4/4/2016. Objectives Pharmacist. Objectives Technicians. WSPA New Drugs New Laws 2016 Seattle, WA Disclosure: No Conflicts of Interest

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1 New Drug Update Terri L. Levien, Pharm.D. Clinical Professor WSU College of Pharmacy Spokane, Washington WSU Drug Information Center: (509) WSPA New Drugs New Laws 2016 Seattle, WA Disclosure: No Conflicts of Interest Objectives Pharmacist At the completion of this presentation, the pharmacist should be able to: 1. Describe indications, pharmacology, adverse effects, and dosing of new drugs and dosage forms recently or soon to be approved by the FDA. 2. Discuss key counseling and monitoring issues for the new drugs and the role these products may play in the participant s practice. 3. Compare the new drugs against existing agents. 4. Identify products approved with REMS, and describe the role of the pharmacist in the strategy Objectives Technicians At the completion of this presentation, the technician should be able to: 1. Recognize new drugs and dosage forms recently or soon to be approved by the FDA. 2. Describe indications and dosing of the new products. 3. Compare the new drugs against existing agents. 1

2 New Drugs Approved in novel drugs 16 First in class 21 Orphan Drugs 14 Fast Track 10 Breakthrough 24 Priority Review 6 Accelerated 87% First cycle 64% U.S. first Elbasvir/Grazoprevir (Zepatier, MSD) Approved January 28, 2016 Chronic hepatitis C virus genotypes 1 or 4 infection In adults With or without ribavirin Guidelines: among preferred regimens for treatment naïve GT1a and GT1b without and with cirrhosis, GT4 with cirrhosis Elbasvir is an HCV NS5A inhibitor Grazoprevir is an HCV NS3/4A protease inhibitor Dose: 1 tablet (50 mg elbasvir/100 mg grazoprevir) once daily with or without food Zepatier Prescribing Information, January 2016; Hepatitis C Online ( AASLD & IDSA HCV Guidance ( Elbasvir/Grazoprevir Efficacy primarily assessed in genotypes 1, 4, and 6 Only 28 patients of 1401 subjects in final studies with type 6 No active comparator studies SVR rates genotype 1 Treatment naïve: 95% Treatment experienced: 94% SVR rates genotype 4 Treatment naïve: 97% Treatment experienced: 100% Zepatier Prescribing Information, January 2016; Ann Intern Med. 2015;163:1 13; Gastroenterology. 2015;148:S1194; Lancet. 2015: 6736:349 9; Lancet HIV. 2015;2: ; J Hepatol. 2015;63:564 72; J Hepatol. 2015;62:2619 2

3 Elbasvir/Grazoprevir Contraindications Moderate or severe hepatic impairment OATP AB1/3 inhibitors, strong CYP3A inducers, and efavirenz Ribavirin contraindications if coadministered Warnings ALT elevations monitor Adverse reactions: fatigue, headache, nausea Drug Interactions Moderate CYP3A inducers not recommended Strong CYP3a inhibitors not recommended Duration of Treatment Elbasvir/Grazoprevir E/G + RBV GT1a: treatment naïve or pegifn/rbv experienced without baseline NS5A polymorphisms GT1a: treatment naïve or PegIFN/RBV experienced with baseline NS5A polymorphisms GT1b treatment naïve or PegIFN/RBV experienced GT1a or 1b: PegIFN/RBV/PIexperienced 12 weeks 16 weeks 12 weeks 12 weeks Daclatasvir (Daklinza, Bristol Myers Squibb) Approved July 24, 2015 For use with sofosbuvir, with or without ribavirin, for the treatment of patients with chronic HCV genotype 1 or genotype 3 infection Reduced SVR rates in genotype 3 infected patients with cirrhosis Guidelines recommend daclatasvir + sofosbuvir as first line for patients with genotype 3 HCV without cirrhosis and genotype 2 with or without cirrhosis; alternative for genotype 1 HCV NS5A inhibitor Tablet: 60 mg PO once daily with or without food 3

