Expanded Asthma Indication Approved for Breo Ellipta
April 30, 2015 - The U.S. Food and Drug Administration (FDA) approved approved Breo Ellipta with a new indication for the treatment of adults with asthma. Originally, Breo Ellipta was approved in May 2013 for the treatment of chronic obstructive pulmonary disease (COPD). Breo Ellipta includes a corticosteroid (fluticasone furoate) to reduce inflammation and a bronchodilating long-acting beta blocker (LABA), vilanterol. Breo Ellipta is not indicated for treating asthma patients under the age of 18 years and it is not a rescue medicine for acute bronchospasms.
For adult patient with Asthma, Breo Ellipta should be used one inhalation daily. Providers are advised to prescribe Breo Ellipta only for adult patients with severe asthma that does not respond to standard therapy. A boxed warning on the labelling indicates that using a LABA increases the risks of hospitalizations for pediatric asthma patients and of death for all patients. Once asthma is stabilized is it recommended that Breo Ellipta treatment should be gradually discontinued.
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- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.