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1 continuing education for pharmacists New Drugs: Arcapta, Brilinta and Xarelto Volume XXIX, No. 11 Thomas A. Gossel, R.Ph., Ph.D., Professor Emeritus, Ohio Northern University, Ada, Ohio and J. Richard Wuest, R.Ph., PharmD, Professor Emeritus, University of Cincinnati, Cincinnati, Ohio Dr. Thomas A. Gossel and Dr. J. Richard Wuest have no relevant financial relationships to disclose. Goal. The goal of this lesson is to provide background information on indacaterol (Arcapta ), ticagrelor (Brilinta ), and rivaroxaban (Xarelto ). Objectives. At the conclusion of this lesson, successful participants should be able to: 1. recognize the new drugs by generic name, trade name and chemical name when relevant;. identify the indication, pharmacologic action and clinical application for each drug; 3. choose important therapeutic uses for the drugs and their applications in specified pathologies; 4. demonstrate an understanding of adverse effects and toxicity, and significant drug-drug interactions for these drugs; and 5. select important information to convey to patients and/or their caregivers. Drugs discussed within this lesson are new molecular entity compounds (Table 1) indicated to treat a variety of afflictions. This lesson provides an introduction to the new drugs and is not intended to extend beyond a brief overview. The Prescribing Information leaflet or Medication Guide, and other published reference sources should be consulted for detailed descriptions. Gossel Wuest Indacaterol (Arcapta) The safety and efficacy of Arcapta (ar-cap-ta) Neohaler was demonstrated in six clinical trials that included 5,474 patients ages 40 Table 1 Selected new drugs for 011 years and older who had a clinical diagnosis of chronic obstructive pulmonary disease (COPD). The patients had a smoking history of at least one pack a day for 10 years and exhibited moderate-to-severe decreases in lung function. Indications and Use. Arcapta is a long-acting bronchodilator indicated for once-daily maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema. Arcapta is NOT indicated to treat acute deteriorations of COPD or asthma. Chronic Obstructive Pulmo- Generic (Proprietary Applicant/Sponsor/ Indication Dosage Form Name) Distributor Indacaterol (Arcapta) Novartis Long-acting β - 75 mcg Pharmaceuticals adrenergic agonist capsules Corporation for maintenance for use in bronchodilator Neohaler treatment of chronic obstructive pulmonary disease Rivaroxaban Janssen Factor Xa inhibitor 10 mg (Xarelto) Pharmaceuticals indicated for prophy- tablets Inc. laxis of deep vein thrombosis during knee or hip replacement surgery Ticagrelor (Brilinta) AstraZeneca LP PY 1 platelet inhib- 90 mg itor to reduce cardio- tablets vascular events in patients with acute coronary syndromes The Georgia Pharmacy Journal February 01 4

2 nary Disease. Approximately 1 million adults in the United States have COPD. The disease is one of the few chronic pathologies that have shown an increase in mortality in recent years. It is projected that by 00, the incidence of COPD will increase from its current level as the fourth leading cause to the third most common cause of death worldwide. COPD is a serious pulmonary disease that makes breathing difficult. Symptoms can include breathlessness, chronic cough and excessive phlegm. Disease exacerbations have a profound effect on patients with COPD, resulting in poor health and high mortality. Exacerbation of COPD is generally defined as an event in the natural course of the disease characterized by a change in the patient s baseline dyspnea (shortness of breath), cough and/or sputum that is beyond normal day-to-day variations, is acute in onset, and may warrant a change in regular medication. An exacerbation can last several weeks and result in lung function decline, increased risk of death, and may be associated with severe anxiety. COPD is often not diagnosed until the disease is very advanced because people do not know the early warning signs. Sometimes they think they are short of breath or less able to perform the tasks they are accustomed to because they are just getting old. But shortness of breath is never normal! The good news is that COPD can be found early and much can be done to treat and help manage the disease. The overall prevalence of COPD has increased more rapidly in women than in men. Chronic bronchitis affects twice as many women as men in the United States; however, the rate for emphysema development in women and men remains approximately equal. More women with COPD suffer from depression than men. Women with COPD experience significantly worse