Rivaroxaban (Xarelto )

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1 New Medications: Recent Releases, Updates, and Coming Attractions Sunny Linnebur, Pharm.D., FCCP, BCPS, CGP Associate Professor Joseph P. Vande Griend, PharmD, BCPS, CGP Assistant Professor Department of Clinical Pharmacy University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences Objectives 1. Identify new medications approved in the last year that may be useful in the clinical care of older adults 2. Identify characteristics, such as dosing, pharmacokinetics, side effects, and monitoring that may require special attention in older adults 3. Recognize patients who may be candidates for these medications, taking into consideration other patient characteristics 4. Describe indication updates to medications already on the market New Drugs VTE treatment Overactive bladder Tafluprost (Zioptan ) Glaucoma Avanafil (Stendra ) Erectile dysfunction Aclidinium bromide (Tudorza Pressair ) COPD Apixaban (Eliquis ) Non-Valvular A-Fib Quick update on Combivent and Cymbalta 1

2 FDA-approved for treatment of acute VTE and reduction in the risk of recurrence of VTE (11/2/12) Previous approvals: DVT ppx with knee & hip replacement (7/11) and atrial fibrillation (11/11) Manufacturer Janssen Pharmaceuticals Mechanism of Action Orally bioavailable factor Xa inhibitor that selectively blocks the active site of factor Xa Approved dosing for VTE tx Acute treatment: 15mg BID with food for the first 21 days, then 20mg daily with food for remaining treatment Long-term treatment: 20mg daily with food Avoid use in patients with a CrCl <30 ml/min No renal dosing recommended Afib renal dosing for CrCl ml/min = 15mg daily Antidote No reversal agent available Potential for prothrombin complex concentrate Absorption maxed at 50mg Monitoring Bleeding, renal function Black Box Warning Discontinuation in A-fib Spinal/epidural hematoma Side effects Bleeding Drug interactions CYP3A4 inducers/inhibitors Cost Currently covered under several formularies $270 monthly Clinical Trials: EINSTEIN studies (DVT/PE) Open label, noninferiority trials for 3-12 months Rivaroxaban 15mg BID X3wks, then 20mg daily OR Enoxaparin 1mg/kg BID + vit K antagonist Goal INR = 2-3 (in range 60%) Inclusion/exclusion DVT study: Acute proximal DVT without PE PE study: Acute PE with/without DVT Excluded: those receiving >48 hrs of heparin/lmwh or >1 dose of warfarin; CrCl< 30 ml/min, liver dz, treatment with CYP3A4 inhibitor/inducer, others NEJM 2010;363: (DVT/Extension); NEJM 2012;366: (PE) 2

3 Clinical Trials: EINSTEIN studies (DVT/PE) DVT study 3449 pts Mean age 56 yrs Cause: unprovoked 61% Hx previous VTE: 19% CrCl 30-49: 7% PE study 4562 pts Mean age 58 yrs Cause: unprovoked 64% Hx previous VTE: 19% CrCl 30-49: 8% 1 Efficacy endpoint: Symptomatic recurrent VTE 1 Safety endpoint: Clinically relevant bleeding (major or clinically relevant non-major bleeding) 2 endpoint: Net clinical benefit (1 outcome or major bleeding) Clinical Trials: EINSTEIN studies (DVT) HR: 0.68 (CI: ; p <0.001 for non-inferiority) NEJM 2010;363: (DVT/Extension); NEJM 2012;366: (PE) NEJM 2010;363: (DVT/Extension); NEJM 2012;366: (PE) Clinical Trials: EINSTEIN studies (DVT) Treatment duration: 3mo (12%), 6mo (63%), 12mo (25%) Clinical Trials: EINSTEIN studies (PE) HR: 1.12 (CI: ; p =0.003 for non-inferiority) Outcome Rivaroxaban Warfarin Events (n) Event rate (%) Events (n) Event rate (%) Hazard ratio (95% CI) P-value 1º Outcome ( ) < º Safety ( ) 0.77 Major bleeding ( ) 0.21 Clinically relevant non-major Net Clinical Benefit ( ) 0.03 NEJM 2010;363: (DVT/Extension); NEJM 2012;366: (PE) NEJM 2010;363: (DVT/Extension); NEJM 2012;366: (PE) 3

