Downloadable Materials

Downloadable XOLAIR materials for healthcare professionals

The following resources are provided to assist healthcare professionals in caring for patients with allergic asthma:

Dosing Card(84k)
A quick reference guide for XOLAIR dosing

A booklet containing step-by-step instructions on how to prepare and administer XOLAIR (Omalizumab) for subcutaneous use
XOLAIR Patient Injection Record(84k)
A form that is used to record the injection history of a XOLAIR patient
Patient Progress Report(84k)
A 1-page questionnaire that will help you and your patient determine how his or her treatment regimen is working over time
XOLAIR Patient Brochure(84k)
A brochure for patients that provides information about allergic asthma, the role of IgE, and treatment with XOLAIR
Patient Assistance Flash Card(84k)
A 1-page guide on the types of co-pay and reimbursement assistance options that may be available to your XOLAIR patients

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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. Healthcare 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.
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 (eg, 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
Which of the following are stated in the 2007 NHLBI Guidelines as signs of lack of control? Please select all that apply
a) >2 exacerbations per year requiring oral corticosteroid bursts
b) Symptoms >2 days per week
c) Reliever medication required >2 days per week
d) Nighttime awakenings 1 to 3 times per week