Indication And Important Safety Information
What is XOLAIR?
XOLAIR® for subcutaneous use is an injectable prescription medicine used to treat:
- moderate to severe persistent asthma in people 6 years of age and older whose asthma symptoms are not well controlled with asthma medicines called inhaled corticosteroids. A skin or blood test is performed to see if you have allergies to year-round allergens. It is not known if XOLAIR is safe and effective in people with asthma under 6 years of age.
- nasal polyps in people 18 years of age and older when medicines to treat nasal polyps called nasal corticosteroids have not worked well enough. It is not known if XOLAIR is safe and effective in people with nasal polyps under 18 years of age.
- chronic spontaneous urticaria , chronic hives without a known cause) in people 12 years of age and older who continue to have hives that are not controlled with H1 antihistamine treatment. It is not known if XOLAIR is safe and effective in people with CSU under 12 years of age.
XOLAIR is not used to treat other allergic conditions, other forms of hives, or sudden breathing problems.
- 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
Do not receive and use XOLAIR if you are allergic to omalizumab or any of the ingredients in XOLAIR.
What Xolair Is Used For
Allergic asthmaXolair is used to prevent or relieve the symptoms of allergic asthma in people who are already using preventer puffers containing steroids. Asthma is a disease where the lining of the lungs becomes inflamed , making it difficult to breathe. This may be due to a reaction to house dust mites, smoke or other irritants.
This medicine can be used in adults and in children aged 6 years or over in allergic asthma.
Chronic Rhinosinusitis with Nasal Polyps Xolair is used to treat nasal polyps in adults whose severe disease is not well controlled with their current nasal polyps medicines. Xolair helps reduce the size of the polyps and improves symptoms caused by nasal polyps including nasal congestion, loss of sense of smell, post-nasal drip and runny nose.
This medicine can be used in adults aged 18 years and over in nasal polyps. Its use in children and adolescents below 18 years of age with nasal polyps has not been studied.
How Is Asthma Managed During Labor And Delivery
Most expectant mothers with asthma deliver healthy, full-term babies . Most do not experience any breathing problems during labor or delivery. Do not stop any of your medications when labor starts unless directed otherwise by your healthcare provider. Your physician may direct you to bring a bronchodilator with you into the delivery or birthing room.
Depending on your health at the time you go into labor, your healthcare provider may give you oxygen through a mask. You may alse be given intravenous fluids to keep you well hydrated. Your physician will monitor contractions, your breathing and heart rate. They will also check the babys heart rate and other vital signs.
If have trouble breathing during labor or delivery, the health care provider can give you medications. Inhaled medications may be given through an oxygen mask. They may also give intravenous medications with the intravenous fluids.
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Receiving Xolair With Other Drugs
Depending on the condition you have, you might need to take Xolair with other medications.
Xolair with other drugs for hives
To help with inflammation from hives, you may use corticosteroid creams with Xolair. These could include creams such as betamethasone valerate .
Xolair with other drugs for asthma
For asthma, you should not use Xolair for sudden trouble breathing or severe breathing problems that dont improve with treatment. These are both possible symptoms of asthma. Instead, you should use a rescue inhaler for sudden breathing problems.
Examples of rescue inhalers include:
- budesonide
Xolair with other drugs for nasal polyps
For nasal polyps, Xolair is always used together with corticosteroid nasal sprays, such as mometasone and budesonide .
Other medications you may take with Xolair if you have nasal polyps include antibiotics for sinus infections, such as:
- amoxicillin-clavulanate
- doxycycline
Find the answers below to some commonly asked questions about Xolair.
How To Take It
The way to take this medicine is: Subcutaneous. This medicine is injected, usually with a short needle or pen-like device, into the fat just beneath the skin.
- Store at 2 to 8 degrees Celsius
- Do not Freeze
- Protect from Light
- Shelf lifetime is 18 Months.
You should seek medical advice in relation to medicines and use only as directed by a healthcare professional.
Always read the label. If symptoms persist see your healthcare professional.
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Will Xolair Weaken My Immune System
Yes, it might. Xolair is a monoclonal antibody, which is a type of drug thats made in a lab from immune system cells. This drug does have an effect on your immune system.
