This medication can rarely cause a very serious (sometimes fatal) allergic reaction. In many cases, this reaction occurred after the first dose, but it can also occur with later doses. This reaction can occur up to 4 days after receiving this medication. The risk of having this reaction 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 an allergic reaction. (See also Side Effects section.)
If you have had an allergic reaction to omalizumab, you must never use omalizumab again.Who should not take Xolair Vial?
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 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.
See also Warning section.
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.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
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.
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, 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.
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.
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.
For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist right away to establish a new dosing schedule.
Not applicable. This medication is given in a clinic or doctor's office and will not be stored at home.Information last revised July 2016. Copyright(c) 2016 First Databank, Inc.
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