Xolair (Omalizumab) - Subcutaneous

What Is Xolair?

Xolair (omalizumab) is a prescription drug injected subcutaneously (under the skin of the thigh, stomach, or outer arm if given by a caregiver). Xolair is available as a prefilled syringe and as single-dose vials.

Xolair is used to treat:

• Moderate to severe persistent asthma caused by allergies in adults and children 6 years and older who are not controlled with inhaled corticosteroids
• Nasal polyps in adults 18 years or older who have not responded to nasal steroids
• Chronic spontaneous urticaria (CSU) in adults and teenagers 12 years and older who have not responded to antihistamines. CSU is a condition where people have frequent hives on their skin, lasting six weeks or more, without a known cause.

Xolair works by blocking the action of a substance in the body that causes asthma, polyps, and hives. Xolair is in a drug class called monoclonal antibodies.

What Is Xolair Used For?

The Food and Drug Administration (FDA) approved Xolair for:

• Adults and children 6 years and older with moderate to severe persistent asthma not controlled with inhaled corticosteroids: This type of asthma is usually diagnosed with a skin test or reactivity to a perennial aeroallergen, which is a substance always in the air like dust mites or mold. This means that allergies are causing asthma.
• Adults 18 years and older with nasal polyps who have not responded to nasal steroids: In this case, Xolair is used in addition to other treatments.
• Adults and teenagers 12 years and older with chronic spontaneous urticaria, or CSU, that has not responded to antihistamines: CSU is a condition in which hives appear almost every day.

Xolair is not used to treat acute bronchospasm (narrowing of the airways that causes wheezing and shortness of breath), acute asthma attacks, other allergic conditions, or other rashes or hives.

How to Take Xolair

Before you start Xolair, make sure to read the prescription label and the information leaflet that comes with your prescription. Consult your healthcare provider if you have any questions.

Use Xolair exactly as directed by your healthcare provider, usually once every two or four weeks. You may receive the injection by a healthcare provider or be trained to self-administer.

For the administration of Xolair:

• The first dose of Xolair should be given by your healthcare provider in a medical setting, under observation.
• If your healthcare provider decides that you or your caregiver can administer Xolair prefilled syringe injections, you will be trained on how to prepare and inject the medication. Do not try to inject Xolair until you have been trained.
• Adolescents 12 years and older may self-inject Xolair with adult supervision.
• Children 6 to 11 years old should have Xolair injected by a caregiver.

People who have asthma or polyps will have a blood test for immunoglobulin E (IgE) before starting Xolair. This test measures immunoglobulin E antibodies and shows what the body is reacting to. The test results will help your healthcare provider determine the proper Xolair dosage and frequency. People with CSU do not require this blood test.

Do not change the dose or stop taking your other medications unless instructed by your healthcare provider. Because Xolair dose is based on weight, notify your healthcare provider if you gain or lose weight as you may need a dosage change.

Your symptoms may not improve right away. If your symptoms worsen quickly or if you feel like your asthma medications are not working, contact your healthcare provider.

Ask your healthcare provider if you have any questions or concerns about Xolair.

Storage

Store the prefilled syringes in the refrigerator (36 to 46 degrees Fahrenheit) in the original carton. The syringe can be taken out and put back in the refrigerator if needed, but the total time out of the refrigerator cannot be more than two days. Do not use Xolair if it has been exposed to temperatures above 77 degrees Fahrenheit. Do not freeze Xolair, and do not use it if it has been frozen.

The vial form of Xolair is for administration by a healthcare provider in the medical setting and should be stored in the refrigerator.

Off-Label Uses

Sometimes Xolair is used off-label for indications that are not FDA approved. In some cases, healthcare providers may prescribe Xolair off-label to people with severe food allergies.

What Are the Side Effects of Xolair?

Like other medications, Xolair can cause side effects. Tell your healthcare provider about any side effects you experience while taking this medication.

This is not a complete list of side effects and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your pharmacist or a healthcare provider. You may report side effects to the FDA at fda.gov/medwatch or 1-800-FDA-1088.

