Disclosures Pharmacist Objectives Technician Objectives New Drug

8/31/2016

Disclosures

• Both presenters have nothing to disclose. New Drug Updates

Lalita Prasad‐Reddy, PharmD, MS, BCACP, BCPS, CDE Clinical Assistant Professor Chicago State University College of Pharmacy

Diana Isaacs, PharmD, BCPS, BC‐ADM, CDE Clinical Pharmacy Specialist Cleveland Clinic Diabetes Center

September 16, 2016

Pharmacist Objectives Technician Objectives

• Describe the place in therapy and mechanisms of action • Describe the place in therapy and mechanisms of of newly approved drugs in the last 15 months. action of newly approved drugs in the last 15 months. • Compare newly approved agents from current agents utilized in the management of disease. • Compare newly approved agents from current agents utilized in the management of disease. • Describe newly approved agents in terms of their place in therapy, effectiveness, safety, and patient administration. • Describe newly approved agents in terms of their place in therapy, effectiveness, safety, and patient administration. • Summarize important patient counseling pearls for newly approved agents for the management of disease.

New Drug Stats New Drugs & Disease States

• From 2006‐2014 • Diabetes • Heart Failure – – – Average 28 novel drugs approved/year Insulin degludec (Tresiba®) Sacubitril/valsartan (Entresto®) – Lixisenatide (Adlyxin®) – Ivabradine (Corlanor®)

• In 2015, 45 novel drugs approved • Gout • Asthma – 16 (36%) are first‐in‐class (ex. Praxbind®) – Lesinurad (Zurampic®) – Reslizumab (Cinqair®) – 21 (47%) to treat rare/orphan diseases (ex. Kanuma®) – Mepolizumab (Nucala®) – 29 (64%) approved in the US before other countries (ex. • Bleeding reversal Entresto®) – Idarucizumab (Praxbind®) • Hepatitis C – Sofosbuvir/velpatasvir (Epclusa®) • Hyperlipidemia • In 2016 (as of July) – Elbasvir/grazoprevir (Zepatier®) – Evolocumab (Repatha®) – Daclatasvir (Daklinza®) – 16 novel drugs approved – Alirocumab (Praluent®)

Novel Drugs Summary 2015. Available at: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm474696.htm. Accessed August 8th, 2016

1 8/31/2016

The Ideal Basal Insulin Insulin Degludec (Tresiba®) • Indications for Insulin Degludec (Ideg) Possess a peakless profile – Improve glycemic control in adults with diabetes mellitus Deliver a consistent and reliable rate of absorption • Provide less variability in coverage among all populations FDA approved September, 2015

Cause no weight gain or hypoglycemia • Specifics – After injection, Ideg dihexamers join together creating Provide a true 24 –hour coverage following a single injection long, soluble multiheximer chains that prolong duration of action – Compared to glargine, exhibits equivalent of even Allow mixing of basal/bolus insulins in same injection syringe superior glycemic control – Available in U‐100 and U‐200 formulations Tresiba Pacakge Insert, NovoNordisk, 2015

A Comparison of Kinetics Tresiba® Clinical Data Property Glargine Glargine Degludec Study Design Intervention Results: Efficacy (U-300) (U-100) Fifty‐two weeks, Adults with type 2 diabetes Insulin degludec and insulin glargine decreased mean randomized, controlled, inadequately A1C concentrations from baseline by 1.06 and 1.19%, Onset 64-51 –2 open‐label, multi‐ controlled with oral glucose lowering respectively, with an estimated treatment difference of national, parallel design, agents were randomized to 0.09% (95% CI –0.04 to 0.22%), indicating that (hours) treat‐to‐target, non‐ insulin degludec (n = 773) or insulin degludec was noninferior to insulin glargine. Rates of inferiority trial glargine (n = 257) once daily, both in hypoglycemia were similar, with nocturnal Duration of 24-36 24 > 42 combination with metformin. hypoglycemia and severe hypoglycemia occurring less Action frequently (p < 0.05) with degludec. (hours) Fifty‐two weeks, Study B: Adults with type 2 diabetes Insulin degludec and insulin Half-life ~ 19 hours ~ 12 hours 25 hours randomized, controlled, inadequately controlled with glargine decreased mean A1C concentrations by 1.10 open‐label, treat‐to‐ Insulin +/‐ oral agents were and (T1/2) target, multi‐national, randomized to degludec (n = 755) or 1.18%, respectively, with an estimated non‐inferiority trial insulin glargine (n = 251) in treatment difference of 0.08% Time to 5 days 24 hours 3 days combination with aspart before (95% CI –0.05 to 0.21%), meeting criteria for meals, +/‐ metformin and/or noninferiority for degludec. Rates of overall Steady pioglitazone. hypoglycemia and nocturnal hypoglycemia were lower in those treated with insulin Degludec, while rates of State severe hypoglycemia were similar between groups.

