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Daclizumab (Zinbryta) for Multiple Sclerosis
The Medical Letter on Drugs and Therapeutics • Sep 12, 2016 (Issue 1503)
: zin brye’ tuh
Table 1. Pharmacology
Class Interleukin-2 antagonist monoclonal antibody
Formulation ...
The FDA has approved daclizumab (Zinbryta – Biogen/Abbvie), an interleukin-2 (IL-2) receptor blocking
monoclonal antibody, for treatment of adults with
relapsing forms of multiple sclerosis (MS). It is the
first subcutaneously injected monoclonal antibody to
be approved for treatment of MS.
In Brief: Epinephrine Auto-Injectors for Anaphylaxis (online only)
The Medical Letter on Drugs and Therapeutics • Sep 12, 2016 (Issue 1503)
of epinephrine
doses, including failure to deliver the drug.1
Adrenaclick and its generic equivalent ...
News about recent price increases for EpiPen and EpiPen Jr (Mylan) may have patients asking about other options for emergency treatment of anaphylaxis. Adrenaclick and its generic equivalent (epinephrine injection auto-injector) are the only other epinephrine auto-injectors currently available in the US. According to Impax (the manufacturer of both the brand and generic products), Adrenaclick is no longer being manufactured; the generic product will continue to be marketed after supplies of Adrenaclick are depleted. Auvi-Q (Sanofi), an epinephrine auto-injector that was approved by the FDA in...
In Brief: Defibrotide (Defitelio) for Hepatic Veno-Occlusive Disease
The Medical Letter on Drugs and Therapeutics • Sep 12, 2016 (Issue 1503)
properties that protect
hepatic endothelial cells from the damage associated
with HSCT.1
Approval ...
The FDA has approved defibrotide sodium (Defitelio – Jazz), a mixture of mostly single-stranded polydeoxyribonucleotide sodium salts, for treatment of adults and children with hepatic veno-occlusive disease (also known as sinusoidal obstruction syndrome) and renal or pulmonary dysfunction following hematopoietic stem cell transplantation (HSCT). It is the first drug to be approved by the FDA for treatment of severe hepatic veno-occlusive disease. Defibrotide was approved earlier by the European Medicines Agency for the same indication.Hepatic veno-occlusive disease is an uncommon (<2%)...
AspireAssist - A New Device for Weight Loss
The Medical Letter on Drugs and Therapeutics • Aug 29, 2016 (Issue 1502)
gastric
banding or sleeve gastrectomy.1 Gastric balloon devices
are inserted endoscopically and can ...
The FDA has approved AspireAssist (Aspire
Bariatrics), a weight-loss device that permits patients
to drain a portion of their stomach contents through
a gastrostomy tube into a toilet after each meal. It
is approved for long-term use in combination with
lifestyle modifications in adults ≥22 years old who
have a body mass index (BMI) of 35 to 55 and have
not been able to achieve and maintain weight loss with
nonsurgical therapy.
Lifitegrast (Xiidra) for Dry Eye Disease
The Medical Letter on Drugs and Therapeutics • Aug 29, 2016 (Issue 1502)
of
lifitegrast (Xiidra – Shire), a lymphocyte functionassociated
antigen-1 (LFA-1) antagonist, for treatment ...
The FDA has approved a 5% ophthalmic solution of
lifitegrast (Xiidra – Shire), a lymphocyte function-associated
antigen-1 (LFA-1) antagonist, for treatment
of the signs and symptoms of dry eye disease.
Lifitegrast is the first LFA-1 antagonist to be approved
for any indication in the US.
An Oral Cholera Vaccine for Travelers (Vaxchora)
The Medical Letter on Drugs and Therapeutics • Aug 29, 2016 (Issue 1502)
, such as Haiti.1
V. cholerae is spread mainly by fecal contamination of
water and food in countries without ...
The FDA has approved Vaxchora (PaxVax), a single-dose,
oral, live-attenuated cholera vaccine, to protect
against disease caused by Vibrio cholerae serogroup
O1 in adults 18-64 years old traveling to cholera-affected
areas. Vaxchora is the only cholera vaccine
available in the US. A whole-cell killed injectable
vaccine was previously approved, but is no longer
available in the US.
Sugammadex (Bridion) for Rapid Reversal of Neuromuscular Blockade
The Medical Letter on Drugs and Therapeutics • Aug 29, 2016 (Issue 1502)
such as hypotension and bradycardia
can occur.1
PHARMACOLOGY — Sugammadex forms complexes
with rocuronium ...
The FDA has approved sugammadex (Bridion – Merck),
a selective relaxant binding agent, for reversal of
rocuronium- or vecuronium-induced neuromuscular
blockade in adult surgical patients. It is the first
selective relaxant binding agent to be approved in the
US. Sugammadex has been available in the European
Union, Japan, and elsewhere for several years. Previous
FDA reviews of sugammadex did not result in approval
because of concerns about a risk of anaphylaxis and
other hypersensitivity reactions with its use.
Sofosbuvir/Velpatasvir (Epclusa) for Hepatitis C
The Medical Letter on Drugs and Therapeutics • Aug 15, 2016 (Issue 1501)
— The prevalence of HCV genotypes
in the US is about 75% for genotype 1, 20-25% for
genotypes 2 and 3, and ...
The FDA has approved Epclusa (Gilead), a fixed-dose
combination of sofosbuvir (Sovaldi) and velpatasvir,
a new direct-acting antiviral agent, for oral treatment
of chronic hepatitis C virus (HCV) infection. Epclusa
is the first oral combination to be approved for
treatment of all six major HCV genotypes.
Jentadueto XR for Type 2 Diabetes
The Medical Letter on Drugs and Therapeutics • Aug 01, 2016 (Issue 1500)
The Medical Letter®
on Drugs and Therapeutics
Volume 58 (Issue 1500) August 1, 2016
Published ...
The FDA has approved Jentadueto XR (Boehringer
Ingelheim/Lilly), a once-daily extended-release formulation
of the dipeptidyl peptidase-4 (DPP-4) inhibitor
linagliptin and the biguanide metformin, for oral
treatment of type 2 diabetes. Linagliptin and metformin
have been available for years in a twice-daily immediate-release combination (Jentadueto). Once-daily
extended-release formulations combining metformin
with the DPP-4 inhibitors saxagliptin (Kombiglyze XR)
and sitagliptin (Janumet XR) are also available.
Emtricitabine/Tenofovir Alafenamide (Descovy) for HIV
The Medical Letter on Drugs and Therapeutics • Aug 01, 2016 (Issue 1500)
The Medical Letter®
on Drugs and Therapeutics
Volume 58 (Issue 1500) August 1, 2016
Published ...
The FDA has approved Descovy (Gilead), a fixed-dose
combination of the nucleoside/nucleotide reverse
transcriptase inhibitors (NRTIs) emtricitabine (FTC)
and tenofovir alafenamide (TAF) for use with other
antiretroviral agents for treatment of HIV-1 infection. A
combination of emtricitabine and tenofovir disoproxil
fumarate (FTC/TDF; Truvada) has been available
since 2004 for the same indication. Emtricitabine
and TAF are also available in combination with the
non-nucleoside reverse transcriptase inhibitor
(NNRTI) rilpivirine as Odefsey and with the integrase
strand transfer...