1. 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

2. 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

3. 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

4. Drug Approval Extension
The FDA approved use of OxyContin (oxycodone) for pain for children ages 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

5. 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

6. 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

7. 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

8. 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

9. 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

10. 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

11. 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

12. 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

13. 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