Xolair Information Overview
What is Xolair?
Some individuals make too much of a certain protein in their blood called IgE antibody. The overproduction of this antibody can result in the development of various allergic conditions such as: nasal allergies, allergic asthma, food allergy or drug allergy. Xolair is a drug that acts by binding to the IgE antibody in the blood stream and hence neutralizing or blocking its actions. In 2003, the U.S. Food and Drug Administration (FDA) approved Xolair for the treatment of patients with moderate to severe persistent asthma that is not controlled with inhaled corticosteroids. These patients are also allergic to year-round aeroallergens, such as: dust mites, animal dander, mold, cockroach, and certain pollens. In 2014 the FDA approved Xolair for the treatment of patients with chronic idiopathic urticaria (chronic hives) not responsive to antihistamines. For both groups, Xolair can be given to patients ages 12 years or older.
What are the benefits of Xolair therapy?
Xolair has been shown to decrease the number of asthma attacks in patients with moderate to severe asthma. Some patients treated with Xolair may be able to reduce or sometimes completely eliminate their other asthma medications. In patients with chronic hives, Xolair can reduce itching and hives within 3 months of starting treatment.
What are the risks of Xolair therapy?
The clinical studies performed for the FDA suggest that Xolair is very safe. In the initial studies, 2000 adults and adolescents took the drug continuously for at least 6 months. The overall number of adverse reactions was similar among those patients taking Xolair or placebo (an inactive ingredient). These adverse reactions included injection site reactions (45%), colds (23%), sinus infections (16%), headache (15%), and sore throat (11%). Serious adverse reactions occurred in less than 1% of patients. The most serious reactions occurring in studies with Xolair were cancers, cardiovascular events and severe generalized allergic reactions (anaphylaxis).
Cancers were seen in 1 of every 200 Xolair-treated study volunteers (0.5%) compared with one of every 500 control (untreated) volunteers (0.2%) prior to 2003. A panel of cancer specialists was asked to review this information and concluded that there was no evidence to suggest that this drug actually causes cancer. Malignancies were of varying types and occurred in a number of different organ systems. Evaluation by cancer experts concluded that no association was observed between Xolair treatment and risk of malignancy and no cause-effect relationship between Xolair therapy and malignancy exists. A subsequent 5-year observational safety study found NO difference in the rates of cancers (per 1000 patient years) between those patients being treated with Xolair (12.3) and those who were not being treated with Xolair (13.0). However, due to limitations in the 5-year study, a potential risk of cancer with Xolair cannot be ruled out, so this information was added to the Warnings and Precautions section of the drug label.
A 5-year safety study found a slightly higher rate of heart and brain blood vessel problems occurred in patients being treated with Xolair compared to those patients not treated with Xolair. The heart and brain blood vessel problems may include: mini-strokes (or TIAs), heart attacks, unexpected chest pain, high blood pressure in the arteries of the lungs (pulmonary hypertension), and blood clots in the lungs and veins.
To further evaluate the heart and brain risks, a combined analysis of 25 randomized double-blind clinical trials was reviewed comparing Xolair to a placebo (a treatment that does not contain any medicine). An increased risk of heart- and brain-related problems in patients treated with Xolair was NOT noted in this combined analysis, but the low number of these events, the young patient population, and the short duration of follow-up prevent us from making any definite conclusions about the absence of a risk. As a result this information was to the Adverse Reactions section of the drug label.
Generalized allergic reactions (anaphylaxis)
Anaphylaxis has been noted to occur within 2 hours of the first or subsequent dose of Xolair in < 0.1% of study volunteers without other identifiable allergic triggers. These events include hives and throat and/or tongue swelling. At the first sign of anaphylaxis, epinephrine is usually given to counteract the reaction. Severe reactions that include chest symptoms are treated the same way as an asthma attack. The FDA advises that patients on Xolair should carry epinephrine and know how to initiate emergency self-treatment for anaphylaxis. This is recommended and will be prescribed by your physician.
Local reactions that consist of swelling of the arm, redness or tenderness at the site of injection are usually handled with simple measures such as local cold compresses or the use of medications such as antihistamines or aspirin.
What does the treatment involve?
For asthma, your Xolair dose will be chosen based on your body weight and the results of a blood test that measures your level of IgE antibody. You will receive 1 or 2 injections of Xolair in your upper arm every 2 to 4 weeks depending on your dose. Unless your weight changes significantly, the dose and injection schedule should not change once your treatment has started. It may take several months before you begin to notice benefits from Xolair, but once benefits are observed, they should last for as long as you continue to receive your regular injections. If for some reason your injections are stopped, we expect the effects to wear off within 6 – 12 months. There are no lasting benefits from taking this drug. For chronic hives, you will receive 2 injections once a month. You may begin to notice benefits from Xolair within the first 3 months of treatment for hives. Since the possibility exists that a Xolair injection may cause a severe allergic reaction, we require that the treatment be administered under a supervision of a physician. You will be observed for 45 minutes after each injection. The period of observation may be adjusted by your physician. If you develop a reaction to your Xolair injection after you leave our office, please either return to clinic or proceed to the nearest emergency room and then contact us as soon as possible. You may need to use your epinephrine auto-injector.
Xolair therapy is expensive (cost of approx. $500-$2000 per month) so a specialty pharmacy company will be contacted to assist with insurance issues. Your allergist will complete initial paperwork and the specialty pharmacy will work with your insurance to obtain authorization of Xolair therapy. Prior to starting Xolair, the specialty pharmacy will inform you of your coverage. You can then make an informed decision knowing what your costs will be. As this therapy is costly, you will need to make your injection appointments with our office ahead of time and you will be responsible for your portion of the costs.