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News You Can Use… Stacey Karl, PharmD Pete Koval, PharmD Cone Health Family Medicine August 2015 New Drug Approval • Entresto (sacubitril/valsartan) gained FDA approval for the treatment of heart failure in patients with NYHA Class II-IV and reduced ejection fraction • It is to be used in the place of an ACE inhibitor or ARB • The target dose is 97/103 mg BID 07/07/2015 FDA.gov New Drug Approval • Praluent (alirocumab), a PCSK9 inhibitor, gained FDA approval for the treatment of adults with heterozygous familial hypercholesterolemia or patients with clinical atheroschlerotic cardiovascular disease • It is to be used in addition to diet and maximally tolerated statin therapy 07/24/2015 FDA.gov New Drug Approval • Rexulti (brexpiprazole) gained FDA approval for the treatment of adults with schizophrenia and as an add-on treatment to antidepressant therapy in adults with MDD • Black box warning: increased risk of death associated with the off-label use to treat dementia-related psychosis 07/13/2015 FDA.gov New Drug Approval • Daklinza (daclatasvir) gained FDA approval for use with sofosbuvir to treat hepatitis C virus genotype 3 infections • Daklinza is the first drug that has demonstrated safety and efficacy to treat genotype 3 without the need for co-administration of interferon or ribavirin 07/24/2015 FDA.gov Generic Approval • Almotriptan, generic for Axert, is now available • Almotriptan is indicated for the acute treatment of migraine attacks in patients with a history of migraine with or without aura • Available as 6.25 mg and 12.5 mg tablets 07/11/2015 Pharmacy Times Generic Approval • Metformin/repaglinide, generic for Prandimet, is now available • Metformin/repaglinide is indicated for the treatment of type two diabetes • Available as 500mg/1mg tablets and 500/2mg tablets 07/15/2015 FDA.gov Trial Review • RE-VERSE trial shows idarucizumab completely reversed the anticoagulant effects of dabigatran • Patients who were included had serious bleeding or required urgent procedures • The median investigator-reported time to the cessation of bleeding was 11.4 hours • Dilute thrombin time and ecarin clotting time was used to determine reversal 06/22/2015 N Engl J Med FDA Warning • FDA issued a warning of increased risk of myocardial infarction or stroke for NSAIDs • The risk of MI or stroke can occur as early as the first weeks of using an NSAID • The risk appears great at higher doses • The risk is also increased in patients without heart disease or risk factors 07/09/2015 FDA.gov