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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 subjects 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 Ridgeback Biotherapeutics, LP at 1-833-846-3789 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 subjects with Zaire ebolavirus infection received EBANGA in one clinical trial and as part of an expanded access program during the 2018 Zaire ebolavirus 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 subjects (119 adults and 54 pediatric subjects) with confirmed Zaire ebolavirus infection received EBANGA as a single 50 mg/kg IV infusion and 168 subjects received an investigational control [see Clinical Studies (14) ] . All subjects 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). Fifty-five percent (55%) of enrolled subjects were female and 45% were male. During the same outbreak, 251 subjects (173 adults and 78 pediatric subjects) with laboratory-confirmed Zaire ebolavirus infection received EBANGA under an expanded access program; 57% of whom were female and 43% of whom were male. 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 subjects who received EBANGA may have been confounded by the signs and symptoms of the underlying Zaire ebolavirus infection. Twenty nine percent (n=51) of subjects 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 subjects who received EBANGA was fever (Table 2). The adverse event profile in adult and pediatric subjects treated with EBANGA was similar. Table 2: Adverse Events That Occurred During Infusion in >10% of Adult and Pediatric Subjects in the PALM Trial Adverse Event Adverse events in this table were reported on the day of infusion, and included signs and symptoms that occurred during or immediately after infusion EBANGA (N=173) % Control Investigational therapy administered as three separate infusions (N=168) % Pyrexia 17 58 Tachycardia 9 32 Diarrhea Adverse events that occurred during infusion but were not pre-specified. 9 18 Vomiting 8 23 Hypotension 8 31 Tachypnea 6 28 Chills The term chills includes other similar adverse events including rigors and tremors 5 33 Hypoxia , 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 subjects who received EBANGA: diarrhea, pyrexia, abdominal pain, and vomiting. Evaluation of these symptoms may have been confounded by the underlying Zaire ebolavirus infection. Discontinuation and Infusion Rate Adjustments Approximately 99% of subjects who received EBANGA in the PALM trial were able to complete their dose within one hour. Two subjects who received EBANGA (1%) did not receive their complete infusion. In eight subjects (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 Laboratory Test Graded per Division of AIDS (DAIDS) v2.1 EBANGA N=173 % Control N=168 % ULN= upper limit of normal 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 Based on a ULN of 1.2 mg/dL. 27 23 Alanine aminotransferase (U/L) ≥ 5 × ULN Based on a ULN of 47U/L. 12 14 Aspartate aminotransferase (U/L) ≥ 5 × ULN Based on a ULN of 38 U/L. 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 subjects with Zaire ebolavirus infection.
adverse reactions table
<table width="75%"><caption>Table 2: Adverse Events That Occurred During Infusion in >10% of Adult and Pediatric Subjects in the PALM Trial</caption><col width="50%" align="left" valign="top"/><col width="25%" align="center" valign="top"/><col width="25%" align="center" valign="top"/><thead><tr><th styleCode="Lrule Rrule">Adverse Event <footnote ID="K1245">Adverse events in this table were reported on the day of infusion, and included signs and symptoms that occurred during or immediately after infusion</footnote></th><th styleCode="Rrule">EBANGA (N=173) % </th><th styleCode="Rrule">Control <footnote ID="K1257">Investigational therapy administered as three separate infusions</footnote> (N=168) % </th></tr></thead><tbody><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Pyrexia</td><td styleCode="Rrule">17</td><td styleCode="Rrule">58</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Tachycardia</td><td styleCode="Rrule">9</td><td styleCode="Rrule">32</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Diarrhea <footnote ID="t2fc">Adverse events that occurred during infusion but were not pre-specified.</footnote></td><td styleCode="Rrule">9</td><td styleCode="Rrule">18</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Vomiting <footnoteRef IDREF="t2fc"/></td><td styleCode="Rrule">8</td><td styleCode="Rrule">23</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Hypotension</td><td styleCode="Rrule">8</td><td styleCode="Rrule">31</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Tachypnea</td><td styleCode="Rrule">6</td><td styleCode="Rrule">28</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Chills <footnote ID="K1340">The term chills includes other similar adverse events including rigors and tremors</footnote></td><td styleCode="Rrule">5</td><td styleCode="Rrule">33</td></tr><tr><td styleCode="Lrule Rrule">Hypoxia <footnoteRef IDREF="t2fc"/><sup>,</sup></td><td styleCode="Rrule">3</td><td styleCode="Rrule">11</td></tr></tbody></table>
adverse reactions table
<table width="75%"><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%" align="left" valign="bottom"/><col width="30%" align="center" valign="bottom"/><col width="20%" align="center" valign="bottom"/><thead><tr><th styleCode="Lrule Rrule">Laboratory Test <footnote ID="K1434">Graded per Division of AIDS (DAIDS) v2.1</footnote></th><th styleCode="Rrule">EBANGA N=173 % </th><th styleCode="Rrule">Control N=168 % </th></tr></thead><tfoot><tr><td colspan="3" align="left" valign="top">ULN= upper limit of normal</td></tr></tfoot><tbody><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Sodium, high ≥ 154 mmol/L</td><td styleCode="Rrule">5</td><td styleCode="Rrule">4</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Sodium, low < 125 mmol/L</td><td styleCode="Rrule">7</td><td styleCode="Rrule">11</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Potassium, high ≥ 6.5 mmol/L</td><td styleCode="Rrule">15</td><td styleCode="Rrule">12</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Potassium, low < 2.5 mmol/L</td><td styleCode="Rrule">6</td><td styleCode="Rrule">8</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Creatinine (mg/dL) > 1.8 × ULN or ≥ 1.5 × baseline <footnote ID="K1507">Based on a ULN of 1.2 mg/dL.</footnote></td><td styleCode="Rrule">27</td><td styleCode="Rrule">23</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Alanine aminotransferase (U/L) ≥ 5 × ULN <footnote ID="K1520">Based on a ULN of 47U/L.</footnote></td><td styleCode="Rrule">12</td><td styleCode="Rrule">14</td></tr><tr><td styleCode="Lrule Rrule">Aspartate aminotransferase (U/L) ≥ 5 × ULN <footnote ID="K1532">Based on a ULN of 38 U/L.</footnote></td><td styleCode="Rrule">13</td><td styleCode="Rrule">18</td></tr></tbody></table>