If you have allergic asthma, chronic hives, or nasal polyps, your doctor may recommend the medication omalizumab (Xolair). You may be wondering how this drug works, how you take it, and how much it will cost. Get answers to some common questions about omalizumab.
What Is Omalizumab (Xolair)?
Omalizumab is a medicine used to treat allergic asthma, chronic hives (chronic idiopathic urticaria), and nasal polyps.
You take this medicine as a shot under your skin every 2 or 4 weeks. The liquid medicine comes prefilled in a syringe or as a powder that’s mixed with liquid and injected.
Once your doctor or other health care provider gives you the shot in the doctor’s office or clinic, they’ll make sure you don’t have a serious reaction. Then, they may teach you to give yourself the shots at home.
Omalizumab came onto the market in 2003. It is the first monoclonal antibody to treat severe allergic asthma, chronic hives, and nasal polyps.
What Is Omalizumab (Xolair) Used For?
It’s approved to treat these conditions:
Allergic asthma. If you have moderate to severe asthma and inhaled corticosteroids aren’t working for you, your doctor may prescribe omalizumab to reduce asthma attacks. It’s approved for people aged 6 and older.
Chronic hives. Omalizumab also is approved to treat chronic hives. You might hear that called idiopathic urticaria. Doctors prescribe it for people 12 and older who don’t respond to antihistamines.
Nasal polyps. Doctors use omalizumab to reduce nasal polyp size and nasal congestion in people 18 and older who haven’t responded well to nasal corticosteroids. Nasal polyps are noncancerous growths in your nasal passages. They can block airflow and cause infections. They’re common if you have allergies or asthma.
Is Omalizumab (Xolair) a Biologic?
Yes. Omalizumab is a type of biologic drug known as a monoclonal antibody. Scientists make biologics from human, animal, or microorganism cells. A monoclonal antibody is a copy of a living protein that functions like the antibodies already in your body.
Biologics are different from traditional chemical drugs because they come from cells of living things. Traditional drugs are made from chemical processes and are easier to make.
How Does Omalizumab (Xolair) Work?
When you come into contact with something you’re allergic to, your body makes an antibody called immunoglobulin E, or IgE. The IgE then attaches to the allergen and your inflammatory cells. This releases substances that can cause inflammation. That can trigger hives, nasal polyps, or asthma symptoms (among other things).
Omalizumab stops IgE from attaching to your inflammatory cells. The medicine lowers certain IgE levels so your body doesn’t go through the process that leads to symptoms.
Though the drug works in a similar way in the conditions it’s approved to treat, here’s what it does in each of them:
Allergic asthma. Omalizumab targets IgE, which is a root cause of allergic asthma. The medicine binds to IgE so it can’t attach to your inflammatory cells. This can reduce asthma attacks. But it’s not meant to be taken when you have a sudden attack. In fact, you’ll probably stay on your inhaler or other long-term control medications when you start omalizumab. Depending on how it works for you, your doctor might decrease your dosage over time.
Chronic hives. It can block IgE from attaching to inflammatory cells. This can lower the number of hives you get and ease itching.
Nasal polyps. It can attach to IgE to prevent the inflammation that leads to nasal polyps. This can reduce the size of polyps and ease congestion so you breathe easier.
How Often Should I Take Omalizumab (Xolair)?
If you have allergic asthma or nasal polyps, you’ll probably take it every 2 or 4 weeks. If you use it to treat chronic hives, you will probably get it every 4 weeks. Your doctor can tell you which dose is right for you and how often you’ll need to take it.
If you have asthma or nasal polyps, your doctor will take your blood before prescribing it. (They won’t have to do bloodwork before starting this medication for hives.) The bloodwork helps them:
- Figure out your IgE levels
- Decide how much omalizumab you should take
- Know how often you should take it
Can I Have Side Effects on Omalizumab (Xolair)?
You may get some side effects or none at all. Common side effects are:
- Reaction – swelling, redness, pain, or itching – where the needle goes in
- Muscle or joint aches
- Fatigue
- Stomach pain
- Nosebleeds
- Nausea
- Headache
- Ear pain
- Swelling in your nose, sinuses, or throat
Serious side effects include:
Is Omalizumab (Xolair) Safe and Effective?
In early testing, it was effective in all the conditions it’s approved to treat.
Follow-up studies show:
- It’s usually safe and people normally see results when they’re on it.
- Staying on it for more than 10 years doesn’t increase your risk for side effects, especially anaphylaxis (a serious reaction).
- Some people on it for 5 years kept asthma symptoms under control.
Don’t take omalizumab if you’re sensitive to any of its ingredients or if you’ve had a severe allergic reaction called anaphylaxis in the past.
