Xolair

Asthma

Xolair is used to treat moderate to severe persistent asthma in adults and children 6 years of age and older. It is specifically for patients whose asthma is triggered by year-round allergens in the air and whose symptoms are not adequately controlled with inhaled corticosteroid medicines.

Chronic Hives

This medication is used to treat chronic spontaneous urticaria (chronic hives) in adults and adolescents 12 years of age and older. It is prescribed when hives continue to occur without a known cause and do not respond well to H1 antihistamine treatments.

Nasal Polyps

Xolair is used as an add-on maintenance treatment for adults with nasal polyps. It is intended for patients who have not had a sufficient response to nasal corticosteroids.

Food Allergies

Xolair is approved for use in adults and children 1 year of age and older to help reduce the risk of allergic reactions, including anaphylaxis, that may occur after accidental exposure to one or more foods. It is used by people with IgE-mediated food allergies.

Important considerations for use include:

• It is not used to treat an active, emergency allergic reaction or sudden asthma attack.
• It is not intended for the immediate treatment of anaphylaxis.
• People using Xolair for food allergies must still continue to avoid the foods they are allergic to.

Mechanism of Action

Xolair (omalizumab) is designed to target and bind to immunoglobulin E (IgE). IgE is a type of antibody produced by the immune system that plays a central role in allergic responses. When a person with allergies is exposed to a trigger—such as pollen, dust mites, or certain foods—their body produces IgE, which then attaches to specific immune cells called mast cells and basophils.

By binding to the IgE circulating in the blood, Xolair prevents it from attaching to these immune cells. This process helps in several ways:

• Reducing Chemical Release: Because the IgE cannot attach to the immune cells, those cells are less likely to release histamine and other chemicals that cause inflammation and allergic symptoms.
• Lowering Sensitivity: Over time, treatment can decrease the number of IgE receptors on the surface of immune cells, making the body less sensitive to allergens.
• Preventing Severe Reactions: In cases of food allergies, blocking IgE helps increase the amount of an allergen a person can be exposed to before a severe reaction occurs.

For conditions like chronic hives, Xolair works by limiting the activation of the immune pathways that cause itchy skin welts, even when a specific external trigger is not identified.

Common Side Effects

The most frequently reported side effects of Xolair include:

• Pain, redness, swelling, or itching at the injection site
• Headache
• Tiredness or fatigue
• Joint or muscle pain
• Nausea or stomach discomfort
• Dizziness
• Ear pain
• Cold symptoms, such as a sore throat or runny nose (common in children)

Serious Side Effects

While less common, Xolair can cause serious side effects. Seek immediate medical attention if you experience:

• Severe allergic reactions (anaphylaxis): This can occur shortly after an injection or several days later. Symptoms include hives, swelling of the tongue or throat, difficulty breathing, and fainting.
• Heart or circulation problems: Symptoms may include chest pain, shortness of breath, or sudden weakness.
• Nervous system issues: Sudden numbness, vision changes, or problems with speech.
• Inflammation of blood vessels: Signs include a rash, fever, or swollen lymph nodes.
• Lung issues: New or worsening cough or coughing up blood.

Severe Allergic Reactions (Anaphylaxis)

Xolair can cause anaphylaxis, a sudden and life-threatening allergic reaction. This reaction can happen after the first dose or after many doses. While it often occurs shortly after the injection, it can also be delayed by 24 hours or more. Because of this risk, healthcare providers monitor patients for a period of time after the injection is administered. Symptoms of a severe reaction may include:

• Wheezing, shortness of breath, or cough
• Swelling of the face, lips, tongue, or throat
• Feeling faint, dizzy, or lightheaded
• Rapid or weak heartbeat
• Hives, itching, or skin rash

Cancer Risk

In clinical trials, a small number of patients taking Xolair developed various types of cancer more frequently than those who did not take the medication. The long-term risk of developing cancer while using this drug is not fully known.

Heart and Brain Circulation Problems

Some data suggests a potential increased risk of serious heart or blood vessel problems in people taking Xolair. These may include heart attack, stroke, transient ischemic attacks (TIAs), chest pain, or blood clots in the lungs or veins.

Parasitic Infections

Xolair may lower the body's ability to fight certain types of parasite infections, such as those caused by roundworms or hookworms. People who live in or travel to areas where these infections are common may be at a higher risk and should be monitored by a healthcare provider.