Your immune system helps your body fight off germs every day. Most peoples immune systems work well to protect them from infections. However, people using Xolair may have weaker immune systems.
Whether Xolair weakens your immune system depends on your overall health and the condition youre using Xolair to treat. If your immune system is weakened, you could have an increased risk of infections.
If youre concerned about how Xolair may affect your immune system, talk with your doctor. They can discuss with you the risks and benefits of using this drug.
Bottom Line Nucala Vs Xolair
Nucala is a monoclonal antibody that is used together with other medications to help control severe asthma in adults and children who are at least 12 years old. It works by reducing levels of a certain type of white blood cell which may contribute to the symptoms of asthma.
Xolair is an antibody that is used to treat moderate to severe asthma which is caused by allergies in adults and children who are at least 6 years old. It works by decreasing allergic responses in the body. This medication is not a rescue medicine for treating an asthma attack.
According to a 2018 study, the efficacy of omalizumab and mepolizumab was similar in the treatment of asthma which was not well controlled on at least high-dose inhaled corticosteroid.
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Does Xolair Cause Weight Gain Or Weight Loss
No, you shouldnt experience weight gain or weight loss during Xolair treatment. Changes in weight were not side effects reported by people receiving Xolair in studies.
If you have unexplained weight changes during treatment with Xolair, talk with your doctor. They can help determine what may be causing your weight changes.
Is Xolair Used For Hives
If you have a certain type of hives, your doctor may recommend Xolair.
Its a prescription drug used to treat hives due to chronic idiopathic urticaria . With CIU, you have hives or angioedema . And the condition lasts for 6 weeks or more.
Xolair is prescribed for adults and children ages 12 years and older. To take Xolair for hives, you must have already tried antihistamine treatments, such as cetirizine or loratadine . And these treatments didnt help with your condition.
Hives can be itchy and may appear as pink-to-red areas on your skin. Usually, the center of the area is pale in color. While hives can occur anywhere on the body, some areas are more prone to hives, such as:
- waist
- armpits
- groin
Xolair isnt used to treat hives that result from allergic reactions or other forms of hives. Its only used for the type of hives described above.
In addition to treating hives, Xolair is used for other purposes. See the Is Xolair used for other conditions? section below.
If you have asthma or nasal polyps, your doctor may prescribe Xolair.
Its a prescription drug used for:
Note: You should not use Xolair for sudden trouble breathing or severe breathing problems that dont improve with treatment. These are both possible symptoms of asthma. Instead, you should use a rescue inhaler for sudden breathing problems. To learn more, see Receiving other drugs with Xolair in the How is Xolair administered? section below.
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What Should I Watch For While Using This Medicine
After receiving each injection, you will be monitored in your doctor’s office or clinic. Your doctor will determine how long you will be observed after each injection. You may need blood work done while you are taking this medicine.
Improvement of your asthma or allergies will not be immediate. Improvements will occur gradually. Do not stop taking any of your other asthma or allergy treatments unless otherwise directed by your doctor.
Some people who are at a high risk for parasite infections, get a parasite infection after receiving this drug. Your healthcare provider can test your stool to check for this type of infection if you are at risk.
How Should This Medicine Be Used
Omalizumab injection comes as a prefilled syringe and as a powder to be mixed with water to be injected subcutaneously . When omalizumab is used to treat allergic asthma or nasal polyps, it is usually injected once every 2 or 4 weeks. You may receive one or more injections, depending on your weight and medical condition. When omalizumab is used to treat chronic hives, it is usually given once every 4 weeks. Your doctor will determine the length of your treatment based on your condition and how well you respond to the medication.
If you will be injecting omalizumab injection by yourself at home or having a friend or relative inject the medication for you, your doctor will show you or the person who will be injecting the medication how to inject it. You and the person who will be injecting the medication should also read the written instructions for use that come with the medication.
Check the prefilled syringe to be sure that the expiration date printed on the package has not passed. Holding the syringe with the covered needle pointing down, look closely at the liquid in the syringe. The liquid should be clear and colorless to pale brownish yellow and should not be cloudy or discolored or contain lumps or particles. Call your pharmacist if there are any problems with the package or the syringe and do not inject the medication.
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What Side Effects Are Possible With This Medication
Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.
The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.
The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.
Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.
