GENERIC NAME: OMALIZUMAB - INJECTION (OH-ma-LIZ-ue-mab)
BRAND NAME(S): Xolair
WARNING: This medication can cause a very serious (sometimes fatal) allergic reaction. In many cases, this type of reaction occurred after the first dose, but it can occur with any later doses. This type of reaction usually occurred within 24 hours or up to 4 days after receiving this medication. Your health care professional will monitor you closely during treatment for any signs of an allergic reaction. Seek immediate medical attention if at any time you develop any signs of an allergic reaction including: trouble breathing, cough, chest tightness, rash, itching, swelling (especially of the throat, tongue), hives, dizziness.
If you have had an allergic reaction to omalizumab, you must never use omalizumab again.
USES: This medication is used to treat moderate to severe asthma in adults and children over 12 years of age. It works by blocking your immune system's natural response to allergic triggers that can lead to an acute asthma attack. This action on your immune system (specifically immunoglobulin E-IgE), helps keep your air passages open and, over time, it keeps your asthma in better control.This medication does not work immediately and should not be used for the quick relief of an acute asthma attack.
HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using omalizumab and each time you get a refill. If you have any questions, consult your doctor or pharmacist.This medication is injected under the skin (subcutaneously-SC) by a health care professional, usually every 2 or 4 weeks as directed by your doctor. 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.Use this medication regularly in order to get the most benefit from it. To help you remember, use it on the same day of the week according to your schedule. It may take up to several months of continued use to see improvement in your condition.Do not stop any of your asthma medications without consulting your doctor. Your condition may become worse if your asthma drugs are abruptly stopped. Any decrease of your medications (e.g., corticosteroids) should be done gradually, under the supervision of your doctor.
SIDE EFFECTS: See also Warning section.Injection site itching, redness, stinging, or pain may occur. Leg, arm or ear pain may also occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she 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/growths/moles.An allergic reaction to this drug is unlikely, but get medical help right away if it occurs. Symptoms of an allergic reaction include: rash, hives, itching/swelling (especially of the face/tongue/throat), dizziness, chest tightness, cough, trouble breathing.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.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: 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, 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.This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: 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.Some products that may interact with this drug include: other medications for asthma.
OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
MISSED DOSE: For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist immediately to establish a new dosing schedule.
Information last revised November 2013. Copyright(c) 2013 First Databank, Inc.
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.