Xolair (Omalizumab) belongs to a group of medications known as antibody neutralizers. It is used to treat allergic Asthma, a particular type of asthma that is triggered by allergens such as cat or dog dander, dust mites, or cockroaches. It is used in addition to other medications to treat moderate-to-severe allergic asthma for adults and children 6 years of age and older, when inhaled corticosteroids are not providing enough control. Allergic asthma causes the release of a chemical in the body called IgE (immunoglobulin E). Xolair (Omalizumab) works by blocking IgE.

Xolair (Omalizumab) is used to decrease the number of asthma attacks and reduce the symptoms associated with asthma. It is important to understand that Xolair (Omalizumab) should not be used to relieve an asthma attack once it has started. Asthma sufferers should always have their fast-acting asthma relief medication on hand to deal with attacks.

Xolair (Omalizumab) is also used by adults and adolescents 12 years of age and older, to treat chronic idiopathic urticaria (CIU) that has not responded to treatment with antihistamines. It helps to reduce symptoms of skin itchiness and Hives.

Xolair (Omalizumab) may be available under multiple brand names and/or in several different forms. Any specific brand name of Xolair (Omalizumab) may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of Xolair (Omalizumab) may not be used for all of the conditions discussed here.

Your doctor may have suggested Xolair (Omalizumab) for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking Xolair (Omalizumab), speak to your doctor. Do not stop taking Xolair (Omalizumab) without consulting your doctor.

Do not give Xolair (Omalizumab) to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take Xolair (Omalizumab) if their doctor has not prescribed it.

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To treat asthma, the recommended dose of Xolair (Omalizumab) for adults and children 6 years of age and older is 75 mg to 375 mg given by subcutaneous (under the skin) injection every 2 or 4 weeks. The dose is determined by age, body weight, and the level of IgE in the body. Each dose is given as 1, 2, or 3 injections and is usually administered by a doctor or nurse.

Xolair (Omalizumab) is usually added to the other medications you are taking for asthma. Do not stop taking any asthma medications without speaking with your doctor. If you feel your asthma symptoms are not improving or are getting worse while taking Xolair (Omalizumab), contact your doctor.

To treat chronic idiopathic urticaria, the recommended dose of Xolair (Omalizumab) for adults and children 12 years of age and older is 150 mg or 300 mg given by subcutaneous (under the skin) injection every 4 weeks. Each dose is given as 1 or 2 injections and is usually administered by a doctor or nurse.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important Xolair (Omalizumab) be given exactly as prescribed by your doctor. If you miss an appointment to receive Xolair (Omalizumab), contact your doctor as soon as possible to reschedule your appointment.

Store Xolair (Omalizumab) in the refrigerator in its original package, protect it from light, and avoid freezing it. Do not shake. Once the medication has been prepared, the solution should be used immediately. Keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

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 Xolair (Omalizumab). If you are concerned about side effects, discuss the risks and benefits of Xolair (Omalizumab) with your doctor.

The following side effects have been reported by at least 1% of people taking Xolair (Omalizumab). 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 (e.g., nasal congestion, runny nose, sore throat)
• dizziness
• hair loss
• headache
• irritation at the site of injection
• nausea
• 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 (Fever or chills, severe Diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
• joint swelling
• muscle or bone pain
• signs of Churg-Strauss syndrome (e.g., pain, numbness, or tingling in the arms and legs; raised patches in the skin; weakness; fatigue; loss of appetite; and weight loss)
• signs of clotting problems (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don't stop bleeding)
• signs of a reaction at the injection site (pain, redness, burning, bruising, swelling)
• signs of respiratory tract infection (symptoms may include fever or chills, shortness of breath, prolonged dizziness, headache, cough, sore throat, sinus pain, weight loss, or listlessness)
• symptoms of a urinary tract infection (e.g., pain when urinating, urinating more often than usual, low back or flank pain, strong odour)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
• signs of serum sickness, a type of allergic reaction (joint pain, stiffness, rash, fever, swollen lymph nodes)
• signs of a Stroke (e.g., numbness or weakness in arm, leg, or any part of the body; loss of coordination; vision changes; sudden headache; difficulty speaking or breathing)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Xolair (Omalizumab).

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Vial
Each single use vial of sterile, white, preservative-free, lyophilized powder contains 202.5 mg of Xolair (Omalizumab). Nonmedicinal ingredients: L-histidine, L-histidine hydrochloride monohydrate, polysorbate 20, and sucrose. It is designed to deliver 150 mg of Xolair (Omalizumab) in 1.2 mL after reconstitution with 1.4 mL of Sterile Water for Injection USP.

