XOLAIR Has Been Shown to Help Relieve the Symptoms of Chronic Hives with No Known Cause
Learn how CSU is diagnosed.
In clinical studies, **XOLAIR was shown to help reduce the severity of itch* and the number of hives† in patients who continued to have symptoms that were not controlled by H1 antihistamine treatment. Individual results may vary.
Scroll down to learn more about clinical study results.
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*To measure itch severity, patients were asked to write down how itchy they felt every morning and night on a scale of 0-3. The average daily score was then added together over 7 days for the weekly itch severity score.
**Based on results from CSU Studies 1 and 2.
†To measure the hive score, patients were asked to count the number of hives on their bodies twice daily. (0= no hives, 1= 1 to 6 hives, 2= 7 to 12 hives, 3= more than 12 hives) The average daily score was then added together over 7 days for the weekly hive count score.
Important Safety Information
- wheezing, shortness of breath, cough, chest tightness, or trouble breathing
- low blood pressure, dizziness, fainting, rapid or weak heartbeat, anxiety, or feeling of “impending doom”
- flushing, itching, hives, or feeling warm
- swelling of the throat or tongue, throat tightness, hoarse voice, or trouble swallowing
Your healthcare provider will monitor you closely for symptoms of an allergic reaction while you are receiving XOLAIR and for a period of time after treatment is initiated. Your healthcare provider should talk to you about getting medical treatment if you have symptoms of an allergic reaction.
XOLAIR Clinical Studies and Results
Results of a CSU Study in Adults and Adolescents
XOLAIR was studied for 24 weeks to measure the severity of itch* and number of hives† (on a weekly basis) of CSU patients who continued to have hives while on antihistamine therapy. Open the tab below to see the results of the study and how it was done. Individual results may vary.
How the study was done§:
- A total of 319 patients with CSU who were already taking an antihistamine participated in the study.
- 81 patients were given 300 mg of XOLAIR.
- 80 patients were given 150 mg of XOLAIR.
- 80 patients were given a placebo.
‡Based on results from CSU Study 1, a 24-week clinical study.
§78 patients were given 75 mg of XOLAIR. The 75 mg dose did not demonstrate consistent evidence of efficacy and is not approved for use.
Possible Level of Hive Reduction
- At 300 mg, patients’ weekly hive count score† was reduced by over two-thirds (67%)
- At 150 mg, patients’ weekly hive count score† was reduced by one-half (50%)
Results reflective of 300 mg dose in one study with CSU patients. Two doses studied. Similar results observed in second study. People who used XOLAIR 150 mg saw a 47% decrease in itch severity and 50% fewer hives, with more than one in six itch and hive free, at 12 weeks. Severity in both studies was measured by weekly itch severity score (range 0-20) and weekly hive count score (range 0-21). A total of 641 CSU patients already taking an antihistamine participated in the two studies.
Individual results may vary.
Itch and hives resolved completely in more than 1 in 3 patients on 300 mg
- At 300 mg, more than 1 in 3 (36%) were completely itch‡ and hive†-free
- At 150 mg, almost 1 in 6 patients (15%) were completely itch‡ and hive†-free
Important Safety Information (continued)
Do not receive and use XOLAIR if you are allergic to omalizumab or any of the ingredients in XOLAIR.
Before receiving XOLAIR, tell your healthcare provider about all of your medical conditions, including if you:
- have a latex allergy. The needle cap on the XOLAIR prefilled syringe contains a type of natural rubber latex
- have ever had a severe allergic reaction called anaphylaxis
- have or have had a parasitic infection
- have or have had cancer
- are pregnant or plan to become pregnant. It is not known if XOLAIR may harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if XOLAIR passes into your breast milk. Talk with your healthcare provider about the best way to feed your baby while you receive and use XOLAIR.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How should I receive and use XOLAIR?
- When starting treatment XOLAIR should be given by your healthcare provider in a healthcare setting.
- If your healthcare provider decides that you or a caregiver may be able to give your own XOLAIR prefilled syringe injections, you should receive training on the right way to prepare and inject XOLAIR.
