<P>TECFIDERAâ„¢ (dimethyl fumarate) delayed-release capsules, for oral use Brief Summary of Full Prescribing Information 1 INDICATIONS AND USAGE TECFIDERA is indicated for the treatment of patients with relapsing forms of multiple sclerosis. 4 CONTRAINDICATIONS None. 5 WARNINGS AND PRECAUTIONS 5.1 Lymphopenia TECFIDERA may decrease lymphocyte counts see Adverse Reactions (6.1). In the MS placebo controlled trials, mean lymphocyte counts with TECFIDERA and then remained stable. Four weeks after stopping TECFIDERA, mean lymphocyte counts increased but did not return to baseline. Six percent (6) of TECFIDERA patients and <1 of placebo patients experienced lymphocyte counts <0.5x109/L (lower limit of normal 0.91x109/L). The incidence of infections (60 vs 58) and serious infections (2 vs 2) was similar in patients treated with TECFIDERA or placebo, respectively. There was no increased incidence of serious infections observed in patients with lymphocyte counts <0.8x109/L or 0.5x109/L. Before initiating treatment with TECFIDERA, a recent CBC (i.e., within 6 months) should be available. A CBC is recommended annually, and as clinically indicated. Withholding treatment should be considered in patients with serious infections until the infection(s) is resolved. TECFIDERA has not been studied in patients with pre-existing low lymphocyte counts. 5.2 Flushing or burning sensation). In clinical trials, 40 of TECFIDERA treated soon after initiating TECFIDERA and usually improved or resolved was mild or moderate in severity. Three percent (3) of patients symptoms that were not life-threatening but led to hospitalization. Administration of TECFIDERA with food may reduce the incidence 6 ADVERSE REACTIONS The following important adverse reactions are described elsewhere in labeling: Lymphopenia, Flushing see Warnings and Precautions (5.1, 5.2). 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and The most common adverse reactions (incidence =10 and =2 diarrhea, and nausea. Adverse Reactions in Placebo-Controlled Trials In the two well-controlled studies demonstrating effectiveness, 1529 patients received TECFIDERA with an overall exposure of 2244 person-years see Clinical Studies (14). The adverse reactions presented in the table below are based on safety information from 769 patients treated with TECFIDERA 240 mg twice a day and 771 placebo-treated patients. Table 1: Adverse Reactions in Study 1 and 2 reported for TECFIDERA 240 mg BID at = 2 higher incidence than placebo Gastrointestinal TECFIDERA caused GI events (e.g., nausea, vomiting, diarrhea, abdominal pain, and dyspepsia). The incidence of GI events was higher early in the course of treatment (primarily in month 1) and usually decreased over time in patients treated with TECFIDERA compared with placebo. Four percent (4) of patients treated with TECFIDERA and less than 1 of placebo patients discontinued due to gastrointestinal events. The incidence of serious GI events was 1 in patients treated with TECFIDERA. Hepatic Transaminases An increased incidence of elevations of hepatic transaminases in patients treated with TECFIDERA was seen primarily during the had levels < 3 times the upper limit of normal (ULN). Elevations of alanine aminotransferase and aspartate aminotransferase to = 3 times the ULN occurred in a small number of patients treated with both TECFIDERA and placebo and were balanced between groups. There were no elevations in transaminases = 3 times the ULN with concomitant elevations in total bilirubin > 2 times the ULN. Discontinuations due to elevated hepatic transaminases were < 1 and were similar in patients treated with TECFIDERA or placebo. Eosinophilia A transient increase in mean eosinophil counts was seen during the TECFIDERAN=769 PlaceboN=771 Blood and Lymphatic System Disorders Lymphopenia 2 <1 Gastrointestinal Disorders Abdominal pain Diarrhea Nausea Vomiting Dyspepsia 18 14 12 9 5 10 11 9 5 3 Vascular Disorders Flushing 40 6 Skin and Subcutaneous Tissue Disorders Pruritus Rash Erythema 8 8 5 4 3 1 Investigations Albumin urine present Aspartate aminotransferase increased 6 4 4 2 432440 02.p1.pdf 16/27/13 8:10 AM , 02-12071A1R03TEUSJournalAdA-size.indd 17/9/14 5:22 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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