health-related quality of life for the same degree of severity of their disease compared with their male counterparts. Although the data are sparse, studies have shown that women with COPD have worse exercise performance than men with the same pathology. The major etiological factor in COPD in both men and women in developed countries is many years of heavy tobacco smoking during the asymptomatic, initial phase of the disease. Tobacco smoke contains reactive oxygen species (ROS) and numerous different chemical components, many of which cause toxic effects on the lung. Additionally, hydrogen sulfide is a potent antioxidant and vasorelaxant. ROS inflicts damage that can cause both immunosuppression and proinflammatory effects such as stimulation of phagocytosis. Despite the enormous global impact of COPD, no drug therapy has been shown to prevent disease progression or reduce mortality. However, medical researchers have shown greatly increased interest in COPD over the past few years. This attention to COPD has been linked to a better understanding of its cellular and molecular mechanisms and identification of novel targets for the discovery of new treatments. Current management guidelines recommend that patients with moderate or more severe COPD should receive treatment with one or more long-acting bronchodilators. Mechanism of Action. Inhaled indacaterol acts locally in the lung as a bronchodilator. Although β -receptors are the predominant adrenergic receptors in bronchial smooth muscle and β -receptors are 1 the predominant receptors in the heart, there are also β -adrenergic receptors in the heart that comprise 10 to 50 percent of the total adrenergic receptors. The pharmacologic effects of β -adrenoceptor agonist drugs, including indacaterol, are at least in part attributable to stimulation of intracellular adenyl cyclase, the enzyme that catalyzes conversion of adenosine triphosphate (ATP) to cyclic-3,5 - adenosine monophosphate (cyclic adenosine monophosphate; cyclic- AMP; c-amp). Increased c-amp levels initiate relaxation of bronchial smooth muscle. In vitro studies have demonstrated that indacaterol has more than 4-fold greater agonist activity on β -receptors compared to β -receptors. 1 Adverse Effects. In premarketing clinical trials, the most common adverse reactions (> percent and more common than placebo) were cough, oropharyngeal pain, nasopharyngitis, headache and nausea. Warnings, Precautions and Contraindications. The following warnings and precautions are listed: Treatment with Arcapta should not be initiated in acutely deteriorating COPD patients. Acutely deteriorating COPD is a life-threatening condition; Arcapta has not been studied in these patients. The drug should not be used for relief of acute symptoms. Concomitant short-acting β -agonists can be used for acute relief. The recommended dose should not be exceeded. Excessive use of Arcapta, or use in conjunction with other medications containing long-acting β -agonists can result in clinically significant cardiovascular events and may be fatal. Life-threatening paradoxical bronchospasm can occur. Arcapta should be discontinued immediately if this appears. In patients with cardiovascular or convulsive disorders, thyrotoxicosis or sensitivity to sympathomimetic drugs, Arcapta should be used with caution. The only contraindication is for use in patients with asthma; the product is not indicated for treatment of asthma. Arcapta carries a boxed warning that long-acting β -adrenergic agonists (LABA) increase the risk of asthma-related death. All LABA, including Arcapta, should not be used in patients with asthma, unless used with a long-term asthma control medication. The Georgia Pharmacy Journal February 01 5

3 Table M a j o r c o u n s e l i n g p o i n t s f o r A r c a p t a ( i n d a c a t e r o l ) i n h a l a t i o n * Arcapta is used to control symptoms of chronic obstructive pulmonary disease (COPD) in adults. It is NOT for use in asthma. Read the Medication Guide before you start using Arcapta and each time you get a refill. Tell your doctor: -if you have asthma, diabetes, heart problems, high blood pressure, seizures, or thyroid problems; -if your breathing problems worsen or your rescue medicine does not work as well; -if you have fast or irregular heartbeat, increased blood pressure, chest pain, or high blood sugar; -about all other prescription and nonprescription (OTC) medicines, vitamin/mineral supplements, natural products and herbal remedies you are taking. WOMEN: Notify your doctor if you become or intend to become pregnant, or are breastfeeding. Arcapta is for inhalation only. Do NOT swallow the