What Is Xolair®:
Indications, Dosing & Side Effects

Xolair® is a biologic medication. Its generic name is omalizumab. It belongs to a drug class known as monoclonal antibodies.

Xolair is approved by the U.S. Food and Drug Administration (FDA) to treat the following allergic conditions:

• moderate to severe persistent asthma
• chronic rhinosinusitis with nasal polyps (CRSwNP)
• chronic spontaneous urticaria (CSU), also called chronic idiopathic urticaria (CIU), or chronic hives
• food allergy

Xolair is given as an injection into the skin. Patients have the option of taking Xolair in a doctor’s office or clinic or self-administering it at home using an injectable pen.

Xolair is designed to stop inflammation in the airways and on the skin before it can start. The medication prevents and reduces symptoms in the airways and on the skin. It can also help prevent severe food-allergic reactions and build tolerance to food allergens.

What is Xolair used for?

Xolair is indicated for people who have moderate to severe asthma, allergies and chronic urticaria.

Xolair indications

• Adults and children ages 6 years and older who have moderate to severe allergic asthma that is not well controlled with other medicines.
• Adults and children ages 18 years and older with severe chronic rhinosinusitis with nasal polyps that is not adequately controlled with other medicine.
• Adults and children ages 12 years and older with chronic spontaneous urticaria who remain symptomatic despite H1 antihistamine treatment.
• Adults and children ages 1 year and older who have a IgE-related severe food allergy and want to reduce the risk of a severe allergic reaction and better tolerate their allergen in case of an accidental exposure.

How does Xolair work?

Xolair works by targeting immunoglobulin E (IgE) antibodies. When someone is exposed to an allergen, Xolair prevents IgE from binding to receptors of mast cells and basophils. This stops the release of the chemical histamine, a key trigger of asthma, allergies and chronic urticaria.

Many people with these conditions see increased levels of IgE when they come into contact with an allergen. Xolair can also reduce the levels of IgE receptors on basophils.

Xolair is an add-on maintenance treatment, meaning that it can be taken alongside other prescribed medications. For example, it can be taken with inhaled corticosteroids that treat asthma. The drug combination can help improve control of symptoms.

If you are prescribed Xolair, work together with your doctor on a treatment plan. Follow it closely, as the specific combination of medications you’re prescribed may vary based on the severity of your condition. Regular appointments and communication with your doctor can ensure your treatment plan is effective.

Xolair dosing

Your Xolair dosage may vary depending on your condition.

• Asthma: Xolair is given every 2 or 4 weeks. The dosage is 75 mg to 375 mg based on evaluation of the serum total IgE level (measured before the start of treatment) and body weight.
• CRSwNP: Xolair is given every 2 or 4 weeks. The dosage is 75 mg to 600 mg based on evaluation of the serum total IgE level (measured before the start of treatment) and body weight.
• Food allergy: Xolair is given every 2 or 4 weeks. The dosage is 75 mg to 600 mg based on evaluation of the serum total IgE level (measured before the start of treatment) and body weight.
• CSU: Xolair is given every 4 weeks. The dosage is 150 mg or 300 mg. It is not dependent on serum IgE level or body weight.

Xolair injection

The Xolair injection is typically administered under the skin in the upper arm, thigh or stomach. The medication is delivered in the tissue layer between the skin and the muscle.

Avoid injecting the biologic into the same site each time. This can cause sensitivity, pain and scarring.

You can choose to receive the medication at your doctor’s office or self-administer at home with the Xolair auto-injector. Your doctor can provide training on how to administer the auto-injector.

Xolair auto-injector

The Xolair auto-injector is a pre-filled syringe that you can self-administer at home. Many people taking Xolair at home feel this option offers greater convenience and a sense of empowerment. They can take the injection when they want, on their own schedule.

People self-administering Xolair should only follow the prescribed dosing regimen. If you choose to self-administer with the Xolair auto-injector, it’s important to follow the specific instructions for taking the medication.

Ask your doctor for training on how to correctly administer the auto-injector. Make sure you know the injection site and proper technique. Talk with your doctor regularly to ensure you are injecting it safely and effectively.