Lantus pacakge insert, Sanofi, 2000. Diabetes Care 2015 Apr; 38(4): 637‐643 Tresiba Pacakge Insert, NovoNordisk, 2015

Diabetes Care 35:2464–2471, 2012. Lancet 379:1498–1507, 2012.

Patient Populations who may Benefit Degludec vs. Glargine from Tresiba® Degludec Glargine • Elderly Can be mixed in one injection Should not be mixed in one syringe with rapid‐acting insulin injection syringe with rapid‐acting • Learning difficulties insulin • Dependent on caretakers or healthcare Day‐to‐day variability of Day‐to‐day variability with absorption is significantly lower glargine seen in multiple patient professionals for insulin administration than glargine populations • Unable to achieve glycemic control despite Flexibility in dosing Requires once to twice daily administration optimized glycemic regimens Overall, Degludec is associated with improved glycemic control overall with less hypoglycemia

Lantus pacakge insert, Sanofi, 2000. Diabetes Care 2015 Apr; 38(4): 637‐643 Tresiba Pacakge Insert, NovoNordisk, 2015

2 8/31/2016

Which of the Following is a Lixisenatide (Adlyxin®) Difference Between Insulin • FDA approved: July, 2016 Degludec and Insulin Glargine? • Glucagon‐like‐peptide receptor agonist (GLP‐1 RA) • MOA: improves glycemic control through effects on glucose‐ dependent insulin secretion, glucagon secretion, gastric A. Insulin degludec can be mixed with insulin emptying, and satiety aspart in a syringe • Shorter half‐life (2‐5 hours), more impact on PPG compared B. Insulin degludec can be inhaled with other GLP‐1 RAs C. Insulin glargine causes less hypoglycemia D. Insulin glargine offers more flexibility in dosing

Lixisenatide. Micromedex 2.0. Available at: http://www.micromedexsolutions.com. Accessed August, 2016

Lixisenatide: GLP-1 RA Comparison A Me Too Drug? GLP‐1 RA Dosing Schedule CrCL Renal Dose A1c • Safety/effectiveness evaluated in 10 clinical trials (SC) Adjustments Lowering including 5400 patients with type 2 diabetes Albiglutide (Tanzeum®) 30mg‐50mg weekly None ~1% – Superior to placebo Dulaglutide (Trulicity®) 0.75‐1.5mg weekly None ~1.5% – Non‐inferior to exenatide BID and insulin glulisine Exenatide (Byetta®) 5mg‐10mg BID 1‐60 30‐50: use caution ~1% minutes before meals <30: not recommended Study Study Design Results Exenatide extended 2mg weekly 30‐50: use caution ~1.5% GetGoal X 634 patients, open‐label, After 24 weeks, similar reductions in A1C release (Bydureon®) <30: not recommended randomized to lixisenatide 20mcg and FBG. More weight loss with exenatide Liraglutide (Victoza®) 0.6mg dailyx1 week, Mild to severe renal ~1.5% daily or exenatide 10mcg bid. (‐3.98 vs. ‐2.96kg) and fewer GI events with then 1.2‐1.8mg daily impairment: not lixisenatide. recommended GetGoal‐ 896 patients on basal insulin After 26 weeks, lixisenatide non‐inferior to Lixisenatide (Aldyxin®) 10mcg daily x 2 weeks, 30‐50: use caution ~0.9% Duo2 randomized to lixisenatide or glulisine in A1C reduction (‐0.6% vs. ‐0.8%) then 20mg daily, 1 <30: not recommended insulin glulisine. and superior in weight loss (LS mean hour before breakfast difference: ‐1.99kg). PL Detail-Document, Comparison of GLP-1 Agonists. Pharmacist’s Letter/Prescriber’s Letter. December 2014 Lixisenatide. Micromedex 2.0. Available at: http://www.micromedexsolutions.com. Accessed August, 2016 Rosenstock et al. Diabetes Care. 2013 Oct; 36(10):2945‐51., Anderson et al. Ther Adv Chronic Dis. 2016 Jan; 7(1): 4–17. .