The FDA prescribing information lists these warnings for those taking omalizumab:
Anaphylaxis. This rare, life-threatening allergic reaction can happen within a couple of hours after taking the drug, or it can happen within 4 days of injection. Some people don’t have anaphylaxis after their first shot but can have a bad reaction even after being on it for a year. Symptoms include:
- Wheezing or shortness of breath, trouble breathing
- Dizziness
- Changes in your heart rate (beating much faster or slower)
- Swelling in your throat or tongue, trouble swallowing
- Feeling flushed
Your doctor will monitor you after you take the shot to see how you react and respond if you need emergency care. That’s why they give it to you -- at least when you first start taking it – in a medical setting.
If you have any of the above symptoms or a severe reaction of any kind, call 911 and get immediate help.
Cancer. Some people taking omalizumab have reported getting cancer after they went on the drug. But so far, the medical research does not support that the drug causes cancer.
Acute or worsening asthma. Omalizumab isn’t used to treat a serious asthma attack or lung muscle tightening (bronchospasm). It’s more of a preventive drug. If your asthma isn’t getting better on omalizumab or seems to get worse after you start taking it, talk to your doctor.
Corticosteroid reduction. You may be able to use these asthma medicines less when you take omalizumab, but check with your doctor first. Avoid stopping corticosteroids suddenly if you take them for nasal polyps or asthma, though.
Corticosteroids and omalizumab haven’t been tested in people with chronic hives.
Eosinophilia. It’s rare, but you may develop eosinophilia when you take omalizumab. Eosinophilia is when your body produces too many of a certain type of white blood cells. It often happens when you reduce oral corticosteroids. There may not be symptoms, but your doctor can diagnose it using routine blood tests.
Fever, rash, or joint pain. Tell your doctor if you have these symptoms within a few days of your injection.
Parasitic infection. While you’re on omalizumab, your doctor may monitor you for signs of soil-transmitted parasitic infections like roundworm, whipworm, and hookworm.
Does Omalizumab (Xolair) Cause Weight Gain?
Weight gain isn’t listed as a side effect of omalizumab in the official prescribing information. Some research shows it can cause weight loss, but there’s not a lot of evidence. One case showed it was linked to weight gain.
Research shows omalizumab works well for people regardless of their weight.
How Much Does Omalizumab (Xolair) Cost?
Generally, monoclonal antibodies cost much more than conventional asthma treatments.
The price of omalizumab depends on how much you need. Depending on your condition, your doctor may recommend anywhere from 75 milligrams to 600 milligrams. The medication comes in 75 milligram and 150 milligram single-dose syringes that are prefilled with the medication. It also comes in a 150-milligram powder that gets mixed with a liquid.
The cost can be based on the type of insurance coverage you have or how much money you make.
It costs anywhere from $5,000 for adults and about $3,000 for children for a 1-month supply of omalizumab without insurance, depending on the dosage you need. Another report says that one 150-milligram syringe is $30,000 - $60,000 a year.
It’s hard to find pricing information online for omalizumab because not many retail pharmacies have it. You will need to get it directly from your doctor or a specialty pharmacy. A specialty pharmacy provides medicines that require special handling or have other unique requirements. The medicines they provide are for chronic conditions that can be complex. A specialty pharmacy can ship drugs to you or to a retail pharmacy where you pick them up.
Medicare may cover omalizumab if your doctor gives you the shot or you get it in a medical office. It may be covered under Medicaid, too, depending on the program where you live. You may need prior authorization. That's when your insurance company has to approve it before you can get it. Ask your doctor or contact your insurance program to confirm if they’ll cover it.
The company that makes omalizumab offers a few financial support options:
- The Xolair Co-pay Program. This is for people who have private medical insurance. You won’t qualify if you’re on Medicare, Medicaid, or another federal or state program. You’ll pay a copay for the medicine but will have to pay the rest out of pocket if you reach their maximum benefit.
- Independent copay assistance foundations. Xolair Access Solutions can refer you to an independent foundation that may be able to help with drug costs if you have government or private health insurance. They can also see if you can get Xolair covered.
- The Genentech Patient Foundation. Omalizumab may be free under this program, which is for people without insurance or those with other financial considerations. You’ll need to meet certain requirements to qualify, which include income limits.
Is a Generic Form of Omalizumab (Xolair) Available?
Omalizumab is the generic name of Xolair. But there is no generic version. There can’t be because generic versions don’t exist for biologics. Generics are only available for traditional, chemical drugs.
When companies make a generic version of a traditional chemical drug, it must be able to work the same way the original drug does. Generics usually cost less than the brand-name drug. Biologics can’t be reproduced the same way chemical drugs can. But versions that are similar can. In fact, these drugs are called biosimilars. They still have to be safe and effective like the original versions. And like generics, biosimilars cost less than the originals.
There’s no biosimilar for omalizumab yet. But it looks like a biosimilar could be on the market soon.
