1. News You Can Use… Simone Carden, PharmD Candidate Pete Koval, PharmD Cone Health Family Medicine July, 2016

2. New Drug Approval Byvalson ® (valsartan and nebivolol) is a combination of an angiotensin II receptor blocker and beta-blocker Indicated for treatment of hypertension Not yet available http://www.prnewswire.com/news-releases/allergan-announces-fda-approval-of-byvalson-nebivolol-and-valsartan-300279934.html

3. New Drug Approval Ocaliva ® (obeticholic acid) is a farnesoid X receptor agonist Indicated for primary biliary cholangitis in combination with ursodeoxycholic acid (Ursodiol) or alone in patients unable to tolerate ursodeoxycholic acid http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm503964.htm

4. New Drug Approval Epclusa ® (sofosbuvir and velpatasvir) is indicated for hepatitis C First drug used to treat all 6 major genotypes Can be used in patients with or without cirrhosis $74,760 for a 12-week course of treatment http://www.cbsnews.com/news/fda-approves-first-drug-epclusa-to-treat-all-forms-of-hepatitis-c/

5. New Drug Approval FDA approves Vaxchora ® A live attenuated vaccine used for prevention of cholera in patients 18 to 64 years of age Given as a single oral dose 10 days before travel to endemic areas http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm506305.htm

6. CDC News Update Live attenuated influenza vaccine (FluMist nasal spray) will not be used during the 2016-2017 flu season Recommend inactivated influenza vaccine (IIV) or recombinant influenza vaccine (RIV) for everyone 6 months and older Data from 2015-2016 in patients 2-17 years old showed the estimated vaccine effectiveness (VE) for LAIV against any flu virus was 3 percent IIV (flu shots) had a VE estimate of 63 percent http://www.cdc.gov/media/releases/2016/s0622-laiv-flu.html

7. LEADER Study Decreased rates of cardiovascular events and death from any cause were found in liraglutide (Victoza ® ) plus standard therapy versus placebo in patients with type 2 diabetes at high risk for cardiovascular events. Marso SP, Daniels GH, Brown-Frandsen K, et al. Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes. NEJM. June 2016.

8. FDA Warnings High doses of loperamide (Imodium ® ) leads to risk of potentially fatal heart problems Most cases were in patients intentionally abusing and misusing the drug to self-treat opioid withdrawal symptoms http:// www.fda.gov/Drugs/DrugSafety/ucm504617.htm

9. FDA Warnings Increased risk of acute kidney injury with Canagliflozin (Invokana ® ) and Dapagliflozin (Farxiga ® ) 101 cases identified via FDA adverse event reporting system http://www.fda.gov/Drugs/DrugSafety/ucm505860.htm

10. Cone Health Formulary Update Move to a “single, standard, intermediate” concentration of each PCA medication Alaris ® infusion pump PCA libraries will be expanded to meet the needs of the opioid- tolerant patient populations There will no longer be any double strength or concentrated PCAs Attempts to avoid potential errors with pump infusion rates Cone Health P&T June 2016