OMALIZUMAB - INJECTION

PHONETIC PRONUNCIATION: (OH-ma-LIZ-ue-mab)

COMMON BRAND NAME(S): Xolair

GENERIC NAME(S): omalizumab

Uses

USES: Omalizumab is used to control and prevent symptoms (such as wheezing and shortness of breath) caused by asthma that is due to year-round allergens. Controlling symptoms of asthma helps you maintain your normal activities and cuts down on time lost from work or school. Omalizumab is also used to treat hives from an unknown cause (chronic idiopathic urticaria-CIU). This medication must be used regularly to be effective. It does not work right away. If an asthma attack occurs, use your quick-relief inhaler (such as albuterol, salbutamol) as prescribed.

How to use OMALIZUMAB - INJECTION

HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using omalizumab and each time you get a refill. If you have any questions, ask your doctor or pharmacist. This medication is injected under the skin by a health care professional as directed by your doctor, usually every 2 or 4 weeks for the treatment of asthma and every 4 weeks for the treatment of CIU. The dosage for the treatment of asthma is based on your weight and lab test results before you start treatment. Contact your doctor if you have any big changes in weight during treatment. Your dose may need to be adjusted. The dosage for the treatment of CIU is based on your medical condition and response to treatment. You should receive this medication regularly to get the most benefit from it. To help you remember, mark your calendar to keep track of when to receive the next dose. Get medical help right away if your asthma symptoms worsen or if you are using your quick-relief inhaler more than usual or more often than prescribed.

Side Effects

SIDE EFFECTS: See also Warning section. Itching, bruising, redness, pain, or swelling at the injection site may occur. Headache may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: unusual lumps/moles/skin changes, numbness/tingling of arms/legs, worsening shortness of breath, coughing up blood, muscle/joint pain, signs of infection (such as sore throat that doesn't go away, fever, cough). Get medical help right away if you have any very serious side effects, including: chest/jaw/left arm pain, unusual sweating, weakness on one side of the body, sudden vision changes, confusion, trouble speaking, pain/redness/swelling of the legs. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

PRECAUTIONS: See also Warning section. Before using omalizumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as latex), which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Interactions

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Overdose

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

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Warning

WARNING: This medication can rarely cause a very serious (sometimes fatal) allergic reaction. This reaction has occurred after the first dose or after later doses, even more than one year after starting treatment. The risk is greater if you have a history of severe allergies to other medications or to foods. Your health care professional will monitor you closely during treatment for any signs of an allergic reaction. Get medical help right away if you notice any symptoms of a serious allergic reaction, including: itching/swelling (especially of the face/tongue/throat), flushing, trouble breathing, severe dizziness, fainting, or rash/hives. If you have had an allergic reaction to omalizumab, you must never use omalizumab again.

Disclaimer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.