<P>© 2014 Biogen Idec. All rights reserved. 06/14 TEC-1007908-02A Make Tecfidera your FIRST CHOICE for FIRST LINE Start at the Tec?dera level PPR=Proportion of patients relapsed; ARR=Annualized relapse rate; CBC=complete blood count. *Determination of the Efficacy and Safety of Oral Fumarate in Relapsing-Remitting MS, a 2-year, randomized, double-blind, placebo-controlled study in 1234 patients with relapsing-remitting multiple sclerosis (RRMS).1,2 † Relapses were defined as new or recurrent neurologic symptoms not associated with fever or infection that lasted for at least 24 hours and were accompanied by new objective neurologic findings.2 ‡ Subject to change. INDICATION Tec?dera® (dimethyl fumarate) is indicated for the treatment of patients with relapsing forms of multiple sclerosis. IMPORTANT SAFETY INFORMATION • Tec?dera may decrease lymphocyte counts; in clinical trials there was a mean decrease of ~30 in lymphocyte counts during the ?rst year which then remained stable. Four weeks after stopping Tec?dera, mean lymphocyte counts increased but not to baseline. Six percent of Tec?dera patients and <1 of placebo patients had lymphocyte counts <0.5x109/L. Tec?dera has not been studied in patients with pre-existing low lymphocyte counts. • The incidence of infections and serious infections was similar in patients treated with Tec?dera or placebo. Consider withholding treatment in patients with serious infections until resolved. A complete blood count is recommended within 6 months before initiating treatment, annually, and as clinically indicated. • Tec?dera may cause ?ushing (e.g. warmth, redness, itching, and/or burning sensation). 40 of patients taking Tec?dera reported ?ushing which was mostly mild to moderate in severity. Three percent of patients discontinued Tec?dera for ?ushing and <1 had serious ?ushing events that led to hospitalization. Taking Tec?dera with food may reduce ?ushing. • Tec?dera may cause gastrointestinal (GI) events (e.g., nausea, vomiting, diarrhea, abdominal pain, and dyspepsia). Four percent of Tec?dera patients and <1 placebo patients discontinued due to GI events. The incidence of serious GI events was 1. The most common adverse reactions associated with Tec?dera versus placebo are ?ushing (40 vs 6) and GI events: abdominal pain (18 vs 10), diarrhea (14 vs 11), nausea (12 vs 9). • Elevations in hepatic transaminases have been reported. A transient increase in mean eosinophil counts was seen during the ?rst two months. Tec?dera should be used during pregnancy only if the potential bene?t justi?es the potential risk to the fetus. Encourage patients who become pregnant while taking Tec?dera to enroll in the Tec?dera pregnancy registry by calling 1-800-456-2255. For additional important safety information, please see Brief Summary of full Prescribing Information on the preceding pages. For more information, please visit Tec?deraHCP.com. References: 1. Tec?dera Prescribing Information, Biogen Idec, Inc., Cambridge, MA. 2. Gold R, Kappos L, Arnold DL, et al. N Engl J Med. 2012;367:1098-1107. Erratum in: N Engl J Med. 2012;367:2362. 3. Fingertip Formulary, April 2014. For your patients with relapsing multiple sclerosis MEANINGFUL EFFICACY In the 2-year DEFINE* trial vs placebo (n=408), Tecfidera (n=410) cut risk and frequency of relapses† in half. PPR: 49 relative risk reduction, placebo 46, Tecfidera 27 (P<0.0001). ARR: 53 relative reduction, placebo 0.364, Tecfidera 0.172 (P<0.0001).1,2 SAFETY STUDIED IN 2 CLINICAL TRIALS The most common adverse reactions were flushing and gastrointestinal events. CBCs are recommended, as Tecfidera may decrease lymphocyte counts.1 ORAL DOSING AND FAVORABLE ACCESS >90 formulary coverage3‡ can help your patients start and stay on therapy. 