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. The risk of having this reaction is greater if you have a history of severe food allergies or have severe allergies to other medications. 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.Who should not take omalizumab subcutaneous?
This medication is used to treat moderate to severe asthma or ongoing hives from an unknown cause (chronic idiopathic urticaria-CIU) 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 or hives. This effect on your immune system (specifically immunoglobulin E-IgE) helps keep your air passages open and, over time, it keeps your asthma in better control. For CIU, omalizumab helps to reduce itching and number of hives on your skin.
This medication does not work right away and should not be used for the quick relief of an acute asthma attack.
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.
For the treatment of asthma, 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.
For the treatment of CIU, this medication is injected under the skin by a health care professional. It is given as directed by your doctor, usually every 4 weeks. The dosage is based on your medical condition and response to treatment.
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 or CIU medications without consulting your doctor. Your condition may become worse if your asthma or CIU drugs are abruptly stopped. Any decrease of your medications (such as corticosteroids, antihistamines) should be done gradually, under the supervision of your doctor.
See also Warning section.
Injection site itching, redness, stinging, or pain may occur. Headache, leg, arm or ear pain may also occur. If any of these effects persist or worsen, tell 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.
Get medical help right away if you have any very serious side effects, including: chest/jaw/left arm pain, unusual sweating, sudden/severe headache, weakness on one side of the body, confusion, trouble speaking, sudden vision changes (such as partial/complete blindness), pain/redness/swelling of legs, tingling/weakness/numbness in the arms/legs, trouble breathing, coughing up blood, sudden dizziness/fainting.
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 or at www.fda.gov/medwatch.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
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. See also Warning section.
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 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.
If overdose is suspected, contact a poison control center or emergency room right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Keep all medical appointments. Laboratory and/or medical tests may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.
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 right away to establish a new dosing schedule.
Not applicable. This medication is given in a clinic or doctor's office and will not be stored at home.
Information last revised December 2015. Copyright(c) 2015 First Databank, Inc.
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