XOLAIR® (Omalizumab)

XOLAIR®

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Important Safety Information

XOLAIR® (omalizumab) is an infusion medication used to treat moderate to severe, persistent asthma. It is effective in patients who are six years of age or older, whose asthma symptoms have not been controlled by inhaled corticosteroids. XOLAIR® is also used to treat chronic idiopathic urticaria (CIU) in patients who are 12 years of age and older, whose hives have not been controlled by H1 antihistamine treatment.

Prior to starting treatment, talk to your doctor about your medical history and all medications you’re currently taking — whether they’re prescription, over-the-counter, vitamins, or herbal supplements. Do not stop taking any asthma or CIU medication unless instructed by your medical provider. Mention any allergies you have, so that your doctor can be aware of how your body may react to some of the active or inactive ingredients in XOLAIR®.

It is unknown whether XOLAIR® could harm your unborn baby. Tell your doctor if you’re pregnant, think you could be pregnant, or are planning on becoming pregnant. It is also unknown if XOLAIR® can pass to a baby through breast milk. Talk with your doctor if you’re currently breastfeeding or planning on breastfeeding.

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.

Indications

XOLAIR® is administered one time every two or four weeks. If the medication is being used to treat severe asthma, perform a blood test for lgE to determine the correct dosage and frequency. If the medication is being used to treat chronic idiopathic urticaria, no blood test is needed.

Please refer to the full prescribing information.