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Antiviral Drugs for COVID-19 in Vaccinated Outpatients
The Medical Letter on Drugs and Therapeutics • Mar 06, 2023 (Issue 1671)
in the US for
treatment of high-risk (see Table 1),1 nonhospitalized
adults with mild to moderate COVID-19: oral ...
Three products are currently available in the US for
treatment of high-risk,1 nonhospitalized adults with
mild to moderate COVID-19: oral ritonavir-boosted
nirmatrelvir (Paxlovid), IV remdesivir (Veklury), and
oral molnupiravir (Lagevrio). Remdesivir is FDA-approved
for such use; nirmatrelvir/ritonavir and
molnupiravir are available under an FDA Emergency
Use Authorization. Because the pivotal clinical trials
of these products for outpatient use were conducted
in patients who were not vaccinated against
COVID-19, some clinicians have questioned whether
they can benefit vaccinated...
Med Lett Drugs Ther. 2023 Mar 6;65(1671):33-4 doi:10.58347/tml.2023.1671a | Show Introduction Hide Introduction
Live Fecal Microbiota (Rebyota) for Prevention of CDI Recurrence
The Medical Letter on Drugs and Therapeutics • Mar 06, 2023 (Issue 1671)
with multiple
CDI recurrences.1
RECURRENT CDI — The recurrence rate after antibiotic
treatment for an initial ...
The FDA has approved Rebyota (Ferring), a rectally-administered,
live fecal microbiota suspension, for
prevention of additional recurrences of Clostridioides
difficile infection (CDI) following antibiotic treatment
for a recurrent episode of CDI in adults. Rebyota is
the first microbiome-based treatment to be approved
for this indication. It is not approved for initial
treatment of CDI. Fecal microbiota transplantation
(FMT) has been used in patients with multiple
CDI recurrences.
Med Lett Drugs Ther. 2023 Mar 6;65(1671):35-6 doi:10.58347/tml.2023.1671b | Show Introduction Hide Introduction
Ublituximab (Briumvi) for Relapsing Multiple Sclerosis
The Medical Letter on Drugs and Therapeutics • Mar 06, 2023 (Issue 1671)
) and SC
ofatumumab (Kesimpta), are also FDA-approved for
these indications.1,2
Table 1. Pharmacology ...
The FDA has approved the recombinant chimeric
anti-CD20 antibody ublituximab-xiiy (Briumvi – TG Therapeutics) for IV treatment of adults with
relapsing forms of multiple sclerosis (MS), including
clinically isolated syndrome (initial neurological
episode), relapsing-remitting disease, and active
secondary progressive MS (SPMS). Two other anti-CD20 antibodies, IV ocrelizumab (Ocrevus) and SC
ofatumumab (Kesimpta), are also FDA-approved for
these indications.
Med Lett Drugs Ther. 2023 Mar 6;65(1671):36-8 doi:10.58347/tml.2023.1671c | Show Introduction Hide Introduction
Elacestrant (Orserdu) for Advanced or Metastatic Breast Cancer
The Medical Letter on Drugs and Therapeutics • Mar 06, 2023 (Issue 1671)
)-positive, human
epidermal growth factor receptor 2 (HER2)-negative,
estrogen receptor 1 (ESR1)-mutated ...
The FDA has approved elacestrant (Orserdu –
Stemline), an oral estrogen receptor antagonist, for
treatment of estrogen receptor (ER)-positive, human
epidermal growth factor receptor 2 (HER2)-negative,
estrogen receptor 1 (ESR1)-mutated advanced or
metastatic breast cancer in postmenopausal women
or men who had disease progression following
endocrine therapy. Elacestrant is the first oral selective
estrogen receptor degrader (SERD) to be approved
for treatment of breast cancer; the injectable SERD
fulvestrant (Faslodex, and generics) was approved
more than 20 years...
