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In Brief: Dinutuximab (Unituxin) for High-Risk Neuroblastoma (online only)

   
The Medical Letter on Drugs and Therapeutics • Mar 28, 2016  (Issue 1491)
on the surface of neuroblastoma cells.1 Dinutuximab received a priority review and orphan drug designation ...
The FDA has approved use of dinutuximab (Unituxin [yoo ni tux' in] – United Therapeutics) in combination with interleukin-2 (IL-2), granulocyte-macrophage colony-stimulating factor (GM-CSF), and isotretinoin for treatment of children with high-risk neuroblastoma who previously responded to first-line therapies. Dinutuximab is a monoclonal antibody that binds to GD2, a glycolipid that is overexpressed on the surface of neuroblastoma cells.1Dinutuximab received a priority review and orphan drug designation. Approval was based on the results of an open-label trial in 226 patients with...
Med Lett Drugs Ther. 2016 Mar 28;58(1491):e48 | Show Introduction Hide Introduction

In Brief: Uridine Triacetate (Xuriden) for Hereditary Orotic Aciduria (online only)

   
The Medical Letter on Drugs and Therapeutics • Mar 28, 2016  (Issue 1491)
(estimated birth prevalence: ...
The FDA has approved the pyrimidine analog uridine triacetate (Xuriden [zur' uh den] – Wellstat Therapeutics) for treatment of hereditary orotic aciduria, a rare autosomal recessive disorder (estimated birth prevalence: <1:1,000,000) in infants and children caused by a deficiency in uridine 5'-monophosphate (UMP) synthase. This deficiency prevents synthesis of uridine nucleotides and causes developmental delays, failure to gain weight, hematologic abnormalities, and excessive urinary excretion of orotic acid, which can lead to urinary obstruction.1 Xuriden is the first drug to be...
Med Lett Drugs Ther. 2016 Mar 28;58(1491):e49 | Show Introduction Hide Introduction

Safety of Testosterone Replacement Therapy

   
The Medical Letter on Drugs and Therapeutics • Mar 14, 2016  (Issue 1490)
to evaluate the safety of testosterone replacement therapy.1 ADVERSE EFFECTS — Testosterone administration ...
Three coordinated double-blind, placebo-controlled clinical trials have evaluated the efficacy of one year of testosterone replacement therapy in improving sexual function, physical function, and vitality in a total of 790 men ≥65 years old with moderately low serum testosterone concentrations and symptoms suggesting hypoandrogenism. Sexual function improved modestly, and there appeared to be marginal benefits in some areas of physical function and vitality as well. The trials were not designed to evaluate the safety of testosterone replacement therapy.
Med Lett Drugs Ther. 2016 Mar 14;58(1490):33-4 | Show Introduction Hide Introduction

Zarxio - A Filgrastim Biosimilar

   
The Medical Letter on Drugs and Therapeutics • Mar 14, 2016  (Issue 1490)
the reference product. A biosimilar that is approved as an “interchangeable product” (see Table 1) can ...
The FDA has approved filgrastim-sndz (Zarxio – Sandoz), a biosimilar of the recombinant human granulocyte colony-stimulating factor filgrastim (G-CSF; Neupogen), which has been available in the US since 1991. Zarxio is the first biosimilar product to be approved in the US; it has been available in Europe as Zarzio since 2009.
Med Lett Drugs Ther. 2016 Mar 14;58(1490):34-5 | Show Introduction Hide Introduction

Low-Dose Meloxicam (Vivlodex) for Osteoarthritis Pain

   
The Medical Letter on Drugs and Therapeutics • Mar 14, 2016  (Issue 1490)
and the recommendation to use the lowest possible doses of these drugs.1 Pronunciation Key Meloxicam : mel ox' i kam ...
The FDA has approved Vivlodex (Iroko), a low-dose formulation of the nonsteroidal anti-inflammatory drug meloxicam (Mobic, and generics), for management of osteoarthritis pain. According to the manufacturer, the new formulation aligns with stronger FDA warnings about the cardiovascular risks of NSAIDs and the recommendation to use the lowest possible doses of these drugs.
Med Lett Drugs Ther. 2016 Mar 14;58(1490):35-6 | Show Introduction Hide Introduction

