XOLAIR® (Omalizumab)
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XOLAIR®

XOLAIR is an anti-IgE antibody indicated for:

  • Moderate to severe persistent asthma in adults and pediatric patients 6
    years of age and older with a positive skin test or in vitro reactivity to a
    perennial aeroallergen and symptoms that are inadequately controlled
    with inhaled corticosteroids
  • Chronic rhinosinusitis with nasal polyps (CRSwNP) in adult patients 18
    years of age and older with inadequate response to nasal corticosteroids,
    as add-on maintenance treatment
  • IgE-mediated food allergy in adult and pediatric patients aged 1 year and
    older for the reduction of allergic reactions (Type I), including
    anaphylaxis, that may occur with accidental exposure to one or more
    foods. To be used in conjunction with food allergen avoidance
  • Chronic spontaneous urticaria (CSU) in adults and adolescents 12 years of
    age and older who remain symptomatic despite H1 antihistamine
    treatment

Please refer to the full prescribing information.

What is the most important information I should know about XOLAIR®?

Some patients have reported experiencing severe allergic reactions while undergoing treatment with XOLAIR® — including anaphylaxis. Sometimes, these reactions could occur days after the infusion. Seek emergency care immediately if you experience any of the following symptoms:

  • Shortness of breath
  • Coughing
  • Chest tightness
  • Breathing difficulties
  • Itching
  • Hives
  • Flushing of the skin
  • Swelling of the face, lips, and/or throat
  • Difficulties swallowing
  • Fast or weak heartbeat
  • Low blood pressure
  • Anxiety

Side Effects of XOLAIR®

As with any prescription medication, XOLAIR® carries a risk of side effects. The most common ones include:

  • Fever
  • Dizziness
  • Fatigue
  • Skin rash
  • Sore throat
  • Pain in your limbs
  • Ear pain
  • Abdominal pain
  • Nausea
  • Vomiting
  • Nose bleeds
  • Swelling of the inside of the nose
  • Coughing
  • Joint pain
  • Upper respiratory tract infection

Some of the most serious side effects include the following:

Inflammation of the blood vessels

Tell your doctor immediately if you experience chest pain, numbness in your arms and/or legs, pins and needles in your limbs, and/or shortness of breath. Restricted blood flow may cause organ or tissue damage if left untreated.

Fever, muscle aches, and rash

Any of these symptoms could occur right after an infusion treatment, and up to five days after administering XOLAIR®. Tell your doctor if something feels off.

Heart and circulation problems

XOLAIR® may increase the risk of ischemic heart disease, arrhythmia, cardiomyopathy, deep vein thrombosis, and heart attack. Other temporary symptoms may occur.

Parasitic infection

XOLAIR® may affect your immune system. Parasitic infections are a serious side effect more likely to occur in patients who have a history of parasite infections.

Cancer

The most common types of cancer associated with using XOLAIR® include breast, skin, and prostate cancer. More than one type of cancer may occur.

Tell your doctor if you experience any negative side effects. You are also encouraged to report such side effects to the Food and Drug Administration (FDA) by visiting www.fda.gov/medwatch, or by calling 1-800-FDA-1088.