Matching articles for "Evusheld"

COVID-19 Update: An EUA for Pemivibart (Pemgarda) for Pre-Exposure Prophylaxis

   
The Medical Letter on Drugs and Therapeutics • May 13, 2024;  (Issue 1702)
The FDA has issued an Emergency Use Authorization (EUA) for the long-acting investigational IV monoclonal antibody pemivibart (Pemgarda – Invivyd) for pre-exposure prophylaxis of COVID-19 in persons ≥12...
The FDA has issued an Emergency Use Authorization (EUA) for the long-acting investigational IV monoclonal antibody pemivibart (Pemgarda – Invivyd) for pre-exposure prophylaxis of COVID-19 in persons ≥12 years old (weight ≥40 kg) who have moderate to severe immune compromise and are unlikely to respond adequately to COVID-19 vaccination (see Table 1). Pemgarda is the only drug that is currently authorized in the US for pre-exposure prophylaxis of COVID-19. Tixagevimab/cilgavimab (Evusheld) was previously available under an EUA for this indication, but it lacks activity against currently circulating SARS-CoV-2 variants.
Med Lett Drugs Ther. 2024 May 13;66(1702):79-80 | Show Full IntroductionHide Full Introduction

COVID-19 Update: Evusheld Unlikely to Neutralize XBB.1.5 Omicron Variant (online only)

   
The Medical Letter on Drugs and Therapeutics • February 6, 2023;  (Issue 1669)
The FDA has warned that the investigational long-acting monoclonal antibodies tixagevimab and cilgavimab (Evusheld – AstraZeneca) are unlikely to neutralize the XBB.1.5 Omicron variant of SARS-CoV-2....
The FDA has warned that the investigational long-acting monoclonal antibodies tixagevimab and cilgavimab (Evusheld – AstraZeneca) are unlikely to neutralize the XBB.1.5 Omicron variant of SARS-CoV-2. Evusheld is available under an Emergency Use Authorization (EUA) for IM pre-exposure prophylaxis of COVID-19 in persons ≥12 years old who weigh ≥40 kg and have either a history of a severe adverse reaction that prevents their vaccination against COVID-19 or moderate or severe immune compromise.
Med Lett Drugs Ther. 2023 Feb 6;65(1669):e25 | Show Full IntroductionHide Full Introduction

COVID-19 Update: Dosing Interval for Tixagevimab/Cilgavimab (Evusheld) (online only)

   
The Medical Letter on Drugs and Therapeutics • August 8, 2022;  (Issue 1656)
The FDA has amended its Emergency Use Authorization (EUA) for the investigational long-acting monoclonal antibodies tixagevimab and cilgavimab (Evusheld – AstraZeneca) to recommend repeat dosing every 6...
The FDA has amended its Emergency Use Authorization (EUA) for the investigational long-acting monoclonal antibodies tixagevimab and cilgavimab (Evusheld – AstraZeneca) to recommend repeat dosing every 6 months in patients who require ongoing protection against COVID-19. Evusheld is authorized for IM pre-exposure prophylaxis of COVID-19 in persons ≥12 years old who weigh ≥40 kg and have either a history of a severe adverse reaction that prevents their vaccination against COVID-19 or moderate or severe immune compromise
Med Lett Drugs Ther. 2022 Aug 8;64(1656):e122-3 | Show Full IntroductionHide Full Introduction

COVID-19 Update: Hypersensitivity Reactions with Tixagevimab/Cilgavimab (Evusheld)

   
The Medical Letter on Drugs and Therapeutics • July 11, 2022;  (Issue 1654)
The labeling for the investigational, long-acting, prophylactic anti-SARS-CoV-2 monoclonal antibodies tixagevimab and cilgavimab (Evusheld; available under an FDA Emergency Use Authorization) now...
The labeling for the investigational, long-acting, prophylactic anti-SARS-CoV-2 monoclonal antibodies tixagevimab and cilgavimab (Evusheld; available under an FDA Emergency Use Authorization) now includes warnings about a risk of serious hypersensitivity reactions, including anaphylaxis, with use of the drugs, particularly in patients who have experienced a hypersensitivity reaction to a COVID-19 vaccine.
Med Lett Drugs Ther. 2022 Jul 11;64(1654):112 | Show Full IntroductionHide Full Introduction

COVID-19 Updates

   
The Medical Letter on Drugs and Therapeutics • March 21, 2022;  (Issue 1646)
The CDC has issued new guidance allowing for an interval of up to 8 weeks between the first and second primary doses of an mRNA COVID-19 vaccine in certain patients 12-64 years old.1 Product...
The CDC has issued new guidance allowing for an interval of up to 8 weeks between the first and second primary doses of an mRNA COVID-19 vaccine in certain patients 12-64 years old.1 Product labeling currently recommends a 3-week interval between the first two doses of the Pfizer/BioNTech mRNA vaccine (Comirnaty) and a 4-week interval between the first two doses of the Moderna mRNA vaccine (Spikevax). The new guidance is based on data suggesting that a longer interval can decrease the risk of myocarditis and may improve vaccine efficacy.
Med Lett Drugs Ther. 2022 Mar 21;64(1646):47-8 | Show Full IntroductionHide Full Introduction

Tixagevimab and Cilgavimab (Evusheld) for Pre-Exposure Prophylaxis of COVID-19

   
The Medical Letter on Drugs and Therapeutics • January 10, 2022;  (Issue 1641)
The FDA has issued an Emergency Use Authorization (EUA) for the investigational long-acting monoclonal antibodies tixagevimab and cilgavimab (Evusheld – AstraZeneca) to be administered concomitantly by...
The FDA has issued an Emergency Use Authorization (EUA) for the investigational long-acting monoclonal antibodies tixagevimab and cilgavimab (Evusheld – AstraZeneca) to be administered concomitantly by IM injection for pre-exposure prophylaxis of COVID-19 in persons ≥12 years old who weigh ≥40 kg and have either a history of severe allergy that prevents their vaccination against COVID-19 or moderate or severe immune compromise (see Table 1). They are the first drugs to be authorized by the FDA for this indication. Two other pairs of antibodies, bamlanivimab plus etesevimab (Lilly) and casirivimab plus imdevimab (REGEN-COV), are authorized for post-exposure prophylaxis of COVID-19.
Med Lett Drugs Ther. 2022 Jan 10;64(1641):1-2 | Show Full IntroductionHide Full Introduction