omalizumab

Generic Name: omalizumab (OH ma LIZ oo mab)

Brand Names: Xolair

What is omalizumab?

Omalizumab is an antibody that helps decrease allergic responses in the body.

Omalizumab is used to treat moderate to severe asthma that is caused by allergies in adults and children who are at least 12 years old.

Omalizumab is usually given after other asthma medications have been tried without successful treatment of symptoms.

Omalizumab may also be used for purposes not listed in this medication guide.

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

Some people using omalizumab have had a severe, life-threatening allergic reaction to this medication, either right after the injection or hours later. Allergic reaction may occur even after using the medication regularly for a year or longer.

Get emergency medical help if you have any of these signs of an allergic reaction: wheezing, tightness in your chest, trouble breathing; hives or skin rash; feeling anxious or light-headed, fainting; warmth or tingling under your skin; or swelling of your face, lips, tongue, or throat.

Asthma is often treated with a combination of different drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice.

If you also use a steroid medication, do not stop using the steroid suddenly or you may have unpleasant withdrawal symptoms. Talk with your doctor if any of your asthma medications do not seem to work as well in treating or preventing attacks. Your symptoms may not improve right away once you start receiving omalizumab. For best results, keep receiving the medication as directed. Talk with your doctor if your symptoms do not improve after a few weeks of treatment.

Use omalizumab regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Using this medication may increase your risk of certain types of cancers of the breast, skin, prostate, or salivary gland. Talk to your doctor about your individual risk.

What should I discuss with my healthcare provider before using omalizumab?

Do not use this medication if you are allergic to omalizumab.

To make sure you can safely take omalizumab, tell your doctor if you have any other medical conditions or if you take other medicines.

Using this medication may increase your risk of certain types of cancers of the breast, skin, prostate, or salivary gland. Talk to your doctor about your individual risk.

While you are using omalizumab, you may also have an increased risk of becoming infected with parasites (worms) if you live in or travel to areas where such infections are common. Talk with your doctor about what to look for and how to treat this condition.

FDA pregnancy category B. Omalizumab is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of omalizumab on the baby.

Omalizumab may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give omalizumab to a child younger than 12 years old.

How should I use omalizumab?

Omalizumab is injected under the skin. You may be shown how to use injections at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

Omalizumab is usually given every 2 or 4 weeks.

Omalizumab is a powder medicine that must be mixed with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medication.

Use a disposable needle only once. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

Omalizumab will not work fast enough to treat an asthma attack that has already begun. Use only a fast-acting inhalation medicine to treat an asthma attack.

Asthma is often treated with a combination of different drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice.

If you also use a steroid medication, do not stop using it suddenly or you may have unpleasant withdrawal symptoms. Talk with your doctor if any of your asthma medications do not seem to work as well in treating or preventing attacks. Your symptoms may not improve right away once you start receiving omalizumab. For best results, keep receiving the medication as directed. Talk with your doctor if your symptoms do not improve after a few weeks of treatment.

Use omalizumab regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

To be sure this medication is helping your condition, your doctor may want you to have allergy tests and lung function tests on a regular basis. Do not miss any scheduled visits to your doctor.

Store omalizumab in the refrigerator. Do not freeze. After mixing omalizumab with a diluent, store in the refrigerator and use it within 8 hours. Do not freeze. Do not use the medication if it has changed colors or has particles in it. Call your doctor for a new prescription.

What happens if I miss a dose?

Contact your doctor if you miss a dose of omalizumab.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using omalizumab?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Omalizumab side effects

Some people using omalizumab have had a severe, life-threatening allergic reaction to this medication, either right after the injection or hours later. Allergic reaction may occur even after using the medication regularly for a year or longer.

Get emergency medical help if you have any of these signs of an allergic reaction:

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  wheezing, tightness in your chest, trouble breathing;

  
  


• 
  

  hives or skin rash;

  
  


• 
  

  feeling anxious or light-headed, fainting;

  
  


• 
  

  warmth or tingling under your skin; or

  
  


• 
  

  swelling of your face, lips, tongue, or throat.

  
  

Other serious side effects include easy bruising or bleeding, numbness, or unusual weakness.

Less serious side effects may include:

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  pain;

  
  


• 
  

  headache, tired feeling;

  
  


• 
  

  joint or muscle pain;

  
  


• 
  

  dizziness;

  
  


• 
  

  ear pain;

  
  


• 
  

  hair loss;

  
  


• 
  

  mild itching or skin rash;

  
  


• 
  

  sore throat or cold symptoms; or

  
  


• 
  

  redness, bruising, warmth, burning, stinging, itching, pain, or swelling of your skin where the injection was given.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Omalizumab Dosing Information

Usual Adult Dose for Asthma -- Maintenance:

150 to 300 mg subcutaneously every 4 weeks or 225 to 375 mg every 2 weeks, depending on pretreatment IgE levels and patient's weight.

30 to 60 kg:
If the patient has an IgE level of >=30 to 100 intl units/mL give 150 mg subcutaneously every 4 weeks.
If the patient has an IgE level of >100 to 200 intl units/mL give 300 mg subcutaneously every 4 weeks.
If the patient has an IgE level of >200 to 300 intl units/mL give 300 mg subcutaneously every 4 weeks.
If the patient has an IgE level of >300 to 400 intl units/mL give 225 mg subcutaneously every 2 weeks.
If the patient has an IgE level of >400 to 500 intl units/mL give 300 mg subcutaneously every 2 weeks.
If the patient has an IgE level of >500 to 600 intl units/mL give 300 mg subcutaneously every 2 weeks.
If the patient has an IgE level of >600 to 700 intl units/mL give 375 mg subcutaneously every 2 weeks.