- Do not try to inject your XOLAIR prefilled syringe until you have been shown the right way to give XOLAIR injections by a healthcare provider. Use XOLAIR exactly as prescribed by your healthcare provider. For children 12 years of age and older, XOLAIR prefilled syringe may be self-injected under adult supervision. For children 6 to 11 years of age, XOLAIR prefilled syringe should be injected by a caregiver.Do not try to inject your XOLAIR prefilled syringe until you have been shown the right way to give XOLAIR injections by a healthcare provider. Use XOLAIR exactly as prescribed by your healthcare provider. For children 12 years of age and older, XOLAIR prefilled syringe may be self-injected under adult supervision. For children 6 to 11 years of age, XOLAIR prefilled syringe should be injected by a caregiver.
- See the detailed Instructions for Use that comes with XOLAIR for information on the right way to prepare and inject XOLAIR.
- XOLAIR is given in 1 or more injections under the skin (subcutaneous), 1 time every 4 weeks.
- In patients with chronic hives, a blood test is not necessary to determine the dose or dosing frequency.
- Do not decrease or stop taking any of your other hive medicine unless your healthcare providers tell you to.
- You may not see improvement in your symptoms right away after XOLAIR treatment.
- If you inject more XOLAIR than prescribed, call your healthcare provider right away.
Results of Another CSU Study in Adults and Adolescents
XOLAIR was studied for 12 weeks to measure the severity of itch* and number of hives† (on a weekly basis) of CSU patients who continued to have hives while on antihistamine therapy. Open the tab below to see the results of the study and how it was done. Your results may vary.
How the study was done:||
- A total of 322 patients already taking an antihistamine participated in the study.
- 79 patients were given 300 mg of XOLAIR.
- 82 patients were given 150 mg of XOLAIR.
- 79 patients were given a placebo.
‖82 patients were given 75 mg of XOLAIR. The 75 mg dose did not demonstrate consistent evidence of efficacy and is not approved for use.
What are the possible side effects of XOLAIR?
XOLAIR may cause serious side effects, including:
- Cancer. Cases of cancer were observed in some people who received XOLAIR.
- Fever, muscle aches, and rash. Some people get these symptoms 1 to 5 days after receiving a XOLAIR injection. If you have any of these symptoms, tell your healthcare provider.
- Parasitic infection. Some people who are at a high risk for parasite (worm) infections, get a parasite infection after receiving XOLAIR. Your healthcare provider can test your stool to check if you have a parasite infection.
- Heart and circulation problems. Some people who receive XOLAIR have had chest pain, heart attack, blood clots in the lungs or legs, or temporary symptoms of weakness on one side of the body, slurred speech, or altered vision. It is not known whether these are caused by XOLAIR.
The most common side effects of XOLAIR:
- In people with chronic spontaneous urticaria: nausea, headaches, swelling of the inside of your nose, throat or sinuses, cough, joint pain, and upper respiratory tract infection.
These are not all the possible side effects of XOLAIR. Call your doctor for medical advice about side effects.
XOLAIR Clinical Studies
To learn how XOLAIR might help patients with CSU, medical teams did research—this is known as clinical studies. Experts wanted to know how much XOLAIR could reduce 1) the severity of itch and 2) the number of hives.
Not all clinical studies are the same. However, many factors, such as the number of people who participate, types of people, the location of the participants, and other external or internal matters, can play a role in the outcome of a clinical study. This is why they are so important to do—and why more than one study may be done. Also remember that all people are unique—even if they do share a common condition such as CSU.
Two studies were conducted looking at the effect of XOLAIR in patients with CSU. In the studies, all the patients remained on an H1 antihistamine. Patients were then split into 3 different groups. Two groups (the XOLAIR groups) received different doses of XOLAIR, and the third (the Control group) received a placebo.
What is a "Control Group"?
In this group, patients received H1 antihistamine treatment and a placebo. A placebo is a look-alike treatment with no active medicine that can affect an illness. Placebos can take many forms, such as a pill, an injection, or even a procedure. In this case, it was an injection.