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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.
Med Lett Drugs Ther. 2015 May 11;57(1468):69-70 | Show Introduction Hide Introduction

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...
Med Lett Drugs Ther. 2015 May 11;57(1468):73-4 | Show Introduction Hide Introduction

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).
Med Lett Drugs Ther. 2015 May 11;57(1468):e74-5 | Show Introduction Hide Introduction

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...
Med Lett Drugs Ther. 2015 May 11;57(1468):74-5 | Show Introduction Hide Introduction

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.
Med Lett Drugs Ther. 2015 May 11;57(1468):74-5 | Show Introduction Hide Introduction

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).
Med Lett Drugs Ther. 2015 Apr 27;57(1467):59-60 | Show Introduction Hide Introduction

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.
Med Lett Drugs Ther. 2015 Apr 27;57(1467):65-6 | Show Introduction Hide Introduction

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...
Med Lett Drugs Ther. 2015 Apr 27;57(1467):61-3 | Show Introduction Hide Introduction

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.
Med Lett Drugs Ther. 2015 Apr 27;57(1467):63-4 | Show Introduction Hide Introduction

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...
Med Lett Drugs Ther. 2015 Apr 27;57(1467):e66 | Show Introduction Hide Introduction