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Asciminib (Scemblix) for Chronic Myeloid Leukemia (online only)
The Medical Letter on Drugs and Therapeutics • Jun 12, 2023 (Issue 1678)
of tyrosine kinase inhibitors will need a change
in their treatment regimen by 5 years.1
MECHANISM OF ACTION ...
Asciminib (Scemblix – Novartis), an oral kinase
inhibitor, has been approved by the FDA for treatment
of adults with Philadelphia chromosome-positive
chronic myeloid leukemia (Ph+ CML) in chronic
phase (CP) previously treated with ≥2 tyrosine kinase
inhibitors and for adults with Ph+ CML in CP with a
T315I mutation.
Med Lett Drugs Ther. 2023 Jun 12;65(1678):e107-8 doi:10.58347/tml.2023.1678g | Show Introduction Hide Introduction
In Brief: Two Doses of Jynneos for Mpox (online only)
The Medical Letter on Drugs and Therapeutics • Jun 02, 2023 (Issue 5065)
Table 1) receive two doses of
the Jynneos vaccine. The recommendation follows
reports of a recent ...
The CDC is recommending that persons at high
risk of mpox (see Table 1) receive two doses of
the Jynneos vaccine. The recommendation follows
reports of a recent cluster of mpox cases in the US
and warnings about the risk of a renewed outbreak
during the spring and summer as people gather
for festivals and other events. The CDC does not
recommend routine immunization against mpox for
the general population.
Med Lett Drugs Ther. 2023 Jun 2;65(5065):1-2 doi:10.58347/tml.2023.5065a | Show Introduction Hide Introduction
COVID-19 Update: An EUA for Vilobelimab (Gohibic) for COVID-19
The Medical Letter on Drugs and Therapeutics • May 29, 2023 (Issue 1677)
is the first anti-C5a antibody to become
available in the US.1
STANDARD TREATMENT ― The NIH recommends ...
The investigational anti-complement component 5a
(C5a) antibody vilobelimab (Gohibic – InflaRx) has
been granted an FDA Emergency Use Authorization
(EUA) for IV treatment of hospitalized adults
with COVID-19 beginning within 48 hours after
invasive mechanical ventilation (IMV) or extracorporeal
membrane oxygenation (ECMO) is started.
Vilobelimab is the first anti-C5a antibody to become
available in the US.
Med Lett Drugs Ther. 2023 May 29;65(1677):86-7 doi:10.58347/tml.2023.1677d | Show Introduction Hide Introduction
Live Fecal Microbiota Oral Capsules (Vowst) for Prevention of CDI Recurrence
The Medical Letter on Drugs and Therapeutics • May 29, 2023 (Issue 1677)
indication.1 Neither
product is approved for acute treatment of CDI.
Description: Oral capsule containing ...
The FDA has approved Vowst (Seres Therapeutics/Nestle HealthScience), an oral capsule containing live
fecal microbiota spores, for prevention of additional
recurrences of Clostridioides difficile infection (CDI)
in adults. Vowst is the first orally administered
microbiota-based treatment to be approved for
this indication. A rectally-administered live fecal
microbiota-based suspension (Rebyota) was
approved in 2022 for the same indication. Neither
product is approved for acute treatment of CDI.
Med Lett Drugs Ther. 2023 May 29;65(1677):81-2 doi:10.58347/tml.2023.1677a | Show Introduction Hide Introduction
Eflapegrastim (Rolvedon) for Prevention of Chemotherapy-Induced Febrile Neutropenia
The Medical Letter on Drugs and Therapeutics • May 29, 2023 (Issue 1677)
decrease the
duration of chemotherapy-induced neutropenia
and the incidence of infection.1 The Fc ...
Eflapegrastim-xnst ((Rolvedon) [Spectrum]; previously
called Rolontis), a granulocyte colony-stimulating
factor (G-CSF) conjugated to an Fc fragment of human
IgG4, has been approved by the FDA to decrease
the incidence of infection, as manifested by febrile
neutropenia, in adults with nonmyeloid malignancies
receiving myelosuppressive chemotherapy that can
cause clinically significant febrile neutropenia.
Med Lett Drugs Ther. 2023 May 29;65(1677):83-4 doi:10.58347/tml.2023.1677b | Show Introduction Hide Introduction
Cariprazine (Vraylar) for Adjunctive Treatment of Depression
The Medical Letter on Drugs and Therapeutics • May 29, 2023 (Issue 1677)
depression,
and for acute treatment of manic or mixed episodes
associated with bipolar I disorder.1
Table ...