4 Clinical Trials: EINSTEIN studies (PE) Treatment duration: 3mo (5%), 6mo (57%), 12mo (37%) Outcome Rivaroxaban Warfarin Events (n) Event rate (%) Events (n) Event rate (%) Hazard ratio (95% CI) P-value 1º Outcome ( ) º Safety ( ) 0.23 Major bleeding ( ) Intracranial 3 < Clinically relevant non-major Net Clinical Benefit ( ) 0.28 NEJM 2010;363: (DVT/Extension); NEJM 2012;366: (PE) Clinical Trial: EINSTEIN-Extension Double-blind, superiority trial for 6-12 months Rivaroxaban 20mg daily OR Placebo Inclusion/exclusion History of symptomatic DVT or PE Completed 6-12 mo treatment for acute event Vit K antagonist or rivaroxaban Excluded: CrCl < 30 ml/min, liver dz, treatment with CYP3A4 inhibitor/inducer, others NEJM 2010;363: (DVT/Extension) Clinical Trial: EINSTEIN-Extension 1197 patients Mean age 58 yrs Initial diagnosis: DVT 64%, PE 36%--mainly unprovoked Time since sx onset: median 6.8 months Previous VTE: 18% CrCl ml/min: 6% 1 Efficacy endpoint: Symptomatic recurrent VTE 2 endpoint: Net clinical benefit (1 outcome or major bleeding) Clinical Trial: EINSTEIN-Extension HR: 0.18 (CI: ; p <0.001 for superiority) NEJM 2010;363: (DVT/Extension) NEJM 2010;363: (DVT/Extension) 4

5 Clinical Trial: EINSTEIN-Extension Treatment duration: 6mo (60%), 12mo (40%) Outcome Rivaroxaban Placebo Events (n) Event rate (%) Events (n) Event rate (%) Hazard ratio (95% CI) P-value 1º Outcome ( ) < º Safety ( ) <0.001 Major bleeding NA 0.11 Clinically relevant non-major NEJM 2010;363: (DVT/Extension) Where does Xarelto fit for VTE tx? Only alternative to warfarin for VTE tx Oral, effective, no monitoring, expensive Similar bleeding to warfarin no reversal Unable to compare long-term therapy to warfarin Tx of recurrent events not really studied Rivaroxaban in older adults Likely good alternative for: Those unable to take warfarin due to inability to comply with INR monitoring Before considering IVC filter Limited to those with CrCl >30mL/min No renal dosing for those with CrCl ml/min Consider patient s insurance coverage may be cheaper than getting INRs FDA-approved for treatment of OAB with symptoms of urge UI, urgency, & urinary frequency (6/28/12) Manufacturer: Astellas Pharma Mechanism of action Β3 adrenergic activation relaxes the detrusor muscle during the storage phase to increase bladder capacity 5

6 Approved dosing Initial dose: 25 mg once daily Can be increased to 50 mg/d Dose adjustment: max 25 mg/d if CrCl ml/min or moderate hepatic impairment Not recommended in ESRD or severe hepatic impairment Pharmacokinetics Metabolism: multiple pathways 6-12% of unchanged drug renally eliminated t½ 50 hours Warnings and Precautions BP increase: B-1 adrenergic activity occurs at 200mg 3 pt in SBP w/50mg Potential worsening of urinary retention Patients with BPH or taking antimuscarinics Side effects: HTN (11%), UTI (4%), HA (3%), nasopharyngitis (4%) Cost: $ 244/mo Drug interactions Moderate inhibitor of CYP2D6 Dose adjustment may be necessary for narrow therapeutic index drugs that rely on CYP2D6 (e.g. thioridazine, flecanide, propafenone) Digoxin: use lowest dose of digoxin and monitor serum concentrations Three 12-week, DB, PBO-controlled studies 2736 patients Mean age 59 yrs (range 18-95) Studied 25mg, 50mg, and 100mg once daily Most took 50mg daily Modest, but significant reductions in incontinence episodes per 24h, micturitions per 24h, volume voided compared to PBO No differences in older adults Head-to-head data: 12 wk DB, RCT 4 treatment arms: Mirabegron 50mg Mirabegron 100mg Tolterodine ER 4mg/d Placebo 1987 patients Mean age 59 yrs 65 yrs: 37% 75 yrs: 9% Eur Urol 2013;63:

7 Adjusted Mean Δ in Incontinence/24h Adjusted Mean Δ in Micturitions/24h Eur Urol 2013;63: Eur Urol 2013;63: Where does Myrbetriq fit for OAB? Alternative to traditional antimuscarinic tx Similar efficacy Different side effect profile Mirabegron in older adults Likely well tolerated unless uncontrolled BP/HR Renal dosing: max 25 mg/d Consider patient s insurance coverage Tafluprost (Zioptan ) FDA-approved 2/10/12 Tafluprost % Indicated for ocular HTN or POAG Same MOA as other PG analogs Dose: one drop each evening Benefit over other products Preservative-free formulation Potentially less dryness/irritation Single use containers pkg #30 or #90 Storage: in refrigerator until the foil pack is opened, then good for 28 days 7

8 Avanafil (Stendra ) FDA-approved 4/27/12 Indicated for erectile dysfunction PDE-5 inhibitor Starting dose: 100mg PRN Available in 50mg, 100mg, 200mg No advantage over other PDE-5 inhibitors Same PK as sildenafil/vardenafil Similar DIs/CIs, except: Nitrates CI within 48 hours >3 EtOH drinks increases hypotension risk Label contains warnings about use in patients with CVD Aclidinium bromide (Tudorza Pressair ) Aclidinium (Tudorza Pressair ) FDA-approved for the long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. (July 23, 2012) Manufacturer Forest Pharmaceuticals, Inc. Mechanism of Action Long-acting anti-muscarinic agent with similar affinity to the M1 to M5 subtypes of muscarinic receptors In the airways, it exhibits pharmacological effects through inhibition of M3 receptor Aclidinium (Tudorza Pressair ) Approved dosing COPD: 400mcg inhaled twice daily No dosage adjustments Inhalation powder: the multi-dose device is a dry powder inhaler metering 400 mcg of aclidinium bromide per actuation 8

9 Warnings and Precautions Contraindications: None Warnings and Precautions Potential worsening of narrow angle glaucoma Potential worsening of urinary retention Absolute bioavailability of ~ 6% in healthy adults Use as indicated by guidelines; educate patients and monitor, especially in BPH/LUTS Drug interactions Limited potential for CYP450 Interactions no studies Side effects: Cost: currently covered under Tricare Administration via Pressair Breathe in until you hear a click sound. Keep breathing in, even after you have heard the inhaler click to be sure you get the full dose. Aclidinium (Tudorza ) Clinical Trials Change in trough FEV 1 from baseline # p < vs. placebo Eur Respir J 2012; 40: Aclidinium (Tudorza ) Aclidinium vs. Placebo vs. Tiotropium Double-blind, placebo- and active-controlled crossover clinical study with three 15-day treatment periods, separated by a 9- to 15-day washout Aclidinium 400 mcg BID vs. Tiotropium 18 mcg daily Inclusion (n = 27 patients completed) Moderate-Severe COPD Clinical diagnosis of COPD, aged 40 years or older, FEV 1 /FVC ratio of < 70% with FEV 1 of 30%-80% predicted, current or ex-smokers CHEST. 2012; 141(3):

10 Aclidinium (Tudorza ) Aclidinium vs. Placebo vs. Tiotropium Where does Tudorza fit? Alternative to tiotropium Limited clinical evidence, no head-to-head clinical comparison to other long-acting bronchodilators At this point, Aclidinium (Tudorza ) would only be preferred if cost was substantially less Statistically different between Aclidinium/Tiotropium vs. Placebo No clinical differences (e.g. rescue med use) between Aclidinium and Tiotropium CHEST. 2012; 141(3): FDA-approved to reduce the risk of stroke and systemic embolism in non-valvular atrial fibrillation (December 28, 2012) Manufacturer Bristol-Myers Squibb Mechanism of Action Oral, reversible, and selective active site inhibitor of factor Xa Approved dosing for non-valvular a-fib 5mg orally twice daily 2.5mg orally twice daily for patients with at least 2 of the following characteristics: Age > 80 years Body weight < 60 kg Serum creatinine > 1.5 mg/dl 10