02-12071A1R03TEUSJournalAdA-size.indd 37/9/14 5:23 PM</p> <UL><LI><a href="http://www.mzines.net/publication/704/lhbdvotqg/1/1/">Front-Cover</a></LI> <LI><a href="http://www.mzines.net/publication/704/lhbdvotqg/2/2/">Inside-Front-Cover</a></LI> <LI><a href="http://www.mzines.net/publication/704/lhbdvotqg/3/3/">Page-3</a></LI> <LI><a href="http://www.mzines.net/publication/704/lhbdvotqg/4/4/">Page-4</a></LI> <LI><a href="http://www.mzines.net/publication/704/lhbdvotqg/5/5/">Page-5</a></LI> <LI><a href="http://www.mzines.net/publication/704/lhbdvotqg/6/6/">Page-6</a></LI> <LI><a href="http://www.mzines.net/publication/704/lhbdvotqg/7/7/">Page-7</a></LI> <LI><a href="http://www.mzines.net/publication/704/lhbdvotqg/8/8/">Page-8</a></LI> <LI><a href="http://www.mzines.net/publication/704/lhbdvotqg/9/9/">Page-9</a></LI> <LI><a href="http://www.mzines.net/publication/704/lhbdvotqg/10/10/">Page-10</a></LI> <LI><a href="http://www.mzines.net/publication/704/lhbdvotqg/11/11/">Page-11</a></LI> <LI><a href="http://www.mzines.net/publication/704/lhbdvotqg/12/12/">Page-12</a></LI> <LI><a href="http://www.mzines.net/publication/704/lhbdvotqg/13/13/">Page-13</a></LI> <LI><a href="http://www.mzines.net/publication/704/lhbdvotqg/14/14/">Page-14</a></LI> <LI><a href="http://www.mzines.net/publication/704/lhbdvotqg/15/15/">Page-15</a></LI> <LI><a href="http://www.mzines.net/publication/704/lhbdvotqg/16/16/">Page-16</a></LI> <LI><a href="http://www.mzines.net/publication/704/lhbdvotqg/17/17/">Page-17</a></LI> <LI><a href="http://www.mzines.net/publication/704/lhbdvotqg/18/18/">Page-18</a></LI> <LI><a href="http://www.mzines.net/publication/704/lhbdvotqg/19/19/">Page-19</a></LI> <LI><a href="http://www.mzines.net/publication/704/lhbdvotqg/20/20/">Page-20</a></LI> <LI><a href="http://www.mzines.net/publication/704/lhbdvotqg/21/21/">Page-21</a></LI> <LI><a href="http://www.mzines.net/publication/704/lhbdvotqg/22/22/">Page-22</a></LI> <LI><a href="http://www.mzines.net/publication/704/lhbdvotqg/23/23/">Page-23</a></LI> <LI><a href="http://www.mzines.net/publication/704/lhbdvotqg/24/24/">Page-24</a></LI> <LI><a href="http://www.mzines.net/publication/704/lhbdvotqg/25/25/">Page-25</a></LI> <LI><a href="http://www.mzines.net/publication/704/lhbdvotqg/26/26/">Page-26</a></LI> <LI><a href="http://www.mzines.net/publication/704/lhbdvotqg/27/27/">Page-27</a></LI> <LI><a href="http://www.mzines.net/publication/704/lhbdvotqg/28/28/">Page-28</a></LI> <LI><a href="http://www.mzines.net/publication/704/lhbdvotqg/29/29/">Page-29</a></LI> <LI><a href="http://www.mzines.net/publication/704/lhbdvotqg/30/30/">Page-30</a></LI> <LI><a href="http://www.mzines.net/publication/704/lhbdvotqg/31/31/">Page-31</a></LI> <LI><a href="http://www.mzines.net/publication/704/lhbdvotqg/32/32/">Page-32</a></LI> <LI><a href="http://www.mzines.net/publication/704/lhbdvotqg/33/33/">Page-33</a></LI> <LI><a href="http://www.mzines.net/publication/704/lhbdvotqg/34/34/">Page-34</a></LI> <LI><a href="http://www.mzines.net/publication/704/lhbdvotqg/35/35/">Page-35</a></LI> <LI><a href="http://www.mzines.net/publication/704/lhbdvotqg/36/36/">Page-36</a></LI> <LI><a href="http://www.mzines.net/publication/704/lhbdvotqg/37/37/">Page-37</a></LI> <LI><a href="http://www.mzines.net/publication/704/lhbdvotqg/38/38/">Page-38</a></LI> <LI><a href="http://www.mzines.net/publication/704/lhbdvotqg/39/39/">Back-Cover</a></LI> <LI><a href="http://www.mzines.net/publications/704/x/sitemap.xml" target="_blank">site map</a></LI> </UL>

 

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