4 Daclatasvir Efficacy with sofosbuvir Genotype 1 SVR12 97% Genotype 2 SVR12 92% Genotype 3 SVR12 96% without cirrhosis SVR12 63% with cirrhosis Daklinza Prescribing Information, February 2016; Hepatology. 2015;61(4): ; N Engl J Med. 2014;370: Daclatasvir Contraindications Strong CYP3A inducers Warnings Bradycardia (with sofosbuvir and amiodarone) Adverse effects: headache and fatigue Drug Interactions Strong CYP3A inhibitors reduce daclatasvir dose (30 mg) Moderate CYP3A inducers increase daclatasvir dose (90 mg) Duration of Treatment Population Treatment and Duration Genotype 1 without cirrhosis Genotype 1 compensated (Child Pugh A) cirrhosis Genotype 1 decompensated (Child Pugh B or C) cirrhosis Genotype 1 post transplant Daclatasvir + Sofosbuvir for 12 weeks Daclatasvir + Sofosbuvir + Ribavirin for 12 weeks 4

5 Ombitasvir, Paritaprevir & Ritonavir (Technivie, AbbVie) Approved July 24, 2015 Treatment of chronic HCV genotype 4 infection without cirrhosis With ribavirin Two tablets once daily in the morning with a meal, without regard to fat or calorie content Duration: 12 weeks Technivie Prescribing Information, January 2016 Indications GT FDA Approved Guideline Recommended 1 Daclatasvir + sofosbuvir +RBV Elbasvir/grazoprevir + RBV Ledipasvir/sofosbuvir + RBV Ombitasvir/paritaprevir/RTV/dasabuvir + RBV Simeprevir + sofosbuvir Daclatasvir + sofosbuvir +RBV Elbasvir/grazoprevir + RBV Ledipasvir/sofosbuvir Ombiasvir/paritaprevir/RTV/dasabuvir + RBV Simeprevir + sofosbuvir +RBV 2 Sofosbuvir + RBV Sofosbuvir + RBV Daclatasvir + sofosbuvir 3 Daclatasvir + sofosbuvir Sofosbuvir + RBV 4 Elbasvir/grazoprevir + RBV Ledipasvir/sofosbuvir + RBV Ombitasvir/paritaprevir ritonavir + RBV Daclatasvir + sofosbuvir Sofosbuvir + RBV + pegifn Elbasvir/grazoprevir Ledipasvir/sofosbuvir Ombitasvir/paritaprevir/ritonavir + RBV 5/6 Ledipasvir/sofosbuvir + RBV Ledipasvir/sofosbuvir Hepatitis C Online ( AASLD & IDSA HCV Guidance ( Tenofovir alafenamide fumarate Cobicistat, elvitegravir, emtricitabine, tenofovir alafenamide fumarate (Genvoya, Gilead) Alternative to Stribild from Gilead same ingredients except contains tenofovir disoproxil fumarate Dosing: 1 tablet once daily with food Emtricitabine, rilpivirine, tenofovir alafenamide (Odefsey, Gilead) Alternative to Complera from Gilead same ingredients except contains tenofovir disoproxil fumarate Dosing: 1 tablet once daily with a meal 5

