omalizumab

What is the most important information I should know about omalizumab?

What is omalizumab?

Omalizumab is used to treat moderate to severe asthma that is caused by allergies in adults and children who are at least 6 years old. Omalizumab is used when asthma symptoms are not controlled by asthma inhaled steroid medicine. Omalizumab is not a rescue medicine for treating an asthma attack.

Omalizumab is used to treat nasal polyps in adults when nasal steroid medicine did not work.

Omalizumab is also used to treat chronic hives (idiopathic urticaria) in adults and children at lest 12 years old, when antihistamines have not worked.

Omalizumab is not for use in treating other allergies, rashes, or attacks of bronchospasm.

Omalizumab may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before using omalizumab?

Tell your doctor if you have any signs of infection (fever, swollen glands, general ill feeling), or if you have ever had:

• any other allergies (foods, pollens, etc);
• allergy shots;
• a severe allergic reaction (anaphylaxis);
• an infection caused by parasites (such as giardia, malaria, leishmaniasis, hookworm, pinworm, toxoplasmosis, and many others);
• a heart attack or stroke;
• cancer; or
• a latex allergy.

While you are using omalizumab, you may also have an increased risk of becoming infected with parasites (worms) if you live in or travel to areas where such infections are common. Talk with your doctor about what to look for and how to treat this condition.

Some babies born to mothers using omalizumab during pregnancy had low birth weight. However, it is not known whether this was due to omalizumab use or to severe asthma in the mothers. The benefit of treating asthma may outweigh any risks to the baby. Tell your doctor if you are pregnant.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of omalizumab on the baby.

How is omalizumab given?

Your doctor may perform an allergy skin test or blood test to make sure this medicine is right for you.

Omalizumab is injected under the skin. A healthcare provider will give you this injection every 2 or 4 weeks.

Your condition may not improve right away. For best results, keep receiving omalizumab as directed. Talk with your doctor if your symptoms do not improve after a few weeks of treatment.

Omalizumab doses are based on weight. Your dose needs may change if you gain or lose weight.

If you also use a steroid medication, you should not stop using it suddenly. Follow your doctor's instructions about tapering your dose.

You may need frequent medical tests, such as allergy tests and lung function tests. Your stools may also need to be checked for parasites, especially if you travel.

What happens if I miss a dose?

What happens if I overdose?

What should I avoid while using omalizumab?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of omalizumab?

You will be watched closely for a short time after each injection, to make sure you do not have an allergic reaction to omalizumab.

• hives, itching;
• anxiety or fear, feeling like you might pass out;
• flushing (warmth, redness, or tingly feeling);
• chest tightness, wheezing, cough, feeling short of breath, difficult breathing;
• fast or weak heartbeats; or
• swelling of your face, lips, tongue, or throat.

• ongoing nausea or vomiting, severe or watery diarrhea;
• trouble breathing;
• numbness or tingling in your arms or legs;
• fever, muscle pain, and rash within a few days after receiving an injection;
• signs of an ear infection --fever, ear pain or full feeling, trouble hearing, drainage from the ear, fussiness in a child;
• heart attack symptoms --chest pain or pressure, pain spreading to your jaw or shoulder; or
• signs of a blood clot --sudden numbness or weakness, problems with vision or speech, coughing up blood, swelling or redness in an arm or leg.

Common side effects may include:

• rash;
• fever;
• nosebleeds;
• joint pain, bone fractures;
• arm or leg pain;
• nausea, vomiting, diarrhea, stomach pain;
• headache;
• dizziness, feeling tired;
• ear pain, ear infection;
• pain, bruising, swelling, or irritation where the medicine was injected; or
• cold symptoms such as stuffy nose, sneezing, sinus pain, cough, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect omalizumab?

Other drugs may affect omalizumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your doctor or pharmacist can provide more information about omalizumab.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2023 Cerner Multum, Inc. Version: 7.01. Revision date: 1/6/2021.