Med Lett Drugs Ther. 2023 Mar 6;65(1671):38-40 doi:10.58347/tml.2023.1671d | Show Introduction Hide Introduction
In Brief: Adstiladrin – A Gene Therapy for Bladder Cancer (online only)
The Medical Letter on Drugs and Therapeutics • Mar 06, 2023 (Issue 1671)
. The median duration of response was 9.7
months.1
ADVERSE EFFECTS — The most common adverse
effects ...
Nadofaragene firadenovec-vncg (Adstiladrin – Ferring), an adenoviral vector-based gene therapy,
has been approved by the FDA for treatment of adults
with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer
(NMIBC) with carcinoma in situ with or without
papillary tumors. It is the first adenoviral vector-based
gene therapy to be approved in the US for
this indication. The immune checkpoint inhibitor
pembrolizumab (Keytruda) was approved for the
same indication in 2021.
Med Lett Drugs Ther. 2023 Mar 6;65(1671):e40-1 doi:10.58347/tml.2023.1671e | Show Introduction Hide Introduction
Mosunetuzumab (Lunsumio) for Follicular Lymphoma (online only)
The Medical Letter on Drugs and Therapeutics • Mar 06, 2023 (Issue 1671)
follicular lymphoma.1,2
MECHANISM OF ACTION — Mosunetuzumab is a
T-cell-engaging bispecific antibody ...
Mosunetuzumab-axgb (Lunsumio – Genentech),
a bispecific CD20-directed CD3 T-cell engager,
has received accelerated approval from the FDA
for treatment of relapsed or refractory follicular
lymphoma in adults who received ≥2 lines of systemic
therapy. It is the first T-cell-engaging bispecific
antibody to be approved in the US for this indication.
Med Lett Drugs Ther. 2023 Mar 6;65(1671):e41-2 doi:10.58347/tml.2023.1671f | 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
In Brief: Expanded Access to Mifepristone
The Medical Letter on Drugs and Therapeutics • Feb 20, 2023 (Issue 1670)
to be dispensed by mail by certified prescribers
or pharmacies.1 The FDA has now announced
that certified retail ...
First approved in 2000 for termination of pregnancies
of ≤49 days' gestation, the indication for the oral
antiprogestin mifepristone (Mifeprex, and generics)
was expanded in 2016 to include pregnancies of
up to 10 weeks' gestation. A single 200-mg oral
dose of mifepristone followed 24-48 hours later by
a single 800-mcg buccal dose of the prostaglandin
analog misoprostol terminates early intrauterine
pregnancies in about 95% of women.
Med Lett Drugs Ther. 2023 Feb 20;65(1670):31 doi:10.58347/tml.2023.1670c | Show Introduction Hide Introduction
Drugs for Hypothyroidism
The Medical Letter on Drugs and Therapeutics • Feb 20, 2023 (Issue 1670)
, and others) is the drug
of choice.1,2
LEVOTHYROXINE (LT4) — Pharmacokinetics – In
healthy fasting adults ...
Primary hypothyroidism is usually the result of
Hashimoto's (autoimmune) thyroiditis, thyroidectomy,
or radioactive iodine therapy. Treatment of
hypothyroidism with replacement doses of thyroid
hormone is usually lifelong. Levothyroxine (LT4;
synthetic thyroxine; Synthroid, and others) is the drug
of choice.1
Med Lett Drugs Ther. 2023 Feb 20;65(1670):25-9 doi:10.58347/tml.2023.1670a | Show Introduction Hide Introduction
Deucravacitinib (Sotyktu) for Plaque Psoriasis
The Medical Letter on Drugs and Therapeutics • Feb 20, 2023 (Issue 1670)
as methotrexate, but its use
is generally restricted to 1-2 years because of a risk
of irreversible ...
The FDA has approved deucravacitinib (Sotyktu –
BMS), an oral tyrosine kinase 2 (TYK2) inhibitor, for
once-daily treatment of moderate to severe plaque
psoriasis in adults who are candidates for systemic
therapy or phototherapy. Deucravacitinib is the first
selective TYK2 inhibitor to be approved in the US for
any indication.
Med Lett Drugs Ther. 2023 Feb 20;65(1670):29-31 doi:10.58347/tml.2023.1670b | Show Introduction Hide Introduction