6 Tenofovir alafenamide fumarate Noninferiority studies Tenofovir alafenamide non inferior to tenofovir disoproxil fumarate decline in viral load Tenofovir alafenamide associated with smaller mean serum creatinine increases (0.08 vs 0.12 mg/dl; p<0.0001) Less proteinuria (median % change 3 vs 20; P<0.0001) Smaller decrease in bone mineral density at spine (mean % change 1.3 vs 2.86; P<0.0001) and hip ( 0.66 vs 2.95; p<0.0001) Lancet 2015;385(9987): PCSK9 Inhibitors Alirocumab Evolocumab Praluent, Sanofi Aventis Repatha, Amgen Approved July 24, 2015 Approved August 27, 2015 Subcutaneous Subcutaneous Adjunct to diet and maximally tolerated statin in heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease, requiring additional LDL cholesterol lowering Pharmacology: Inhibitors of proprotein convertase subtilisin kexin type 9 (PCSK9) Adjunct to diet and maximally tolerated statin in heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease, requiring additional LDL cholesterol lowering Adjunct to diet and other LDL lowering therapies in homozygous familial hypercholesterolemia requiring additional LDL C lowering Efficacy & Dosing Alirocumab 43 58% LDL reduction alone 46 52% LDL reduction with statin Limited outcomes data 75 mg subcutaneously every 2 weeks May increase to 150 mg Thigh, abdomen, upper arm Store in refrigerator Evolocumab 58 64% LDL reduction alone 52% LDL reduction with statin Limited outcomes data 140 mg subcutaneously every 2 weeks or 420 mg once monthly Thigh, abdomen, upper arm Store in refrigerator (pharmacy) Room temp. in carton at home BMC Medicine 2015;13:123; Praluent Prescribing Information, July 2015; Repatha Prescribing Information, August

7 Contraindications Alirocumab Serious hypersensitivity Evolocumab Serious hypersensitivity Cautions Alirocumab Allergic reactions Evolocumab Allergic reactions Alirocumab & Evolocumab Adverse events (>5%) Nasopharygitis, influenza, and injection site reactions Drug drug interactions None Sacubitril/Valsartan (Entresto, Novartis) Approved July 7, 2015 Reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure NYHA Class II IV Reduced ejection fraction Sacubitril neprilysin inhibitor Valsartan angiotensin II receptor blocker Canadian Guidelines: replace ACEi or ARB if hospitalization within past 12 months Can J Cardiol. 2015; 31:3 16; Entresto Prescribing Information, July

8 Sacubitril/Valsartan Efficacy vs enalapril in 8,442 patients with NYHA class II IV heart failure Composite Endpoint (CV death or CHF hospitalization) Sacubitril/valsartan 21.8% HR 0.9, 95% CI NNT 21.3 CV death 13.3% HR 0.8, 95% CI NNT 31.3 HF hospitalization 12.8% HR 0.79, 95% NNT 35.7 Enalapril 26.5% 16.5% 15.6% N Engl J Med. 2014;371(11): Sacubitril/Valsartan Contraindications Hypersensitivity History of angioedema from ACE inhibitor or ARB Concomitant ACE inhibitor Concomitant aliskiren in patients with diabetes Warnings Fetal toxicity black box warning Observe for angioedema and hypotension Monitor renal function and potassium Sacubitril/Valsartan Adverse effects >5% Hypotension (18%), hyperkalemia (12%), cough (9%), dizziness (6%), renal failure (5%) Drug interactions Concomitant blockade of renin angiotensin system Potassium sparing diuretics may increase potassium NSAIDs may increase renal impairment risk Lithium increased risk of lithium toxicity 8

9 Sacubitril/Valsartan Dose: Sacubitril 49 mg/valsartan 51 mg twice daily Double to 97/103 mg twice daily after 2 4 weeks Reduce starting dose to 24/26 mg twice daily Patients not currently taking an ACE inhibitor or ARB, or taking a low dose Patients with severe renal impairment Patients with moderate renal impairment Double dose as tolerated to 97/103 mg twice daily 97/103 Tablets (film coated, unscored): 24/26 mg, 49/51 mg, 97/103 mg Ivabridine (Corlanor, Amgen) Approved April 15, 2015 Reduce the risk of hospitalization for worsening heart failure Stable symptomatic chronic heart failure Left ventricular ejection fraction <35% In sinus rhythm with resting heart rate >70 beats per minute On maximally tolerated dose of beta blocker or contraindication to betablocker use Hyperpolarization activated cyclic nucleotide gated channel blocker Ivabridine Composite Endpoint (CV death or CHF hospitalization) Ivabridine (n=3,241) 24% HR 0.82, 95% CI 0.75 to 0.9 NNT 20 CV death 14% HR 0.91, 95% CI HF hospitalization 16% HR 0.74, 95% CI NNT 20 Placebo (n=3,264) Dose: starting dose is 5 mg twice daily 2.5 mg twice daily in patients with conduction defects or if bradycardia could lead to hemodynamic compromise Adjust based on heart rate after 2 weeks Maximum dose: 7.5 mg twice daily 29% 15% 21% Lancet. 2010;376:875 85; Corlanor Prescribing Information, April