60 to 70 kg:
If the patient has an IgE level of >=30 to 100 intl units/mL give 150 mg subcutaneously every 4 weeks.
If the patient has an IgE level of >100 to 200 intl units/mL give 300 mg subcutaneously every 4 weeks.
If the patient has an IgE level of >200 to 300 intl units/mL give 225 mg subcutaneously every 2 weeks.
If the patient has an IgE level of >300 to 400 intl units/mL give 225 mg subcutaneously every 2 weeks.
If the patient has an IgE level of >400 to 500 intl units/mL give 300 mg subcutaneously every 2 weeks.
If the patient has an IgE level of >500 to 600 intl units/mL give 375 mg subcutaneously every 2 weeks.
Do not dose if the patient has an IgE level >600 intl units/mL.

70 to 90 kg:
If the patient has an IgE level of >=30 to 100 intl units/mL give 150 mg subcutaneously every 4 weeks.
If the patient has an IgE level of >100 to 200 intl units/mL give 300 mg subcutaneously every 4 weeks.
If the patient has an IgE level of >200 to 300 intl units/mL give 225 mg subcutaneously every 2 weeks.
If the patient has an IgE level of >300 to 400 intl units/mL give 300 mg subcutaneously every 2 weeks.
If the patient has an IgE level of >400 to 500 intl units/mL give 375 mg subcutaneously every 2 weeks.
Do not dose if the patient has an IgE level >500 intl units/mL.

>90 kg:
If the patient has an IgE level of >=30 to 100 intl units/mL give 300 mg subcutaneously every 4 weeks.
If the patient has an IgE level of >100 to 200 intl units/mL give 225 mg subcutaneously every 2 weeks.
If the patient has an IgE level of >200 to 300 intl units/mL give 300 mg subcutaneously every 2 weeks.
Do not dose if the patient has an IgE level >300 intl units/mL.

Usual Pediatric Dose for Asthma -- Maintenance:

>=12 years: 150 to 300 mg subcutaneously every 4 weeks or 225 to 375 mg every 2 weeks, depending on pretreatment IgE levels and patient weight.

30 to 60 kg:
If the patient has an IgE level of >=30 to 100 intl units/mL give 150 mg subcutaneously every 4 weeks.
If the patient has an IgE level of >100 to 200 intl units/mL give 300 mg subcutaneously every 4 weeks.
If the patient has an IgE level of >200 to 300 intl units/mL give 300 mg subcutaneously every 4 weeks.
If the patient has an IgE level of >300 to 400 intl units/mL give 225 mg subcutaneously every 2 weeks.
If the patient has an IgE level of >400 to 500 intl units/mL give 300 mg subcutaneously every 2 weeks.
If the patient has an IgE level of >500 to 600 intl units/mL give 300 mg subcutaneously every 2 weeks.
If the patient has an IgE level of >600 to 700 intl units/mL give 375 mg subcutaneously every 2 weeks.

60 to 70 kg:
If the patient has an IgE level of >=30 to 100 intl units/mL give 150 mg subcutaneously every 4 weeks.
If the patient has an IgE level of >100 to 200 intl units/mL give 300 mg subcutaneously every 4 weeks.
If the patient has an IgE level of >200 to 300 intl units/mL give 225 mg subcutaneously every 2 weeks.
If the patient has an IgE level of >300 to 400 intl units/mL give 225 mg subcutaneously every 2 weeks.
If the patient has an IgE level of >400 to 500 intl units/mL give 300 mg subcutaneously every 2 weeks.
If the patient has an IgE level of >500 to 600 intl units/mL give 375 mg subcutaneously every 2 weeks.
Do not dose if the patient has an IgE level >600 intl units/mL.

70 to 90 kg:
If the patient has an IgE level of >=30 to 100 intl units/mL give 150 mg subcutaneously every 4 weeks.
If the patient has an IgE level of >100 to 200 intl units/mL give 300 mg subcutaneously every 4 weeks.
If the patient has an IgE level of >200 to 300 intl units/mL give 225 mg subcutaneously every 2 weeks.
If the patient has an IgE level of >300 to 400 intl units/mL give 300 mg subcutaneously every 2 weeks.
If the patient has an IgE level of >400 to 500 intl units/mL give 375 mg subcutaneously every 2 weeks.
Do not dose if the patient has an IgE level >500 intl units/mL.

>90 kg:
If the patient has an IgE level of >=30 to 100 intl units/mL give 300 mg subcutaneously every 4 weeks.
If the patient has an IgE level of >100 to 200 intl units/mL give 225 mg subcutaneously every 2 weeks.
If the patient has an IgE level of >200 to 300 intl units/mL give 300 mg subcutaneously every 2 weeks.
Do not dose if the patient has an IgE level >300 intl units/mL.

What other drugs will affect omalizumab?

Before using omalizumab, tell your doctor if you are receiving allergy shots.

There may be other drugs that can interact with omalizumab. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More omalizumab resources

• Omalizumab Side Effects (in more detail)
• Omalizumab Use in Pregnancy & Breastfeeding
• Omalizumab Drug Interactions
• Omalizumab Support Group
• 9 Reviews for Omalizumab - Add your own review/rating

• omalizumab Subcutaneous Advanced Consumer (Micromedex) - Includes Dosage Information


• Omalizumab Professional Patient Advice (Wolters Kluwer)


• Omalizumab MedFacts Consumer Leaflet (Wolters Kluwer)


• Omalizumab Monograph (AHFS DI)


• Xolair Prescribing Information (FDA)


• Xolair Consumer Overview

Compare omalizumab with other medications

• Asthma, Maintenance

Where can I get more information?

• Your pharmacist can provide more information about omalizumab.

See also: omalizumab side effects (in more detail)