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Concentrated Insulin Glargine (Toujeo) for Diabetes
The Medical Letter on Drugs and Therapeutics • May 11, 2015 (Issue 1468)
of action. The
prolonged time in subcutaneous tissue may reduce
the bioavailability of Toujeo.1 ...
The FDA has approved Toujeo (Sanofi), a more
concentrated form of insulin glargine containing 300
IU/mL compared to the 100 IU/mL in Lantus (Sanofi).
Lantus is nearing the end of its patent protection in the
US, and biosimilars are expected to become available.
Testosterone Nasal Gel (Natesto) for Hypogonadism
The Medical Letter on Drugs and Therapeutics • May 11, 2015 (Issue 1468)
infarction (MI)
and stroke.1
Pronunciation Key
Testosterone: tes tos' ter one Natesto: na tes' toe ...
The FDA has approved an intranasal gel formulation of
testosterone (Natesto – Trimel/Endo) for replacement
therapy in men with hypogonadism. Packaged in a
metered-dose pump, Natesto is the first intranasal
testosterone to become available in the US. Like other
testosterone products, it is classified as a schedule
III controlled substance. The FDA recently cautioned
against using testosterone to treat low testosterone
levels solely due to aging because the benefits and
safety of such use have not been established, and there
is a possible increased risk of myocardial infarction...
Blinatumomab (Blincyto) for Acute Lymphoblastic Leukemia (online only)
The Medical Letter on Drugs and Therapeutics • May 11, 2015 (Issue 1468)
months.1
ADVERSE EFFECTS – A boxed warning in the labeling of blinatumomab states that life ...
The FDA has approved blinatumomab (Blincyto –
Onyx/Amgen) for treatment of relapsed or refractory
Philadelphia chromosome-negative (Ph-) B-cell precursor
acute lymphoblastic leukemia (ALL).
Ramucirumab (Cyramza) for Gastric and GEJ Cancer (online only)
The Medical Letter on Drugs and Therapeutics • May 11, 2015 (Issue 1468)
(5.2 vs. 3.8
months). Median progression-free survival was 2.1
months in patients who received ...
Ramucirumab (Cyramza – Lilly), a monoclonal antibody
that inhibits vascular endothelial growth factor
receptor 2 (VEGFR2), has been approved by the FDA for
use as monotherapy or in combination with paclitaxel
for treatment of advanced or metastatic gastric or
gastroesophageal junction (GEJ) adenocarcinoma
that has progressed on or after platinum- or
fluoropyrimidine-based chemotherapy. Ramucirumab
is also approved for use in combination with docetaxel
(Taxotere, and others) for treatment of metastatic
non-small cell lung cancer that has progressed on or
after platinum-based...
Idelalisib (Zydelig) for Chronic Lymphocytic Leukemia and Non-Hodgkins Lymphoma (online only)
The Medical Letter on Drugs and Therapeutics • May 11, 2015 (Issue 1468)
CLL usually includes
fludarabine, rituximab, and cyclophosphamide
(Cytoxan, and others).1 Combining ...
The FDA has approved idelalisib (Zydelig – Gilead),
an oral kinase inhibitor, for use in combination with
rituximab (Rituxan) for treatment of relapsed chronic
lymphocytic leukemia (CLL). It is also approved as
monotherapy for treatment of relapsed follicular
lymphoma and relapsed small lymphocytic lymphoma
(both are subtypes of indolent non-Hodgkins
lymphoma) in patients who have received at least two
prior systemic therapies.
Carbidopa/Levodopa Extended-Release Capsules (Rytary)
The Medical Letter on Drugs and Therapeutics • Apr 27, 2015 (Issue 1467)
for symptomatic relief
of PD.1 It has been available for many years as
immediate- and sustained-release tablets ...
The FDA has approved a new formulation of carbidopa/levodopa (Rytary – Impax) in extended-release capsules for treatment of Parkinson’s disease (PD).
Glyxambi - A New Combination for Type 2 Diabetes
The Medical Letter on Drugs and Therapeutics • Apr 27, 2015 (Issue 1467)
glycated
hemoglobin (HbA1c) by 0.5%-1.5%. In the absence
of contraindications, metformin is the preferred ...
The FDA has approved Glyxambi (Boehringer
Ingelheim/Lilly), a fixed-dose combination of empagliflozin
(Jardiance) and linagliptin (Tradjenta), for oral
treatment of type 2 diabetes in adults. It is the first
combination of a sodium-glucose co-transporter 2
(SGLT2) inhibitor and a dipeptidyl peptidase-4 (DPP-4) inhibitor to be approved in the US.
Netupitant/Palonosetron (Akynzeo) for Chemotherapy-Induced Nausea and Vomiting
The Medical Letter on Drugs and Therapeutics • Apr 27, 2015 (Issue 1467)
(Helsinn/Eisai), an oral
fixed-dose combination of the substance P/neurokinin
1 (NK1) receptor antagonist ...
The FDA has approved Akynzeo (Helsinn/Eisai), an oral
fixed-dose combination of the substance P/neurokinin
1 (NK1) receptor antagonist netupitant and the
serotonin-3 (5-HT3) receptor antagonist palonosetron,
for prevention of acute and delayed nausea and
vomiting associated with cancer chemotherapy
in adults. Akynzeo is the first product to combine
drugs from these two classes. Palonosetron (Aloxi)
is also available as a single agent for prevention of
chemotherapy-induced and postoperative nausea
and vomiting. Netupitant is the second substance
P/NK1 receptor antagonist to be...
Umeclidinium (Incruse Ellipta) for COPD
The Medical Letter on Drugs and Therapeutics • Apr 27, 2015 (Issue 1467)
-adrenergic
agonist vilanterol as Anoro Ellipta.1
Pronunciation Key
Umeclidinium: ue mek" li din' ee um ...
The FDA has approved Incruse Ellipta (GSK), a
single-agent inhaler containing the long-acting
anticholinergic umeclidinium, for once-daily maintenance
treatment of chronic obstructive pulmonary
disease (COPD). Umeclidinium was initially approved
in combination with the long-acting beta2-adrenergic
agonist vilanterol as Anoro Ellipta.
In Brief: Mechlorethamine Gel (Valchlor) for Cutaneous T-Cell Lymphoma (online only)
The Medical Letter on Drugs and Therapeutics • Apr 27, 2015 (Issue 1467)
daily for up to 1 year. Response rates, based on a composite assessment of index lesion severity, were ...
The FDA has approved a 0.016% gel formulation of the nitrogen mustard mechlorethamine (Valchlor – Actelion) for second-line topical treatment of patients with stage IA or IB mycosis fungoides, the most common type of cutaneous T-cell lymphoma. Topical nitrogen mustard has been used off-label for decades for this indication, usually as a pharmacy-compounded ointment, but no clinical trials evaluating its efficacy and safety have been done. Mechlorethamine is also available in an injectable formulation (Mustargen – Recordati) for the same and other indications.FDA approval of Valchlor was...