omalizumab 300 mg/2 mL subcutaneous syringe

Generic name:
Omalizumab - injection

Pronunciation
(OH-ma-LIZ-ue-mab)

Brand name(s)
Xolair

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.

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 may also be used to treat certain growths in the nose (chronic rhinosinusitis with nasal polyps) or to treat hives from an unknown cause (chronic spontaneous urticaria-CSU).

Omalizumab is also used in people with a certain type of food allergy (IgE-mediated food allergy) while continuing to avoid food allergens. It may help lower the risk of having serious allergic reactions.

This medication must be used regularly to be effective. It does not work right away and should not be used as an emergency treatment for serious allergic reactions or to relieve sudden asthma attacks. If an asthma attack occurs, use your quick-relief inhaler (such as albuterol, salbutamol) as prescribed.

Read the Medication Guide and Instructions for Use 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.

Inject this medication under the skin as directed by your doctor, usually every 2 or 4 weeks. The injection is given in the upper arms, thighs, or abdomen (except for a 2-inch area around your belly button). 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. The dosage and treatment schedule are based on your medical condition and response to treatment. For the treatment of asthma, nasal polyps, and food allergies, the dosage is also based on your weight and labs.

If you are using this medication at home, learn all preparation and usage instructions from your health care professional. For a more comfortable injection, take the medication out of the refrigerator at least 30 to 45 minutes before you inject it to allow it to reach room temperature. Do not warm up this medication in any other way (for example, do not heat it in the microwave or place it in hot water). Before using, check this product for particles or discoloration. If either is present, do not use the liquid. Before injecting each dose, clean the skin you are going to inject into (the injection site) with rubbing alcohol. Change the injection site each time to lessen injury under the skin. Do not inject into skin that is tender, bruised, red, hard, or damaged, or into moles or scars. To lessen bruising, do not rub the injection site after a shot. Learn how to store and discard medical supplies safely.

Use this medication regularly to get the most benefit from it. To help you remember, mark your calendar with a reminder.

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 found in some brands), 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 breastfeeding.

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 1-800-222-1222. Canada residents can call 1-844-764-7669.

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 in the refrigerator. Do not freeze. Keep the medication in the original carton to protect from light. The prefilled syringe/autoinjector may be taken out of the refrigerator and put back in the refrigerator if needed. The total time out of the refrigerator should not be more than 2 days. Keep all medications away from children and pets.

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.

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.