Xolair

Read the Medication Guide provided by your pharmacist before you start using omalizumab and each time you get a refill. If you are using this medication at home, read and follow the Instructions for Use leaflet. If you have any questions, ask your doctor or pharmacist.

This medication is injected under the skin as directed by your doctor, usually every 2 or 4 weeks for the treatment of asthma or nasal polyps, and every 4 weeks for the treatment of CIU. The first dose is given by a health care professional and you will be monitored in case you have a severe allergic reaction. Later doses may be given by a health care professional or at home.

If you are using this medication at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.

To increase comfort and make it easier to inject, take the pre-filled syringe out of the refrigerator and let it warm to room temperature for at least 15 to 30 minutes before injecting. Do not warm up this medication in any other way such as heating in the microwave or placing in hot water.

The dosage for the treatment of asthma/nasal polyps is based on your weight and lab test results before you start treatment. Tell 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.

Use this medication regularly to get the most benefit from it. To help you remember, mark your calendar to keep track of when to get 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.

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 this medication has been prescribed because your doctor 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.

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.

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.

Lab and/or medical tests (such as lung function, antibody levels) should be done before you start using this medication and while you are using it. Keep all medical and lab appointments. Consult your doctor for more details.

Avoid substances that can worsen breathing problems by causing irritation or allergic reaction, such as smoke, pollen, pet dander, dust, and mold.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Store the pre-filled syringes in the refrigerator. Do not freeze. Keep in the original carton and protect from direct sunlight. After taking it out of the refrigerator, use or discard within 4 hours. Keep all medications away from children and pets.

Store the vials in a refrigerator away from light.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.