10 Ivabridine Contraindications Acute decompensated heart failure Blood pressure less than 90/50 mmhg Sick sinus syndrome, sinoatrial block or 3 rd degree AV block Resting heart rate < 60 beats per minute Severe hepatic impairment Pacemaker dependence Strong CYP3A4 inhibitors Warnings Fetal toxicity females should use effective contraception Atrial fibrillation monitor Bradycardia monitor heart rate Not recommended in 2 nd degree AV block Ivabridine Adverse effects >1% Bradycardia (10%), hypertension (9%), atrial fibrillation (8%), luminous phenomena (phosphenes, visual brightness, 3%) Drug interactions CYP3A4 inhibitors strong contraindicated, moderate avoid CYP3A4 inducers avoid Negative chronotropes Monitor heart rate when taking with beta blockers, digoxin, amiodarone Selexipag (Uptravi, Actelion) Approved December 21, 2015 Treatment of pulmonary arterial hypertension WHO Group 1 To delay disease progression and reduce hospitalization risk Selective non prostanoid prostacyclin receptor agonist Alternative to treprostinil (an oral prostacyclin analog and other prostacyclin analogs) Dose titrated from 200 mcg twice daily to maximum dose of 1600 mcg twice daily, as tolerated 10

11 Idarucizumab (Praxbind, Boehringer Ingelheim) Approved October 16, 2015 Indicated in patients treated with dabigatran when reversal of the anticoagulant effect is needed: For emergency surgery/urgent procedures In life threatening or uncontrolled bleeding Monoclonal antibody fragment binds dabigatran and its acylglucuronide metabolites with higher affinity than the binding affinity of dabigatran to thrombin Neutralizes their anticoagulant effect Guidelines? Idarucizumab Efficacy: 100% reversal of anticoagulant effect in 90 patients Dose: 5 g IV provided as two separate 2.5 g/50 ml vials Limited data on additional 5 g dose Praxbind Prescribing Information, October 2015; NEJM. 2015;373: Idarucizumab Cautions Thromboembolic risk Re elevation of coagulation parameters Hypersensitivity reactions Hereditary fructose intolerance sorbitol excipient Adverse effects >5% Headache (5%), hypokalemia (7%), delirium (7%), constipation (7%), pyrexia (6%), pneumonia (6%) 11

12 Patiromer Sorbitex Calcium (Veltassa, Relypsa) Approved October 21, 2015 Treatment of hyperkalemia Not for emergency treatment of life threatening hyperkalemia Potassium binder nonabsorbable, anionic polymer Patiromer Efficacy in patients with chronic hyperkalemia Target potassium levels reached in 76% (95% CI 70 81) Mean dose 12.8 g in mild hyperkalemia Mean dose 21.4 g in moderate to severe hyperkalemia Remaining 24% of patients did not achieve target patiromer dose Starting dose 8.4 g PO once daily with food Adjust dose by 8.4 g daily as needed at one week intervals to desired serum potassium target range Mix with 30 ml + 60 ml water immediately prior to administration Veltassa Prescribing Information, October 2015; N Engl J Med. 2015;372: Patiromer Contraindications Hypersensitivity Cautions Binds many oral medications black box warning Administer other oral medications 6 hours before or 6 hours after patiromer Worsening gastrointestinal motility Hypomagnesemia Adverse effects (>2%) Constipation (7%), hypomagnesemia (5%), diarrhea (5%), nausea (2%), abdominal discomfort (2%), flatulence (2%) 12

