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Ribociclib (Kisqali) for Advanced or Metastatic Breast Cancer (online only)
The Medical Letter on Drugs and Therapeutics • Oct 23, 2017 (Issue 1532)
to be approved in the US
for this indication; palbociclib (Ibrance) was the first.1
Abemaciclib (Verzenio ...
The oral cyclin-dependent kinase (CDK) 4/6 inhibitor
ribociclib (Kisqali – Novartis) has been approved by
the FDA for use in combination with an aromatase
inhibitor for first-line endocrine-based therapy in
postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor
2 (HER2)-negative advanced or metastatic breast
cancer. Ribociclib is also available copackaged
with the aromatase inhibitor letrozole (Femara, and
generics) as Kisqali Femara Co-Pack. Ribociclib is
the second CDK 4/6 inhibitor to be approved in the US
for this indication;...
Mavyret and Vosevi - Two New Combinations for Chronic HCV Infection
The Medical Letter on Drugs and Therapeutics • Oct 09, 2017 (Issue 1531)
-experienced
patients. Mavyret is also approved for treatmentnaive
patients.
HCV GENOTYPES — HCV genotype 1 ...
The FDA has approved Mavyret (Abbvie) and Vosevi
(Gilead), two new fixed-dose combinations of direct-acting
antiviral (DAA) drugs, for treatment of chronic
hepatitis C virus (HCV) infection caused by any of the
six major HCV genotypes in patients without cirrhosis
or with compensated cirrhosis. Both are approved for
use in treatment-experienced patients. Mavyret is also
approved for treatment-naive patients.
In Brief: Pancreatic Enzyme Replacement Products
The Medical Letter on Drugs and Therapeutics • Oct 09, 2017 (Issue 1531)
IN BRIEF
Pancreatic Enzyme Replacement
Products
Table 1. FDA-Approved Pancreatic Enzyme ...
Pancreatic enzyme replacement products have been used for years to improve digestion in patients with exocrine pancreatic insufficiency (EPI). These products were initially marketed before formal FDA approval was required; in 1991, however, the FDA told all manufacturers of pancreatic enzyme replacement products that they would have to submit a new drug application by April 2010 in order to keep their products on the market.EPI is a chronic disorder characterized by a deficiency of exocrine pancreatic enzymes, which results in malabsorption, steatorrhea, and weight loss. Irreversible EPI is...
Tocilizumab (Actemra) for Giant Cell Arteritis
The Medical Letter on Drugs and Therapeutics • Sep 25, 2017 (Issue 1530)
idiopathic arthritis, and cytokine
release syndrome.1
THE DISEASE — Giant cell arteritis is a systemic ...
The FDA has approved the interleukin-6 (IL-6) receptor
antagonist tocilizumab (Actemra – Genentech) for
subcutaneous (SC) treatment of giant cell arteritis
in adults. It is the first drug to be approved in the US
for this indication. Tocilizumab is also approved for
treatment of rheumatoid arthritis, polyarticular or
systemic juvenile idiopathic arthritis, and cytokine
release syndrome.
Prasterone (Intrarosa) for Dyspareunia
The Medical Letter on Drugs and Therapeutics • Sep 11, 2017 (Issue 1529)
, cardiovascular,
and neuropsychiatric dysfunction.1-3
Table 1. Pharmacology
Class Steroid
Formulation 6.5-mg ...
The FDA has approved the steroid prasterone
(Intrarosa – Endoceutics) for intravaginal treatment
of postmenopausal women with moderate-to-severe
dyspareunia due to vulvovaginal atrophy (VVA). Also
called dehydroepiandrosterone (DHEA), prasterone
is produced in the adrenal glands, gonads, and brain
and converted intracellularly into active metabolites
of estrogens and androgens. DHEA has been available
over the counter for years as an oral dietary supplement
claimed to benefit sexual, cardiovascular, and
neuropsychiatric dysfunction.
Safinamide (Xadago) for Parkinson's Disease
The Medical Letter on Drugs and Therapeutics • Sep 11, 2017 (Issue 1529)
can be problematic as the disease
advances and higher doses are required.1-3 Adding
a dopamine ...
The FDA has approved the monoamine oxidase
type B (MAO-B) inhibitor safinamide (Xadago – US
Worldmeds) as an adjunct to levodopa/carbidopa
for management of "off" episodes in patients with
Parkinson’s disease (PD). It is the first reversible
MAO-B inhibitor to be approved for this indication.
Selegiline (Eldepryl, and others) and rasagiline
(Azilect, and generics), two irreversible MAO-B
inhibitors, have been used alone and as adjuncts to
levodopa/carbidopa for many years. Safinamide is
not approved for use as monotherapy.
Insulin Degludec/Liraglutide (Xultophy 100/3.6) for Type 2 Diabetes
The Medical Letter on Drugs and Therapeutics • Sep 11, 2017 (Issue 1529)
/3.6 (Novo
Nordisk), a fixed-ratio combination of insulin degludec
and the GLP-1 (glucagon-like ...
The FDA has approved Xultophy 100/3.6 (Novo
Nordisk), a fixed-ratio combination of insulin
degludec and the GLP-1 (glucagon-like peptide-1)
receptor agonist liraglutide, for once-daily treatment
of adults with type 2 diabetes inadequately controlled
on basal insulin (<50 units daily) or liraglutide (≤1.8
mg daily).
Deflazacort (Emflaza) for Duchenne Muscular Dystrophy
The Medical Letter on Drugs and Therapeutics • Sep 11, 2017 (Issue 1529)
skipping
(about 13% of DMD cases), was the first.1
Pronunciation Key
Deflazacort: dee flayz' a kort ...
Deflazacort (Emflaza – PTC Therapeutics), an oral
corticosteroid, has been approved by the FDA for
treatment of Duchenne muscular dystrophy (DMD) in
patients ≥5 years old. It has been available outside
the US for many years. Deflazacort is the second
drug to be approved for treatment of DMD; eteplirsen
(Exondys 51), an antisense oligonucleotide approved
for IV administration in patients with mutations of
the dystrophin gene amenable to exon 51 skipping
(about 13% of DMD cases), was the first.
Correction: Drugs for Helicobacter pylori Infection
The Medical Letter on Drugs and Therapeutics • Sep 11, 2017 (Issue 1529)
as stated in
footnote 1. The footnote has been corrected and the price of the
generic formulation ...
In Table 3 on page 116 (Med Lett Drugs Ther 2017; 59:113), the price provided for Prevpac was for a 14-day supply, rather than for a 10-day supply as stated in footnote 1. The footnote has been corrected and the price of the generic formulation of Prevpac has been added.
Safety of Long-Term PPI Use
The Medical Letter on Drugs and Therapeutics • Aug 14, 2017 (Issue 1527)
and generally
well tolerated,1,2 but their long-term use has been
associated with a number of safety concerns ...
Proton pump inhibitors (PPIs), which are used for
treatment of gastroesophageal reflux disease (GERD)
and for prevention of upper gastrointestinal adverse
effects caused by NSAIDs and aspirin, are one of
the most commonly prescribed classes of drugs in
the US. All PPIs are similarly effective and generally
well tolerated, but their long-term use has been
associated with a number of safety concerns.
Recommendations addressing these concerns have
recently been published.