Common Side Effects

Common side effects of Xolair include:

• Injection site reaction
• Viral infection/common cold symptoms
• Headache/migraine
• Muscle/joint pain
• General pain
• Tiredness
• Dizziness
• Nausea
• Itching
• Stomach pain
• Nosebleeds
• Ear infection/ear pain
• Dermatitis (skin irritation)
  
• Fractures
• Swelling of the extremities
• Fever
• Anxiety
• Hair loss
• Worm infections
• Low platelet levels

Severe Side Effects

Call your healthcare provider right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:

• Hypersensitivity reaction or anaphylaxis: Symptoms can include rash, hives, swelling around the lips, tongue, face, and difficulty breathing. These symptoms require medical attention. 
• Eosinophilia: A higher number of eosinophils (a type of white blood cell), which can cause wheezing, shortness of breath, and allergy symptoms.
• Churg-Strauss syndrome: An inflammation of the blood vessels, which usually requires steroids for treatment.
• Risk of cancer: Using Xolair can increase the risk of certain breast, skin, prostate, or salivary gland cancers. Talk to your healthcare provider about your risk before taking Xolair.
• Risk of cardiovascular events: Get immediate medical care if you have chest pain or pressure or pain that spreads to the jaw or shoulder.
• Risk of clotting: Get immediate medical care if you have sudden numbness or weakness, vision or speech difficulties, if you are coughing up blood, or have swelling or redness in an arm or leg.

Long-Term Side Effects

While many people tolerate Xolair well, long-term or delayed side effects are possible. Some long-term side effects can be mild, such as: 

• Infections, including sinus and throat infections
• Joint pain
• Cough
• Hair loss
• Anxiety
• Nosebleeds
  

Moderate long-term side effects can include: 

• Urinary tract infection (UTI)
• Swelling of the extremities
• Lymph node swelling
• Eosinophilia
• Low platelet levels

Severe long-term side effects may include: 

• Bone Fractures
• Cancer
• Serum sickness (a reaction to the medication that can cause fever, rash, and joint pain)
• Blood vessel inflammation
• Blood clots (may travel to the lungs)
• Heart attack
• High blood pressure in the lungs

Dosage: How Much Xolair Should I Take?

Modifications

You may need to use caution when taking Xolair if you are 65 years or older. Studies did not include many older adults, so consult your healthcare provider for guidance. There are no specific guidelines recommended for people with kidney or liver problems. People with kidney or liver conditions should consult their healthcare provider for medical advice before using Xolair.

People who are pregnant, planning to become pregnant, or are breastfeeding, should consult their healthcare provider before using Xolair.

Missed Dose

If you miss a dose of Xolair, call your healthcare provider as soon as possible for instructions.

Overdose: What Happens If I Take Too Much Xolair?

No reports of toxicities related to Xolair intravenous dosing have been established.

Precautions

What Are Reasons I Shouldn't Take Xolair?

Xolair is not appropriate for everyone. You should not take this medication if you are allergic to omalizumab or any of the inactive ingredients in Xolair. 

Other people who should not take Xolair include:

• People who are experiencing bronchospasm (narrowing of the airways, causing symptoms of wheezing and shortness of breath)
• People in status asthmaticus (a medical emergency due to a severe asthma attack that does not respond to initial treatments)

Xolair may be prescribed with caution in some people, only if the healthcare provider determines it is safe. This includes:

• People with a history of anaphylaxis
• People who are at risk for worm infection (due to living in or traveling to certain areas where worm infections are common)

What Other Medications May Interact With Xolair?

Xolair has not been studied in drug interaction studies. Therefore, no significant interactions are known with other drugs.

What Medications Are Similar?

