SOTROVIMAB injection, solution, concentrate

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

SOTROVIMAB (UNII: 1MTK0BPN8V) (SOTROVIMAB - UNII:1MTK0BPN8V)

Disponible desde:

GlaxoSmithKline LLC

Vía de administración:

INTRAVENOUS

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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.

Resumen del producto:

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.

Estado de Autorización:

unapproved drug other

Ficha técnica

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