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warnings and cautions
5 WARNINGS AND PRECAUTIONS There are limited clinical data available for GOHIBIC. Serious and unexpected adverse events (AEs) may occur that have not been previously reported with GOHIBIC use. 5.1 Serious Infections Serious infections due to bacterial, fungal, and viral pathogens have been reported in patients with COVID-19 receiving GOHIBIC. In patients with COVID-19, monitor for signs and symptoms of new infections during and after treatment with GOHIBIC. There is limited information regarding the use of GOHIBIC in patients with COVID-19 and concomitant active serious infections. The risks and benefits of treatment with GOHIBIC in COVID-19 patients with other concurrent infections should be considered [see Adverse Reactions (6) ] . 5.2 Hypersensitivity Reactions Hypersensitivity reactions have been observed with GOHIBIC. If a severe hypersensitivity reaction occurs, administration of GOHIBIC should be discontinued and appropriate therapy initiated.
6 ADVERSE REACTIONS 6.1 Clinical Trial Experience The following adverse reactions have been observed in the clinical studies of GOHIBIC that supported the EUA. The adverse reaction rates observed in these clinical studies cannot be directly compared to rates in the clinical studies of other products and may not reflect the rates observed in clinical practice. The safety of GOHIBIC is based on PANAMO, a Phase 3 randomized, placebo-controlled trial in COVID-19 patients requiring IMV or ECMO [see Clinical Studies (14) ] . The analysis of adverse reactions included a total of 364 adult patients who received at least one dose of either GOHIBIC (n=175) or placebo (n=189) plus standard of care. Patients received GOHIBIC 800 mg administered by intravenous infusion on Days 1, 2, 4, 8, 15 and 22 or placebo. During the study, there were 62 deaths in the GOHIBIC arm and 85 deaths in the placebo arm [see Clinical Studies (14) ] . Fatal infections occurred in more placebo patients. Nonfatal serious infections occurred in 58 patients (33.1%) in the GOHIBIC arm and in 55 patients (29.1%) in the placebo arm. The most commonly reported nonfatal serious infections with GOHIBIC were pneumonia (18.9% vs 13.8% in placebo), sepsis (14.9% versus 7.4% in placebo), and septic shock (9.1% versus 7.4% in placebo). Discontinuation of study treatment due to an adverse reaction occurred in 2.9% of the GOHIBIC group and 1.6% of the placebo group. Adverse reactions leading to discontinuation of GOHIBIC included eczema, bronchopulmonary aspergillosis, rash, hemodynamic instability, thrombocytopenia, and multi-organ failure. The most common adverse reactions occurring in at least 3% of GOHIBIC-treated patients and at least 1% more frequently than observed in the placebo arm are summarized in Table 1. Table 1. Adverse Reactions that Occurred in ≥3% of Patients Treated with GOHIBIC and at least 1% More Frequently than Observed in the Placebo Arm through Day 60 Adverse Reactions GOHIBIC + SoC (N=175) Placebo + SoC (N=189) n (%) n (%) SoC = standard of care. A patient is only listed once (regardless of event numbers) but one patient can be listed in different categories with one or additional reactions Pneumonia "Pneumonia" includes preferred terms containing the term "pneumonia"; does not include "COVID-19 pneumonia" 55 (31.4%) 44 (23.3%) Sepsis "Sepsis" includes preferred terms containing the term "sepsis". 