capsules. Ask your doctor or pharmacist if you are not sure how to use the Neohaler device. The usual dose is once a day, at about the same time of day. Store Arcapta in a dry place. The capsules must be kept in the foil package until just before placing in the Neohaler. Do not use after the expiration date on the label. Properly discard unused medication. *Excerpted from the FDA-approved Medication Guide Drug Interactions. Drugdrug interactions listed include: Other adrenergic drugs: Arcapta may potentiate their effect and should be used with caution. Xanthine derivatives, steroids, diuretics or non-potassiumsparing diuretics that may potentiate hypokalemia or ECG changes: use with caution. MAO inhibitors, tricyclic antidepressants, and drugs that prolong the QTc interval: Arcapta may potentiate the effect on the cardiovascular system and should be used only with extreme caution. Beta-adrenergic blockers: Arcapta may decrease effectiveness of these drugs and should be used with caution and only when medically necessary. Dosage and Availability. Arcapta is to be used only by oral inhalation, 75 mcg once daily. The capsules must not be swallowed as the intended effect on the lungs will not be obtained, and should only be used with the Neohaler device that is provided. When used correctly, bronchodilation begins within five minutes of inhalation with peak effects in two to four hours. When beginning therapy with Arcapta, patients who have been taking inhaled, short-acting β -agonists on a regular basis (e.g., four times a day) should be instructed to discontinue the regular use of these drugs and use them only for symptomatic relief of acute respiratory symptoms. No dose adjustment is warranted based on age, gender, weight or ethnic subgroup. The product is available as inhalation powder contained in a hard capsule holding 75 mcg of indacaterol. Each dispensing pack contains a box of 30 capsules (five blister cards containing six capsules each) and a Neohaler device. Patient Information. Excerpts from the FDA-approved Medication Guide are shown in Table. Rivaroxaban (Xarelto) The risk of venous thromboembolism (VTE) following arthroplasty (total hip or total knee replacement surgery) is high and can result in significant morbidity and mortality. More than 6000 patients having had hip or knee replacement surgery received rivaroxaban in clinical studies. Among patients undergoing knee replacement surgery, 9.7 percent of those treated with rivaroxaban experienced a VTE compared with 18.8 percent of patients who received enoxaparin (Lovenox). In a study involving hip replacement surgery, 1.1 percent of patients who received rivaroxaban had a VTE compared with 3.9 percent of those who received enoxaparin. In another study of hip replacement patients,.0 percent of those treated with rivaroxaban had a VTE compared with 8.4 percent of those who received enoxaparin. Indications and Use. Xarelto (za-rel-toh) is a factor Xa inhibitor indicated for prophylaxis of deep vein thrombosis (DVT) which may lead to pulmonary embolism in patients undergoing knee or hip replacement surgery. Factor Xa is one of many substances involved in the formation of permanent clots. There are no data on the use of the International Normalized Ratio (INR) to monitor the dosage of rivaroxaban. Thromboembolic Disease. Arterial and venous thromboses remain the major cause of morbidity and mortality in the developed world. Arterial thrombosis has been directly associated with development of myocardial ischemia and stroke. Venous emboli, on the other hand, originate from deep vein thrombi in more than 95 percent of cases. These emboli are transported through the larger channels and generally pass through the right side of the heart and into the pulmonary vasculature where they form potentially fatal, pulmonary emboli. The estimated annual incidence of VTE approaches 00,000 cases per year in the United States. Among hospitalized patients, DVT occurs in 10 to 40 percent of patients undergoing medical or general surgical procedures. The incidence increases to 40 to 60 percent in persons undergoing major orthopedic surgery. Approximately 6 percent of persons with pulmonary embolism and 1 percent of those with DVT die within one month of diagnosis. At the present time, the standard treatment for acute VTE is limited to the use of low-molecularweight heparin that needs to be given subcutaneously. These drugs, which are often discontinued after The Georgia Pharmacy Journal February 01 6

