Before or even during treatment, you may have questions about XOLAIR and how it works. Listed here are some common questions about XOLAIR and answers you may find useful. If you would like more information, talk to your doctor or asthma specialist.
Who is XOLAIR for?
Who should not receive XOLAIR?
What can XOLAIR mean for me?
What is the most important information I should know about XOLAIR?
How does XOLAIR work?
How quickly does XOLAIR work?
How is XOLAIR given?
How often is XOLAIR given?
Can I take XOLAIR with my current medicines?
What will happen if I stop taking XOLAIR?
What are the signs and symptoms of anaphylaxis?
Are there any other serious side effects associated with XOLAIR?
What are other possible side effects of XOLAIR?
What other important safety information should I know about?
How can I get more information about XOLAIR?
Q: Who is XOLAIR for?
A: XOLAIR is a steroid-free prescription medication given by injection to people who:
- Are 12 years of age and above
- Have moderate to severe persistent asthma
- Have asthma triggered by year-round allergens in the air. This is known as allergic asthma, and can only be confirmed by a doctor using a simple skin or blood test
- Continue to have asthma symptoms even though they are taking inhaled steroids
Important Limitations of Use
- XOLAIR has not been proven to work in other allergic conditions.
- XOLAIR is not a rescue medicine and should not be used to treat sudden asthma attacks.
- XOLAIR should not be used in children under 12 years
of age.
Adding XOLAIR injections to an existing treatment program using inhaled steroids has been clinically proven to help reduce the number of asthma attacks a person experiences. XOLAIR has not been proven to work in other allergic conditions.
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Q: Who should not receive XOLAIR?
A: Do not take XOLAIR if you are allergic to any of its ingredients.
XOLAIR is sterile, white, preservative-free, lyophilized powder contained in a single-use vial that is reconstituted with Sterile Water for Injection (SWFI), USP, and administered as a subcutaneous (SC) injection.
A XOLAIR vial contains 202.5 mg of Omalizumab, 145.5 mg sucrose, 2.8 mg L-histidine hydrochloride monohydrate, 1.8 mg L-histidine, and 0.5 mg polysorbate 20, and is designed to deliver 150 mg of Omalizumab in 1.2 mL after reconstitution with 1.4 mL SWFI, USP.
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Q: What can XOLAIR mean for me?
A: In 2 clinical studies, XOLAIR helped reduce the number of asthma attacks in patients with moderate to severe allergic asthma who had asthma symptoms even though they were taking inhaled steroids. When the patients' inhaled steroid doses were lowered, those receiving XOLAIR still had fewer asthma attacks than those receiving a placebo (an injection with no active medicine).
In a third study, the number of asthma attacks in patients receiving XOLAIR was similar to the number of asthma attacks in patients receiving a placebo. However, this study was conducted differently from the other 2 studies; it also included different types of patients.
XOLAIR may not be effective in all patients. Talk to your doctor to see if XOLAIR is right for you.
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Q: What is the most important information I should know about XOLAIR?
A: XOLAIR should always be injected in a doctor's office. A severe allergic reaction called anaphylaxis has happened in some patients after they received XOLAIR. Anaphylaxis is a life-threatening condition. Seek emergency medical treatment right away if symptoms occur.
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Q: How does XOLAIR work?
A: XOLAIR works differently from any other medication you may be taking now. Only XOLAIR captures IgE (the molecule in your body that can play a major role in your asthma) to help stop asthma attacks and symptoms before they start.
Your body produces IgE in response to certain allergens. For 6 in 10 people with asthma, IgE triggers the release of chemicals, which may lead to an attack. XOLAIR captures most of the IgE related to allergic asthma.
XOLAIR has not been proven to work in other allergic conditions.
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Q: How quickly does XOLAIR work?
A: You may not see an immediate improvement in your asthma after XOLAIR treatment begins. It takes time for the medicine to work. If you don't feel a difference right away, it doesn't mean XOLAIR is not working. So don’t give up. It is important to continue your XOLAIR injections until your doctor tells you otherwise.
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Q: How is XOLAIR given?
A: XOLAIR is given through subcutaneous injection, which means it is injected just under the skin. XOLAIR should always be injected in a doctor's office.
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Q: How often is XOLAIR given?
A: You will receive XOLAIR once every 2 or 4 weeks. Your body weight and your IgE level, which is measured with a simple skin or blood test, will determine your dose. And based on your dose, your doctor will tell you if you need 1, 2, or 3 injections per dose. If you need more than 1 injection, each injection will be given in a different place on your body.
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Q: Can I take XOLAIR with my current medicines?
A: XOLAIR is approved for use in patients who are already taking inhaled steroids. As with all medicines, be sure to tell your doctor about any medicines you are taking for your asthma or any other condition. This includes prescription and nonprescription medicines, vitamins, and herbal supplements.
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Q: What will happen if I stop taking XOLAIR?
A: If you stop receiving XOLAIR injections, your symptoms can be expected to return.
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Q: What are the signs and symptoms of anaphylaxis?