13 Patients receiving which of the following agents should be counseled about phosphenes? a. Patiromer b. Ivabridine c. Sacubitril/Valsartan d. Evolocumab Hyperkalemia is an adverse effect of which agent? a. Patiromer b. Ivabridine c. Idarucizumab d. Sacubitril/Valsartan Interleukin 5 Antagonists Mepolizumab Reslizumab Nucala, GlaxoSmithKline Cinqair, Teva Approved November 4, 2015 Approved March 23, 2016 Subcutaneous Intravenous Add on maintenance treatment of patients with severe asthma with an eosinophilic phenotype Aged 12 and older Pharmacology: interleukin 5 antagonist monoclonal antibodies Add on maintenance treatment of patients with severe asthma with an eosinophilic phenotype Aged 18 and older Nucala Prescribing Information, October 2015; Cinqair Prescribing Information, March

14 Efficacy & Dosing Mepolizumab 0.83 exacerbations/year vs 1.74/year with placebo (RR 0.47, 95% CI 0.35 to 0.64) 100 mg subcutaneously every 4 weeks Thigh, abdomen, upper arm Reconstituted and administered by healthcare professional Reslizumab 0.86 exacerbations/yr vs 2.11/yr with placebo (RR 0.41, 95% CI 0.28 to 0.59) & 0.9 exacerbations/yr vs 1.8/yr with placebo (RR 0.5, 95% CI 0.37 to 0.67) 3 mg/kg IV every 4 weeks infused over minutes Administered by healthcare professional N Engl J Med. 2014; 371(13): ; Lancet Respir Med. 2015;3: Contraindications Cautions Mepolizumab Hypersensitivity Mepolizumab Hypersensitivity reactions Not for acute bronchospasm Discontinue corticosteroids gradually Herpes zoster Helminth infections Reslizumab Hypersensitivity Reslizumab Anaphylaxis black box Not for acute bronchospasm Discontinue corticosteroids gradually Malignancies Helminth infections Mepolizumab & Reslizumab Mepolizumab adverse events (>5%) Headache, injection site reactions, back pain, fatigue Reslizumab adverse events (>2%) Oropharyngeal pain 14

15 Glycopyrrolate inhalation powder (Seebri Neohaler, Novartis) Approved October 29, 2015 Long term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD) Anticholinergic Capsules: 15.6 mcg for use with Neohaler device Inhale the contents of one capsule twice daily Indacaterol/Glycopyrrolate inhalation powder (Utibron, Novartis) Approved October 29, 2015 Long term maintenance treatment of airflow obstruction in patients with COPD Long acting beta agonist (LABA)/anticholinergic (LAMA) Capsules: 27.5 mcg indacaterol/15.6 mcg glycopyrrolate Inhale contents of one capsule twice daily Lesinurad (Zurampic, AstraZeneca) Approved December 22, 2015 In combination with a xanthine oxidase inhibitor for treatment of hyperuricemia associated with gout in patients who have not achieved target serum uric acid levels with a xanthine oxidase inhibitor alone Mechanism: uric acid transporter 1 (URAT1) inhibitor 15

16 Lesinurad Efficacy Proportion achieving serum uric acid < 6 mg/dl after 6 months Study Placebo + Allopurinol Lesinurad + Allopurinol CLEAR 1 (N=603) 28% 54% CLEAR 2 (N=610) 23% 55% Dose: 200 mg once daily in the morning with food and water Stay well hydrated (2 L liquid per day) Do not initiate if CrCl < 45 ml/min Discontinue if CrCl persistently below 45 ml/min Zurampic Prescribing Information, December 2015; American College of Rheumatology Annual Meeting 2014; November 14 19, 2014; Boston, MA. Abstract L10 Lesinurad Contraindications Severe renal impairment, end stage renal disease, kidney transplant recipients, or patients on dialysis Tumor lysis syndrome or Lesch Nyhan syndrome Warnings Acute renal failure boxed warning More common if used alone Monitor renal function Cardiovascular events Not recommended in severe hepatic impairment Lesinurad Adverse effects (>2%) Headache (5%), influenza (5%), blood creatinine increased (10%), gastroesophageal reflux disease (3%) Drug Interactions Moderate CYP2C9 inhibitors caution Sensitive CYP3A substrates monitor for efficacy of substrate Hormonal contraceptives use nonhormonal method 16

