Transcript NEWS YOU CAN USE 2015 10 UPD

News You Can Use…
Tommi Cooke, PharmD Candidate 2016
Pete Koval, PharmD
Cone Health Family Medicine
September 2015
New Drug Approval
• Addyi (flibanserin) gained FDA
approval for the treatment of acquired,
generalized hypoactive sexual desire
disorder (HSDD) in premenopausal
women
• It is a serotonin 1A receptor agonist and
serotonin 2A receptor antagonist
• It is dosed 100 mg daily at bedtime
08/18/2015 FDA.gov
New Drug Approval
• Repatha (evolocumab) gained FDA
approval for use in addition to diet and
maximally-tolerated statin therapy in
adult patients with heterozygous and
homozygous familial hypercholesterolemia or clinical ASCVD
• It is the second in PCSK9 class, with
Praluent (alirocumab) released in July
2015
08/27/2015 FDA.gov
Drug Approval Extension
• The FDA approved use of OxyContin
(oxycodone) for pain for children ages
11-16 years who can already tolerate a
minimum dose of 20 mg of oxycodone
• Potential uses endorsed by FDA – severe
pain due to trauma, surgery, or cancer
• Only other opioid approved for children is
Duragesic patch (fentanyl transdermal)
08/13/2015 AP.org
Drug Approval Extension
• The FDA has approved the use of
Aptiom (eslicarbazepine) as first-line
therapy for use in patients with partialonset seizures
• It was previously only approved for use if
the patient had failed 1-2 anticonvulsive
therapies
08/28/2015 BostonGlobe.com
FDA Warning
• FDA issued a warning of severe joint
pain for DPP-IV inhibitors (sitagliptin,
saxagliptin…)
• Patients are NOT advised to stop
taking these medications but are
advised to report joint pain to their
prescriber
• Monitor closely or avoid initiation in
patients with joint pain?
08/28/2015 FDA.gov
E-prescribing of Controlled
Substances
• E-prescribing of controlled
substances is now legal nationwide
• Vermont was the last state to legalize e-
prescribing of controlled substances
• Novant Health launched electronic
prescriptions for controlled
substances August 25th
8/31/15 MedScape
www.novanthealth.org
Trial Review
• OPT Compare trial shows tofacitinib
non-inferior to etanercept for chronic
plaque psoriasis
• Tofacitinib oral 5 mg and 10 mg
compared to etanercept 50 mg injected
twice weekly and placebo
• Patients on tofacitinib 10 mg rated noninferior symptom response scores
compared to patients on etanercept
08/15/2015 N Engl J Med
FDA Approvals
• Tresiba (insulin degludec): ultra long-
acting basal insulin that lasts up to 42
hours that may be given once or twice
daily
• Ryzodeg (insulin degludec/insulin
aspart) 70/30: premixed basal and
prandial insulin
09/25/2015 FDA.gov
FDA Approvals
• New treatment for schizophrenia and
bipolar disorder called cariprazine
(Vraylar®)
• Black Box Warning: Increased risk of
death if used in patients with
dementia-related psychosis
09/17/2015 FDA.gov
P&T Committee
• Sacubitril/valsartan (Entresto®) now
on formulary
• Indication: alternative treatment for
HFrEF
• Available strengths: 24/26mg,
49/51mg, and 97/103mg
9/16/15 Cone Health P & T
P&T Committee
• SGLT-2 Inhibitors will not be added to
the formulary
• Concerns: New FDA alerts about
increased incidence of euglycemic
DKA, increased risk of bone fracture
due to decreased BMD, dose-related
increases in LDL, hypotension,
hyperkalemia, yeast infections, and
UTIs
9/16/15 Cone Health P & T
P&T Committee
• Ceftazidime/avibactam (Avycaz®) and
ceftolozane/tazobactam (Zerbaxa®)
• On formulary – restricted to ID consult
• Indications: Complicated UTIs and
intraabdominal infections
• Available strenghts: Avycaz –
2GM/0.5GM, Zerbaxa – 1GM/0.5GM
9/16/15 Cone Health P & T