Eosinophilic Conditions

In rare cases, patients with asthma taking Xolair have developed a serious condition involving blood vessel inflammation (vasculitis) and an increase in certain white blood cells. This typically occurs when oral corticosteroid medications are being reduced or stopped. Symptoms can include a rash, worsening chest symptoms, or numbness in the arms or legs.

Latex Sensitivity

The needle cap on the prefilled syringe version of Xolair may contain natural rubber latex. This can cause allergic reactions in individuals with a known latex allergy.

Corticosteroid Use

Xolair is not a replacement for steroid medications. Other asthma or allergy medications, especially oral or inhaled corticosteroids, should not be stopped or reduced suddenly when starting Xolair treatment.

Pregnancy

There is limited information regarding the safety of using Xolair during pregnancy. It is not yet known if the medication can cause harm to an unborn baby. Because of this uncertainty, healthcare providers typically evaluate whether the benefits of the medication for the mother outweigh the potential risks to the fetus.

A pregnancy registry exists to monitor the outcomes of individuals who use Xolair while pregnant. This registry helps researchers and healthcare professionals better understand the drug's effects on pregnancy and infant health.

Breastfeeding

It is unknown if Xolair passes into human breast milk or how it might affect a nursing infant. Because many medications are excreted in breast milk, it is important for patients to discuss breastfeeding with their healthcare provider. They can help weigh the necessity of the medication against any potential risks to the baby.

Available Forms

Xolair is administered as a subcutaneous injection. It is available in the following formats:

• Prefilled Syringe: A syringe for manual administration.
• Autoinjector: A device for administration.
• Vial: A vial containing a powder that must be mixed with liquid by a healthcare professional before it is injected.

FDA Approval and Indications

Xolair was first approved by the U.S. Food and Drug Administration (FDA) in 2003. It is currently authorized for several specific uses:

• Allergic Asthma: For adults and children 6 years of age and older with moderate-to-severe persistent asthma that is not well-controlled by inhaled corticosteroids.
• Chronic Spontaneous Urticaria (CSU): For adults and adolescents 12 years of age and older who continue to experience hives without a known cause despite antihistamine treatment.
• Nasal Polyps: For adults with chronic rhinosinusitis with nasal polyps when steroid nasal sprays have not worked well enough.
• Food Allergies: Approved in 2024 to help reduce the risk of severe allergic reactions, including anaphylaxis, following accidental exposure to one or more foods in adults and children aged 1 year and older.

Boxed Warning

The FDA has issued a boxed warning for Xolair due to the risk of anaphylaxis, a sudden and life-threatening allergic reaction. This reaction can occur after the first dose or after many doses, and it may happen immediately or several hours after the injection. Because of this risk, the medication must be administered in a healthcare setting for the initial doses, and patients are typically prescribed an epinephrine auto-injector for emergency use at home.

Safety Communications

The FDA has monitored the long-term safety of Xolair through post-market reviews. This includes investigations into a potential increased risk of serious cardiovascular and cerebrovascular events, such as heart attacks, mini-strokes, or blood clots in the lungs and veins. While the evidence for these risks was not conclusive, they are noted in the drug's safety labeling to inform providers and patients.

Insurance and Coverage

Xolair is classified as a specialty biologic medication. Because of this classification, most insurance plans, including private insurance and Medicare, typically require prior authorization before they will cover the cost. The amount you pay out-of-pocket will depend on your specific plan's deductible, co-payment, or coinsurance requirements for specialty drugs.

Administration Costs

The total cost of treatment may be affected by where the medication is administered. Xolair can be given by a healthcare professional in a medical office or, in some cases, self-injected by the patient at home. If the medication is administered in a clinic, there may be additional costs associated with the office visit and the professional services required to give the injection.

Dosage and Frequency

The price of therapy varies between individuals because the dosage is not the same for everyone. For many conditions, a healthcare provider determines the dose based on the patient's body weight and the results of blood tests that measure immunoglobulin E (IgE) levels. Patients who require higher doses or more frequent injections will have higher overall treatment costs than those on a lower-dose schedule.

Financial Assistance

For patients who are concerned about the cost of Xolair, there may be financial assistance programs available. These can include manufacturer-sponsored support for those with commercial insurance or programs for individuals who are uninsured or underinsured. Patients should discuss these options with their healthcare provider or specialty pharmacy.