Pre-Filled Syringe

75 mg
Each 0.5 mL pre-filled syringe contains 75 mg of Xolair (Omalizumab). Nonmedicinal ingredients: L-arginine hydrochloride, L-histidine, L-histidine hydrochloride, polysorbate, and water for injection. The needle cap of the syringe may contain latex.

150 mg
Each 1 mL pre-filled syringe contains 150 mg of Xolair (Omalizumab). Nonmedicinal ingredients: L-arginine hydrochloride, L-histidine, L-histidine hydrochloride, polysorbate, and water for injection. The needle cap of the syringe may contain latex.

Do not use Xolair (Omalizumab) if you are allergic to Xolair (Omalizumab) or any ingredients of the medication.

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There may be an interaction between Xolair (Omalizumab) and Belimumab. If you are taking belimumab, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Xolair (Omalizumab). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Xolair (Omalizumab).

Acute asthma attacks: Xolair (Omalizumab) will not help to stop an asthma attack and should not be used to treat an acute asthma attack. If you start developing an asthma attack, be sure to use your "reliever" medication for rapid relief of your asthma symptoms. Contact your doctor immediately if you find you are using your "reliever" medications (e.g., salbutamol, terbutaline, formoterol) more often or if they are not working as well as they used to.

Cancer: Although early studies comparing those taking Xolair (Omalizumab) and those not taking Xolair (Omalizumab) showed a small difference in the percentage of people developing cancer, additional observation and studies have shown that this is not the case.

Corticosteroid withdrawal: Oral or inhaled corticosteroids for asthma should not be stopped suddenly when treatment with Xolair (Omalizumab) is started. Decreases in corticosteroid doses should be closely supervised by your doctor. Check with your doctor before stopping or decreasing the dose of any of your asthma medications.

Heart problems: Xolair (Omalizumab) has been linked to heart problems, although the exact frequency with which this happens is not clear. If you have any heart problems, such as abnormal heart rhythms, heart failure, or a history of Heart Attack, discuss with your doctor how Xolair (Omalizumab) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Xolair (Omalizumab), and whether any special monitoring is needed.

Kidney function: Xolair (Omalizumab) has not been studied for use by people with kidney problems. If you have reduced kidney function or Kidney Disease, discuss with your doctor how Xolair (Omalizumab) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Xolair (Omalizumab), and whether any special monitoring is needed.

Liver function: Xolair (Omalizumab) has not been studied for use by people with liver problems. If you have reduced liver function or liver disease, discuss with your doctor how Xolair (Omalizumab) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Xolair (Omalizumab), and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking Xolair (Omalizumab).

Parasite infections: Xolair (Omalizumab) may weaken your resistance to parasite infections. If you are living in or travelling to a region where parasite infections are frequent, discuss with your doctor any special precautions that may be needed.

Serum sickness: In rare cases, serum sickness can occur with the use of Xolair (Omalizumab). This is a delayed allergic reaction that can happen at any time during treatment with Xolair (Omalizumab) and occurs between 1 and 5 days after an injection. If you experience painful joints or muscles, swollen lymph nodes with a rash and fever, contact your doctor immediately.

Severe allergic reactions: Although rare, severe allergic reactions to Xolair (Omalizumab) may occur. After your injection, the doctor may ask you to remain at the office or clinic for a short period of time. This way, if you do have an allergic reaction, medical attention will be nearby.

If you experience sudden difficulty breathing, fainting, swelling of the throat or tongue, or severe dizziness (especially when rising from a sitting or lying position), get medical attention immediately.

Stroke: Although rare, there is the possibility of experiencing a stroke when using Xolair (Omalizumab). If you have a history of stroke or are at risk of stroke, discuss with your doctor how Xolair (Omalizumab) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Xolair (Omalizumab), and whether any special monitoring is needed.

If you experience weakness or inability to move arms, legs, or face; numbness on one side of the body; difficulty speaking or understanding; loss of vision; or sudden headache, get medical attention immediately.

Pregnancy: Xolair (Omalizumab) has not been studied for use by pregnant women. Xolair (Omalizumab) should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking Xolair (Omalizumab), contact your doctor immediately.

Breast-feeding: It is not known whether Xolair (Omalizumab) passes into breast milk. If you are a breast-feeding mother and are taking Xolair (Omalizumab), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of Xolair (Omalizumab) for the treatment of allergic asthma have not been established for use by children under the age of 6 years of age. The safety and effectiveness of Xolair (Omalizumab) for the treatment of chronic idiopathic urticaria have not been established for use by children under the age of 12 years of age.

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