Omalizumab (Injection)

Introduction

Omalizumab (oh-ma-LIZ-oo-mab)

Treats asthma.

Brand Name(s)

Xolair

When This Medicine Should Not Be Used

How to Use This Medicine

Injectable

• Your doctor will tell you how much of this medicine to use and how often. Your dose may need to be changed several times in order to find out what works best for you. Do not use more medicine or use it more often than your doctor tells you to.
• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot under your skin.
• A nurse or other trained health professional will give you this medicine.
• You may not see immediate improvement in your asthma after omalizumab treatment begins. It takes time for the medicine to work. It is important to continue your omalizumab injections until your doctor tells you otherwise.
• Your doctor will ask you to remain at the healthcare facility or clinic for at least two hours after each injection to watch for immediate side effects that can be serious.
• This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.

If a dose is missed:

• This medicine needs to be given on a fixed schedule. Be sure to keep all appointments.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or breastfeeding.
• This medicine will not stop an asthma attack that has already started. Your doctor may prescribe another medicine for you to use in case of an acute asthma attack. If the other medicine does not work as well, tell your doctor right away.
• If you use any type of corticosteroid medicine to control your asthma, keep using it as ordered by your doctor. This includes corticosteroid medicines that are taken by mouth or inhaled (such as cortisone, prednisone, Advair®, Azmacort®, Celestone®, Cortone®, Deltasone®, Flovent®, Prelone®, Pediapred®, Serevent®, Singulair®, or Vanceril®).
• This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. You will be observed for signs and symptoms of anaphylaxis after you receive this medicine. Tell your doctor right away if you have a rash, cough, chest tightness, shortness of breath, trouble breathing, wheezing, lightheadedness, dizziness, fainting, rapid or weak heartbeat, anxiety, flushing, itching, hives, feeling warm, swelling of the throat or tongue, throat tightness, hoarseness, or trouble with swallowing after receiving this medicine.
• A rare but serious condition called eosinophilia (increased white blood cells in the body) may occur while you are receiving this medication. A condition called vasculitis (inflammation of the blood vessels) may also be present. Eosinophilia can be serious and requires immediate medical attention. Tell your doctor right away if you have worsening lung symptoms, rash or bruising of the skin, fever, chest pain, or burning, tingling, or numbness in the hands and feet after receiving this medicine.
• This medicine may increase your risk of certain types of cancer or infections. Talk with your doctor about this risk.
• This medicine may make you dizzy. Avoid driving, using machines, or doing anything else that could be dangerous if you are not alert.
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments.
• Your doctor will need to check your blood at regular visits while you are using this medicine. Be sure to keep all appointments.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Anxiety.
• Fast or weak heartbeat.
• Fever, sore throat, cough, or hoarseness.
• Lightheadedness, dizziness, or fainting.
• Pain, itching, burning, swelling, or lump under your skin where the shot was given.
• Shortness of breath, chest pain, or troubled breathing.
• Trouble swallowing.
• Unusual bleeding or bruising.
• Warmth or redness in your face, neck, arms, or upper chest.

If you notice these less serious side effects, talk with your doctor:

• Earache or headache.
• Hair loss.
• Joint, leg, or arm pain.
• Skin rash or itching.
• Stuffy or runny nose.
• Unusual tiredness or weakness.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088