Herbal Spotlight
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 omalizumab |
| Xolair |
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Pharmaceutical
company:
Genentech and Novartis
www.xolair.com |
NEW WARNING
The FDA has issued a new warning about the monoclonal antibody omalizumab (Xolair), which is approved for management of asthma in particular patients. A new black box warning has been added to the prescribing information. The warning outlines the risk for anaphylaxis following use of Xolair, after the first dose and for up to 1 year after the start of therapy. It is advised that the drug should only be given under the supervision of healthcare providers prepared to deal with acute anaphylaxis. The patient should be observed for a period of time and the patient should be given written information on the signs and symptoms of anaphylaxis and urged to seek immediate care if they experience any signs and symptoms. The new prescribing information also outlines the incidence of anaphylaxis and precautions, and includes a new Medication Guide to be given to patients after each administration of the drug.
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