- cold symptoms
- dizziness
- sore throat
- vomiting
Although most of the side effects listed below don’t happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
- hives or rash
- increased frequency or severity of infections
- joint swelling
- muscle or bone pain
- signs of Churg-Strauss syndrome
- signs of clotting problems
- signs of a reaction at the injection site
- signs of respiratory tract infection
- symptoms of a urinary tract infection
Stop taking the medication and seek immediate medical attention if any of the following occur:
Can I Take Xolair For Angioedema
No, you shouldnt take Xolair to treat angioedema . This drug isnt approved to treat angioedema.
In fact, angioedema has been reported as a serious side effect of Xolair. And there havent been any studies done to look at using Xolair to treat the condition.
If you have questions about how to treat angioedema, talk with your doctor.
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Questions About Xolairs Dosage
Heres a list of common questions related to doses of Xolair.
- What if I miss a dose of Xolair? If youre receiving Xolair doses from your doctor, call your doctors office and reschedule the appointment for your injection. Your doctor will tell you when your next dose should be given. If youre injecting Xolair doses at home, call your doctor and ask them when you should take your next dose.
- Will I need to use Xolair long term? You may need to use Xolair long term. The conditions that Xolair treats are long-lasting diseases. Talk with your doctor to find out how long youll need to take Xolair.
- How long does Xolair take to work? Xolair takes several months to start working. How long it takes to work depends on the condition its treating. You might only notice a reduction in your symptoms after youve been taking Xolair for a while. Your doctor can tell you when you can expect to notice your symptoms lessen.
- Should I take doses of Xolair with food? You dont need to take Xolair doses with food. Xolair will be injected under your skin. Having a full or empty stomach wont change how much medication your body absorbs.
What Is The Most Important Information I Should Know About Xolair
Xolair may cause serious side effects, including:
Severe allergic reaction. A severe allergic reaction called anaphylaxis can happen when you receive Xolair. The reaction can occur after the first dose, or after many doses. It may also occur right after a Xolair injection or days later. Anaphylaxis is a life-threatening condition and can lead to death. Go to the nearest emergency room right away if you have any of these symptoms of an allergic reaction:
- 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 your injection. Your healthcare provider should talk to you about getting medical treatment if you have symptoms of an allergic reaction after leaving the healthcare provider’s office or treatment center.
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How Xolair Is Given
Follow all directions given to you by your doctor or healthcare professional carefully.
Xolair is given as a subcutaneous injection. This means that it is injected into the fatty tissue just under the skin.
There are two different ways Xolair can be given:
The injections are usually given in the upper arm or thigh.
Drug Forms And Strengths
Xolair is available in two strengths:
- 75 mg/0.5 mL and 150 mg/1 mL. These strengths each come as a liquid solution inside prefilled single-dose syringes.
- 150 mg. This strength comes as a powder thats mixed with liquid to form a solution. It comes in single-dose vials.
Both forms of Xolair are given by subcutaneous injection . Youll receive Xolair injections at your healthcare providers office.
The maximum dose of Xolair that can be injected into one area of your body is 150 mg. If your dose of Xolair is greater than 150 mg, youll get more than one injection, in different areas of your body. Xolair can be injected into your upper arms or thighs.
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What Is In This Leaflet
This leaflet answers some common questions about Xolair.
It does not contain all the available information. It does not take the place of talking to your doctor, pharmacist or healthcare provider.
You should ensure that you speak to your pharmacist or doctor to obtain the most up to date information on the medicine. You can also download the most up to date leaflet from www.novartis.com.au. Those updates may contain important information about the medicine and its use of which you should be aware.
All medicines have risks and benefits. Your doctor has weighed the risks of you having Xolair against the benefits they expect it will have for you.
If you have any concerns about having this medicine, ask your doctor or pharmacist.
Keep this leaflet. You may need to read it again.
What Should I Know About Storage And Disposal Of This Medication
Keep this medication in the package it came in, away from light, tightly closed, and out of reach of children. Store omalizumab injection in the refrigerator, but do not freeze it. Discard any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
It is important to keep all medication out of sight and reach of children as many containers are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location â one that is up and away and out of their sight and reach.
Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA’s Safe Disposal of Medicines website for more information if you do not have access to a take-back program.
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