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Booster Dose of the Pfizer/BioNTech COVID-19 Vaccine (Comirnaty)
The Medical Letter on Drugs and Therapeutics • Oct 18, 2021 (Issue 1635)
exposure
to SARS-CoV-2 (see Table 1).1 The FDA Advisory
Committee recommended against authorization ...
On September 22, on the advice of its Vaccines and
Related Biologic Products Advisory Committee, the
FDA expanded the Emergency Use Authorization
(EUA) for the Pfizer/BioNTech mRNA-based COVID-19
vaccine (Comirnaty) to include administration of a
booster dose ≥6 months after a 2-dose primary series
in adults who are ≥65 years old or at high risk for severe
COVID-19 because of an underlying medical condition
or frequent institutional or occupational exposure
to SARS-CoV-2 (see Table 1). The FDA Advisory
Committee recommended against authorization of a
booster dose of Comirnaty...
Once-Weekly or Once-Monthly Subcutaneous Buprenorphine (Brixadi) for Opioid Use Disorder
The Medical Letter on Drugs and Therapeutics • Aug 21, 2023 (Issue 1683)
monthly, was the first.1
Buprenorphine is also available for treatment of
opioid use disorder ...
The FDA has approved a subcutaneously injected,
extended-release formulation of the mu-opioid
receptor partial agonist and kappa-opioid receptor
antagonist buprenorphine (Brixadi – Braeburn)
for once-weekly or once-monthly treatment of
moderate to severe opioid use disorder. Brixadi is
the second subcutaneously injected buprenorphine
formulation to be approved in the US; Sublocade,
which is administered once monthly, was the first.
Buprenorphine is also available for treatment of
opioid use disorder in sublingual formulations with
and without the opioid antagonist...
Med Lett Drugs Ther. 2023 Aug 21;65(1683):133-5 doi:10.58347/tml.2023.1683c | Show Introduction Hide Introduction
In Brief: A Second Indication for Tucatinib (Tukysa) (online only)
The Medical Letter on Drugs and Therapeutics • Feb 20, 2023 (Issue 1670)
at least one prior
anti-HER2-based regimen for metastatic disease.1
MECHANISM OF ACTION — Tucatinib binds ...
The oral kinase inhibitor tucatinib (Tukysa – Seagen)
has received accelerated approval from the FDA for
use in combination with trastuzumab (Herceptin)
for treatment of adults with RAS wild-type human
epidermal growth factor receptor 2 (HER2)-positive
unresectable or metastatic colorectal cancer
that has progressed following treatment with
fluoropyrimidine-, oxaliplatin-, and irinotecan-based
chemotherapy regimens. Tucatinib was approved in
2020 for use in combination with trastuzumab and
capecitabine (Xeloda, and generics) for treatment
of adults with advanced unresectable or...
Med Lett Drugs Ther. 2023 Feb 20;65(1670):e37-8 doi:10.58347/tml.2023.1670g | Show Introduction Hide Introduction
In Brief: A New Breast Cancer Indication for Sacituzumab Govitecan (Trodelvy) (online only)
The Medical Letter on Drugs and Therapeutics • Mar 06, 2023 (Issue 1671)
platinum-based chemotherapy and a
programmed death receptor-1 (PD-1) or programmed
death-ligand 1 (PD-L1 ...
Sacituzumab govitecan-hziy (Trodelvy – Gilead) has
been approved for treatment of unresectable locally
advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2
(HER2)-negative breast cancer in adults who received
prior endocrine therapy and ≥2 additional systemic
therapies for metastatic disease. It was previously
approved for treatment-refractory metastatic triplenegative
breast cancer and for treatment of locally
advanced or metastatic urothelial cancer in adults
who received platinum-based chemotherapy and a
programmed death receptor-1...
Med Lett Drugs Ther. 2023 Mar 6;65(1671):e43-4 doi:10.58347/tml.2023.1671g | Show Introduction Hide Introduction
Sotorasib (Lumakras) for NSCLC (online only)
The Medical Letter on Drugs and Therapeutics • Jun 12, 2023 (Issue 1678)
. Sotorasib is the
first KRAS inhibitor to be approved in the US.
chemotherapy and a programmed death 1 (PD ...