The FDA has approved the second-generation
antipsychotic drug cariprazine (Vraylar — Abbvie) for
adjunctive treatment of major depressive disorder
(MDD) in adults. Cariprazine was previously approved
for treatment of schizophrenia and bipolar depression,
and for acute treatment of manic or mixed episodes
associated with bipolar I disorder.
Med Lett Drugs Ther. 2023 May 29;65(1677):84-6 doi:10.58347/tml.2023.1677c | Show Introduction Hide Introduction
COVID-19 Update: Metformin to Prevent Long Covid?
The Medical Letter on Drugs and Therapeutics • May 29, 2023 (Issue 1677)
ward
than in those who did not (43.1% and 27.5% vs 5.7%).
It was most prevalent in adult females.1 ...
Results from a double-blind trial suggest that off-label
use of the oral antihyperglycemic drug metformin
in patients with COVID-19 may decrease the risk
of post-acute sequelae of SARS-CoV-2 infection
("long COVID").
Med Lett Drugs Ther. 2023 May 29;65(1677):87-8 doi:10.58347/tml.2023.1677e | Show Introduction Hide Introduction
Polatuzumab vedotin (Polivy) for Lymphoma (online only)
The Medical Letter on Drugs and Therapeutics • May 29, 2023 (Issue 1677)
, and prednisone (R-CHOP). The risk
of relapse is highest within one year following
treatment.1
MECHANISM ...
Polatuzumab vedotin-piiq (Polivy – Genentech), a
CD79b-directed antibody and microtubule inhibitor
conjugate, has been approved by the FDA for use
in combination with rituximab, cyclophosphamide,
doxorubicin, and prednisone (R-CHP) for first-line
treatment of diffuse large B-cell lymphoma
(DLBCL), not otherwise specified (NOS), or high-grade
B-cell lymphoma (HGBL) in adults who have
an International Prognostic Index (IPI) score ≥2. The
drug was previously approved for use in combination
with bendamustine and rituximab for treatment of
patients with relapsed or refactory DLBCL,...
Med Lett Drugs Ther. 2023 May 29;65(1677):e89-90 doi:10.58347/tml.2023.1677f | Show Introduction Hide Introduction
Omidubicel (Omisirge) for Neutrophil Recovery Following Myeloablative Conditioning Therapy (online only)
The Medical Letter on Drugs and Therapeutics • May 29, 2023 (Issue 1677)
donors) is often used,
but it can delay the time to neutrophil engrafment.1
Before undergoing stem cell ...
The FDA has approved omidubicel-onlv (Omisirge –
Gamida Cell), a nicotinamide-modified, allogeneic
hematopoietic progenitor cell therapy derived from
cord blood, to reduce the time to neutrophil recovery
and the risk of infection in patients ≥12 years old
with hematologic malignancies who will undergo
umbilical cord blood transplantation following
myeloablative conditioning therapy. Hematopoietic
progenitor cell (HPC) umbilical cord products (e.g.,
Allocord, Clevecord, Ducord) have been available in
the US for years for the same indication. Cord blood
banks also supply cord...
Med Lett Drugs Ther. 2023 May 29;65(1677):e93-4 doi:10.58347/tml.2023.1677h | Show Introduction Hide Introduction
Enfortumab Vedotin (Padcev) for Urothelial Cancer (online only)
The Medical Letter on Drugs and Therapeutics • May 22, 2023 (Issue 1677)
received enfortumab vedotin 1.25 mg/kg
IV on days 1 an 8 of a 21-day cycle, followed by
pembrolizumab 200 ...
Enfortumab vedotin-ejfv (Padcev – Astellas), a
nectin-4-directed antibody and microtubule inhibitor
conjugate, has received accelerated approval
from the FDA for use with the immune checkpoint
inhibitor pembrolizumab (Keytruda) for treatment
of locally advanced or metastatic urothelial cancer
in adults who are ineligible for cisplatin-containing
chemotherapy. Accelerated approval was based on
tumor response rates and the durability of response.
Med Lett Drugs Ther. 2023 May 22;65(1677):e91-2 doi:10.58347/tml.2023.1677g | Show Introduction Hide Introduction