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In Brief: Severe Hypocalcemia with Denosumab (Prolia) in Chronic Kidney Disease
The Medical Letter on Drugs and Therapeutics • Mar 04, 2024 (Issue 1697)
4, 2024
The FDA is requiring a boxed warning in the label
of denosumab (Prolia – Amgen)1 ...
The FDA is requiring a boxed warning in the label
of denosumab (Prolia – Amgen), a monoclonal
antibody that inhibits osteoclasts, about an
increased risk of severe hypocalcemia in patients
with advanced chronic kidney disease (CKD;
eGFR <30 mL/min/1.73 m2), particularly those on
dialysis. FDA-approved indications for Prolia are
listed in Table 1.
Med Lett Drugs Ther. 2024 Mar 4;66(1697):40 doi:10.58347/tml.2024.1697c | Show Introduction Hide Introduction
Prucalopride (Motegrity) for Chronic Idiopathic Constipation
The Medical Letter on Drugs and Therapeutics • Jun 03, 2019 (Issue 1573)
of anal blockage
or incomplete evacuation, and a need for manual
maneuvers to aid defecation.1 ...
The FDA has approved the 5-HT4 receptor agonist
prucalopride (Motegrity – Shire) for treatment of chronic
idiopathic constipation (CIC) in adults. Prucalopride is
the only drug currently approved in the US for treatment
of CIC that stimulates colonic peristalsis. It has been
available in Europe and Canada for several years.
Atogepant (Qulipta) for Migraine Prevention
The Medical Letter on Drugs and Therapeutics • Nov 01, 2021 (Issue 1636)
in the US for this indication; the first was
rimegepant (Nurtec ODT), which is also approved
for acute treatment of migraine.1 ...
Atogepant (Qulipta – Abbvie), an oral small-molecule
calcitonin gene-related peptide (CGRP) receptor
antagonist ("gepant"), has been approved by the
FDA for prevention of episodic migraine in adults. It
is the second oral CGRP receptor antagonist to be
approved in the US for this indication; the first was
rimegepant (Nurtec ODT), which is also approved
for acute treatment of migraine. Parenteral CGRP
monoclonal antibodies are approved for prevention
of migraine (see Table 3).
Faricimab (Vabysmo) for Age-Related Macular Degeneration and Diabetic Macular Edema
The Medical Letter on Drugs and Therapeutics • Mar 21, 2022 (Issue 1646)
for treatment of
nAMD and DME (see Table 2).1,2
Pronunciation Key
Faricimab: far ik’ i mab Vabysmo: vah buys ...
Faricimab-svoa (Vabysmo – Genentech), an inhibitor
of both vascular endothelial growth factor (VEGF)
and angiopoietin-2 (Ang-2), has been approved by
the FDA for intravitreal treatment of neovascular
(wet) age-related macular degeneration (nAMD) and
diabetic macular edema (DME). It is the first drug to
become available in the US that targets two pathways
involved in maintaining vascular homeostasis.
Several VEGF inhibitors are available for treatment of
nAMD and DME (see Table 2).
Fluvoxamine for COVID-19?
The Medical Letter on Drugs and Therapeutics • May 03, 2021 (Issue 1623)
for treatment of COVID-19,1 and several
monoclonal antibodies have been granted emergency
use authorizations ...
A recent article in JAMA and an interview of its senior
author on 60 Minutes have heightened interest in
off-label use of the oral selective serotonin reuptake
inhibitor (SSRI) fluvoxamine (Luvox, and generics) to
treat COVID-19.
In Brief: A New OTC Naloxone Nasal Spray (RiVive)
The Medical Letter on Drugs and Therapeutics • Mar 18, 2024 (Issue 1698)
) product for emergency
treatment of opioid overdose.1 Two 4-mg naloxone
nasal spray formulations, Narcan ...
The FDA has approved RiVive (Harm Reduction
Therapeutics), a 3-mg naloxone nasal spray, as
an over-the-counter (OTC) product for emergency
treatment of opioid overdose. Two 4-mg naloxone
nasal spray formulations, Narcan and one of its
generics, were approved for OTC sale in 2023.
Med Lett Drugs Ther. 2024 Mar 18;66(1698):47-8 doi:10.58347/tml.2024.1698d | Show Introduction Hide Introduction
Tixagevimab and Cilgavimab (Evusheld) for Pre-Exposure Prophylaxis of COVID-19
The Medical Letter on Drugs and Therapeutics • Jan 10, 2022 (Issue 1641)
Table 1). They are the first
drugs to be authorized by the FDA for this indication.1
Two other pairs ...
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...
Lumateperone (Caplyta) for Bipolar Depression
The Medical Letter on Drugs and Therapeutics • Aug 08, 2022 (Issue 1656)
of depressive episodes associated with
bipolar I or II disorder in adults.1
Pronunciation Key
Lumateperone ...
The oral second-generation antipsychotic drug
lumateperone (Caplyta – Intra-Cellular Therapies),
which was approved by the FDA in 2020 for treatment
of schizophrenia, is now approved for use as
monotherapy or as an adjunct to lithium or valproate
for treatment of depressive episodes associated with
bipolar I or II disorder in adults.
COVID-19 Update: Pfizer/BioNTech and Moderna Vaccines Authorized for Children ≥6 Months Old
The Medical Letter on Drugs and Therapeutics • Jul 11, 2022 (Issue 1654)
was authorized for use in
adults ≥18 years old.1
CLINICAL STUDIES — Expansion of the EUAs of both
vaccines ...
The FDA has expanded its Emergency Use Authorizations
(EUAs) for the mRNA COVID-19 vaccines
manufactured by Pfizer/BioNTech (Comirnaty) and
Moderna (Spikevax) to allow for their use in children
as young as 6 months old. The Pfizer vaccine was
previously authorized for use in persons ≥5 years old,
and the Moderna vaccine was authorized for use in
adults ≥18 years old.
Dupilumab (Dupixent) for Eosinophilic Esophagitis and Prurigo Nodularis
The Medical Letter on Drugs and Therapeutics • Feb 06, 2023 (Issue 1669)
with nasal polyposis.1
EOSINOPHILIC ESOPHAGITIS — EoE is a chronic
inflammatory disease characterized ...
The FDA has approved the subcutaneously
injected interleukin (IL)-4 receptor alpha antagonist
dupilumab (Dupixent – Sanofi/Regeneron)
for treatment of eosinophilic esophagitis (EoE)
in patients ≥12 years old who weigh ≥40 kg and
treatment of prurigo nodularis in adults. Dupilumab
is the first drug to be approved in the US for each
of these indications. It is also FDA-approved for
treatment of atopic dermatitis, asthma, and chronic
rhinosinusitis with nasal polyposis.
Med Lett Drugs Ther. 2023 Feb 6;65(1669):18-20 doi:10.58347/tml.2023.1669b | Show Introduction Hide Introduction