Sotorasib (Lumakras — Amgen), an oral KRAS
inhibitor, has received accelerated approval by the
FDA for treatment of KRAS G12C-mutated locally
advanced or metastatic non-small cell lung cancer
(NSCLC) in adults who received at least one prior
systemic therapy. Accelerated approval was based
on the overall response rate and duration of response.
KRAS mutations are found in 25-30% of non-squamous-cell NSCLC cases and the G12C mutation
is the most common KRAS mutation. Sotorasib is the
first KRAS inhibitor to be approved in the US.
Med Lett Drugs Ther. 2023 Jun 12;65(1678):e104-5 doi:10.58347/tml.2023.1678e | Show Introduction Hide Introduction
Tenapanor (Ibsrela) for Irritable Bowel Syndrome with Constipation
The Medical Letter on Drugs and Therapeutics • Jun 13, 2022 (Issue 1652)
-M), or unclassified IBS
(IBS-U).1,2
STANDARD TREATMENT — The goal of IBS treatment
is symptom ...
The FDA has approved tenapanor (Ibsrela - Ardelyx),
a sodium/hydrogen exchanger 3 (NHE3) inhibitor, for
twice-daily oral treatment of irritable bowel syndrome
with constipation (IBS-C) in adults. Tenapanor is the
first NHE3 inhibitor to become available in the US.
Addendum: Drug Interaction between Opioids and Oral P2Y12 Platelet Inhibitors
The Medical Letter on Drugs and Therapeutics • Mar 09, 2020 (Issue 1593)
of oral P2Y12
inhibitors and increased platelet reactivity.1 Recently published
clinical outcomes data ...
Opioids delay gastric emptying and the absorption of many
oral drugs, including the P2Y12 inhibitors clopidogrel (Plavix,
and generics), prasugrel (Effient, and generics), and ticagrelor
(Brilinta), which are commonly used for initial treatment of
acute coronary syndrome (ACS). An article in our February 25,
2019 issue reviewed studies showing that coadministration
of opioids delayed and decreased absorption of oral P2Y12
inhibitors and increased platelet reactivity. Recently published
clinical outcomes data may add to these concerns.
Pemigatinib (Pemazyre) for Cholangiocarcinoma (online only)
The Medical Letter on Drugs and Therapeutics • Dec 28, 2020 (Issue 1614)
is given once daily in 21-day treatment cycles (2 weeks
on, 1 week off); one 21-day treatment cycle ...
The oral kinase inhibitor pemigatinib (Pemazyre –
Incyte) has received accelerated approval from
the FDA for treatment of adults with previously
treated, unresectable, locally advanced or metastatic
cholangiocarcinoma with fibroblast growth factor
receptor 2 (FGFR2) fusions or other rearrangements.
Pemigatinib is the first drug to be approved in the US
for this indication.
Two New Pneumococcal Vaccines - Prevnar 20 and Vaxneuvance
The Medical Letter on Drugs and Therapeutics • Nov 29, 2021 (Issue 1638)
≥2 years old.1
Table 1. Pneumococcal Vaccines Licensed in the US1
Usual Dose/
Vaccine Formulations ...
The FDA has licensed two new pneumococcal
conjugate vaccines (PCVs) for prevention of invasive
pneumococcal disease in adults: Prevnar 20 (PCV20;
Pfizer), which contains antigens from 20 serotypes of
pneumococcus, and Vaxneuvance (PCV15; Merck),
which contains antigens from 15 serotypes. Two
other pneumococcal vaccines are available in the
US: Prevnar 13 (PCV13; Pfizer), a 13-valent conjugate
vaccine licensed for use in persons ≥6 weeks old,
and Pneumovax 23 (PPSV23; Merck), a 23-valent
pneumococcal polysaccharide vaccine licensed for
use in persons ≥2 years...
Comparison Table: Some Drugs for HFrEF (online only)
The Medical Letter on Drugs and Therapeutics • Mar 08, 2021 (Issue 1619)
/51 mg bid Renal impairment: eGFR ...
View the Comparison Table: Some Drugs for HFrEF