11 Approved dosing for non-valvular a-fib 2.5mg orally twice daily for patients who are taking strong dual inhibitors of CYP3A4 and P-gp e.g. ketoconazole, itraconazole, ritonavir, clarithromycin Do not use with these drugs if already on 2.5mg twice daily because of age, weight, or renal function Avoid apixaban with strong dual inducers of CYP3A4 and P-gp due to reduced drug exposure e.g. rifampin, CBZ, PHT, St. John s Wort Antidote No reversal agent available Monitoring Weight, bleeding, renal function Black Box Warning Discontinuing in patients without adequate continuous anticoagulation increases the risk of stroke Side effects Bleeding Warnings/Precaution Use not recommended in patients with heart valves Cost Clinical Trials: Aristotle Noninferiority trial for median of 1.8 years 5mg twice daily or 2.5mg twice daily for those with 2 of the following: age > 80; weight < 60kg; SrCr > 1.5 mg/dl Warfarin adjusted to INR 2-3 (TTR = 62%) Inclusion/exclusion Non-valvular a-fib with intermediate risk (mean CHADS 2 = 2.1) One of the following: age > 75 yrs, previous stroke/tia, systemic embolism, LVEF < 35%, heart failure, diabetes, or HTN requiring treatment Excluded: conditions requiring warfarin (e.g. prostetic heart valve, aspirin > 165 mg/d, SrCr > 2.5 mg/dl, or calculated CrCl < 25 ml/min NEJM. 2011; 365: Clinical Trials: Aristotle 18,201 patients Median age 70 yrs (IQR: yrs) CHADS 2 score: 1 (34%); 2 (36%); > 3 (30%) 20% had previous TIA/stroke/systemic embolism 31% were using aspirin at baseline 1 Efficacy endpoint: Stroke and systemic embolism 1 Safety endpoint: major bleeding NEJM. 2011; 365:

12 Clinical Trials: Aristotle Newer anticoagulants vs. Warfarin Study RE-LY (dabigatran) Dose 1º outcome (% per year) Major bleeding All stroke Hemorrhagic stroke 110mg BID 1.53 vs vs vs vs mg BID 1.11 vs vs vs vs ROCKET-AF (rivaroxaban) 15 or 20mg daily 1.7 vs vs vs vs. 0.7 p < for non-inferiority p = 0.01 for superiority p < ARISTOTLE (apixaban) 2.5 or 5mg BID 1.27 vs vs vs vs Compared to warfarin, overall similar or lower rates in both ischemic stroke and major bleeding, lack of need for monitoring, small reduction in ICH, and less susceptibility to dietary and drug interactions. NEJM. 2011; 365: Yellow: statistical non-inferiority Green: statistical superiority Orange: statistically significant NEJM. 2009; 361: NEJM. 2011; 365: NEJM. 2011; 365: Newer Anticoagulant Comparison Apixaban Rivaroxaban Dabigatran* Mechanism Factor Xa inhibitor Factor Xa inhibitor Approved indications Non-valvular a-fib 1) Non-valvular a-fib 2) DVT/PE treatment 3) DVT prophylaxis Direct Thrombin Inhibitor Non-valvular a-fib Dosing 2.5 or 5mg BID 10, 15, or 20mg daily 110 or 150mg BID Elimination 25% renal 33% Renal, 66% Hepatic Renal Drug interactions CHADS 2 studied Strong CYP3A4/P-gp inhibitors/inducers Strong and weak CYP3A4/P-gp inhibitors/inducers N/A *Listed on the 2012 Beers list to use caution in those > 75 years or if CrCl < 30 ml/min Where does Eliquis fit? Alternative to warfarin, rivaroxaban, and dabigatran for non-valvular a-fib Will likely be chosen after rivaroxaban and dabigatran until clinical experience increases Twice daily dosing with similar drug interactions and features to rivaroxaban, so minimal advantage over rivaroxaban 12

13 Other Tidbits for Your Practice Duloxetine (Cymbalta ) FDA-approved for chronic musculoskeletal pain, in addition to all of the other indications Combivent reformulated to remove CFCs New version Combivent Respimat Old version gone 7/13 Brand name only No propellent Only alternative to warfarin for VTE New MOA, different SEs Apixaban (Eliquis ) Conclusions Tafluprost (Zioptan ) Brand, but no preservative Avanafil (Stendra ) Another option Aclidinium (Tudorza ) 13

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