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 BID07/07/2015 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