4/5/19. Pharmacy Update Jamie Hall, PharmD, BCPS. Objectives. Disclosure. No conflicts of interest to disclose Use of brand names

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1 Pharmacy Update Jamie Hall, PharmD, BCPS Objectives Determine the therapeutic class, indication(s), and place in therapy for a selection of drugs recently approved by the FDA Review the pharmacology of selected drugs including mechanism of action, dosing, adverse events, drug interactions, and other considerations Identify first time generics coming to market in 2019 Interpret new guideline recommendations Disclosure No conflicts of interest to disclose Use of brand names 1

2 Presentation Order New Drugs and Dosage Forms New Generics New Guidelines Diabetes New Drugs and Dosage Forms Toujeo Max SoloStar: Insulin Glargine Mechanism of Action Cost Long acting concentrated insulin (300 units/ml) Exogenous insulin replacement Administer once daily at the same time each day Delivers dose in two unit increments Maximum dose per injection is 160 units Hypoglycemia, weight gain Each pen holds 3mL (900 units) and there are two pens in each box 1 box = ~ $550 Must be discarded after 56 days at room temperature or after first use 2

3 Chronic Obstructive Pulmonary Disease New Drugs and Dosage Forms Duaklir: Aclidinium, Formoterol Inhaled long acting beta agonist and long acting anticholinergic One puff twice daily Anticholinergic effects Cost??? Discard 60 days after opening foil tray Not for use in asthma FDA approved with release set for end of 2019 Yupelri: Revefenacin Inhaled long acting anticholinergic Cost Inhale contents of one vial (175mcg) per nebulizer once daily Anticholinergic effects > $1,000 for 1 month supply FDA indicated for COPD Medication should be removed from foil pouch immediately before use Can be administered using a standard nebulizer 3

4 Influenza Treatment New Drugs and Dosage Forms Xofluza (Baloxavir) Antiviral endonuclease inhibitor <80 kg: 40 mg as a single dose 80 kg: 80 mg as a single dose GI upset, nasopharyngitis Cost ~ $150 Must be started within 48 hours of onset of influenza symptoms Renal and severe hepatic dysfunction have not been studied Indicated in adults and children 12 years of age Migraine Prophylaxis New Drugs and Dosage Forms 4

5 Aimovig (Erenumab) Cost Monoclonal antibody, Calcitonin Gene-Related Peptide (CGRP) Receptor Antagonist 70mg subcutaneous injection once monthly Max dose 140mg once monthly Injection site reaction, constipation, muscle cramps and spasms ~$600 for 1 month supply Store in refrigerator and discard if out of refrigerator for >7 days Allow to come to room temperature for 30 minutes before administration Ajovy (Fremanezumab) Cost Monoclonal antibody, Calcitonin Gene-Related Peptide (CGRP) Receptor Antagonist 225mg subcutaneous injection once monthly Or 675 mg subcutaneous injection every three months Injection site reaction ~$600 for 1 month supply Store in refrigerator and discard if out of refrigerator for >24 hours Allow to come to room temperature for 30 minutes before administration Emgality (Galcanezumab) Cost Monoclonal antibody, Calcitonin Gene-Related Peptide (CGRP) Receptor Antagonist 240mg subcutaneous injection as a single loading dose and then 120mg subcutaneous injection monthly Injection site reaction ~$600 for 1 month supply Store in refrigerator and discard if out of refrigerator for >7 days Allow to come to room temperature for 30 minutes before administration 5

6 Formulation Confusion Epinephrine Injection Devices EpiPen Auto-injector EpiPen Jr. Auto-injector Auvi-Q Auto-injector Adrenaclick Auto-injector Symjepi Prefilled Syringe Epinephrine Injection Devices EpiPen: 0.3mg/0.3mL and EpiPen Jr: 0.15mg/0.3mL Epinephrine injection, USP auto-injector (U.S.; Mylan Specialty L.P.) is the authorized generic for EpiPen and EpiPen Jr. Adrenaclick (brand no longer manufactured in the US) 0.3mg/0.3mL and 0.15mg/0.15mL Epinephrine injection, USP auto-injector (U.S.; Impax Generics/Lineage Therapeutics) is the authorized generic for Adrenaclick 6

7 Epinephrine Injection Devices Auvi-Q: mg/0.3ml (30 kg and greater) mg/0.15ml (15 kg to 30 kg) mg/0.1ml (7.5 kg to 15 kg) No authorized generic for Auvi-Q Epinephrine Injection Devices Symjepi 0.3 mg/0.3ml prefilled syringe No authorized generic for Symjepi Epinephrine Injection Devices If your patient wants an auto-injector, consider writing your prescription for generic epinephrine auto-injector If your patient wants a prefilled syringe, consider writing your prescription for Symjepi prefilled syringe 7

8 New Generics New Generics Vardenafil (Levitra): Available now Tadalafil (Cialis): Available now Fluticasone/salmeterol (Advair Diskus): Available now Lispro (Humalog):?? Fesoterodine (Toviaz): May 2019 Solifenacin (Vesicare): May 2019 Pregabalin (Lyrica): July 2019 New Guidelines 8

9 American Diabetes Association 2019 Metformin and lifestyle modification are still first line Consideration of comorbidities including atherosclerotic cardiovascular disease (ASCVD), chronic kidney disease (CKD), congestive heart failure (CHF) 9

10 Other Updates GOLD COPD 2019 AGS Beers Criteria 2019 ACC/AHA CVD Primary Prevention 2019 ACC/AHA Cholesterol

11 Questions 11