Xolair ingredients

Active ingredient: Omalizumab

Inactive ingredients (pre-filled syringe): arginine hydrochloride, histidine, L-histidine hydrochloride monohydrate, and polysorbate 20

Inactive ingredients (Vial): histidine, L-histidine hydrochloride monohydrate, polysorbate 20 and sucrose

Xolair side effects

Xolair can cause side effects that range from mild to serious. The most common side effects from this medication include:

• Joint pain in the arms or legs
• Dizziness
• Fatigue
• Fever
• Headache
• Skin rash
• Itchy skin
• Ear discomfort or pain
• Injection site reactions

In children between the ages of 6 and 12, side effects may also include:

• Swelling inside the nose, throat or sinuses
• Ear or throat infection
• Fever
• Abdominal pain
• Nose bleeds

Some people may experience an allergic reaction soon after the Xolair injection. Tell your healthcare provider or get emergency help right away if the allergic reaction is severe. This is anaphylaxis, a potentially life-threatening condition. Symptoms of anaphylaxis may include:

• hives on the skin
• swelling of your face, mouth and/or tongue
• breathing problems
• nausea, abdominal cramps or vomiting
• low blood pressure
• fainting, dizziness, feeling lightheaded

If you take Xolair at home, you will need a prescription for epinephrine. Epinephrine is the first-line treatment for anaphylaxis. Take it at the first sign of symptoms.

Before using Xolair, tell your healthcare provider about all of your medical conditions. Provide a list of any other medications you’re taking that could cause drug interactions. Do not stop taking other medications unless instructed to do so by your healthcare provider.

Xolair and pregnancy

Currently, there is limited data on the safety of Xolair in pregnancy. Some studies suggest Xolair is safe during pregnancy and breastfeeding, but more research is needed.

The decision to use Xolair during pregnancy should involve a thorough discussion between doctor and patient. Together they can weigh the potential benefits of the biologic against potential risks to the parent and the developing fetus.

Doctors may consider alternative treatment options or determine if the benefits of Xolair outweigh the potential risks based on the specific situation.

Can you experience withdrawal when stopping Xolair?

Research shows people who stop Xolair do not report withdrawal symptoms. Xolair is prescribed for the long-term management of conditions such as moderate to severe persistent allergic asthma and chronic spontaneous urticaria. It should not be abruptly stopped without careful consideration by healthcare providers.

The decision to stop Xolair should only be made in consultation with a doctor. If there is a need to discontinue your treatment, healthcare providers will typically develop a plan to taper or transition the dosage to minimize any potential impact on the individual’s health and symptoms.

It’s important for people taking Xolair to communicate openly with their doctor about any concerns, including the potential for changes in the treatment plan.

How much does Xolair cost?

Biologics are expensive medications due to their complex production process. The list price for Xolair without insurance is $5,000 for adults and about $3,000 for children per month. Most people will not pay the list price. The actual cost will vary based on your insurance coverage.

Check your health insurance plan to see if you’re covered for Xolair. The Xolair Co-Pay Program is available for eligible people with commercial insurance. It provides financial assistance up to $15,000 yearly for Xolair costs and/or up to $1,500 in assistance yearly for injection costs. Eligible people enrolled in the program may pay as little as $0.

Does Medicare cover Xolair? Yes, it is covered under all Medicare plans. If you receive Xolair injections in the doctor’s office or clinic, it is covered under Medicare Part B. If you obtain your Xolair auto-injector at a specialty pharmacy to take it at home, it is covered under Part D instead. According to Genentech, more than 50% of Xolair patients on Medicare pay $0 out-of-pocket costs per month. For people who do have out-of-pocket Medicare costs, 90% pay between $5 to $868 per month.

People on Medicare Part D may be eligible for the Social Security Administration’s Extra Help (also known as Low-Income Subsidy, or “LIS”), a patient support program. People eligible for Extra Help typically pay between $0 and $9 for their prescriptions.

Many people who rely on Medicaid can pay $0 out-of-pocket costs per month for Xolair. This amount may vary depending on your income level and state regulations.

The Genentech Patient Foundation provides complimentary Xolair doses to eligible people who are prescribed the medication but lack insurance coverage or face financial challenges.

Charitable organizations such as The Assistance Fund, Inc., Patient Advocate Foundation and The HealthWell Foundation are dedicated to offering financial support to patients with specific medical conditions, irrespective of their chosen treatment. People with commercial or public insurance, including those under Medicare and Medicaid, can reach out directly to these foundations for financial assistance.