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warnings and cautions
5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions Including Infusion-Associated Events: Hypersensitivity reactions including infusion-associated events have been reported with EBANGA. These may include acute, life- threatening reactions during and after the infusion. Monitor patients and in the case of severe or life-threatening hypersensitivity reactions, discontinue the administration of EBANGA immediately and administer appropriate emergency care. ( 5.1 ) 5.1 Hypersensitivity Reactions Including Infusion-Associated Events Hypersensitivity reactions including infusion-associated events have been reported with EBANGA. These may include acute, life-threatening reactions during and after the infusion. Monitor all patients for signs and symptoms including, but not limited to, hypotension, chills and elevation of fever, during and following EBANGA infusion. In the case of severe or life-threatening hypersensitivity reactions, discontinue the administration of EBANGA immediately and administer appropriate emergency care [see Adverse Reactions (6.1) ]. Infusion could not be completed in 1% of participants who received EBANGA due to infusion-associated adverse events. The rate of infusion of EBANGA may be slowed or interrupted if the patient develops any signs of infusion-associated events or other adverse events [see Adverse Reactions (6.1) ].
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions Including Infusion-Associated Events [see Warnings and Precautions (5.1) ] The most frequently reported adverse events (≥ 5%) after administration of EBANGA were pyrexia, tachycardia, diarrhea, vomiting, hypotension, tachypnea, and chills. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Emergent BioSolutions at 1-800-768-2304 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice. Overall, 424 adult and pediatric participants with Orthoebolavirus zairense infection received EBANGA in one clinical trial and as part of an expanded access program during the 2018 Orthoebolavirus zairense outbreak in the Democratic Republic of Congo (DRC). In the PALM trial, the safety of EBANGA was evaluated in a multi-center, open-label, randomized controlled trial, in which 173 participants (119 adults and 54 pediatric participants) with confirmed Orthoebolavirus zairense infection received EBANGA as a single 50 mg/kg IV infusion and 168 participants received an investigational control [see Clinical Studies (14) ] . All participants received optimized standard of care treatment (oSOC). The median age of the study population that received EBANGA was 26 years (range: 1 day to 85 years) and 55% were female. During the same outbreak, 251 participants (173 adults and 78 pediatric participants) with laboratory-confirmed Orthoebolavirus zairense infection received EBANGA under an expanded access program, 57% of whom were female. Ages ranged from 6 days to 80 years, with a median age of 25 years. Common Adverse Events Table 2 summarizes the adverse events that were reported in the PALM trial from a pre-defined list of signs and symptoms that occurred during EBANGA infusion. The evaluation of adverse events in participants who received EBANGA may have been confounded by the signs and symptoms of the underlying Orthoebolavirus zairense infection. Twenty nine percent (n=51) of participants who received EBANGA in the PALM Trial experienced a pre-specified infusion-related adverse event. The most common pre-specified infusion-related adverse event reported in at least 10% of participants who received EBANGA was fever ( Table 2 ). The adverse event profile in adult and pediatric participants treated with EBANGA was similar. Table 2 Adverse Events That Occurred During Infusion in >10% of Adult and Pediatric Participants in the PALM Trial Adverse Event a EBANGA (N=173) % Control b (N=168) % a Adverse events in this table were reported on the day of infusion, and included signs and symptoms that occurred during or immediately after infusion b Investigational therapy administered as three separate infusions c Adverse events that occurred during infusion but were not pre-specified. d The term chills includes other similar adverse events including rigors and tremors Pyrexia 17 58 Tachycardia 9 32 Diarrhea c 9 18 Vomiting c 8 23 Hypotension 8 31 Tachypnea 6 28 Chills d 5 33 Hypoxia c 3 11 The following pre-specified symptoms, which were assessed on a daily basis during admission while admitted to the treatment unit, were reported in ≥40% of participants who received EBANGA: diarrhea, pyrexia, abdominal pain, and vomiting. Evaluation of these symptoms may have been confounded by the underlying Orthoebolavirus zairense infection. Discontinuation and Infusion Rate Adjustments Approximately 99% of participants who received EBANGA in the PALM trial were able to complete their dose within one hour. Two participants who received EBANGA (1%) did not receive their complete infusion. In eight participants (5%) the EBANGA infusion rate was decreased due to an AE [see Warnings and Precautions (5.1) ] . Selected Laboratory Abnormalities in the PALM Trial Table 3 presents selected laboratory abnormalities (worsening to Grade 3 or 4 compared to baseline) in the PALM trial. Table 3 Selected Grade 3 and 4 Laboratory Abnormalities a , Worsened Grade from Baseline in the PALM Trial ULN= upper limit of normal a Graded per Division of AIDS (DAIDS) v2.1 b Based on a ULN of 1.2 mg/dL. c Based on a ULN of 47 U/L. d Based on a ULN of 38 U/L. Laboratory Test a EBANGA N=173 % Control N=168 % Sodium, high ≥ 154 mmol/L 5 4 Sodium, low < 125 mmol/L 7 11 Potassium, high ≥ 6.5 mmol/L 15 12 Potassium, low < 2.5 mmol/L 6 8 Creatinine (mg/dL) > 1.8 × ULN or ≥ 1.5 × baseline b 27 23 Alanine aminotransferase (U/L) ≥ 5 × ULN c 12 14 Aspartate aminotransferase (U/L) ≥ 5 × ULN d 13 18 6.2 Immunogenicity As with all therapeutic proteins, there is potential for immunogenicity from using ansuvimab-zykl. There are no data to assess the effects of potential immunogenicity on efficacy and safety in participants with Orthoebolavirus zairense infection.