A: Get emergency medical treatment right away if you experience these signs and symptoms of anaphylaxis after receiving XOLAIR:
- Wheezing, shortness of breath, coughing, 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
Anaphylaxis from XOLAIR can happen:
- Right after receiving a XOLAIR injection or hours later
- After any XOLAIR injection. Anaphylaxis has occurred after the first XOLAIR injection or after many XOLAIR injections
Your doctor should watch you for some time in his or her office for signs or symptoms of anaphylaxis after injecting XOLAIR. If you have signs or symptoms of anaphylaxis, tell your doctor right away.
Your doctor should also instruct you about getting emergency medical treatment and further medical care if you have signs or symptoms of anaphylaxis after leaving the doctor's office.
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Q: Are there any other serious side effects associated with XOLAIR?
A: In clinical studies, cancer was seen in a small number of patients receiving XOLAIR, as well as those receiving placebo injections.
- The rate of cancer was higher in patients treated with XOLAIR than a placebo (0.5% vs 0.2%)
- Several different types of cancer were seen
Please discuss this information with your doctor. Only your doctor can help you decide if XOLAIR is right for you.
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Q: What are other possible side effects of XOLAIR?
A: The most common side effects in patients who received XOLAIR during clinical studies are listed below. This is not a complete list of all the side effects of XOLAIR that were reported.
- Injection-site reaction (45%)
- Viral infections (23%)
- Upper respiratory tract infection (20%)
- Sinusitis (16%)
- Headache (15%)
- Sore throat (11%)
These side effects were about as common in patients receiving placebo injections.
Other side effects included:
- Joint pain (8%)
- Pain (general) ( 7%)
- Leg pain (4%)
- Tiredness (fatigue) (3%)
- Dizziness (3%)
- Fracture (2%)
- Arm pain (2%)
- Itching (2%)
- Inflammation of the skin (2%)
- Earache (2%
Q: What other important safety information should I know about?
A: XOLAIR is not a rescue medicine and should not be used to treat sudden asthma attacks. It is not a substitute for the medicines you are already taking. Never suddenly stop taking, or change the dose of, your inhaled steroids or any other asthma medicine you are taking, unless your doctor tells you to do so.
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Q: How can I get more information about XOLAIR?
A: Talk to your doctor if you have any more questions about XOLAIR treatment.
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| WHO is XOLAIR for? | |||||||||||||||||
| XOLAIR® (omalizumab) for subcutaneous use is an injectable, prescription medicine for patients ages 12 and older. It is for patients with moderate to severe persistent allergic asthma caused by year-round allergens in the air. A skin or blood test is done to see if you have allergic asthma. XOLAIR is for patients who are not controlled by asthma medicines called inhaled steroids. | |||||||||||||||||
| XOLAIR helps reduce the number of asthma attacks in people with allergic asthma who still have asthma symptoms even though they are taking inhaled steroids. | |||||||||||||||||
| Important Limitations of Use | |||||||||||||||||
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| IMPORTANT SAFETY INFORMATION | |||||||||||||||||
| XOLAIR should always be injected in a doctor's office. You should read the Medication Guide before starting XOLAIR treatment and before each and every treatment. | |||||||||||||||||
| A severe allergic reaction called anaphylaxis has happened in some patients after they received XOLAIR. Anaphylaxis is a life-threatening condition and can lead to death. Seek emergency medical treatment right away if symptoms occur. Signs and symptoms of anaphylaxis include: | |||||||||||||||||
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| You should not receive XOLAIR if you have ever had an allergic reaction to a XOLAIR injection. Do not use XOLAIR if you are allergic to any of its ingredients. | |||||||||||||||||
| In clinical studies 0.5% of patients receiving XOLAIR developed cancer, compared to 0.2% of patients receiving placebo (an injection with no active medicine). | |||||||||||||||||
| Joint inflammation or pain, rash, fever, and swollen lymph nodes have been seen in patients taking XOLAIR. Talk to your doctor if you’ve experienced any of these signs and symptoms. | |||||||||||||||||
| In patients >12 years of age, the most commonly observed side effects in asthma studies that had a >1% difference between XOLAIR and placebo were joint pain (8%), pain (general) ( 7%), leg pain (4%), tiredness (fatigue) (3%), dizziness (3%), fracture (2%), arm pain (2%), itching (2%), inflammation of the skin (2%), and earache (2%). | |||||||||||||||||
| In asthma studies, the most common side effects in patients, who either needed to stop XOLAIR or needed medical attention, were injection site reaction (45%), viral infections (23%), upper respiratory tract infection (20%), sinusitis (16%), headache (15%), and sore throat (11%). These side effects were seen at the same rates in XOLAIR-treated patients as in patients in the control group who received placebo. | |||||||||||||||||
| XOLAIR is not a rescue medicine and should not be used to treat sudden asthma attacks. | |||||||||||||||||
| XOLAIR is not a substitute for the medicines you are already taking. Do not change or stop taking any of your other asthma medicines unless your doctor tells you to do so. You may not see an immediate improvement in your asthma when beginning XOLAIR therapy. | |||||||||||||||||
| You are encouraged to report negative side effects of prescription drugs to the FDA at www.fda.gov/medwatch, or by calling 1-800-FDA-1088. You may also report any side effects at 1-866-4XOLAIR (1-866-496-5247). | |||||||||||||||||
| Talk to your doctor for more information and if you have any questions about your treatment. | |||||||||||||||||
| Please see full Prescribing Information and Medication Guide for additional important safety information. | |||||||||||||||||
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