Ample Supplies of Relenza Available as Flu Season Peaks
March 02 2009 - 11:47AM
PR Newswire (US)
RESEARCH TRIANGLE PARK, N.C., March 2 /PRNewswire-FirstCall/ --
GlaxoSmithKline (NYSE:GSK) is prepared with ample supplies of the
influenza antiviral medication RELENZA(R) (zanamivir) Inhalation
Powder (http://www.relenza.com/) to meet public health needs as the
current influenza season peaks. According to newly updated
influenza activity data (http://www.cdc.gov/flu/weekly/) released
by the Centers for Disease Control and Prevention (CDC), the flu
virus is widespread in 27 states. Relenza is a preferred medication
for all circulating subtypes of influenza virus according to CDC
interim guidance, issued on December 19th, 2008
http://www2a.cdc.gov/HAN/ArchiveSys/ViewMsgV.asp?AlertNum=00279.
Based on the latest CDC influenza activity data, the influenza A
(H1N1) virus appears to be the most prevalent strain circulating
this flu season in the United States, but concern of antiviral
resistance persists with the influenza A (H1N1) strain. According
to CDC surveillance data, RELENZA has not shown resistance to the
influenza A (H1N1) virus or any of the other CDC-tested influenza
virus subtypes circulating this flu season. Clinical significance
cannot be inferred from this surveillance data. Pharmacies can
obtain RELENZA from their wholesalers. About RELENZA RELENZA is a
medicine for the treatment of influenza and for reducing the chance
of getting the flu in community and household settings. It belongs
to a group of medicines called neuraminidase inhibitors. These
medications attack the influenza virus and prevent it from
spreading inside your body. RELENZA treats the cause of influenza
at its source, rather than simply masking the symptoms. RELENZA is
delivered via oral inhalation using a Diskhaler. Step-by-step
instructions for proper use of the Diskhaler are available at
http://www.relenza.com/, including a short instruction video.
Important Safety Information RELENZA is not recommended for
treatment or prophylaxis of influenza in individuals with
underlying airways disease (such as asthma or chronic obstructive
pulmonary disease). Serious cases of bronchospasm, including
fatalities, have been reported during treatment with RELENZA in
patient with and without underlying airways disease. Many of these
cases were reported during postmarketing and causality was
difficult to assess. If use of RELENZA is considered for a patient
with underlying airways disease, the potential risks and benefits
should be carefully weighed. Use in these patients should be done
only under conditions of careful monitoring or respiratory
function, close observation, and appropriate supportive care
including availability of fast-acting bronchodilators. Discontinue
RELENZA and initiate appropriate treatment if an allergic reaction
occurs or is suspected. Patients with influenza, particularly
pediatric patients, may be at an increased risk of seizures,
confusion, or abnormal behavior early in their illness. Monitor for
signs of abnormal behavior. Safety and efficacy have not been
demonstrated in patients with high-risk underlying medical
conditions. RELENZA has not been proven effective for prophylaxis
of influenza in the nursing home setting. RELENZA is not a
substitute for early influenza vaccination on an annual basis as
recommended by the Centers for Disease Control's Immunization
Practices Advisory Committee. Influenza viruses change over time.
Emergence of resistance mutations could decrease drug
effectiveness. Other factors (for example, changes in viral
virulence) might also diminish clinical benefit of antiviral drugs.
Prescribers should consider available information on influenza drug
susceptibility patterns and treatment effects when deciding whether
to use RELENZA. GlaxoSmithKline: A Leader in Flu GlaxoSmithKline
has an active research and development program targeted at both
seasonal and pandemic flu and has recently invested more than $2
billion to expand capacity for manufacturing its flu vaccines
FLUARIX(R) [Influenza Virus Vaccine] and FLULAVAL(TM) [Influenza
Virus Vaccine] and its antiviral flu medication RELENZA.
GlaxoSmithKline -- one of the world's leading research-based
pharmaceutical and healthcare companies -- is committed to
improving the quality of human life by enabling people to do more,
feel better and live longer. For company information, visit
GlaxoSmithKline at http://www.gsk.com/. Cautionary statement
regarding forward-looking statements Under the safe harbor
provisions of the U.S. Private Securities Litigation Reform Act of
1995, GSK cautions investors that any forward-looking statements or
projections made by GSK, including those made in this announcement,
are subject to risks and uncertainties that may cause actual
results to differ materially from those projected. Factors that may
affect GSK' s operations are described under 'Risk Factors' in the
'Business Review' in the company' s Annual Report on Form 20-F for
2007. DATASOURCE: GlaxoSmithKline CONTACT: Media enquiries: Jeff
McLaughlin, +1-215-751-7709, Mary Ann Rhyne, +1-919-483-2839, or
Sarah Alspach, +1-215-751-7709, or US Analyst Web Site:
http://www.relenza.com/
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