Generic Name: omalizumab (OH-ma-LIZ-oo-mab)
Brand Name: Xolair
Omalizumab may rarely cause a severe and sometimes life-threatening allergic reaction. This may occur right after receiving a dose or hours later. It may occur after the first dose or after many doses. Your doctor will monitor you for a period of time after your receive your dose of omalizumab. Contact your doctor or seek medical care at once if you develop anxiety; chest tightness; cough; dizziness; fainting; fast or weak heartbeat; feeling unusually warm; flushing; hives; hoarseness; itching; rash; shortness of breath; swelling of the mouth, face, lips, tongue, or throat; trouble breathing; trouble swallowing; or wheezing.
Omalizumab is used for:
Treating moderate to severe persistent asthma in certain patients who have had a positive allergy skin test and whose symptoms are not controlled by inhaled corticosteroids.
Omalizumab is an anti-immunoglobulin E (IgE) monoclonal antibody. It works by blocking your immune system's natural response to allergens, which can lead to an acute asthma attack. This action on the immune system (specifically, IgE) helps keep your air passages open and, over time, keeps asthma under better control.
Do NOT use omalizumab if:
- you are allergic to any ingredient in omalizumab
Contact your doctor or health care provider right away if this applies to you.
Before using omalizumab:
Some medical conditions may interact with omalizumab. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances, including murine proteins
- if you have severe bronchospasms or are currently taking other medicines for asthma
- if you have a history of cancer
- if you will be traveling to areas where exposure to a parasitic infection (eg, roundworm, hookworm) is possible
Some MEDICINES MAY INTERACT with omalizumab. However, no specific interactions with omalizumab are known at this time.
Ask your health care provider if omalizumab may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use omalizumab:
Use omalizumab as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Omalizumab comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get omalizumab refilled.
- Omalizumab is usually given as an injection at your doctor's office, hospital, or clinic.
- If you miss a dose of omalizumab or you are unable to keep your doctor's appointment, contact your doctor right away.
Ask your health care provider any questions you may have about how to use omalizumab.
Important safety information:
- Omalizumab may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use omalizumab with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Talk with your doctor or pharmacist about all of your asthma medicines and how to use them. Do not start, stop, or change the dose of any asthma medicine unless your doctor tells you to.
- Omalizumab will not stop an asthma attack once one has started.
- The dosage is based on your body weight and blood level of IgE antibody, as well as your medical condition and response to therapy. Contact your doctor if you have a significant change in body weight during treatment. Your dose may need to be adjusted.
- It may take several months for omalizumab to work.
- Use caution if you switch from an oral steroid (eg, prednisone) to omalizumab. It may take several months for your body to make enough natural steroids to handle events that cause physical stress. Such events may include injury, surgery, infection, loss of blood electrolytes, or a sudden asthma attack. These may be severe and sometimes fatal. Contact your doctor right away if any of these events occur. You may need to take an oral steroid (eg, prednisone) again. Carry a card at all times that says you may need an oral steroid (eg, prednisone) if any of these events occur.
- Omalizumab may increase the levels of IgE in your blood during therapy and for up to 1 year after discontinuing use of omalizumab. Be sure your doctor and lab personnel know you are taking omalizumab.
- Lab tests may be performed while you use omalizumab. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Omalizumab should be used with extreme caution in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using omalizumab while you are pregnant. It is not known if omalizumab is found in breast milk. If you are or will be breast-feeding while you use omalizumab, check with your doctor. Discuss any possible risks to your baby.
Possible side effects of omalizumab:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Bruising, itching, pain, redness, stinging, swelling, or warmth at the injection site; headache; itching and swelling of the skin; leg, arm, or ear pain; sinus inflammation.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, tongue or throat); anxiety; calf pain, swelling, or tenderness; chest pain; confusion; cough; dizziness; fainting; fast, weak, or irregular heartbeat; feeling unusually warm; flushing; hoarseness; new or worsening breathing problems or shortness of breath; numbness or tingling; one-sided weakness; speech problems; swelling of a vein; symptoms of sinus or lung infection (congestion, cough, or fever); trouble swallowing; unusual bruising or bleeding; unusual lumps, growths, or moles; unusual swelling of the hands or feet; vision problems; wheezing.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of omalizumab:
Omalizumab is usually handled and stored by a health care provider. If you are using omalizumab at home, store omalizumab as directed by your pharmacist or health care provider. Keep omalizumab out of the reach of children and away from pets.
- If you have any questions about omalizumab, please talk with your doctor, pharmacist, or other health care provider.
- Omalizumab is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take omalizumab or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about omalizumab. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to omalizumab. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using omalizumab.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.