Xolair

Generic name: Omalizumab
Drug class: Selective immunosuppressants

Usage of Xolair

Xolair (omalizumab) injection is a medication used to treat types of allergic asthma, nasal polyps and chronic hives (chronic spontaneous urticaria). Xolair works by reducing the release of inflammatory substances that cause allergy symptoms, thereby decreasing allergic responses in the body.

Xolair is a monoclonal antibody that is usually given every 2 or 4 weeks to maintain its therapeutic effects.

Xolair side effects

Some people using Xolair have had a severe, life-threatening allergic reaction either right after the injection or hours later. Allergic reaction may occur even after using the medication regularly for a year or longer.

Get emergency medical help if you have any signs of an allergic reaction to Xolair:

  • 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.

    • Call your doctor at once if you have:

  • 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 Xolair 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.

    Before taking Xolair

    You should not use this medicine if you are allergic to omalizumab, or any of the inactive ingredients.  Click here for a full list of ingredients: Xolair ingredients.

    To make sure Xolair is safe for you, tell your doctor if you have:

  • any signs of infection (fever, swollen glands, general ill feeling)
  • any other allergies (foods, pollens, etc.)
  • an infection caused by parasites (such as giardia, malaria, leishmaniasis, hookworm, pinworm, toxoplasmosis, and many others)
  • past or present cancer
  • a history of heart attack or stroke
  • if you are receiving allergy shots
  • if you have ever had a severe allergic reaction (anaphylaxis)
  • if you have a latex allergy, as the needle cap on the prefilled syringe contains a type of natural rubber latex.

    • Using this injection may increase your risk of certain types of cancers of the breast, skin, prostate, or salivary gland. Talk to your doctor about your individual risk.

    While you are using this medicine, 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.

    Pregnancy

    Tell your doctor if you are pregnant or plan to become pregnant during treatment.   If you become pregnant while using this injection, call your doctor.

    If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of Xolair on the baby.

    Breastfeeding 

    It is not known whether Xolair could harm a nursing baby. Tell your doctor if you are breastfeeding or planning to breastfeed a baby.

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    How to use Xolair

    Usual Adult and Pediatric Dose for Asthma:

    Dose: Xolair 75 mg to 375 mg by suBCutaneous injection every 2 or 4 weeks. Dose and frequency of injection is based on weight and pre-treatment IgE levels. Click on the link below "Detailed Xolair dosage information" for dose details.

    Comments: 

  • Interruptions lasting less than 1 year: Dose based on serum IgE levels obtained at the initial dose determination.
  • Interruptions lasting 1 year or more: Retest total serum IgE levels for dose determination.
  • Periodically reassess the need for continued therapy based on the patient's disease severity and level of asthma control.

    • Use: Management of moderate to severe persistent asthma in patients  (12 Years and Older) who are inadequately controlled with inhaled corticosteroids and with a positive skin test or in vitro reactivity to a perennial aeroallergen.

    Usual Adult Dose for Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

    Dose: 75 mg to 600 mg by subcutaneous injection every 2 or 4 weeks. The dose and frequency of injection are based on weight and pre-treatment IgE levels. Click on the link below "Detailed Xolair dosage information" for dose details.

    Comments:

  • Periodically reassess the need for continued therapy based upon the patient's disease severity and level of symptom control.
  • Interruptions lasting less than 1 year: Dose based on serum IgE levels obtained at the initial dose determination.
  • Interruptions lasting 1 year or more: Retest total serum IgE levels for dose determination.

    • Use: As an add-on maintenance treatment for Chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients 18 years of age and older with inadequate response to nasal corticosteroids.

    Usual Adult Dose for Chronic Spontaneous Urticaria (CSU):

    Dose: 150mg or 300 mg subcutaneously every 4 weeks.

    Comments:

  • Dosing not dependent on IgE levels or body weight.
  • Avoid administering more than 150 mg per injection site.
  • The appropriate duration of therapy for CSU has not been evaluated. Periodically reassess the need for continued therapy.

    • Use: Chronic idiopathic urticaria in patients remaining symptomatic after H1 antihistamine treatment.

    Warnings

    Some people using this injection have had a severe, life-threatening allergic reaction either right after the injection or hours later. Allergic reactions may occur even after using this injection regularly for a year or longer.

    Get emergency medical help if you have any signs of an allergic reaction to Xolair: hives, rash; anxiety or fear; flushing (warmth, redness, or tingly feeling); feeling like you might pass out; chest tightness, wheezing, feeling short of breath, difficult breathing; fast or weak heartbeats; swelling of your face, lips, tongue, or throat.

    Asthma is often treated with a combination of different drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice.

    If you also use an oral steroid medication, do not stop using the steroid suddenly or you may have unpleasant withdrawal symptoms. Talk with your doctor if any of your asthma medications do not seem to work as well in treating or preventing attacks. Your symptoms may not improve right away once you start receiving Xolair. For best results, keep receiving the injection as directed. Talk with your doctor if your symptoms do not improve after a few weeks of treatment.

    Use Xolair regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

    What other drugs will affect Xolair

    Other drugs may interact with this medicine including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your healthcare providers about all medicines you use now and any medicine you start or stop using. It is important to tell your doctor or healthcare provider if you have any of the following: allergy shots (a series of injections given regularly to prevent the body from developing allergic reactions to specific substances) and medications that suppress your immune system. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

    This list is not complete. Many other drugs may interact with Xolair, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

    Disclaimer

    Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com'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. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com 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.

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