Which of the Following is an In the Pipeline: iGlarLixi Important Patient Counseling • Lixisenatide + insulin glargine in a fixed‐ratio pen Point for Lixisenatide? • Daily dose range: 10‐60 units corresponding to lixisenatide 5‐20mcg A. Take with food to avoid upset stomach B. Do not use if you are already taking insulin C. Common side effects include nausea and diarrhea D. Only needs to be injected once weekly

Lixisenatide and Insulin Glargine/Lixisenatide Briefing Document . Available at: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/UCM502559.pdf. Accessed August 11th, 2016

3 8/31/2016

Lesinurad (Zurampic®) Zurampic® Clinical Trials

• FDA approved December, 2015 for hyperuricemia in gout • 3 randomized, placebo‐controlled studies • MOA: reduces serum uric acid by inhibiting transporter proteins Drugs Design Results involved in uric acid reabsportion including uric acid transporter 1 (URAT1) and organic anion transporter 4 (OAT4) Zurampic® + 2 randomized 12 month A greater proportion of patients allopurinol vs. trials (n=1213) treated with Zurampic® combination allopurinol alone achieved UA<6mg/dL compared • Dose: 200mg QAM with food and in combo with a xanthine oxidase with allopurinol alone (54 vs 28% inhibitor and 55 vs 23%). No major differences in gout flares from 6‐12 • Adverse Effects: headache, Scr increase, GERD months. Zurampic® + 1 randomized 12 month More uric acid lowering with • Place in therapy: add on to allopurinol or febuxostat in patients not febuxostat vs. trial Zurampic® combination. No at target uric acid levels febuxostat alone significant difference in the rate of gout flares.

Lesinurad package insert. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207988lbl.pdf. Accessed August 12th, 2016 Lesinurad package insert. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207988lbl.pdf. Accessed August 12th, 2016

Other Chronic Gout Drugs

Uric Acid Lowering Drug MOA Usual Dose Place in Therapy Comments

Allopurinol Xanthine oxidase 100‐800mg PO 1st line Generic/cheap inhibitor (XOI) daily Febuxostat Xanthine oxidase 40‐80mg PO 1st line Brand/expensive inhibitor (XOI) daily Probenecid Uricosuric 250‐1000mg PO Alternative 1st line if CI Many drug BID or intolerance to XOI interactions Colchicine Anti‐inflammatory 0.6mg PO daily 1st line for acute gout Many drug or BID for attacks and gout interactions/ prophylaxis prophylaxis with uric expensive acid lowering therapy Pegloticase Catalyzes the 8mg IV infusion Gout refractory to Many adverse oxidation of uric q 2 weeks conventional therapy effects/ acid to allantoin expensive

Lesinurad package insert. Available at: Fleischmann et al. Rheumatology (2014) 53 (12): 2167‐2174. http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207988lbl.pdf. Accessed August 12th, 2016 Khanna et al. Arthritis Care & Research Vol. 64, No. 10, October 2012, pp 1431–1446

Which of the Following Zurampic®‐Clinical Pearls Drugs/Doses is Most Appropriate to Combine with Zurampic® for • Avoid if CrCL<45 ml/min Gout Treatment? • Take with food at the same time as xanthine oxidase inhibitor A. Colchicine 0.6mg PO daily • Black box warning: acute renal failure B. Probenecid 500mg PO BID • Monitor uric acid, renal function C. Allopurinol 100mg PO daily • Advise patients to drink 2L of fluid daily D. Febuxostat 80mg daily • Max out allopurinol or febuxostat before

adding Lesinurad package insert. Available at: Assume normal renal function http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207988lbl.pdf. Accessed August 12th, 2016

4 8/31/2016

Idarucizumab (Praxbind®) Praxbind®: Important Points

• Supplied: 2.5 GM/50 ML • Bleeding reversal for dabigatran (Pradaxa®) due to uncontrolled life‐threatening bleeding or a need to • Dose: 5g (2 vials) IV 1 time dose undergo emergency surgery • Keep refrigerated, unopened vials protected from light may be stored at • FDA approved October, 2015 room temp up to 48 hours, 6 hours if in light • Use solution within 1 hour of removing from vial • First and only DOAC reversal agent • Most common adverse effects (>5%): hypokalemia, constipation, fever, • MOA: humanized monoclonal antibody fragment‐ delirium binds to dabigatran and its metabolites with higher • affinity than dabigatran to thrombin, neutralizing its Increases thromboembolic risk anticoagulant effects • May restart dabigatran 24 hours later

Praxbind package insert. Available at http://docs.boehringer‐ingelheim.com/Prescribing%20Information/PIs/Praxbind/Praxbind.pdf. Accessed Aug 11th, 2016. Praxbind package insert. Available at http://docs.boehringer‐ingelheim.com/Prescribing%20Information/PIs/Praxbind/Praxbind.pdf. Accessed Aug 11th, 2016.

