Assessing Your Asthma is Key to Taking Control

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May 13, 2013, 03:00 ET

WILMINGTON, Del., May 13, 2013 /PRNewswire/ -- Approximately 25 million Americans suffer from asthma, which accounts for more than 3300 deaths each year. AstraZeneca (NYSE: AZN) is urging Americans to embrace National Asthma & Allergy Awareness Month this May by taking proactive steps to gain control of their asthma and learn more about how it may be impacting their lives.

To view the multimedia assets associated with this release, please click: http://www.multivu.com/mnr/60910-astrazeneca-symbicort-national-asthma-and-allergy-awareness-month

People living with asthma have inflammation, also known as swelling, in their airways. When left uncontrolled, the inflammation makes their airways more sensitive to common asthma triggers like pollen, dust, and smoke. Exposure to these asthma triggers can cause the muscles around the airways to tighten, leading to asthma symptoms like shortness of breath, wheezing, tightness of the chest, and coughing. Medicines that help to control asthma can help control the inflammation and help reduce sensitivity to asthma triggers.

"It is important for patients with asthma to gain control of their symptoms on an ongoing basis, allowing them to live their lives with fewer interruptions – asthma doesn't have to limit their daily activities," said Frank Trudo, MD, Medical Affairs, AstraZeneca. "National Asthma and Allergy Awareness Month is an opportune time for patients with asthma to work with their health care providers, reexamine asthma triggers and symptoms, to determine if their asthma is under control and their lungs are functioning optimally."

A doctor may recommend controlling asthma symptoms with SYMBICORT^® (budesonide/formoterol fumarate dihydrate) inhalation aerosol, a combination of inhaled corticosteroid (ICS) and long-acting beta₂-adrenergic agonist (LABA). SYMBICORT is a medicine, which contains two medicines to reduce the inflammation in the lungs and keep airways open. SYMBICORT helps to control asthma in appropriate patients who are 12 years or older and who are uncontrolled on an ICS or whose disease severity clearly warrants an ICS/LABA therapy. When used as prescribed, SYMBICORT has been shown to help significantly improve lung function, starting within 15 minutes.* SYMBICORT will not replace a rescue inhaler for sudden symptoms.

AstraZeneca is committed to helping people living with asthma. By visiting www.mysymbicort.com/asthma, patients can access a number of useful multimedia disease management resources, including an Asthma Assessment quiz, a tool to help patients and their doctors determine their level of asthma control and the impact asthma has on their lives and a free prescription offer to save on the cost of SYMBICORT.

Please see full Prescribing Information, including Boxed WARNING.

*Your results may vary.

IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING

WARNING: Long-acting beta₂-adrenergic agonists (LABA), such as formoterol, one of the active ingredients in SYMBICORT, increase the risk of asthma-related death. A placebo controlled study with another LABA (salmeterol) showed an increase in asthma-related deaths in patients receiving salmeterol. This finding with salmeterol is considered a class effect of LABA, including formoterol. Currently available data are inadequate to determine whether concurrent use of inhaled corticosteroids or other long-term asthma control drugs mitigates the increased risk of asthma-related death from LABA. Available data from controlled clinical trials suggest that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent patients
When treating patients with asthma, prescribe SYMBICORT only for patients not adequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and LABA. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (eg, discontinue SYMBICORT) if possible without loss of asthma control, and maintain the patient on a long-term asthma control medication, such as an inhaled corticosteroid. Do not use SYMBICORT for patients whose asthma is adequately controlled on low or medium dose inhaled corticosteroids

SYMBICORT is NOT a rescue medication and does NOT replace fast-acting inhalers to treat acute symptoms.

It is possible that systemic corticosteroid effects such as hypercorticism and adrenal suppression may occur, particularly at higher doses. Particular care is needed for patients who are transferred from systemically active corticosteroids to inhaled corticosteroids. Deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids.

Patients who are receiving SYMBICORT should not use additional formoterol or other LABA for any reason.

Due to possible immunosuppression, potential worsening of infections could occur. A more serious or even fatal course of chickenpox or measles can occur in susceptible patients.

Excessive beta-adrenergic stimulation has been associated with central nervous system and cardiovascular effects. SYMBICORT, like all products containing sympathomimetic amines, should be used with caution in patients with convulsive disorders, thyrotoxicosis, and cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension. Beta-adrenergic agonist medications may produce hypokalemia and hyperglycemia in some patients. As with other inhaled medications, paradoxical bronchospasm may occur with SYMBICORT. Use with caution in patients with diabetes mellitus.

Long-term use of orally inhaled corticosteroids, such as budesonide, a component of SYMBICORT, may result in a reduction in growth velocity and/or a loss of bone mineral density.

Glaucoma, increased intraocular pressure, and cataracts have been reported following the inhaled administration of corticosteroids, including budesonide, a component of SYMBICORT.

In rare cases, patients on inhaled corticosteroids may present with systemic eosinophilic conditions.

SYMBICORT should be administered with caution to patients being treated with MAO inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents. Caution should also be exercised in patients on long-term ketoconazole and other known potent CYP3A4 inhibitors.

The most common adverse reactions ≥3% reported in clinical trials included nasopharyngitis, headache, upper respiratory tract infection, pharyngolaryngeal pain, sinusitis, influenza, back pain, nasal congestion, stomach discomfort, vomiting, and oral candidiasis.

INDICATIONS

SYMBICORT is indicated for the treatment of asthma in patients 12 years and older (also see Boxed WARNING).

SYMBICORT is NOT indicated for the relief of acute bronchospasm and should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of asthma.

Please see full Prescribing Information, including Boxed WARNING.

About AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialization of prescription medicines for gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

For more information about AstraZeneca in the US or our AZ&Me™ Prescription Savings programs, please visit: www.astrazeneca-us.com or call 1-800-AZandMe (292-6363).

SYMBICORT is a registered trademark, and AZ&Me is a trademark, of the AstraZeneca group of companies.