<P>Adverse Reactions in Placebo-Controlled and Uncontrolled Studies In placebo-controlled and uncontrolled clinical studies, a total of 2513 patients have received TECFIDERA and been followed for periods up to 4 years with an overall exposure of 4603 person- years. Approximately 1162 patients have received more than 2 years of treatment with TECFIDERA. The adverse reaction pro?le of TECFIDERA in the uncontrolled clinical studies was consistent with the experience in the placebo-controlled clinical trials. 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. In animals, adverse effects on offspring survival, growth, sexual maturation, and neurobehavioral function were observed when dimethyl fumarate (DMF) was administered during pregnancy and lactation at clinically relevant doses. TECFIDERA should be used during pregnancy only if the potential bene?t justi?es the potential risk to the fetus. In rats administered DMF orally (25, 100, 250 mg/kg/day) throughout organogenesis, embryofetal toxicity (reduced fetal body weight and delayed ossi?cation) were observed at the highest dose tested. This dose also produced evidence of maternal toxicity (reduced body weight). Plasma exposure (AUC) for monomethyl fumarate (MMF), the major circulating metabolite, at the no-effect dose is approximately three times that in humans at the recommended human dose (RHD) of 480 mg/day. In rabbits administered DMF orally (25, 75, and 150 mg/kg/day) throughout organogenesis, embryolethality and decreased maternal body weight were observed at the highest dose tested. The plasma AUC for MMF at the no-effect dose is approximately 5 times that in humans at the RHD. Oral administration of DMF (25, 100, and 250 mg/kg/day) to rats throughout organogenesis and lactation resulted in increased lethality, persistent reductions in body weight, delayed sexual maturation (male and female pups), and reduced testicular weight at the highest dose tested. Neurobehavioral impairment was observed at all doses. A no-effect dose for developmental toxicity was not identi?ed. The lowest dose tested was associated with plasma AUC for MMF lower than that in humans at the RHD. Pregnancy Registry There is a pregnancy registry that monitors pregnancy outcomes in women exposed to TECFIDERA during pregnancy. Encourage patients to enroll by calling 1-800-456-2255. 8.3 Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when TECFIDERA is administered to a nursing woman. 8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established. 8.5 Geriatric Use Clinical studies of TECFIDERA did not include suf?cient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. 17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Patient Information) 17.1 Dosage Inform patients that they will be provided two strengths of TECFIDERA when starting treatment: 120 mg capsules for the 7 day starter dose and 240 mg capsules for the maintenance dose, both to be taken twice daily. Inform patients to swallow TECFIDERA capsules whole and intact. Inform patients to not crush, chew, or sprinkle capsule contents on food. Inform patients that TECFIDERA can be taken with or without food see Dosage and Administration (2.1). 17.2 Flushing and Gastrointestinal (GI) Reactions Flushing and GI reactions (abdominal pain, diarrhea, and nausea) are the most common reactions, especially at the initiation of therapy, and may decrease over time. Advise patients to contact their healthcare provider if they experience persistent and/or severe ?ushing or GI reactions, as taking TECFIDERA with food may help see Adverse Reactions (6.1). 17.3 Pregnancy and Pregnancy Registry Instruct patients that if they are pregnant or plan to become pregnant while taking TECFIDERA they should inform their physician. Encourage patients to enroll in the TECFIDERA Pregnancy Registry if they become pregnant while taking TECFIDERA. Advise patients to call 1-800-456-2255 for more information see Use in Speci?c Populations (8.1). 17.4 Lymphocyte Counts Inform patients that TECFIDERA may decrease lymphocyte counts. A recent blood test (i.e., within 6 months) should be available before they start therapy to identify patients with pre-existing low lymphocyte counts. Blood tests are also recommended annually, and as clinically indicated see Warnings and Precautions (5.1), Adverse Reactions (6.1). 41347-02 Manufactured by: Biogen Idec Inc. Cambridge, MA 02142 TECFIDERA is a trademark of Biogen Idec. © 2013 Biogen Idec 03/2013 432440 03.p1.pdf 16/27/13 8:11 AM02-12071A1R03TEUSJournalAdA-size.indd 27/9/14 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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