17 Eluxadoline (Viberzi, Forest) Approved May 27, 2015 Treatment of irritable bowel syndrome with diarrhea Mechanism: mu opioid receptor agonist Eluxadoline Composite endpoint of reduced abdominal pain and improved Bristol Stool Score improved with eluxadoline vs placebo Abdominal pain response not different from placebo Bristol Stool Score improved vs placebo Dose: 100 mg twice daily with food Dose of 75 mg twice daily if: No gallbladder Unable to tolerate 100 mg dose Receiving concomitant OATP1B1 inhibitors Mild to moderate hepatic impairment Viberzi Prescribing Information, January 2016; N Engl J Med Jan 21;374(3): Eluxadoline Contraindications Biliary duct obstruction or sphincter of Oddi disease or dysfunction Alcoholism, alcohol abuse, or drink more than 3 alcoholic beverages/day History of pancreatitis or structural disease of the pancreas Severe hepatic impairment Severe constipation or known or suspected obstruction Warnings Sphincter of Oddi spasm and pancreatitis 17

18 Eluxadoline Adverse effects (>5%) Constipation (8%), nausea (8%), abdominal pain (7%) Discontinue if severe constipation for more than 4 days Drug interactions OATP1B1 inhibitors (eg, cyclosporine, gemfibrozil, rifampin) Strong CYP inhibitors (eg, fluconazole, clarithromycin, bupropion) Drugs that cause constipation CYP3A substrates with narrow therapeutic index (eg, fentanyl) Rosuvastatin (OATP1B1 and BCRP substrate) Insulin degludec (Tresiba, Novo Nordisk) Approved September 25, 2015 Long acting insulin to improve glycemic control in adults with diabetes mellitus Forms multi dexamers when injected into subcutaneous tissue resulting in a subcutaneous insulin degludec depot Delayed absorption from subcutaneous depot to systemic circulation Lesser effect from binding of insulin degludec to circulating albumin Combination product with insulin aspart (Ryzodeg 70/30) Insulin degludec Multiple studies versus insulin glargine and insulin detemir Type 1 diabetes vs insulin glargine and insulin detemir Noninferiority for HbA1c reduction Comparable hypoglycemia Lower incidence confirmed nocturnal hypoglycemia Type 2 diabetes vs insulin glargine Noninferiority for HbA1c reduction Comparable hypoglycemia Lower incidence confirmed nocturnal hypoglycemia Can be stored at room temperature up to 8 weeks Tresiba Prescribing Information, September 2015; Lancet. 2012;379: ; Diabetes Obes Metab. 2014;16:922 30; Diabetes Care. 2012;35: ;Lancet. 2012;379(9825):

19 Ixekizumab (Taltz, Lilly) Approved March 22, 2016 Treatment of moderate to severe plaque psoriasis in adult patients eligible for systemic therapy or phototherapy Human interleukin 17A antagonist Like secukinumab PASI 75 response at week 12 in 3 studies: 87 90% UNCOVER studies: PASI 75 at week 12: UNCOVER 2: 89.7% ixekizumab (87.4% difference from placebo; 48.1% difference from etanercept NNT = 2.1 UNCOVER 3: 87.3% ixekizumab (80% difference from placebo; 34% difference from etanercept NNT 2.9 Lancet 2015;386:541 51; Taltz Prescribing Information, March 2016 Ixekizumab Contraindications Hypersensitivity Warnings/precautions Infections (upper respiratory tract, oral candidiasis, conjunctivitis, tinea) Evaluate for tuberculosis Inflammatory bowel disease exacerbations Hypersensitivity Avoid live vaccines Adverse effects (>1%): injection site reactions (17%), upper respiratory tract infections (14%), nausea (2%), and tinea infections (2%) Ixekizumab Dosing 160 mg as two 80 mg subcutaneous injections at week 0 80 mg subcutaneously at weeks 2, 4, 6, 8, 10, and mg subcutaneously every 4 weeks thereafter Administration Single dose pen and prefilled syringe Remove from refrigerator 30 minutes before use Injection technique May self inject after training Sites: thighs, abdomen, or upper arms 19