38 (21.7%) 30 (15.9%) Delirium "Delirium includes the following preferred terms: Delirium, Intensive care unit delirium 22 (12.6%) 20 10.6%) Pulmonary embolism 19 (10.9%) 17 (9.0%) Hypertension 16 (9.1%) 13 (6.9%) Pneumothorax 14 (8.0%) 11 (5.8%) Deep vein thrombosis 11 (6.3%) 9 (4.8%) Herpes simplex 11 (6.3%) 5 (2.6%) Enterococcal infection 10 (5.7%) 8 (4.2%) Bronchopulmonary aspergillosis 10 (5.7%) 7 (3.7%) Hepatic enzyme increased 9 (5.1%) 7 (3.7%) Urinary tract infection 9 (5.1%) 6 (3.2%) Hypoxia 8 (4.6%) 6 (3.2%) Thrombocytopenia 8 (4.6%) 2 (1.1%) Pneumomediastinum 8 (4.6%) 0 (0.0%) Respiratory tract infection 7 (4.0%) 5 (2.6%) Supraventricular tachycardia 7 (4.0%) 1 (0.5%) Constipation 6 (3.4%) 3 (1.6%) Rash 6 (3.4%) 0 (0.0%) 6.3 Required Reporting for Serious Adverse Events and Medication Errors The prescribing healthcare provider and/or the provider's designee is/are responsible for mandatory reporting of all serious adverse events (SAEs) SAEs are defined as: Death;A life-threatening AE;Inpatient hospitalization or prolongation of existing hospitalization;A persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions;A congenital anomaly/birth defect;Other important medical event, which may require a medical or surgical intervention to prevent death, a life-threatening event, hospitalization, disability, or congenital anomaly and medication errors potentially related to GOHIBIC within 7 calendar days from the healthcare provider's awareness of the event, using FDA Form 3500 (for information on how to access this form, see below). The FDA requires that such reports, using FDA Form 3500, include the following: Patient demographics and baseline characteristics (e.g., patient identifier, age or date of birth, gender, weight, ethnicity, and race) A statement "GOHIBIC use for COVID-19 under Emergency Use Authorization (EUA)" under the " Describe Event, Problem, or Product Use/Medication Error " heading Information about the SAE or medication error ( e.g ., signs and symptoms, test/laboratory data, complications, timing of drug initiation in relation to the occurrence of the event, duration of the event, treatments required to mitigate the event, evidence of event improvement/disappearance after stopping or reducing the dosage, evidence of event reappearance after reintroduction, clinical outcomes). Patient's preexisting medical conditions and use of concomitant products Information about the product ( e.g ., dosage, route of administration, NDC #). Submit AE and medication error reports, using Form 3500, to FDA MedWatch using one of the following methods: Complete and submit the report online: www.fda.gov/medwatch/report.htm Complete and submit a postage-paid FDA Form 3500 (https://www.fda.gov/media/76299/download) and return by: Mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787, or Fax to 1-800-FDA-0178, or Call 1-800-FDA-1088 to request a reporting form In addition, please provide a copy of all FDA MedWatch forms to: InflaRx GmbH Fax: 1-866-728-2630 E-mail: pvusa@inflarx.de Or call InflaRx GmbH at 1-888-254-0602 to report AEs. The prescribing healthcare provider and/or the provider's designee is/are responsible for mandatory responses to requests from FDA for information about AEs and medication errors following receipt of GOHIBIC.
adverse reactions table
<table width="85%" ID="table1"><caption>Table 1. Adverse Reactions that Occurred in ≥3% of Patients Treated with GOHIBIC and at least 1% More Frequently than Observed in the Placebo Arm through Day 60</caption><col width="60%" align="left" valign="top"/><col width="9%" align="center" valign="top"/><col width="11%" align="center" valign="top"/><col width="9%" align="center" valign="top"/><col width="11%" align="center" valign="top"/><thead><tr styleCode="Botrule"><th styleCode="Lrule Rrule" valign="bottom">Adverse Reactions</th><th colspan="2" styleCode="Rrule">GOHIBIC + SoC (N=175) </th><th colspan="2" styleCode="Rrule">Placebo + SoC (N=189) </th></tr><tr><th styleCode="Lrule Rrule"/><th styleCode="Rrule">n</th><th styleCode="Rrule">(%)</th><th styleCode="Rrule">n</th><th styleCode="Rrule">(%)</th></tr></thead><tfoot><tr><td colspan="5" align="left">SoC = standard of care.