Xolair is a monoclonal antibody used for allergic asthma, polyps, or hives. Other monoclonal antibodies include:

• Cinqair (reslizumab) is given as an intravenous (into a vein) infusion. It is used in addition to other treatments to treat severe eosinophilic asthma in adults. Eosinophilic asthma is a type of severe asthma caused by high levels of a type of white blood cell called eosinophils.
• Dupixent (dupilumab) is given by subcutaneous injection. It can be used alone or with topical steroids to treat adults and children ages 6 years and older with moderate to severe atopic dermatitis not controlled with topical medications. Dupixent can also be used with other medications to treat adults and children 6 years and older with moderate to severe eosinophilic asthma or with asthma that requires oral steroids (such as oral prednisone tablets). It can also be used, along with other medications, in adults with chronic rhinosinusitis (inflammation of the nasal passages and sinuses), with nasal polyps that are not controlled.
• Fasenra (benralizumab) is given by subcutaneous injection. It is used in combination with other medicines in adults and adolescents 12 years and older with severe eosinophilic asthma.
• Nucala (mepolizumab) is given by subcutaneous injection. It is used with other medications in adults and children 6 years and older with severe eosinophilic asthma. Nucala can also be used with other medications in adults with chronic rhinosinusitis, with nasal polyps, that is not controlled with nasal steroids. It can also be used to treat a condition in adults called eosinophilic granulomatosis with polyangiitis (EGPA), a very rare form of blood vessel inflammation that can cause organ damage if not treated. Nucala can also be used in adults and adolescents 12 years and older who have had hypereosinophilic syndrome (HES) for six months or more. HES is a group of rare blood disorders caused by high levels of eosinophils and can lead to organ damage.

People who take Xolair for asthma also take other medications for asthma. A rescue inhaler, also known as a short-acting beta-agonist, is used for acute asthma exacerbations or before exercise in people with exercise-induced bronchospasm. Examples of rescue inhalers are:

• ProAir HFA (albuterol)
• Proventil HFA (albuterol)
• Ventolin HFA (albuterol)
• Xopenex HFA (levalbuterol)

Long-acting beta-agonists, also called LABAs, should never be taken alone. A LABA may increase the risk of death if it is not taken with a steroid. Therefore, a LABA should always be taken with an inhaled steroid. This can be done either as two individual separate products or as a combination product. An example of a LABA is Serevent (salmeterol). 

An inhaled corticosteroid (ICS) can be taken alone or with a LABA. Examples of inhaled steroids are:

• Alvesco (ciclesonide)
• Asmanex (mometasone)
• Flovent HFA (fluticasone)
• Pulmicort Flexhaler (budesonide)
• Qvar RediHaler (beclomethasone)

There are some combination inhaled drugs that contain both a steroid and a LABA. Some examples of steroid/LABA combination inhalers include:

• Advair Diskus (fluticasone and salmeterol)
• Breo (fluticasone and vilanterol)
• Dulera (mometasone and formoterol)
• Symbicort (budesonide and formoterol)

Trelegy Ellipta contains three drugs: fluticasone, which is a steroid; umeclidinium, which is an anticholinergic drug; and vilanterol, which is a LABA. 

There are also other drugs that can be prescribed to control asthma symptoms, for example, oral medications like Singulair (montelukast) or oral steroids, such as prednisone. 

This list is a list of drugs also prescribed for asthma. It is NOT a list of drugs recommended to take with Xolair. Ask your pharmacist or a healthcare provider if you have questions.

How Can I Stay Healthy While Taking Xolair?

Before you take Xolair, discuss your medical history and all medication you take with your healthcare provider. When taking Xolair, follow your healthcare provider’s instructions for use. Read the information leaflet that comes with your prescription. Ask your healthcare provider if you have any questions. Be sure to get all of the bloodwork that your healthcare provider orders before and during treatment. 

Before self-injecting Xolair, or before a caregiver injects it, be sure that you or your caregiver have been fully trained. It can feel intimidating to give yourself an injection, but after several times, you will feel more comfortable, and you will begin to feel more confident in your ability to inject yourself. 

Your healthcare provider will advise you if you need to change your other medications. Do not stop taking your steroid medications unless instructed by your healthcare provider.

Xolair does not treat acute bronchospasm or acute exacerbation of asthma. Always carry a fast-acting rescue inhaler. It can be helpful to have two rescue inhalers, so you can keep one inhaler at home and one inhaler at work or school. Check the expiration date and how many puffs are remaining on a regular basis. Call in refills to the pharmacy several days ahead to ensure you never run out.