Xolair for subcutaneous use is an injectable prescription medicine used to treat adults and children 12 years of age and older with:
• moderate to severe persistent allergic asthma who have had a skin or blood test that is positive for allergic asthma and whose asthma symptoms are not controlled by asthma medicines called inhaled corticosteroids.
• chronic idiopathic urticaria (CIU; chronic hives without a known cause) who continue to have hives that are not controlled by H1 -antihistamine treatment. Until now, H1-antihistamines have been the only approved therapy for CIU, with about 50 percent of patients having an inadequate response.
An allergic person makes too much of a certain protein in the body, called IgE antibody. The overproduction of this protein may result in various allergic conditions such as allergic rhinitis (hayfever), allergic asthma and CIU. Omalizumab is a drug that binds to the allergic antibody (IgE) in the blood stream and neutralizes (blocks) its actions
Omalizumab has been shown to decrease the number of asthma attacks in patients with more moderate to severe asthma, and in some patients it allows a reduction in, and sometimes complete elimination of, other asthma medications.
For asthma, your Omalizumab dose will be chosen based on your body weight and the results of a blood test that measures your level of IgE. For CIU, your Omalizumab dose will be based on your doctor’s recommendation. You will receive 1-2 injections of Omalizumab in your upper arm every 2 to 4 weeks depending on the above factors. 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 Omalizumab. 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 would expect the effects to wear off within 6 months to a year.
This is an expensive medication. Because each insurance company has their own rules, we will request approval from your insurance company before starting this therapy. Once approved, you will learn exactly how much the injections will cost or be covered by your insurance company.
The clinical studies performed for the FDA suggest that omalizumab is very safe. 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 Omalizumab were cancers and generalized allergic reactions from receiving the drug
• Generalized allergic reactions (anaphylaxis)
Anaphylaxis was noted to occur within 2 hours of the first or subsequent dose of Omalizumab in 3 (< 0.1%) study volunteers without other identifiable allergic triggers. These events included hives and throat and/or tongue swelling. At the first sign of a generalized allergic reaction, adrenaline (epinephrine) is usually given to counteract the reaction.
Some previous clinical trials have shown slightly higher rates of various cancers in patients treated with Omalizumab compared with non-Omalizumab-treated patients. The FDA review of the 5-year safety study found no difference in the rates of cancer between those patients being treated with Omalizumab and those who were not being treated with Omalizumab. However, due to limitations in the 5-year study, the FDA cannot rule out the potential risk of cancer with Omalizumab, so they have added this information to the Warnings and Precautions section of the drug label.
• Cardiovascular disease
The FDA review of a 5-year safety study found a slightly higher rate of heart and brain blood vessel problems occurred in patients being treated with Omalizumab compared to those patients not treated with Omalizumab. The heart and brain blood vessel problems included mini-strokes known as transient ischemic attacks or TIAs; heart attacks; sudden, unexpected chest pain; high blood pressure in the arteries of the lungs called pulmonary hypertension; and blood clots in the lungs and veins. Although the data are suggestive of a serious safety signal, due to weaknesses in how the safety study was designed and carried out, we are unable to definitively confirm or determine the exact increased level of these risks with Omalizumab.
• Local reactions and their treatment
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.
Since the possibility exists that a Omalizumab injection may cause a generalized allergic reaction, we require that Omalizumab be administered in our clinic. You will be observed 30-60 minutes after each injection. The period of observation will be determined based on your physician’s instructions. If a severe allergic reaction to Omalizumab occurs, you will not receive any additional Omalizumab treatments. If you develop a delayed reaction to your Omalizumab injection (after you leave our facility) please either return to our Center or proceed to the nearest emergency room and then contact us as soon as possible.