</td></tr><tr><td colspan="5" align="left">A patient is only listed once (regardless of event numbers) but one patient can be listed in different categories with one or additional reactions</td></tr></tfoot><tbody><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Pneumonia <footnote ID="K1178">"Pneumonia" includes preferred terms containing the term "pneumonia"; does not include "COVID-19 pneumonia"</footnote></td><td styleCode="Rrule">55</td><td styleCode="Rrule">(31.4%)</td><td styleCode="Rrule">44</td><td styleCode="Rrule">(23.3%)</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Sepsis <footnote ID="K1197">"Sepsis" includes preferred terms containing the term "sepsis".</footnote></td><td styleCode="Rrule">38</td><td styleCode="Rrule">(21.7%)</td><td styleCode="Rrule">30</td><td styleCode="Rrule">(15.9%)</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Delirium <footnote ID="K1216">"Delirium includes the following preferred terms: Delirium, Intensive care unit delirium</footnote></td><td styleCode="Rrule">22</td><td styleCode="Rrule">(12.6%)</td><td styleCode="Rrule">20</td><td styleCode="Rrule">10.6%)</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Pulmonary embolism</td><td styleCode="Rrule">19</td><td styleCode="Rrule">(10.9%)</td><td styleCode="Rrule">17</td><td styleCode="Rrule">(9.0%)</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Hypertension</td><td styleCode="Rrule">16</td><td styleCode="Rrule">(9.1%)</td><td styleCode="Rrule">13</td><td styleCode="Rrule">(6.9%)</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Pneumothorax</td><td styleCode="Rrule">14</td><td styleCode="Rrule">(8.0%)</td><td styleCode="Rrule">11</td><td styleCode="Rrule">(5.8%)</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Deep vein thrombosis</td><td styleCode="Rrule">11</td><td styleCode="Rrule">(6.3%)</td><td styleCode="Rrule">9</td><td styleCode="Rrule">(4.8%)</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Herpes simplex</td><td styleCode="Rrule">11</td><td styleCode="Rrule">(6.3%)</td><td styleCode="Rrule">5</td><td styleCode="Rrule">(2.6%)</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Enterococcal infection</td><td styleCode="Rrule">10</td><td styleCode="Rrule">(5.7%)</td><td styleCode="Rrule">8</td><td styleCode="Rrule">(4.2%)</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Bronchopulmonary aspergillosis</td><td styleCode="Rrule">10</td><td styleCode="Rrule">(5.7%)</td><td styleCode="Rrule">7</td><td styleCode="Rrule">(3.7%)</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Hepatic enzyme increased</td><td styleCode="Rrule">9</td><td styleCode="Rrule">(5.1%)</td><td styleCode="Rrule">7</td><td styleCode="Rrule">(3.7%)</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Urinary tract infection</td><td styleCode="Rrule">9</td><td styleCode="Rrule">(5.1%)</td><td styleCode="Rrule">6</td><td styleCode="Rrule">(3.2%)</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Hypoxia</td><td styleCode="Rrule">8</td><td styleCode="Rrule">(4.6%)</td><td styleCode="Rrule">6</td><td styleCode="Rrule">(3.2%)</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Thrombocytopenia</td><td styleCode="Rrule">8</td><td styleCode="Rrule">(4.6%)</td><td styleCode="Rrule">2</td><td styleCode="Rrule">(1.1%)</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Pneumomediastinum</td><td styleCode="Rrule">8</td><td styleCode="Rrule">(4.6%)</td><td styleCode="Rrule">0</td><td styleCode="Rrule">(0.0%)</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Respiratory tract infection</td><td styleCode="Rrule">7</td><td styleCode="Rrule">(4.0%)</td><td styleCode="Rrule">5</td><td styleCode="Rrule">(2.6%)</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Supraventricular tachycardia</td><td styleCode="Rrule">7</td><td styleCode="Rrule">(4.0%)</td><td styleCode="Rrule">1</td><td styleCode="Rrule">(0.5%)</td></tr><tr styleCode="Botrule"><td styleCode="Lrule Rrule">Constipation</td><td styleCode="Rrule">6</td><td styleCode="Rrule">(3.4%)</td><td styleCode="Rrule">3</td><td styleCode="Rrule">(1.6%)</td></tr><tr><td styleCode="Lrule Rrule">Rash</td><td styleCode="Rrule">6</td><td styleCode="Rrule">(3.4%)</td><td styleCode="Rrule">0</td><td styleCode="Rrule">(0.0%)</td></tr></tbody></table>