIR for information on the right way to prepare and inject XOLAIR.
  • XOLAIR is given in 1 or more injections under the skin (subcutaneous), 1 time every 4 weeks.
  • In people with chronic hives, a blood test is not necessary to determine the dose or dosing frequency.
  • Do not decrease or stop taking any of your other hive medicine unless your healthcare providers tell you to.
  • You may not see improvement in your symptoms right away after XOLAIR treatment.
  • If you inject more XOLAIR than prescribed, call your healthcare provider right away.
What are the possible side effects of XOLAIR?
XOLAIR may cause serious side effects, including:
  • Cancer. Cases of cancer were observed in some people who received XOLAIR.
  • Fever, muscle aches, and rash. Some people get these symptoms 1 to 5 days after receiving a XOLAIR injection. If you have any of these symptoms, tell your healthcare provider.
  • Parasitic infection. Some people who are at a high risk for parasite (worm) infections, get a parasite infection after receiving XOLAIR. Your healthcare provider can test your stool to check if you have a parasite infection.
  • Heart and circulation problems. Some people who receive XOLAIR have had chest pain, heart attack, blood clots in the lungs or legs, or temporary symptoms of weakness on one side of the body, slurred speech, or altered vision. It is not known whether these are caused by XOLAIR.

The most common side effects of XOLAIR in people with chronic spontaneous urticaria: nausea, headaches, swelling of the inside of your nose, throat or sinuses, cough, joint pain, and upper respiratory tract infection.

These are not all the possible side effects of XOLAIR. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555 or Novartis Pharmaceuticals Corporation at (888) 669-6682.

Please see full Prescribing Information, including Medication Guide, for additional Important Safety Information and Instructions for Use.