4 discharge from the hospital, are cost-effective only when the patients or their caregivers can be taught to inject the drug at home with overlapping administration of a vitamin K antagonist (e.g., warfarin). This presents a substantial challenge to outpatient management, since treatment with warfarin requires regular laboratory monitoring (INR determination) and dose adjustment, and may be complicated by numerous drug and food interactions. After the first year, the annual risk of major bleeding associated with warfarin is 1 to percent. Consequently, the balance between risk and benefit of continued warfarin therapy remains a subject of debate, despite the high long-term risks of recur- rent venous thromboembolism. A practical solution to some of these issues could be to administer an oral anticoagulant such as Xarelto, that does not require laboratory monitoring, as a single agent for treatment of acute venous thromboembolism and for continued treatment. Mechanism of Action. Xarelto is an orally bioavailable factor Xa inhibitor that selectively and directly blocks the active site of factor Xa without the need for the cofactor anti-thrombin for activity. This distinguishes its mechanism of action from that of the indirect Xa inhibitors, such as the lowmolecular-weight heparins (e.g., the pentasaccharide fondaparinux [Arixtra]). Activation of factor X to factor Xa via the intrinsic and extrinsic pathways plays a central role in the cascade of blood coagulation. Direct thrombin inhibition impairs both the clotting cascade, and thrombin-induced platelet activation and aggregation. By inhibiting factor Xa, generation of thrombin from prothrombin is reduced. Besides, tissue factor-induced thrombin generation is inhibited. As a consequence, the prothrombin time increases with factor Xa inhibition in a dose-dependent fashion. Rivaroxaban is also being developed for prevention of recurrent DVT and for prevention of stroke in patients with atrial fibrillation. It is the second oral anticoagulant approved by FDA within the past year. Dabigatran (Pradaxa), a direct thrombin inhibitor, won FDA approval in 010 for prevention of stroke in patients with atrial fibrillation. It is not approved for DVT prophylaxis. Adverse Effects. The most common adverse reaction (>5 percent) noted in premarketing trials was hemorrhage. Warnings, Precautions and Contraindications. The following warnings and precautions are listed: Risk of bleeding: Xarelto can cause serious and fatal bleeding. Signs and symptoms of blood loss should be promptly evaluated. Pregnancy related hemorrhage: Xarelto should be used only with caution in pregnant women due to the potential for obstetric hemorrhage and/or emergent delivery. Signs and symptoms of blood loss should be promptly evaluated. Contraindications listed include hypersensitivity to Xarelto, and active major bleeding. Drug Interactions. The manufacturer lists the following interactions. Combined P glycoprotein (Pgp) and strong CYP3A4 inhibitors (e.g., carbamazepine, phenytoin, rifampin, St. John s Wort): Concomitant use should be avoided unless the lack of a significant interaction is proven. A Xarelto dose increase to 0 mg should be considered if these drugs must be coadministered. The 0 mg dose should be taken with food. Combined P-gp and weak or moderate CYP3A4 inhibitors (e.g., erythromycin, azithromycin, diltiazem, verapamil, quinidine, ranolazine, dronedarone, amiodarone, and felodipine): Concomitant use in patients with renal impairment should be avoided unless the benefit outweighs the bleeding risk. Combined P-gp and strong CYP3A4 inducers: Concomitant use should be avoided, or the healthcare provider should consider an increased dose. Anticoagulants (e.g., NSAIDs/aspirin): Concomitant use should be avoided. Clopidogrel (Plavix): Concomitant use should be avoided unless the benefit outweighs the bleeding risk. Dosage and Availability. The recommended dose is 10 mg taken orally, once daily, with or without food. For patients with hip replacement surgery, a treatment duration of 35 days is recommended. For patients undergoing knee replacement surgery, a treatment duration of 1 days is recommended. If a dose of Xarelto is missed, the dose should be taken as soon as possible on the same day and continued on the following day with once-daily intake as recommended. Xarelto is available as film-coated tablets containing 10 mg rivaroxaban. Patient Information. Excerpts from the FDA-approved Patient Counseling Information are shown in Table 3. Ticagrelor (Brilinta) Brilinta (brih-lin-tah) was approved to maintain blood flow to the heart to reduce the risk of a cardiovascular event. It was evaluated for safety and effectiveness in more than 10,000 patients, including more than 3,000 patients treated for more than one year. In clinical