ABSTRACT
The Food and Drug Administration has granted emergency use authorization to sotrovimab for the treatment of mild to moderate COVID-19 in patients at increased risk for progression to severe illness.Sotrovimab is a monoclonal antibody that works directly against the spike protein of SARS-CoV-2 to block its attachment and entry into a human cell.
Subject(s)
Antibodies, Monoclonal/therapeutic use , Prior Authorization/legislation & jurisprudence , United States Food and Drug Administration/legislation & jurisprudence , COVID-19/prevention & control , Humans , Prior Authorization/trends , United States , United States Food and Drug Administration/organization & administration , United States Food and Drug Administration/trends , COVID-19 Drug TreatmentABSTRACT
The Food and Drug Administration (FDA) is advising health care practitioners that lamotrigine (Lamictal), used in managing seizures and bipolar disorder, may increase the risk of serious and potentially lethal arrythmias.The risk is greater if the patient has underlying cardiac disease or is taking medications that affect heart conduction.The FDA is requiring in vitro studies of other sodium channel blockers to determine if this risk is a class effect or unique to lamotrigine.
Subject(s)
Arrhythmias, Cardiac/etiology , Lamotrigine/adverse effects , Anticonvulsants/adverse effects , Anticonvulsants/therapeutic use , Bipolar Disorder/drug therapy , Epilepsy/drug therapy , Humans , Lamotrigine/therapeutic use , Treatment OutcomeABSTRACT
The emergency use authorization for REGEN-COV (a combination of two monoclonal antibodies, casirivimab and imdevimab) has been revised to include postexposure prophylaxis of COVID-19 in adults and children 12 years of age and older who, if they become COVID-19 positive, are at high risk for severe disease.Prophylaxis with REGEN-COV is not a substitute for vaccination against COVID-19.
Subject(s)
Antibodies, Monoclonal, Humanized/therapeutic use , COVID-19/prevention & control , Drug Approval , Post-Exposure Prophylaxis , Adolescent , Adult , Aged , Child , Drug Combinations , Humans , Middle Aged , United States , Young AdultABSTRACT
A combination of two monoclonal antibodies, casirivimab and imdevimab, has received emergency use authorization for the treatment of mild to moderate COVID-19.Casirivimab and imdevimab come in separate packages but must be combined into one IV infusion after dilution.
Subject(s)
Antibodies, Monoclonal, Humanized/therapeutic use , COVID-19 Drug Treatment , Humans , Infusions, Intravenous , Severity of Illness Index , United StatesABSTRACT
Remdesivir (Veklury) is the first antiviral drug approved to treat patients ages 12 and older who are hospitalized with COVID-19.The drug is administered via slow IV infusion.Elevated liver enzymes are common with treatment. Hypersensitivity reactions, including anaphylaxis, are possible.