Omalizumab

Omalizumab is a prescription medication used to decrease asthma attacks (wheezing, shortness of breath, difficulty breathing) in people with asthma caused by dander, pollen, and dust mites (allergic asthma). 

Omalizumab belongs to a group of drugs called monoclonal antibodies which work by blocking IgE antibodies. IgE antibodies play a role in allergic reactions.

This medication comes in an injectable form to be given just under the skin by a healthcare provider. It is usually given once every 2 weeks, or once every 4 weeks.

Common side effects include redness and pain at the site of injection, and joint or body pains.

Omalizumab is a prescription medication used in those 6 years of age and older, with moderate to severe allergic asthma, whose symptoms are not controlled by inhaled corticosteroid medications.  

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Omalizumab may be found in some form under the following brand names:

• Xolair

The most common side effects of omalizumab include:

• pain, redness at injection site
• joint pain
• body pain
• leg pain
• fatigue
• dizziness
• ear pain

This is not a complete list of omalizumab side effects. Ask your doctor or pharmacist for more information.

No omalizumab drug interactions have been identified, however, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Tell your doctor if you are receiving allergy shots (allergy immunotherapy). It is not known if omalizumab interacts with allergen immunotherapy.

A severe allergic reaction called anaphylaxis has happened in some patients after they received omalizumab. Anaphylaxis is a life-threatening condition and can lead to death so get emergency medical treatment right away if symptoms occur.

Signs and Symptoms of anaphylaxis include:

• 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

Get emergency medical treatment right away if you have signs or symptoms of anaphylaxis after receiving omalizumab.

Anaphylaxis from omalizumab can happen:

• right after receiving a omalizumab injection or hours later
• after any omalizumab injection. Anaphylaxis has occurred after the first omalizumab injection or after many omalizumab injections.

Your healthcare provider should watch you for some time in the office for signs or symptoms of anaphylaxis after injecting omalizumab. If you have signs or symptoms of anaphylaxis, tell your healthcare provider right away. In addition, your healthcare provider should instruct you about getting emergency medical treatment and further medical care if you have signs or symptoms of anaphylaxis after leaving the doctor’s office.

Safety studies suggests a slightly increased risk of problems involving the heart and blood vessels supplying the brain with the use of omalizumab. The heart and brain blood vessel problems includes mini-strokes known as transient ischemic attacks (TIAs); heart attacks; sudden, unexpected chest pain; high blood pressure in the arteries of the lungs called pulmonary hypertension; and blood clots in the lungs and veins. Patients taking omalizumab should continue to take the medication as prescribed and discuss any questions or concerns with their health care professional.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of omalizumab there are no specific foods that you must exclude from your diet when receiving this medication.

Before receiving omalizumab, tell your doctor:

• if you are allergic to omalizumab or any other medicine
• if you will be traveling to (or live in) areas that have high risk for parasitic infections
• if you are pregnant
• if you are breastfeeding

Tell your doctor about all the medicines you take including prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Omalizumab falls into category B. There are no well-done studies that have been done in humans with montelukast. But in animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication.

If you receive omalizumab during pregnancy (or within 8 weeks prior to conception), call 1-866-4XOLAIR (1-866-496-5247) to enroll in the Xolair Pregnancy Exposure Registry.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if omalizumab is excreted in human breast milk or if it will harm your nursing baby.

Omalizumab comes as a solution to be injected just under the skin. It is usually given by injection once every 2 weeks, or once every 4 weeks, by a healthcare provider in a doctor's office or other medical setting. 

Your doctor will determine the omalizumab dose you require. The dose varies depending on your weight and your IgE level. IgE is a natural substance in your body that that is elevated in allergic asthma. A blood test is used to test your IgE level.

Omalizumab is usually administered by a healthcare provider in a medical setting making it unlikely for an overdose to occur. However, if overdose is suspected, seek emergency medical attention.

Keep all medical and laboratory appointments.

WARNING: Anaphylaxis

Anaphylaxis presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of omalizumab. Anaphylaxis has occurred as early as after the first dose of omalizumab, but also has occurred beyond 1 year after beginning regularly administered treatment. Because of the risk of anaphylaxis, observe patients closely for an appropriate period of time after omalizumab administration. Health care providers administering omalizumab should be prepared to manage anaphylaxis that can be life-threatening. Inform patients of the signs and symptoms of anaphylaxis and instruct them to seek immediate medical care should symptoms occur.