<P>* Sustained disability progression was de? ned as at least a 1-point increase from baseline Expanded Disability Status Scale (EDSS) score =5.5 (or at least a 0.5-point increase for those with a baseline EDSS score >5.5) sustained for at least 12 weeks.1 † In the double-blind, placebo-controlled Teriflunomide Multiple Sclerosis Oral (TEMSO) study, 1088 patients with relapsing forms of MS were randomized to receive AUBAGIO 14 mg (n=359), AUBAGIO 7 mg (n=366), or placebo (n=363) once daily for 108 weeks.1,2 Please see Brief Summary of Full Prescribing Information, including boxed WARNING. PROVEN EFFECTIVE IN PATIENTS WITHACTIVE DISEASE 1,2 Positive impact on 3 key measures of MS disease activity at week 108 with AUBAGIO® (teri? unomide) 14 mg1,2 57 80 7 mgg 14mmmggP<0.001 P<0.001 31 7 mgg P<0.00131 1114mmmgg P<0.001 2430 7 mgg1444mmgg P=0.08 P=0.03AUBAGIO 7 mg did not achieve a statistically signi?cant reduction versus placebo. Reduction in risk of sustained disability progression1,2* Signi? cant reduction in rate of relapse1,2Signi? cant reduction in Gd-enhancing T1 lesions per MRI scan1,2 8 out of 10 patients were free of sustained disability progression* at week 108 with AUBAGIO 14 mg2,3 SLOW DISEASE PROGRESSION IN YOUR PATIENTS Safety pro? le evaluated in the TEMSO study1,2† • The most frequent adverse events (AEs) (incidence =10 and at a =2 greater incidence than placebo) with AUBAGIO 14 mg, AUBAGIO 7 mg, and placebo, respectively, were alanine aminotransferase (ALT) increased (14, 12, and 7), alopecia (13, 10, and 3), diarrhea (18, 15, and 9), in? uenza (12, 9, and 10), nausea (14, 9, and 7), and paresthesia (10, 9, and 8) INDICATION AUBAGIO® (teri? unomide) is indicated for the treatment of patients with relapsing forms of multiple sclerosis. IMPORTANT SAFETY INFORMATION WARNING: HEPATOTOXICITY AND RISK OF TERATOGENICITY Severe liver injury including fatal liver failure has been reported in patients treated with le? unomide, which is indicated for rheumatoid arthritis. A similar risk would be expected for teri? unomide because recommended doses of teri? unomide and le? unomide result in a similar range of plasma concentrations of teri? unomide. AUBAGIO is contraindicated in patients with severe hepatic impairment and in patients taking le? unomide. Concomitant use of AUBAGIO with other potentially hepatotoxic drugs may increase the risk of severe liver injury. Obtain transaminase and bilirubin levels within 6 months before initiation of AUBAGIO therapy. Monitor ALT levels at least monthly for 6 months after starting AUBAGIO. If drug-induced liver injury is suspected, discontinue AUBAGIO and start an accelerated elimination procedure with cholestyramine or charcoal. Patients with pre-existing liver disease may be at increased risk of developing elevated serum transaminases when taking AUBAGIO. Based on animal data, AUBAGIO may cause major birth defects if used during pregnancy. Pregnancy must be excluded before starting AUBAGIO. AUBAGIO is contraindicated in pregnant women or women of childbearing potential who are not using reliable contraception. Pregnancy must be avoided during AUBAGIO treatment or prior to the completion of an accelerated elimination procedure after AUBAGIO treatment. Warnings and Precautions Patients with pre-existing acute or chronic liver disease, or those with serum ALT >2 times the upper limit of normal (ULN) before initiating treatment, should not normally be treated with AUBAGIO. In clinical trials, if ALT elevation was >3 times the ULN on 2 consecutive tests, patients discontinued AUBAGIO and underwent accelerated elimination. Consider additional monitoring if coadministering AUBAGIO with other potentially hepatotoxic drugs; monitor patients who develop symptoms suggestive of hepatic dysfunction (eg, unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or dark urine). If drug-induced liver injury is suspected, discontinue use of AUBAGIO, start accelerated elimination, and monitor liver tests weekly until normalized. Before starting therapy, use of reliable contraception must be con? rmed, and the patient counseled on risks to the fetus. Patients with delayed onset of menses or other reason to