Praxbind®: Clinical Trials (Cont) Praxbind®: Clinical Trials Goal: Determine safety/efficacy of idarucizumab Study Study Design Results • Approved based on 3 clinical trials in healthy RE‐VERSE • 2arms of dabigatran: • Median age: 76.5 years volunteers AD • Group A (51 patients): life‐ • Median hospitalization: 8 days threatening bleeding • Dilute thrombin time was normalized in – Patients given dabigatran and then various amounts of • Group B (39 patients): invasive 98% of patients in group A and 93% of Praxbind® to establish effective dose and side effects surgery required that could patients in group B – Median age: 36 years not be delayed • Ecarin clotting time normalized in 89% • Over 90% received dabigatran for of group A and 88% group B stroke prevention in afib • 18 deaths overall (9 in each group) • • All patients received 5g of IV • 5 thrombotic events Accelerated FDA approval idarucizumab • 21 patients with severe adverse events Interim Analysis: plan to enroll ~300 patients • Summary: Idarucizumab rapidly and completely reversed the anticoagulant activity of dabigatran Ongoing trial in patients with life‐threatening or in 88 to 98% of patients uncontrolled bleeding or who need emergency surgery/urgent procedures

th http://www.praxbind.com/idarucizumab/clinical‐evidence. Accessed August 12 , 2016 Pollack CV et al. N ENGL J Med; 373;6

Praxbind® is Used to Reverse PCSK9 Inhibitors Which Anticoagulant(s)? • Indications: A. Warfarin only • Treatment of adults with heterozygous familial B. Dabigatran only hypercholesterolemia or clinical atherosclerotic cardiovascular disease C. Rivaroxaban only D. Any of the DOAC’s • Place in therapy: E. Enoxaparin • Those who need additional LDL lowering despite maximally tolerated statin Effects on cardiovascular mortality have NOT been determined!

N Engl J Med 2015; 373:1588‐1591

5 8/31/2016

PCSK‐9 Pharmacology A Comparison of Agents

Evolocumab (Repatha®) Alirocumab (Praluent®)

• FDA Approved • FDA Approved July, August, 2015 2015 • Reduced LDL ~ 55 – • Reduced LDL 46 – 75% 60% • 140 mg SUB‐Q every • 75 mg SUB‐Q every 2 2 weeks weeks • Associated with • Associated with drug‐ angioedema neutralizing antibodes

N Engl J Med 2015; 373:1588‐1591

Which of the Following Ivabradine (Corlanor®) Statements is True Regarding • FDA Approved April, 2015 PCSK‐9 Inhibitors? • Indications A. They are less effective than statins at LDL • To reduce the risk of hospitalization for lowering worsening heart failure in patients with B. They are dosed via a weekly IV infusion stable, symptomatic chronic heart failure C. They are associated with angioedema and • Left ventricular ejection fraction ≤ 35% drug‐neutralizing antibodies • Sinus rhythm with resting heart rate ≥ 70 beats per minute D. They reduce cardiovascular mortality • Must be on maximally tolerated doses of beta‐ blockers or have a contraindication to beta‐

blocker use Corlanor® pacakge insert, Amgen, 2015

Ivabradine Ivabradine Dosing and Monitoring

• Mechanism of action Initial Dose Dose Adjustments for Heart Rate Dosage Adjustments – Selectively and specifically inhibits the cardiac 5 mg twice daily with If heart rate > 60 bpm: 7.5 mg BID Dosage adjustments are pacemaker current within the SA node that regulates meals required in patients at heart rate If heart rate < 50 bpm: 2.5 mg BID risk for hemodynamic compromise, heart – Administration results in a dose‐dependent reduction conduction defects, in heart rate sinus node dysfunction, and elderly patients – Cardiac effects are specific to SA node • No effect on blood pressure Efficacy monitoring: Blood pressure, heart rate, heart rhythm

• No effect on myocardial contractility Safety monitoring: Heart rate, dizziness, fatigue, syncope • No effect on intra‐cardiac conduction If heart rate < 50 bpm on 2.5 mg dose, Corlanor® should be discontinued Does not exhibit negative inotropic effects!!! Corlanor® pacakge insert, Amgen, 2015 Corlanor® pacakge insert, Amgen, 2015

