Download NEWS YOU CAN USE 2015 08 UPD

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