Omalizumab (subcutaneous route)
Available brands
Xolair
About this medication
Omalizumab injection is used to treat moderate to severe persistent allergic asthma. It is used when a patient's asthma has not been controlled sufficiently on other asthma medicines. This medicine will not relieve an asthma attack that has already started. Your doctor will perform a skin or blood test to check if you have allergies to year-round allergens. Omalizumab injection is also used to treat chronic rhinosinusitis with nasal polyps (CRSwNP) in patients who have tried other medicines (eg, nasal corticosteroids) but they did not work well enough. Omalizumab injection is also used to treat food allergy. It is used to reduce allergic reactions that may occur after accidentally eating one or more foods to which you are allergic. Omalizumab injection is also used to treat chronic idiopathic urticaria (CIU) in patients who continue to have hives that are not controlled by an antihistamine (allergy medicine). Omalizumab is a medicine called an IgE blocker. IgE is short for immunoglobulin E, a substance that occurs naturally in the body in small amounts. This substance plays an important role in allergic asthma. When people with allergic asthma breathe in a year-round allergen, such as cat or dog dander, their bodies make more IgE. This may cause a series of reactions in your body that can lead to asthma attacks and symptoms. Omalizumab works by helping to block IgE. This medicine is to be given only by or under the direct supervision of your doctor. This product is available in the following dosage forms:
Before using this medication
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered: Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully. Appropriate studies on the relationship of age to the effects of omalizumab injection to treatasthma in children younger than 6 years of age,chronic rhinosinusitis with nasal polyps in children,chronic idiopathic urticaria in children younger than 12 years of age, andfood allergy in children younger than 1 year of agehave not been performed. Safety and efficacy have not been established. Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of omalizumab injection in the elderly. There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding. Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine. Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco. The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
How to use this medication
A nurse or other trained health professional will give you or your child this medicine in a medical facility. It is given as a shot under your skin, usually in the upper arms, stomach, or thighs. This medicine comes with a Medication Guide and patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. If you are receiving this medicinefor asthma or nasal polyps, you will receive omalizumab once every 2 or 4 weeks. Your dose will be determined by your IgE level, which your doctor will measure with a simple blood test before treatment begins, and your body weight. Based on your dose, your doctor will also tell you if you will need 1, 2, or 3 injections per dose. If you need more than 1 injection, each will be given in a different place on your body. Omalizumab is not a rescue medication and should not be used to treat sudden asthma attacks. It is not a substitute for the medicines you are already taking. Never suddenly stop taking, or change the dose of your steroid medicine (inhaled or taken by mouth) unless your doctor tells you to do so. If you are receiving this medicine forchronic idiopathic urticaria, you will receive this medicine every 4 weeks. Omalizumab injection may also be given at home to patients who have received at least 3 doses of this medicine under the supervision of a doctor. If you are using this medicine at home, your doctor or nurse will teach you how to inject the medicine. Be sure that you understand exactly how to use this. If you use this medicine at home, you will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems. Do not inject into scars, moles, or skin areas that are red, bruised, tender, hard, or not intact. This medicine comes in 2 forms: anautoinjectorand aprefilled syringe. Your doctor will tell you which dosage form you should use. Check the liquid in the autoinjector or prefilled syringe. It should be clear and colorless to pale brownish yellow. Do not use this medicine if it is cloudy, discolored, or if you see particles in it. Do not use the autoinjector or prefilled syringe if it looks damaged or has been dropped. To use theautoinjector: To use theprefilled syringe: The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so. The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine. This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions. Keep out of the reach of children. Do not keep outdated medicine or medicine no longer needed. Ask your healthcare professional how you should dispose of any medicine you do not use. Store in the refrigerator. Do not freeze. Protect the medicine from direct light. Keep the medicine in the original carton until you are ready to use it. Throw away any unused medicine after 4 hours of removing from the refrigerator. Do not use if the autoinjector or prefilled syringe has been frozen. Before giving an injection, you can remove the carton and place it back in the refrigerator if needed. The total combined time out of the refrigerator should not be more than 2 days. Throw away the used autoinjector or prefilled syringe in a sharps disposal container or in a hard, closed container where the needles cannot poke through. Keep this container away from children and pets.
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