6 8/31/2016

Clinical Data: SHIFT Study Primary Composite Endpoint

Study Design Intervention Results: Efficacy Results: Safety

Randomized, double‐blind, Patients were Ivabradine was associated Ivabradine was placebo‐controlled, randomized to with a significant reduction in associated with fewer parallel group study in ivabradine 5mg BID the primary outcome (24% in serious adverse events patients with systolic HF, (titrated to max the ivabradine group vs. 29% in the ivabradine NYHA class II, III, IV 7.5mg BID) or in the placebo group) group (45% ivabradine symptoms, in a stable matching placebo (95% CI 0.75‐0.90; p<0.0001) vs. 48% placebo; condition for >4 weeks, on p=0.025) guideline‐based medical Background Cardiovascular deaths & all therapy with unchanged medications were cause deaths were not HF medications and doses continued which significantly reduced in the for >4 weeks, and with a included beta‐ ivabradine group (p=0.128) documented hospital blockers, ACE‐ but deaths due to HF (3% admission for worsening inhibitors, diuretics, ivabradine vs. 5% placebo; HF within the previous 12 and aldosterone p=0.014) & hospital months antagonists admissions for worsening heart failure decreased significantly (16% ivabradine vs. 21% placebo; p<0.0001) Lancet. 2010 Sep 11; 376(9744):875‐85.

Lancet. 2010 Sep 11; 376(9744):875‐85.

Stepwise Approach to Treatment of Sacubitril/Valsartan (Entresto® ) Heart Failure FDA Approved July, 2015 Indications If heart rate > 70 bpm • To reduce the risk of hospitalization and Aldosterone consider cardiovascular death in patients with chronic Antagonist addition of Beta‐blocker Ivabradine heart failure (NYHA Class II – IV) and reduced ejection fraction ACE/ARB

• Useful in patients who have progressed in heart failure severity despite the use of ACE- inhibitor therapy Entresto® package insert, Novartis, 2015

Sacubitril/Valsartan PARADIGM Study Study Design Intervention Results: Efficacy Results: Safety

• Mechanism of action due to combination neprilysin Randomized, Patients were Patients who were Entresto® was inhibiton (sacubitril) + ARB double‐blind, randomized to randomized to associated with phase 3 trial Entresto® 200 Entresto® had a an increased comparing mg vs. significant reduction n incidence of • Cardiovascular effects Entresto® to enalapril 10 the incidence of death hypotension, enalapril in mg BID from cardiovascular although – Enhanced levels of peptides due to inhibition of peptide patients with causes, hospitalization enalapril was degradation chronic heart due to heart failure, associated with • Vasodilation failure with a and death from any an increased • Sodium loss reduced ejection cause incidence of • Decrease in cardiac and vascular remodeling fraction currently hyperkalemia, – Inhibition of the effects of angiotensin II on a beta‐blocker and serum and ACE‐inhibitor creatinine • Vasodilation therapy increase

• Inhibits aldosterone release Entresto® package insert, Novartis, 2015 N Engl J Med 2014; 371:993‐1004

7 8/31/2016

Dosing and Monitoring What is the Mechanism of Action Initial Doses Target Dose Dosage Adjustments of Ivabradine? Previous ACE‐I or ARB – Titrate after 2 – 4 weeks Dosage adjustments are 49/51 mg bid to 97/103 mg bid as required in severe renal A. Improves glycemic control in adults with tolerated by the patient and moderate hepatic diabetes mellitus No ACE‐I or ARB or low impairment doses – 24/26 mg bid B. Inhibits the cardiac placement current within Use is not recommended in severe hepatic the SA node that regulates heart rate impairment C. Reduces LDLR degradation and increases If switching from another ACE/ARB therapy, 36 hour washout period is LDLR reutilization recommended D. Binds to dabigatran neutralizing its Efficacy monitoring: Blood pressure anticoagulant effects Safety monitoring: Serum creatinine, Electrolytes

Entresto® package insert, Novartis, 2015

Asthma – Monoclonal Antibodies Monoclonal Antibodies for Omalizumab (Xolair®) Resilizumab (Cinquair®) Mepolizumab (Nucala®) (March 2016) (November 2015)

Asthma Mechanism of IgE antibody Interleukin‐5 antagonist Interleukin‐5 antagonist action monoclonal antibody monoclonal antibody (IgG1 kappa) (IgG1 kappa)

