Država: Sjedinjene Američke Države
Jezik: engleski
Izvor: NLM (National Library of Medicine)
SOTROVIMAB (UNII: 1MTK0BPN8V) (SOTROVIMAB - UNII:1MTK0BPN8V)
GlaxoSmithKline LLC
INTRAVENOUS
PRESCRIPTION DRUG
The Secretary of Health and Human Services (HHS) has issued an Emergency Use Authorization (EUA) for the emergency use of sotrovimab for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. However, sotrovimab is not approved for this use (i.e., sotrovimab has not been demonstrated to be safe and effective for this use). LIMITATIONS OF AUTHORIZED USE Benefit of treatment with sotrovimab has not been observed in patients hospitalized due to COVID‑19. SARS-CoV-2 monoclonal antibodies may be associated with worse clinical outcomes when administered to hospitalized patients with COVID‑19 requiring high flow oxygen or mechanical ventilation [see Warnings and Precautions (5.2)] . Sotrovimab is not FDA-approved for any use, including for the treatment of COVID-19.
How Supplied Sotrovimab injection 500 mg (62.5 mg/mL) is a sterile, preservative-free, clear, colorless or yellow to brown solution supplied in a carton containing one single-dose glass vial with a rubber vial stopper (not made with natural rubber latex) and a flip-off cap (NDC 0173-0901-86). Storage and Handling Sotrovimab is preservative-free. Discard unused portion. Store unopened vials refrigerated at 2°C to 8°C (36°F to 46°F) in original carton. Do not freeze or shake. Protect from light. The concentrate for solution of sotrovimab in the vial is preservative-free and requires dilution prior to IV administration. The diluted infusion solution of sotrovimab should be administered immediately. If immediate administration is not possible, store the diluted infusion solution for up to 24 hours at refrigerated temperature (2°C to 8°C [36°F to 46°F]) or up to 6 hours at room temperature (up to 25°C [up to 77°F]) including transportation and infusion time. If refrigerated, allow the infusion solution to equilibrate to room temperature for approximately 15 minutes prior to administration.
unapproved drug other
SOTROVIMAB- SOTROVIMAB INJECTION, SOLUTION, CONCENTRATE GLAXOSMITHKLINE LLC _Disclaimer: This drug has not been found by FDA to be safe and effective, and this_ _labeling has not been approved by FDA. For further information about unapproved_ _drugs, click here._ ---------- FACT SHEET FOR HEALTHCARE PROVIDERS: EMERGENCY USE AUTHORIZATION FOR SOTROVIMAB HIGHLIGHTS OF EMERGENCY USE AUTHORIZATION (EUA) THESE HIGHLIGHTS OF THE EUA DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE SOTROVIMAB UNDER THE EUA. SEE THE FULL FACT SHEET FOR HEALTHCARE PROVIDERS FOR SOTROVIMAB. SOTROVIMAB INJECTION, FOR INTRAVENOUS USE ORIGINAL EUA AUTHORIZED DATE: 05/2021 ---------------------------- RECENT MAJOR CHANGES ------------------------- - Clinical Pharmacology, Microbiology (12.4) 3/2023 Emergency Use Authorization, Limitations of Authorized Use (1) 2/2022 Dosage and Administration, Recommended Dosage (2.3) 2/2022 Dosage and Administration, Preparation and Administration (2.5) 2/2022 ----------------------------EUA FOR SOTROVIMAB -------------------------- • ---------------------------- WARNINGS AND PRECAUTIONS --------------------- ----- Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions: Serious hypersensitivity reactions, including anaphylaxis, have been observed with administration of sotrovimab. If clinically significant hypersensitivity reactions or anaphylaxis occur, discontinue and initiate appropriate supportive care. Infusion-related reactions have occurred during the infusion and up to 24 hours post infusion. These reactions may be severe or life threatening. (5.1) Clinical Worsening After SARS-CoV-2 Monoclonal Antibody Administration: Clinical worsening of COVID-19 after administration of SARS-CoV-2 monoclonal antibody treatment has been reported and may include signs or symptoms of fever, hypoxia or increased respiratory difficulty, arrhythmia (e.g., atrial fibrillation, tachycardia, bradycardia), fatigue, and altered mental status. (5.2) Limitations of Benefit and Potential for Risk in Patients wit Pročitajte cijeli dokument