20 Flibanserin (Addyi, Sprout) Approved August 18, 2015 Treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (low sexual desire that causes marked distress or interpersonal difficulty) Not caused by: Co existing medical or psychiatric condition Problems within the relationship The effects of a medication or other drug substance Not indicated for use in postmenopausal women or in men Serotonin 5 HT 1A agonist, 5 HT 2A antagonist, plus moderate 5 HT 2B, 5 HT 2C and dopamine D 4 receptor antagonist Mechanism unknown Addyi Prescribing Information, August 2015 Flibanserin Efficacy vs placebo same results in 2 large phase 3 studies Change in sexually satisfying events per month: +0.8 vs placebo No difference in sexual desire score vs placebo Dose: 100 mg once daily at bedtime Discontinue after 8 weeks if no improvement J Sex Med. 2012;9(4): ; J Sex Med. 2012;9(3): Flibanserin Contraindications due to risk of severe hypotension and syncope Alcohol must abstain Moderate or strong CYP3A4 inhibitors Hepatic impairment Warnings Hypotension and syncope CNS depression somnolence, sedation CYP2C19 poor metabolizers REMS certified prescribers and certified pharmacies 20

21 Flibanserin Adverse effects (>2%) Dizziness (11%), somnolence (11%), nausea (10%), fatigue (9%), insomnia (5%), dry mouth (2%) Drug interactions Oral contraceptives & other weak CYP3A4 inhibitors Strong CYP2C19 inhibitors CYP3A4 inducers Digoxin Brivaracetam (Briviact, UCB) Approved February 18, 2016 Adjunctive therapy in the treatment of partial onset seizures in patients 16 years of age and older with epilepsy High and selective affinity for synaptic vesicle protein 2A (SV2A) in the brain May contribute to anticonvulsant effect Brivaracetam Starting dose: 50 mg twice daily Adjust down to 25 mg twice daily or up to 100 mg twice daily based on tolerability and response Available as tablets, oral solution, and injection Injection dose (IV) same as oral Hepatic impairment: starting dose 25 mg twice daily; max dose 75 mg twice daily 21

22 Brivaracetam Contraindications Hypersensitivity Warnings Suicidal behavior and ideation Neurologic adverse effects: somnolence, fatigue, dizziness, gait disturbance, abnormal coordination Psychiatric adverse effects: non psychotic and psychotic Hypersensitivity: bronchospasm and angioedema Withdraw gradually Brivaracetam Adverse effects (>2%) Somnolence/sedation (16%), dizziness (12%), fatigue (9%), nausea/vomiting (5%), cerebellar disorders/balance disorders (3%), irritability (3%), constipation (2%) To be scheduled Brexpiprazole (Rexulti, Otsuka Pharm) Approved July 10, 2015 Adjunctive therapy to antidepressants for treatment of major depressive disorder Treatment of schizophrenia Partial agonist at serotonin 5 HT 1A and dopamine D 2 receptors Potent antagonist at serotonin 5 HT 2A and noradrenaline alpha 1B and alpha 2C receptors Similar to aripiprazole 22

