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US FDA Approves Extavia(R) - the First in a New Portfolio of Planned MS Therapies from Novartis to Help Patients with this Devastating Disease
Date:8/16/2009

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Extavia should be used with caution in patients with depression. Injection site necrosis has been reported in 4% of patients in controlled trials. Typically, injection site necrosis occurs within the first four months of therapy. Necrosis may occur at a single injection site or multiple injection sites. Patient understanding and use of aseptic self-injection techniques and procedures should be periodically reevaluated, particularly if injection site necrosis has occurred. Anaphylaxis has been reported as a rare complication of interferon use. Other allergic reactions have included dyspnea, bronchospasm, tongue edema, skin rash, and urticaria.

The rate of flu-like symptom complex was approximately 57% in the four controlled clinical trials. The incidence decreased over time, with only 10% of patients reporting flu-like symptom complex at the end of the studies. Monitoring of complete blood and differential white blood cell counts, platelet counts and blood chemistries, including liver function tests, are recommended at regular intervals.

The most commonly reported adverse reactions are lymphopenia, injection site reaction, asthenia, flu-like symptom complex, headache and pain. Based on all the available evidence, the relationship between antibody formation and clinical safety and efficacy is not known. Female patients should be warned about the potential risk to pregnancy. The mechanism of action of interferon beta-1b in patients with multiple sclerosis is unknown. Gradual dose titration and use of analgesics during treatment initiation may help reduce flu-like symptoms. Patients should be advised of the importance of rotating injection sites.

* Novartis gained the rights to seek approval for its own branded version of interferon beta-1b through agreements with Bayer Schering, the company that markets Betaseron.

Betaseron is marketed under the name of Betaferon(R) outside
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SOURCE Novartis Pharmaceuticals Corporation
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