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Label Changes for:

Xolair (omalizumab) Lyophilized Powder

July 2016

Changes have been made to the PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

July 2016


Clinical Trials Experience
Adverse Reactions from Clinical Studies in Adult and Adolescent Patients 12 Years of Age and Older with Asthma replaces Adverse Reactions from Clinical Studies in Patients with Asthma
  • Table #5 replaces Table #4
  • Table 5. Adverse Reactions ≥ 1% More Frequent in Xolair-Treated Adult or Adolescent Patients 12 years of Age and Older in Four Placebo-controlled Asthma Trials
Adverse Reactions from Clinical Studies in Pediatric Patients 6 to <12 Years of Age with Asthma (new subheading and section)
  • The data described below reflect Xolair exposure for 926 patients 6 to < 12 years of age, including 583 patients exposed for six months and 292 exposed for one year or more, in either placebo-controlled or other controlled asthma studies. The mean age of pediatric patients receiving Xolair was 8.8 years; 69% were male, and 64% were Caucasian. Pediatric patients received Xolair 75 mg to 375 mg every 2 or 4 weeks or, for patients assigned to control groups, standard therapy with or without a placebo. No cases of malignancy were reported in patients treated with Xolair in these trials.
  • The most common adverse reactions occurring at ≥3% in the pediatric patients receiving Xolair and more frequently than in patients treated with placebo were nasopharyngitis, headache, pyrexia, upper abdominal pain, pharyngitis streptococcal, otitis media, viral gastroenteritis, arthropod bite, and epistaxis.
  • The adverse events most frequently resulting in clinical intervention (e.g., discontinuation of Xolair, or the need for concomitant medication to treat an adverse event) were bronchitis (0.2%), headache (0.2%) and urticaria (0.2%). These events were observed at similar rates in Xolair-treated patients and control patients.
Adverse Reactions from Clinical Studies in Patients with Chronic Idiopathic Urticaria (CIU)
  • Table #6 replaces Table #5
  • Table 6. Adverse Reactions Occurring in 2% in Xolair-Treated Patients and More Frequently than in Patients Treated with Placebo (Day 1 to Week 12) in CIU Trials
Immunogenicity (new info added to paragraph)
  • Antibodies to Xolair were detected in approximately 1/1723 (< 0.1%) of patients treated with Xolair in the clinical studies evaluated for approval of asthma in patients 12 years of age and older. In three pediatric studies, antibodies to Xolair were detected in one patient out of 581 patients 6 to <12 years of age treated with Xolair and evaluated for antibodies.
  • PLLR conversion, please refer to label.
Pediatric Use


  • (addition of the following sentence) Safety and efficacy in pediatric patients with asthma below 6 years of age have not been established.
Chronic Idiopathic Urticaria
  • (addition of the following sentence) Safety and efficacy in pediatric patients with CIU below 12 years of age have not been established.

MEDICATION GUIDE (has been reformatted, please refer to label)

What is XOLAIR?

XOLAIR is an injectable prescription medicine used to treat: (additional phrases are added below)

  • moderate to severe persistent asthma in patients 6 years of age and older…
  • chronic idiopathic urticaria (CIU; chronic hives without a known cause) in patients 12 years of age and older

What are the possible side effects of XOLAIR?

XOLAIR may cause serious side effects, including:

  • Cancer. Cases of cancer were observed in some people who received XOLAIR. (updated sentence)
  • (new) Inflammation of your blood vessels. Rarely, this can happen in people with asthma who receive XOLAIR. This usually, but not always, happens in people who also take a steroid medicine by mouth that is being stopped or the dose is being lowered. It is not known whether this is caused by XOLAIR. Tell your healthcare provider right away if you have:
    • rash
    • shortness of breath
    • chest pain
    • a feeling of pins and needles or numbness of your arms or legs
  • Heart and circulation problems (new subheading for Some people who receive XOLAIR have had chest pain…)

The most common side effects of XOLAIR: (new bullets below)

  • In adults and children 12 years of age and older with asthma: pain especially in your arms and legs, dizziness, feeling tired, skin rash, bone fractures, and pain or discomfort of your ears.
  • In children 6 to less than 12 years of age with asthma: common cold symptoms, headache, fever, sore throat, pain or discomfort of your ear, abdominal pain, nausea, vomiting and nose bleeds.


December 2015


  • A case-control study showed that, among Xolair users, patients with a history of anaphylaxis to foods, medications, or other causes were at increased risk of anaphylaxis associated with Xolair, compared to those with no prior history of anaphylaxis


September 2014


5.2 Malignancy Risks
  • In a subsequent observational study of 5007 Xolair-treated and 2829 non-Xolair-treated patients with moderate to severe persistent asthma and a positive skin test reaction or in vitro reactivity to a perennial aeroallergen, patients were followed ..... while a history of cancer or a premalignant condition were study exclusion criteria, and the high study discontinuation rate (44%).


6.1 Clinicial Trials Experience
  • new subsection added to describe EXCELS safety study


  • minor wording changes to include new indication of CIU