Appropriate XOLAIR Patients

Identify your moderate-to-severe patients with allergic asthma

XOLAIR may be right for some of your patients. To make the correct assessment, consider XOLAIR for patients aged 12 and older who have:1

  • Moderate-to-severe persistent asthma
  • Positive skin test and in vitro reactivity to a perennial aeroallergen
  • IgE-mediated asthma (with IgE levels of 30 IU/mL to 700 IU/mL)
  • Body weight between 66 lb and 330 lb
  • Asthma symptoms that are inadequately controlled with inhaled corticosteroids (ICS)

Important Limitations of Use

  • XOLAIR is not indicated for treatment of other allergic conditions
  • XOLAIR is not indicated for the relief of acute bronchospasm or status asthmaticus
  • XOLAIR is not indicated for use in pediatric patients less than 12 years of age

The NHLBI Guidelines include XOLAIR for consideration for patients in steps 5 and 6*1

Stepwise approach for managing asthma in youths aged >12 years and adults

Steps for managing asthma

EIB=exercise-induced bronchospasm; ICS=inhaled corticosteroid; LABA=long-acting inhaled beta2-agonist;
LTRA=leukotriene receptor antagonist; SABA=short-acting beta2-agonist.

See chart notes

Notes:1

  • The stepwise approach is meant to assist, not replace, the clinical decision-making required to meet individual patient needs
  • If alternative treatment is used and response is inadequate, discontinue it and use the preferred treatment before stepping up
  • Zileuton is a less desirable alternative due to limited studies as adjunctive therapy and the need to monitor liver function. Theophylline requires monitoring of serum concentration levels
  • In step 6, before oral systemic corticosteroids are introduced, a trial of high-dose ICS + LABA + either LTRA, theophylline, or zileuton may be considered, although this approach has not been studied in clinical trials
  • Step 1, 2, and 3 preferred therapies are based on Evidence A; step 3 alternative therapy is based on Evidence A for LTRA, Evidence B for theophylline, and Evidence D for zileuton. Step 4 preferred therapy is based on Evidence B, and alternative therapy is based on Evidence B for LTRA and theophylline and Evidence D for zileuton. Step 5 preferred therapy is based on Evidence B. Step 6 preferred therapy is based on (EPR—2 1997) and Evidence B for Omalizumab
  • Immunotherapy for steps 2-4 is based on Evidence B for house-dust mites, animal danders, and pollens; evidence is weak or lacking for molds and cockroaches. Evidence is strongest for immunotherapy with single allergens. The role of allergy in asthma is greater in children than in adults
  • Clinicians who administer immunotherapy or Omalizumab should be prepared and equipped to identify and treat anaphylaxis that may occur

For the full NHLBI Guidelines and an explanation of Evidence A-D,
click here.

INDICATION
XOLAIR® (omalizumab) for subcutaneous use is indicated for adults and adolescents (12 years of age and above) with moderate to severe persistent asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids.

XOLAIR has been shown to decrease the incidence of asthma exacerbations in these patients.

Important Limitations of Use
XOLAIR is not indicated for treatment of other allergic conditions
XOLAIR is not indicated for the relief of acute bronchospasm or
status asthmaticus
XOLAIR is not indicated for use in pediatric patients less than
12 years of age

IMPORTANT SAFETY INFORMATION

WARNING: Anaphylaxis

Anaphylaxis presenting as bronchospasm, hypotension, syncope, urticaria, and/or angioedema of the throat or tongue, has been reported to occur after administration of XOLAIR. Anaphylaxis has occurred as early as after the first dose of XOLAIR, but also has occurred beyond 1 year after beginning regularly administered treatment. Because of the risk of anaphylaxis, observe patients closely for an appropriate period of time after XOLAIR administration. Health care providers administering XOLAIR should be prepared to manage anaphylaxis that can be life-threatening. Inform patients of the signs and symptoms of anaphylaxis and instruct them to seek immediate medical care should symptoms occur (see Warnings and Precautions: Anaphylaxis).

XOLAIR should only be administered in a healthcare setting by healthcare providers prepared to manage anaphylaxis that can be life-threatening.
XOLAIR should not be administered to patients who have experienced a severe hypersensitivity reaction to XOLAIR or any ingredient of XOLAIR (see Warnings and Precautions). XOLAIR should be discontinued in patients who experience a severe hypersensitivity reaction.
Malignant neoplasms were observed in 20 of 4127 (0.5%) XOLAIR-treated patients compared with 5 of 2236 (0.2%) control patients in clinical studies of asthma and other allergic disorders.
XOLAIR has not been shown to alleviate asthma exacerbations acutely. Do not use XOLAIR to treat acute bronchospasm or status asthmaticus.
A constellation of signs and symptoms including arthritis/arthralgia, rash (urticaria or other forms), fever and lymphadenopathy similar to serum sickness have been reported in post-approval use of XOLAIR in some patients. Physicians should stop XOLAIR if a patient develops this constellation of signs and symptoms.
Patients should be given and instructed to read the accompanying Medication Guide before starting treatment and before each subsequent treatment.
Do not abruptly discontinue corticosteroid use upon initiation of XOLAIR therapy. Decrease corticosteroids gradually under the direct supervision of a physician.
In patients ≥12 years of age, the most commonly observed adverse reactions (>1% more frequent in XOLAIR-treated patients) from 4 placebo-controlled asthma studies were arthralgia (8%), pain (general) (7%), leg pain (4%), fatigue (3%), dizziness (3%), fracture (2%), arm pain (2%), pruritus (2%), dermatitis (2%), and earache (2%).
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), in either placebo-controlled or other controlled asthma studies, were injection site reaction (45%), viral infections (23%), upper respiratory tract infection (20%), sinusitis (16%), headache (15%), and pharyngitis (11%). These events were observed at similar rates in XOLAIR-treated patients and control patients.

 
Related
 
Allergic Asthma Facts
The risk of allergic asthma starts at relatively low IgE levels.
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