Indications Moderate to severe persistent Add‐on maintenance Add‐on maintenance asthma in patients 6 years of age treatment of patients treatment of patients Three hallmark signs of and older with a positive skin test with severe asthma aged with severe asthma > 12 asthma to aeroallgen inadequately ≥18 years with an years 1) Airway inflammation controlled on ICS eosinophilic phenotype 2) Airway hyper‐ responsiveness Dosing 75 to 375 mg SC every 2 or 4 weeks 3 mg/kg IV q4wk infused 100 mg SQ q 4 weeks 3) Reversible airway (dependent on IgE level and weight) over 20‐50 minutes obstruction Adverse Arthralagias, myalgias, headache, Myalgias, elevated CPK, Headache, injection site effects viral infections , injection site oropharyngeal pain reactions, back pain, and reactions fatigue Anaphylaxis reactions are possible, and have occurred with all of the above!!!

Nucala pacakge insert. Glasko Smith Klein, 2015. ERJ Open Research 2015 1: 00024‐2015 Omalizumab pacakge insert, Novartis, 2003. Cinquair® pacakge insert, Teva Pharmaceuticals, 2016.

Novel Approaches to Hepatitis C Which of the Following Agents Virus (HCV) Requires Monitoring in a Physician’s Epclusa® Zepatier® Daklinza® (sofosbuvir/velpatasvir) (Elbasvir‐grazoprevir) (Daclatasvir) Office After Administration Due to (June 2016) (January 2016) (July 2016) Indications Indicated for adults with HCV Indicated for adults with HCV with or Indicated for adults with HCV infection genotypes 1, 2, 3, 4, 5, without ribavirin for genotypes 1 or 3 and 6 with and without cirrhosis treatment of chronic HCV genotypes 1 or 4 Anaphylaxis Concerns? infection in adults

Concomitant therapy Approved for use in combination Does not need to be administered with Must be taken with sofosbuvir, or with the drug ribavirin interferon and ribavirin with sofosbuvir + ribavirin A. Xolair® Adverse Effects Headache, fatigue Fatigue, headache, nausea, anemia* Headache, fatigue ,nausea, anemia Dosing One tablet (400 mg of sofosbuvir One tablet taken orally once daily with or 60 mg once daily and 100 mg of velpatasvir) taken without food (Tablets: 50 mg elbasvir and B. Nucalla® orally once daily with or without 100 mg grazoprevir) food Clinical Pearls First drug available that treats all Breakthrough therapy for patients with Dose adjustments necessary for C. Cinquair® major genotypes of HCV hepatitis C genotype 1 disease who have CYP3A medications ESRD or HD, and for patients with hepatitis Bradycardia is a concern; Epcusa® C genotype 4 should not be used with D. All of the above amiodarone

Daklinza® package insert, BMS, 2015. Epclusa® package insert, Gilead Sciences, 2016. Zapatier package insert, Merck, 2016..

8 8/31/2016

Which of the Following Agents Other Notable New Agents Drug Name Generic Approval Date Indication Can be Administered Without Xlidra® lifitegrast ophthalmic 7/11/16 Dry eye disease solution Ribavirin for Treatment of HCV? Zinbryta® Daciluzumab 5/27/16 Multiple sclerosis Nuplazid® Pimavanserin 4/29/16 Hallucinations/delusions associated A) Epclusa® with Parkinson’s Disease Defitelio® defibrotide sodium 3/30/16 Hepatic veno‐occlusive disease s/p B) Daklinza® stem cell transplant Taltz® ixekizumab 3/22/16 Plaque psoriasis C) Zepatier® Anthim® obiltoxaximab 3/18/16 Inhalational anthrax D) All must be administered with ribavirin Briviact® brivaracetam 2/18/16 Partial onset seizures Uptravi® Selexipag 12/22/15 Pulmonary arterial hypertension Kanuma® Sebelipase alfa 12/8/15 Lysosomal acid lipase (LAL) deficiency Veltassa® Patiromer 10/21/15 Hyperkalemia Vraylar® Cariprazine 9/17/15 Schizophrenia/bipolar disorder

Summary

• Several groundbreaking new drugs for chronic disease states over the past year Questions?

• Most clinic guidelines not updated yet to reflect new drug choices Lalita Prasad‐Reddy, PharmD, MS, BCACP, BCPS, CDE [email protected] • Knowledge of new agents and clinical judgment is essential when treating patients Diana Isaacs, Pharm.D., BCPS, BC‐ADM, CDE [email protected]