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Emergency Use Authorization (EUA) Checklist: - Mount … - consulado eua
Emergency Use Authorization (EUA) Checklist:Casirivimab/Imdevimab (REGEN-COV?)Criteria for Use: This EUA is for the use of the unapproved products casirivimab/imdevimab for the treatment of mild to moderate COVID-19 in adults and pediatric patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kg, and who are at high risk for progression to severe COVID-19, including hospitalization or death. This EUA has been updated for use in adult and pediatric individuals (12 years of age and older weighing at least 40 kg) for post-exposure prophylaxis of COVID-19 in individuals who are at high risk for progression to severe COVID-19, including hospitalization or death, and are: not fully vaccinated1 or who are not expected to mount an adequate immune response to complete SARS-CoV-2 vaccination (for example, individuals with immunocompromising conditions including those taking immunosuppressive medications) ANDOR have been exposed to an individual infected with SARS-CoV-2 consistent with close contact2 criteria per Center for Disease Control and Prevention (CDC)who are at high risk of exposure to an individual infected with SARS-CoV-2 because of occurrence of SARS-CoV-2 infection in other individuals in the same institutional setting (for example, nursing homes, prisons)1 Individuals are considered to be fully vaccinated 2 weeks after their second vaccine dose in a 2-dose series, or 2 weeks after a single-dose vaccine.2 Close contact with an infected individual is defined as: being within 6 feet for a total of 15 minutes or more, providing care at home to someone who is sick, having direct physical contact with the person (hugging or kissing, for example), sharing eating or drinking utensils, or being exposed to respiratory droplets from an infected person (sneezing or coughing, for example).Indication:----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------For Treatment: Casirivimab/Imdevimab should be administered as soon as possible after positive viral test for SARS-CoV-2 and within 10 days of symptom onset.For Post-Exposure Prophylaxis: Casirivimab/Imdevimab should be administered as soon as possible following exposure to SARS-CoV-2.----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------The following medical conditions or other factors may place adults and pediatric patients (age 12-17 years and weighing at least 40 kg) at higher risk for progression to severe COVID-19: (check all that apply):Other medical conditions or factors (for example, race or ethnicity) may also place individual patients at high risk for progression to severe COVID-19 and authorization of Casirivimab/Imdevimab under the EUA is not limited to the medical conditions or factors listed below.Older Age (for example age >65 years of age)Obesity or being overweight (for example, adults with BMI >25 kg/m2, or if age 12-17, have BMI ≥85th percentile for their age and gender based on CDC growth charts: https://www.cdc.gov/growthcharts/clinical_charts.htmPregnancyChronic kidney diseaseDiabetesImmunosuppressive disease or immunosuppressive treatmentCardiovascular disease (including congenital heart disease) or hypertensionChronic lung diseases (for example, chronic obstructive pulmonary disease, asthma [moderate-to-severe], interstitial lung disease, cystic fibrosis and pulmonary hypertension)Sickle cell diseaseNeurodevelopmental disorders (for example, cerebral palsy) or other conditions that confer medical complexity (for example, genetic or metabolic syndromes and severe congenital anomalies)Having a medical-related technological dependence (for example, tracheostomy, gastrostomy, or positive pressure ventilation [not related to COVID-19])----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Patients must have mild to moderate disease, including but not limited to the following symptoms (check all that apply):Subjective fever or feeling feverishCoughLoss of taste or smellSore throatBody pain or muscle pain/achesChillsShortness of breath or difficulty breathing at rest or with activityFatigueNausea or vomitingDiarrhea Documented temperature >37.8°CNasal obstruction or congestionNasal dischargeHeadacheEXCLUSION Criteria NOT met. Casirivimab/Imdevimab is not authorized for patients:hospitalized due to COVID-19, ORrequire oxygen therapy due to COVID-19, ORrequire an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity.with known hypersensitivity to any ingredient of casirivimab/imdevimab.Patient Communication: As the healthcare provider, you must communicate to your patient or parent/caregiver, as age appropriate, information consistent with the “Fact Sheet for Patients, Parents and Caregivers” (and provide a copy of the Fact Sheet) prior to the patient receiving casirivimab/imdevimab. Casirivimab/Imdevimab HCP link.Links are also available on the IV guideline.Provide Fact Sheet:208915698500Casirivimab/Imdevimab P/C link (English)Casirivimab/Imdevimab P/C link (Spanish)2095502984500Communicate: The FDA has authorized the emergency use of casirivimab/imdevimab for the treatment of mild to moderate COVID-19 in adults and pediatric patients with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID-19 and/or hospitalization, or for post-exposure prophylaxis of COVID-19 in individuals who are at high risk for progression to severe COVID-19, including hospitalization or death. Casirivimab/imdevimab are unapproved drugs that are authorized for use under this Emergency Use Authorization. 2095503302000Communicate: The significant known and potential risks and benefits of casirivimab/imdevimab, and the extent to which such potential risks and benefits are unknown.2095501968500Communicate: Information on available alternative treatments and the risks and benefits of those alternatives, including clinical trials. Additional information on COVID-19 treatments can be found at https://www.cdc.gov/coronavirus/2019-ncov/index.html.2095502349500The patient or parent/caregiver has the option to accept or refuse casirivimab/imdevimab. Patient or caregiver agrees to receive casirivimab/imdevimab.2095501841500Communicate: Patients treated with casirivimab/imdevimab should continue to self-isolate and use infection control measures (e.g., wear mask, isolate, social distance, avoid sharing personal items, clean and disinfect “high touch” surfaces, and frequent handwashing) according to CDC guidelines.2095501587500Document in the patient’s medical record that the patient/caregiver has been:Given the “Fact Sheet for Patients, Parents and Caregivers”, Informed of alternatives to receiving authorized casirivimab/imdevimab, and Informed that casirivimab/imdevimab is an unapproved drug that is authorized for use under this Emergency Use Authorization. ADDITIONAL MANDATORY REQUIREMENTS FOR CASIRIVIMAB/IMDEVIMAB ADMINISTRATION UNDER EMERGENCY USE AUTHORIZATION:The prescribing health care provider and/or the provider’s designee are/is responsible for mandatory reporting of all medication errors and serious adverse events* potentially related to casirivimab/imdevimab treatment within 7 calendar days from the onset of the event. The reports should include unique identifiers and the words “REGEN-COV use for COVID-19 under Emergency Use Authorization (EUA).”in the description section of the report. Submit adverse event reports to FDA MedWatch using one of the following methods: Complete and submit the report online: www.fda.gov/medwatch/report.htm, or By using a postage-paid Form FDA 3500 (www.fda.gov/media/76299/download) and returning by mail (MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787), or by fax (1-800-FDA-0178), or Call 1-800-FDA-1088 to request a reporting form Submitted reports should include in the field name, “Describe Event, Problem, or Product Use/Medication Error” the statement “REGEN-COV use for COVID-19 under Emergency Use Authorization (EUA).”*Serious Adverse Events are defined as:death; a life-threatening adverse event; 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; a medical or surgical intervention to prevent death, a life-threatening event, hospitalization, disability, or congenital anomaly. The prescribing health care provider and/or the provider’s designee are/is to provide mandatory responses to requests from FDA for information about adverse events and medication errors following receipt of casirivimab/imdevimab. OTHER REPORTING REQUIREMENTS In addition, please provide a copy of all FDA MedWatch forms to:Regeneron Pharmaceuticals, IncFax: 1-888-876-2736E-mail: medical.information@regeneron.comOr call Regeneron Pharmaceuticals at 1-844-734-6643 to report adverse events.
Is EUA a pathway to permanent marketing?
