FDA label c91aa928-c045-4a6e-a5d0-a5051f4e9635

ADVERSE REACTIONS Clinical Adverse Experience **sfROWASA™ (mesalamine) Rectal Suspension is usually well tolerated. Most adverse effects have been mild and transient. ADVERSE REACTIONS OCCURRING IN MORE THAN O.1% OF **sfROWASA™ (MESALAMINE) RECTAL SUSPENSION TREATED PATIENTS (COMPARISON TO PLACEBO) **sfROWASA™ PLACEBO N = 815 N = 128 SYMPTOM N % N % Abdominal Pain/Cramps/Discomfort 66 8.10 10 7.81 Headache 53 6.50 16 12.50 Gas/Flatulence 50 6.13 5 3.91 Nausea 47 5.77 12 9.38 Flu 43 5.28 1 0.78 Tired/Weak/Malaise/Fatigue 28 3.44 8 6.25 Fever 26 3.19 0 0.00 Rash/Spots 23 2.82 4 3.12 Cold/Sore Throat 19 2.33 9 7.03 Diarrhea 17 2.09 5 3.91 Leg/Joint Pain 17 2.09 1 0.78 Dizziness 15 1.84 3 2.34 Bloating 12 1.47 2 1.56 Back Pain 11 1.35 1 0.78 Pain on Insertion of Tip 11 1.35 1 0.78 Hemorrhoids 11 1.35 0 0.00 Itching 10 1.23 1 0.78 Rectal Pain 10 1.23 0 0.00 Constipation 8 0.98 4 3.12 Hair Loss 7 0.86 0 0.00 Peripheral Edema 5 0.61 11 8.59 UTI/Urinary Burning 5 0.61 4 3.12 Rectal Pain/Soreness/Burning 5 0.61 3 2.34 Asthenia 1 0.12 4 3.12 Insomnia 1 0.12 3 2.34 In addition, the following adverse events have been identified during post-approval use of products which contain (or are metabolized to) mesalamine in clinical practice: nephrotoxicity, pancreatitis, fibrosing alveolitis and elevated liver enzymes. Cases of pancreatitis and fibrosing alveolitis have been reported as manifestations of inflammatory bowel disease as well. Published case reports and/or spontaneous post marketing surveillance have described rare instances of aplastic anemia, agranulocytosis, thrombocytopenia, eosinophilia, pancytopenia, neutropenia, oligospermia, and infertility in men. Anemia, leukocytosis, and thrombocytosis can be part of the clinical presentation of inflammatory bowel disease. Hair Loss Mild hair loss characterized by "more hair in the comb" but no withdrawal from clinical trials has been observed in 7 of 815 mesalamine patients but none of the placebo-treated patients. In the literature there are at least six additional patients with mild hair loss who received either mesalamine or sulfasalazine. Retreatment is not always associated with repeated hair loss.

<table width="100%"> <caption>ADVERSE REACTIONS OCCURRING IN MORE THAN O.1% OF **sfROWASA&#x2122; (MESALAMINE) RECTAL SUSPENSION TREATED PATIENTS (COMPARISON TO PLACEBO)</caption> <col width="40%" align="left" valign="bottom"/> <col width="15%" align="left" valign="bottom"/> <col width="15%" align="left" valign="bottom"/> <col width="15%" align="left" valign="bottom"/> <col width="15%" align="left" valign="bottom"/> <thead> <tr> <th/> <th colspan="2">**sfROWASA&#x2122;</th> <th colspan="2">PLACEBO</th> </tr> <tr> <th/> <th colspan="2">N = 815</th> <th colspan="2">N = 128</th> </tr> <tr> <th>SYMPTOM</th> <th>N</th> <th>%</th> <th>N</th> <th>%</th> </tr> </thead> <tbody> <tr> <td>Abdominal Pain/Cramps/Discomfort</td> <td>66</td> <td>8.10</td> <td>10</td> <td> 7.81</td> </tr> <tr> <td>Headache</td> <td>53</td> <td>6.50</td> <td>16</td> <td>12.50</td> </tr> <tr> <td>Gas/Flatulence</td> <td>50</td> <td>6.13</td> <td> 5</td> <td> 3.91</td> </tr> <tr> <td>Nausea</td> <td>47</td> <td>5.77</td> <td>12</td> <td> 9.38</td> </tr> <tr> <td>Flu</td> <td>43</td> <td>5.28</td> <td> 1</td> <td> 0.78</td> </tr> <tr> <td>Tired/Weak/Malaise/Fatigue</td> <td>28</td> <td>3.44</td> <td> 8</td> <td> 6.25</td> </tr> <tr> <td>Fever</td> <td>26</td> <td>3.19</td> <td> 0</td> <td> 0.00</td> </tr> <tr> <td>Rash/Spots</td> <td>23</td> <td>2.82</td> <td> 4</td> <td> 3.12</td> </tr> <tr> <td>Cold/Sore Throat</td> <td>19</td> <td>2.33</td> <td> 9</td> <td> 7.03</td> </tr> <tr> <td>Diarrhea</td> <td>17</td> <td>2.09</td> <td> 5</td> <td> 3.91</td> </tr> <tr> <td>Leg/Joint Pain</td> <td>17</td> <td>2.09</td> <td> 1</td> <td> 0.78</td> </tr> <tr> <td>Dizziness</td> <td>15</td> <td>1.84</td> <td> 3</td> <td> 2.34</td> </tr> <tr> <td>Bloating</td> <td>12</td> <td>1.47</td> <td> 2</td> <td> 1.56</td> </tr> <tr> <td>Back Pain</td> <td>11</td> <td>1.35</td> <td> 1</td> <td> 0.78</td> </tr> <tr> <td>Pain on Insertion of Tip</td> <td>11</td> <td>1.35</td> <td> 1</td> <td> 0.78</td> </tr> <tr> <td>Hemorrhoids</td> <td>11</td> <td>1.35</td> <td> 0</td> <td> 0.00</td> </tr> <tr> <td>Itching</td> <td>10</td> <td>1.23</td> <td> 1</td> <td> 0.78</td> </tr> <tr> <td>Rectal Pain</td> <td>10</td> <td>1.23</td> <td> 0</td> <td> 0.00</td> </tr> <tr> <td>Constipation</td> <td> 8</td> <td>0.98</td> <td> 4</td> <td> 3.12</td> </tr> <tr> <td>Hair Loss</td> <td> 7</td> <td>0.86</td> <td> 0</td> <td> 0.00</td> </tr> <tr> <td>Peripheral Edema</td> <td> 5</td> <td>0.61</td> <td>11</td> <td> 8.59</td> </tr> <tr> <td>UTI/Urinary Burning</td> <td> 5</td> <td>0.61</td> <td> 4</td> <td> 3.12</td> </tr> <tr> <td>Rectal Pain/Soreness/Burning</td> <td> 5</td> <td>0.61</td> <td> 3</td> <td> 2.34</td> </tr> <tr> <td>Asthenia</td> <td> 1</td> <td>0.12</td> <td> 4</td> <td> 3.12</td> </tr> <tr> <td>Insomnia</td> <td> 1</td> <td>0.12</td> <td> 3</td> <td> 2.34</td> </tr> </tbody> </table>