Rachel Mccaleb, Pharmd, BCPS

New Drug Update: 2016-2017 October 6, 2017 Rachel McCaleb, PharmD, BCPS

1. Objectives a. Pharmacist a.i. Recognize drugs that gained FDA approval within the last year a.ii. Describe indications, doses, formulations, adverse effects, and drug interactions of recently approved drugs a.iii. Summarize clinical data for recently approved drugs a.iv. Identify information regarding the recently approved drugs that should be communicated to patients b. Technician b.i. List new drugs that gained FDA approval within the last 12 months b.ii. Identify doses and formulation of the recently approved drugs b.iii. Be able to state the indication for the recently approved drugs 2. Introduction 3. Hepatology a. Sofosbuvir/velpatasvir/voxilaprevir (Vosevi®) b. Glecaprevir/pibrentasvir (Mavyret®) 4. Dermatology a. Crisaborole (Eucrisa®) b. Dupilumab (Dupixent®) c. Oxymetazoline hydrochloride (Rhofade®) d. Brodalumab (Siliq®) e. Guselkumab (Tremfya®) 5. Infectious Disease a. Bezlotoxumab (Zinplava®) b. Delafloxacin (Baxdela®) 6. Cardiology a. Betrixaban (Bevyxxa®) 7. Immunology a. Sarilumab (Kevzara®) 8. Endocrinology a. Dapagliflozin/saxagliptin (Qtern®) b. Etelcalcetide (Parsabiv®) 9. Gastroenterology a. Plecanatide (Trulance®) b. Telotristat etiprate (Xermelo®) c. Naldemedine (Symproic®) 10. Musculoskeletal a. Ocrelizumab (Ocrevus®) b. Abaloparatide (Tymlos®) 11. Neurology a. Deutetrabenazine (Austedo®) b. Valbenazine (Ingrezza®) c. Edaravone (Radicava®) d. Safinamide (Xadago®) 12. Oncology a. Rucaparib (Rubraca®) b. Ribociclib (Kisqali®) c. Neratinib (Nerlynx®) d. Niraparib (Zejula®) e. Brigatinib (Alunbrig®) f. Inotuzumab ozogamicin (Besponsa®) g. Enasidenib (IDHIFA®) h. Midostaurin (Rydapt®) i. Avelumab (Bavencio®) j. Durvalumab (Imfinzi®) k. Olaratumab (Lartruvo®)