1. News You Can Use… Pete Koval, PharmD Lauren Hickman, PharmD Candidate Cone Health Family Medicine April 2015

2. New Drug Approval Toujeo (insulin glargine [rDNA origin] injection, 300 U/ml), a once-daily long-acting basal insulin, received FDA approval to treat Type 1 and Type 2 diabetes Same active ingredient as Lantus, but at three times the concentration and suggested to have a design to release insulin more gradually Lower rates of hypoglycemia were seen in clinical trials by not mentioned in the FDA- approved label 02/25/2015 FDA News and Events

3. New Drug Approval Skyla (levonorgestrel-releasing IUD) received FDA approval. The IUD continuously releases levonorgestrel, a progestin, to help prevent pregnancy for up to three years. Mirena is the other levonorgestrel-releasing IUD. Both products are made by Bayer. Skyla is smaller in size than Mirena, releases less levonorgestrel (14 mcg/day vs. 20 mcg/day), and is effective for a shorter period of time (3 years vs. 5 years). 03/02/2015 American Pharmacists Association

4. New Drug Approval Eylea (afilbercept): FDA approves new treatment for diabetic retinopathy in patients with diabetic macular edema An injection into the eye once a month for the first five injections, then once every two months Common side effects are bleeding of the conjunctiva, eye pain, cataracts, floaters, increased IOP, vitreous detachment, and endophthalmitis 03/25/2015 FDA News and Events

5. New Drug Approval FDA approves first-in-class Glyxambi (empagliflozin/linagliptin) tablets for adults with type 2 diabetes Only SGLT2/DPP-4 inhibitor combination to improve glycemic control as an adjunct to diet and exercise As an add-on to metform, Glyxambi was superior in reducing A1C when compared with either empagliflozin or linagliptin alone 03/24/2015 FDA News and Events

6. New Drug Approval FDA approves Jadenu (deferasirox), a new formulation of Exjade (deferasirox) to simplify treatment administration for patients with chronic iron overload Jadenu is the only once-daily oral tablet for iron chelation For patients with chronic iron overload due to blood transfusions in patients 2 years of age and older and in chronic iron overload in non- transfusion-dependent thalassemia syndromes (NTDT) in patients 10 years of age and older 03/30/2015 Novartis

7. New Drug Approval FDA approves Elepsia XR (levetiracetam) tablets for partial onset in patients with epilepsy Extended release formulation will help to decrease the pill burden for patients Supplied as 1000 mg and 1500 mg once- daily tablets For patients of 12 years of age or older 03/04/2015 First Word Pharma

8. New Drug Approval FDA has approved albuterol sulfate inhalation powder (ProAir RespiClick) for the treatment or prevention of bronchospasm in patients aged 12 years and older with reversible obstructive airway disease. Also approved for the prevention of exercised-induced bronchospasm in patients aged 12 years and older This is the first and only breath-actuated dry- powder rescue inhaler. 04/02/2015 APhA Pharmacy Today

9. New Vaccine Approval Quadracel: FDA approves Sanofi’s new vaccine that provides active immunization against: Diptheria,Tetanus, Pertussis, and Poliomyelitis For children ages 4-6 years old A single dose of Quadracel is a approved as a fifth dose in the DTaP series and as a fourth or fifth dose in the inactivated poliovirus vaccination (IPV) series, in children who have received four doses of Pentacel and/or DAPTACEL vaccine 03/24/2015 FDA Vaccines

10. Label Update FDA updates label for Chantix (varenicline): Chantix can change the way people react to alcohol (decreased tolerance, increased drunkenness, unusual or aggressive behavior, memory loss) Seizures occurred in patients that had no history of seizures and in patients that had a seizure disorder that had been well controlled 03/09/2015 FDA Drug Safety