CSL Biotherapies, and its parent company, CSL Limited have reached an agreement with Merck & Co., Inc. on rights to market and distribute Afluria® in the United States under an exclusive, six-year agreement effective September 3, 2009. Merck has the exclusive right to sell and distribute Afluria® in the United States beginning with the 2010-2011 influenza season. The manufacture, filling and packaging of Afluria® will continue and will not change with this agreement; CSL Ltd. will retain the Afluria® license.

For information on prebooking Afluria® for the 2010-2011 season, please visit www.merckvaccines.com/afluria or call the Merck Vaccine Customer Center at 877-829-6372.

For any questions relating to Afluria® 2009-2010, please contact 1-888-435-8633 or CustomerSupport@cslbiotherapies.com.

Afluria® 2009-2010 Prescribing Information (Revised 11/2009)

CSL Biotherapies' plans or capacity for manufacturing and delivering its pandemic Influenza A (H1N1) Monovalent Vaccine to US Human Health Services (HHS) are not affected by the seasonal influenza vaccine agreement. For any questions relating to CSL Biotherapies' Influenza A (H1N1) 2009 Monovalent Vaccine, please contact 1-888-435-8633 or CustomerSupport@cslbiotherapies.com.

CSL Biotherapies' Influenza A (H1N1) 2009 Monovalent Vaccine Prescribing Information

 

Important Safety Information

Afluria® is indicated for active immunization of persons age 18 and older against influenza disease caused by influenza virus subtypes A and type B present in the vaccine. The indication is based on the immune response elicited by Afluria®; no controlled clinical studies have demonstrated a decrease in influenza disease after vaccination with Afluria®.

Afluria® should not be administered to individuals with hypersensitivity to eggs or chicken protein or other components of Afluria®, or to anyone who has had a life-threatening reaction to previous influenza vaccination.

The most common injection-site adverse reactions were tenderness, pain, redness, and swelling. The most common systemic adverse reactions were headache, malaise, and muscle aches.

Vaccination with Afluria® may not protect all individuals. Immunocompromised persons may have a diminished immune response. If Guillain-Barrė syndrome has occurred within 6 weeks of receipt of prior influenza vaccine, the decision to give Afluria® should be based on careful consideration of the potential benefits and risks.

Please see full prescribing information.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
 

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