Epocrates Drug Updates - Editor's Pick

November 6, 2014
Ofev and Esbriet, First Drugs Approved for Idiopathic Pulmonary Fibrosis

The FDA recently approved Ofev (nintedanib) and Esbriet (pirfenidone), two "first-in-class" agents for the treatment of idiopathic pulmonary fibrosis (IPF). Both drugs have been shown to slow progression of lung function decline in IPF patients. Ofev is a kinase inhibitor that blocks multiple pathways involved with intracellular signaling of fibroblasts, while the mechanism of action for Esbriet is currently unknown.
Ofev and Esbriet, First Drugs Approved for Idiopathic Pulmonary Fibrosis

Recent Updates

October 30, 2014
Harvoni, New Combination Approved for Hepatitis C
The FDA recently approved Harvoni (ledipasvir/ sofosbuvir), a once-daily oral combination tablet for the treatment of chronic hepatitis C genotype 1 infection. Harvoni contains ledipasvir, a non-structural protein 5A (NS5A) inhibitor, and sofosbuvir, a non-structural protein 5B (NS5B) polymerase inhibitor previously approved as Sovaldi.
Harvoni, New Combination Approved for Hepatitis C

October 9, 2014
Hydrocodone Combination Products Now Schedule II
Effective October 6, 2014, the DEA has moved hydrocodone combination products from Schedule III to Schedule II. Hydrocodone combination products are among the most widely prescribed drugs in the United States, and are approved for the treatment of pain and for cough suppression.
Epocrates Drug Updates

October 9, 2014
Xolair FDA Medwatch Safety Alert
A recent FDA review of a 5-year safety study found a slightly increased risk of serious cardiovascular and cerebrovascular adverse events in patients treated with Xolair (omalizumab). Reported adverse events include transient ischemic attack, myocardial infarction, unstable angina, pulmonary embolism/venous thrombosis, and pulmonary hypertension. Early clinical studies demonstrated slightly higher malignancy rates in patients treated with omalizumab, but the 5-year safety study found similar rates between patients treated with and without omalizumab. The FDA was unable to rule out malignancy risk due to limitations in the safety study.
Xolair

September 25, 2014
Obesity Treatment Contrave Approved
Contrave, an extended-release combination of naltrexone and bupropion hydrochloride was recently approved for the treatment of obesity in conjunction with a reduced-calorie diet and exercise. Contrave is indicated in overweight adults that have a weight-related comorbidity and in obese adults. It carries a Boxed Warning for suicidality and neuropsychiatric reactions related to use of other bupropion products in depression and smoking cessation.
Obesity Treatment Contrave Approved

September 25, 2014
Keytruda Approved for Metastatic Melanoma
The FDA recently approved Keytruda (pembrolizumab) for melanoma deemed unresectable or progressing after therapy with ipilimumab and/or a BRAF inhibitor. Keytruda is a first-in-class monoclonal antibody directed against the programmed-death 1 (PD-1) receptor on T-cells, thus enhancing the immune response against malignant cells. However, due to its mechanism of action, notable toxicities include immune-mediated reactions that can involve nearly every organ (e.g., pneumonitis, colitis, hepatitis, and nephritis).
Keytruda Approved for Metastatic Melanoma

New Drug Monographs

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