23 Cariprazine (Vraylar, Forest) Approved September 17, 2015 Treatment of schizophrenia Acute treatment of manic or mixed episodes associated with bipolar I disorder Antagonism and partial activation of dopamine D2 and serotonin 5 HT 1A receptors 10 fold higher affinity for D3 versus D2L and D2S receptors Antagonism of the serotonin 5 HT 2A receptors High binding affinity for serotonin 5 HT 2B receptors Unique half life 2 4 days for cariprazine and 1 3 weeks for major active metabolite Which agent was approved with a REMS? a. Brivaracetam b. Flibanserin c. Idarucizumab d. ixekizumab Rolapitant (Varubi, Tesaro) Approved September 1, 2015 Indicated in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including highly emetogenic chemotherapy Substance P/neurokinin 1 receptor antagonist Dose 180 mg (2 tablets) 1 2 hours prior to start of chemotherapy With dexamethasone and a 5 HT3 receptor antagonist 23

24 Uridine triacetate (Vistogard, Wellstat) Approved December 11, 2015 Emergency treatment of adult and pediatric patients: Following a fluorouracil or capecitabine overdose regardless of the presence of symptoms Who exhibit early onset, severe or life threatening toxicity affecting the cardiac or CNS, and/or early onset, unusually severe adverse reactions within 96 hours following the end of fluorouracil or capecitabine administration Acetylated pro drug of uridine Uridine competitively inhibits cell damage and cell death caused by fluorouracil Uridine triacetate Contraindications, Warnings & Precautions None in labeling Adverse effects (>2%) Vomiting (10%), nausea (5%), diarrhea (3%) Adult dose: 10 g (1 packet) orally every 6 hours for 20 doses Pediatric dose: 6.2 g/m2 orally every 6 hours for 20 doses Do not chew granules mix with soft food (applesauce, pudding or yogurt) Oncology Medications Drug Route Class & Indication Necitumumab (Portrazza, Lilly) Alectinib (Alcensa, Roche) Osimertinib (Tagrisso, AstraZeneca) Cobimetinib fumarate (Cotellic, Genentech) Sonidegib (Odomzo, Novartis) IV PO PO PO PO Epidermal growth factor receptor (EGFR) antagonist; first line treatment metastatic squamous non small cell lung cancer (NSCLC) Kinase inhibitor; anaplastic lymphoma kinase (ALK) positive metastatic NSCLC (after crizotinib) Kinase inhibitor; metastatic EGFR T790M mutation positive NSCLC (after EGFR TKI therapy) Kinase inhibitor; unresectable or metastatic melanoma with a BRAF V600E or V600K mutation (with vemurafenib) Hedgehog pathway inhibitor; locally advanced basal cell carcinoma 24

25 Oncology Medications Drug Daratumumab (Darzalex, Janssen) Elotuzumab (Empliciti, BMS) Ixazomib (Ninlaro, Millennium) Trabectedin (Yondelis, Janssen) Dinutuximab (Unituxin, United) Tipiracil/Trifluridine (Lonsurf, Taiho) Route Class & Indication IV IV PO IV IV PO CD38 directed monoclonal antibody; multiple myeloma after at least 3 prior lines of therapy SLAMF7 directed immunostimulatory antibody; multiple myeloma after 1 to 3 prior therapies (give with lenalidomide and dexamethasone Proteasome inhibitor; multiple myeloma after at least 1 prior therapy (give with lenalidomide and dexamethasone) Alkylating agent; liposarcoma or leiomyosarcoma (after anthracycline containing regimen) GD2 binding monoclonal antibody; high risk neuroblastoma after partial response to first line therapy Thymidine phosphorylase inhibitor/nucleoside metabolic inhibitor; colorectal cancer (after FOLFIRI, anti VEGF, and anti EGFR) Which agent was approved as a first in class agent? a. Brivaracetam b. Ixekizumab c. Lesinurad d. Reslizumab Which agent is indicated for reversing the anticoagulant effects of dabigatran? a. Daratumumab b. Idarucizumab c. Ixekizumab d. Ivabridine 25

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