suspect pregnancy should immediately see their physician for pregnancy testing. Patients who become pregnant or wish to become pregnant should discontinue treatment, followed by accelerated elimination until plasma concentrations of <0.02 mcg/mL are veri? ed. Women who become pregnant while taking AUBAGIO may enroll in the AUBAGIO pregnancy registry by calling 1-800-745-4447, option 2. Teri? unomide is eliminated slowly from the plasma—it takes an average of 8 months, or up to 2 years in some patients, to reach plasma concentrations <0.02 mcg/mL. Elimination may be accelerated by administration of cholestyramine or charcoal, but this may cause disease activity to return in patients who were responding to AUBAGIO. Decreases in white blood cell counts, mainly of neutrophils and lymphocytes, and platelets have been reported with AUBAGIO. Obtain a complete blood cell count within 6 months before starting treatment, with further monitoring based on signs and symptoms of bone marrow suppression. AUBAGIO is not recommended for patients with severe immunode? ciency, bone marrow disease, or severe uncontrolled infections. Tuberculosis (TB) has been observed in clinical studies of AUBAGIO. Before starting treatment, screen patients for latent TB infection with a tuberculin skin test. Treatment in patients with acute or chronic infections should not be started until the infection(s) is resolved. Administration of live vaccines is not recommended. The risk of malignancy, particularly lymphoproliferative disorders, or infection may be increased with the use of some medications with immunosuppressive potential, including teri? unomide. Peripheral neuropathy, including polyneuropathy and mononeuropathy, has been reported with AUBAGIO. Age >60 years, concomitant neurotoxic medications, and diabetes may increase the risk. If peripheral neuropathy is suspected, consider discontinuing treatment and performing accelerated elimination. Transient acute renal failure and treatment-emergent hyperkalemia, as well as increased renal uric acid clearance, have been reported with AUBAGIO. Monitor renal function and potassium if symptoms of acute renal failure or hyperkalemia appear. Interstitial lung disease and rare cases of Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported with le? unomide; a similar risk would be expected for teri? unomide. If a severe skin reaction develops with AUBAGIO, stop treatment and use accelerated elimination. Blood pressure increases and hypertension have occurred with AUBAGIO. Measure blood pressure at treatment initiation and manage any elevations during treatment. Adverse Reactions: The most frequent adverse reactions (=10 and =2 greater than placebo) with AUBAGIO 7 mg and 14 mg and placebo, respectively, were ALT increased (12 and 14 vs 7), alopecia (10 and 13 vs 3), diarrhea (15 and 18 vs 9), in? uenza (9 and 12 vs 10), nausea (9 and 14 vs 7), and paresthesia (9 and 10 vs 8). Drug Interactions: Monitor patients when teri? unomide is coadministered with warfarin or drugs metabolized by CYP1A2 or CYP2C8. Use in Speci? c Populations: AUBAGIO is detected in human semen. To minimize any possible fetal risk, men not wishing to father a child and their female partners should use reliable contraception and men wishing to father a child should discontinue therapy and undergo accelerated elimination, with veri? cation of plasma concentrations <0.02 mcg/mL. Nursing mothers should not use AUBAGIO. AUBAGIO 14 mg358329302285262251234227217175 Disability progression sustained for =12 weeks ( of patients) Weeks 0 0 12 10 20 30 40 24364860 7 mg vs placebo: 23.7 reduction, P=0.0814 mg vs placebo: 29.8 reduction, P=0.03 72 27.3 20.221.7 8496108 AUBAGIO 14 mg AUBAGIO 7 mg Placebo Number at risk Placebo363336306279258242224211200160 AUBAGIO 7 mg365343309290266252238234224178 2430 7 mgg1444mmgg P=0.08 P=0.03AUBAGIO 7 mg did not achieve a statistically signi?cant reduction versus placebo. Percentage of patients with disability progression sustained for =12 weeks Sustained disability progression1,2 140155L012.indd 21/31/14 8:51 AM</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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