Matching articles for "tixagevimab"
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.
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.
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
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.
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.
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.