Isavuconazonium Sulfate (Cresemba) - A New Antifungal

   
The Medical Letter on Drugs and Therapeutics • Mar 14, 2016  (Issue 1490)
treatment has not been well established.1 A lipid formulation of amphotericin B (AmBisome, Abelcet ...
The FDA has approved isavuconazonium sulfate (Cresemba – Astellas) for intravenous and oral treatment of invasive aspergillosis and invasive mucormycosis in adults. Isavuconazonium sulfate is a prodrug of isavuconazole, a broad-spectrum triazole antifungal.
Med Lett Drugs Ther. 2016 Mar 14;58(1490):37-8 | Show Introduction Hide Introduction

Elbasvir/Grazoprevir (Zepatier) for Hepatitis C

   
The Medical Letter on Drugs and Therapeutics • Feb 29, 2016  (Issue 1489)
of chronic hepatitis C virus (HCV) genotype 1 or 4 infection. Pronunciation Key Elbasvir : elb' as veer ...
The FDA has approved Zepatier (Merck), a fixed-dose combination of two direct-acting antiviral agents — elbasvir, an NS5A inhibitor, and grazoprevir, an NS3/4A protease inhibitor — for oral treatment of chronic hepatitis C virus (HCV) genotype 1 or 4 infection.
Med Lett Drugs Ther. 2016 Feb 29;58(1489):25-7 | Show Introduction Hide Introduction

Sonidegib (Odomzo) for Basal Cell Carcinoma

   
The Medical Letter on Drugs and Therapeutics • Feb 29, 2016  (Issue 1489)
for treatment of metastatic basal cell carcinoma.1 STANDARD TREATMENT — Basal cell carcinomas that cannot ...
The FDA has approved the hedgehog pathway inhibitor sonidegib (Odomzo – Novartis) for oral treatment of locally advanced basal cell carcinoma that cannot be treated with surgery or radiation or has recurred following such treatment. Vismodegib (Erivedge), another oral hedgehog pathway inhibitor, was approved earlier for the same indication and also for treatment of metastatic basal cell carcinoma.
Med Lett Drugs Ther. 2016 Feb 29;58(1489):31-2 | Show Introduction Hide Introduction

Clarification: Half-Life of Heroin

   
The Medical Letter on Drugs and Therapeutics • Feb 29, 2016  (Issue 1489)
Drugs Ther 2016; 58:1) might be misleading. We stated that heroin has a half-life of 2-6 minutes, which ...
A reader expressed concern that a statement in our article Naloxone (Narcan) Nasal Spray for Opioid Overdose (Med Lett Drugs Ther 2016; 58:1) might be misleading. We stated that heroin has a half-life of 2-6 minutes, which is correct, but heroin is a prodrug that is rapidly metabolized to 6-acetylmorphine and morphine. The risk of respiratory depression is related to those active metabolites, and it may persist well beyond the clearance of heroin from the blood.
Med Lett Drugs Ther. 2016 Feb 29;58(1489):32 | Show Introduction Hide Introduction

Olaparib (Lynparza) for Advanced Ovarian Cancer (online only)

   
The Medical Letter on Drugs and Therapeutics • Feb 29, 2016  (Issue 1489)
mild to moderate (grade 1-2) in severity. Fatal pneumonitis has been reported with olaparib ...
The FDA has approved the oral poly (ADP-ribose) polymerase (PARP) inhibitor olaparib (Lynparza – Astra-Zeneca) as monotherapy for treatment of women with advanced ovarian cancer who have BRCA1/2 germline mutations and have received at least 3 prior lines of chemotherapy. Olaparib is the first PARP inhibitor to be approved in the US. It is approved outside the US for maintenance treatment of relapsed BRCA-mutated ovarian cancer.
Med Lett Drugs Ther. 2016 Feb 29;58(1489):e32-33 | Show Introduction Hide Introduction