adverse reactions table
<table ID="_Ref121818800" width="100%"><caption>Table 2 Adverse Events That Occurred During Infusion in >10% of Adult and Pediatric Participants in the PALM Trial</caption><col width="50%"/><col width="25%"/><col width="25%"/><thead><tr><th align="left" styleCode="Rrule Botrule Lrule Toprule " valign="top"><content styleCode="bold">Adverse Event <sup>a</sup></content></th><th align="center" styleCode="Rrule Botrule Toprule " valign="top"><content styleCode="bold">EBANGA</content> <content styleCode="bold">(N=173)</content> <content styleCode="bold">%</content></th><th align="center" styleCode="Rrule Botrule Toprule " valign="top"><content styleCode="bold">Control <sup>b</sup></content> <content styleCode="bold">(N=168)</content> <content styleCode="bold">%</content></th></tr></thead><tfoot><tr><td align="left" colspan="3" valign="top"><sup>a</sup>Adverse events in this table were reported on the day of infusion, and included signs and symptoms that occurred during or immediately after infusion <sup>b</sup>Investigational therapy administered as three separate infusions <sup>c</sup>Adverse events that occurred during infusion but were not pre-specified. <sup>d</sup>The term chills includes other similar adverse events including rigors and tremors </td></tr></tfoot><tbody><tr><td styleCode="Rrule Lrule Toprule Botrule " valign="top"><paragraph>Pyrexia</paragraph></td><td align="center" styleCode="Rrule Toprule Botrule " valign="top"><paragraph>17</paragraph></td><td align="center" styleCode="Rrule Toprule Botrule " valign="top"><paragraph>58</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Tachycardia</paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>9</paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>32</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Diarrhea <sup>c</sup></paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>9</paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>18</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Vomiting <sup>c</sup></paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>8</paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>23</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Hypotension</paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>8</paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>31</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Tachypnea</paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>6</paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>28</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Chills <sup>d</sup></paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>5</paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>33</paragraph></td></tr><tr><td styleCode="Rrule Botrule Lrule " valign="top"><paragraph>Hypoxia <sup>c</sup></paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>3</paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>11</paragraph></td></tr></tbody></table>
adverse reactions table
<table ID="_Ref121819290" width="100%"><caption>Table 3 Selected Grade 3 and 4 Laboratory Abnormalities <sup>a</sup>, Worsened Grade from Baseline in the PALM Trial </caption><col width="50%"/><col width="30%"/><col width="20%"/><tfoot><tr><td align="left" colspan="3" valign="top">ULN= upper limit of normal <sup>a</sup> Graded per Division of AIDS (DAIDS) v2.1 <sup>b</sup> Based on a ULN of 1.2 mg/dL. <sup>c</sup> Based on a ULN of 47 U/L. <sup>d</sup> Based on a ULN of 38 U/L. </td></tr></tfoot><tbody><tr><td styleCode="Rrule Botrule Lrule Toprule " valign="top"><paragraph><content styleCode="bold">Laboratory Test <sup>a</sup></content></paragraph></td><td align="center" styleCode="Rrule Botrule Toprule " valign="bottom"><paragraph><content styleCode="bold">EBANGA</content> <content styleCode="bold">N=173</content> <content styleCode="bold">%</content></paragraph></td><td align="center" styleCode="Rrule Botrule Toprule " valign="bottom"><paragraph><content styleCode="bold">Control</content> <content styleCode="bold">N=168</content> <content styleCode="bold">%</content></paragraph></td></tr><tr><td styleCode="Rrule Lrule Toprule Botrule " valign="bottom"><paragraph>Sodium, high ≥ 154 mmol/L</paragraph></td><td align="center" styleCode="Rrule Toprule Botrule " valign="bottom"><paragraph>5</paragraph></td><td align="center" styleCode="Rrule Toprule Botrule " valign="bottom"><paragraph>4</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>Sodium, low < 125 mmol/L</paragraph></td><td align="center" styleCode="Rrule Botrule " valign="bottom"><paragraph>7</paragraph></td><td align="center" styleCode="Rrule Botrule " valign="bottom"><paragraph>11</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>Potassium, high ≥ 6.5 mmol/L</paragraph></td><td align="center" styleCode="Rrule Botrule " valign="bottom"><paragraph>15</paragraph></td><td align="center" styleCode="Rrule Botrule " valign="bottom"><paragraph>12</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>Potassium, low < 2.5 mmol/L</paragraph></td><td align="center" styleCode="Rrule Botrule " valign="bottom"><paragraph>6</paragraph></td><td align="center" styleCode="Rrule Botrule " valign="bottom"><paragraph>8</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>Creatinine (mg/dL) > 1.8 × ULN or ≥ 1.5 × baseline <sup>b</sup></paragraph></td><td align="center" styleCode="Rrule Botrule " valign="bottom"><paragraph>27</paragraph></td><td align="center" styleCode="Rrule Botrule " valign="bottom"><paragraph>23</paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="bottom"><paragraph>Alanine aminotransferase (U/L) ≥ 5 × ULN <sup>c</sup></paragraph></td><td align="center" styleCode="Rrule Botrule " valign="bottom"><paragraph>12</paragraph></td><td align="center" styleCode="Rrule Botrule " valign="bottom"><paragraph>14</paragraph></td></tr><tr><td styleCode="Rrule Botrule Lrule " valign="bottom"><paragraph>Aspartate aminotransferase (U/L) ≥ 5 × ULN <sup>d</sup></paragraph></td><td align="center" styleCode="Rrule Botrule " valign="bottom"><paragraph>13</paragraph></td><td align="center" styleCode="Rrule Botrule " valign="bottom"><paragraph>18</paragraph></td></tr></tbody></table>