Tommi Cooke, PharmD Candidate 2016 Cone Health Family Medicine 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 hyper- cholesterolemia 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 partial- onset 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 non- inferior 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