trials, ticagrelor was more effective than clopidogrel (Plavix) in preventing heart attack and death. That advantage was seen with aspirin maintenance doses of 75 to 100 mg daily. Indications and Use. Brilinta is a platelet inhibitor indicated to reduce the rate of thrombotic cardiovascular events in patients with acute coronary syndromes (ACS). Brilinta has been shown to reduce the rate of a combined endpoint of cardiovascular death, myocardial infarction, or stroke compared to clopidogrel. The difference between treatments was driven by cardiovascular death and myocardial infarction with no difference in the rate or severity of stroke. Acute Coronary Syndromes. ACS are the most common cause of The Georgia Pharmacy Journal February 01 7

5 that results in oxygen deprivation pathways and are associated with Table 3 in myocardial tissue. Platelets thus increased bleeding risk. M a j o r c o u n s e l i n g p o i n t s play a critical role in initiation and The substantial residual risk for f o r X a r e l t o ( r i v a r o x a b a n ) propagation of thrombosis. ischemic events and increased tablets* Multiple pathways mediate propensity for bleeding with aspiplatelet activation. Initial deposi- rin and clopidogrel highlight the Xarelto is used to help prevent blood clots from forming in patients after hip or knee replacement surgery. tion and activation is accomplished by interaction of cell surface glycoprotein (GP) receptors with subendothelial matrix proteins including need for novel therapeutic agents that can reduce cardiovascular events, ideally without increasing the risk for bleeding. Hemorrhage Read the Patient Information collagen and von Willebrand factor. has emerged as a major adverse before you start taking Xarelto and These events lead to release of outcome in patients with ACS, and each time you get a refill. various soluble agonists by adher- several trials have confirmed the Tell your doctor: ent platelets, which in turn stimu- association of bleeding with mortal- -if you have had any unusual bleeding. late recruitment and activation ity. The influence of major bleeding -if you have tingling, numbness or of circulating platelets to form a on mortality seems equivalent to muscle weakness, especially in your propagating thrombus. the effect of a myocardial infarclegs; unusual bleeding or bruising; The key platelet agonist throm- tion. new bleeding such as nose bleed, boxane A (TXA ), adenosine Unlike clopidogrel and pra- bleeding gums, blood in your urine diphosphate (ADP) and thrombin sugrel, ticagrelor is a member of or bowel movements, coughing up bind to distinct G protein-coupled a new class of PY antagonists 1 or vomiting blood; heavy bleeding receptors on the platelet surface. (see Acute Coronary Syndromes) from cuts or menstruation; dizzi- Although these substances initiate that bind reversibly. This provides ness or tiredness; pain, swelling or fluid leakage around your surgical signaling via distinct pathways, flexibility to the patient, allowing incision. they all lead to multiple common more rapid recovery of platelet -about all other prescription and events, including platelet degran- function after the drug is disconnonprescription (OTC) medicines, vitamin/mineral supplements, natuulation and release of soluble agonists, platelet shape change, actitinued. More rapid recovery of platelet function may be a doubleral products and herbal remedies vation of the GP IIb/IIIa fibrinogen edge sword, however, placing the you are taking. receptor, and ultimately platelet noncompliant patient at risk of a WOMEN: Notify your doctor if aggregation. thrombotic event at an earlier time you become or intend to become Before approval of ticagrelor, point when therapy is interrupted. pregnant, or are breastfeeding. Xarelto is usually taken once a available oral antiplatelet agents Studies have demonstrated greater day around the same time, with or approved in ACS included aspirin, antiplatelet effects of ticagrelor without food. an irreversible inhibitor of cyclo- compared with clopidogrel and Store Xarelto at room tempera- oxygenase 1-mediated TXA syn- greater reversibility. The anti- ture in its tightly closed container. thesis, and the PY antagonists platelet effects seen three days 1 Do not use after the expiration clopidogrel (Plavix) and prasugrel after discontinuation of ticagrelor date on the label. Properly discard (Effient) that selectively and ir- are comparable with those seen unused medication. reversibly bind to the PY ADP five days after discontinuation of 1 receptor. clopidogrel. *Excerpted from the FDA-approved Patient Counseling Information Treatment with the combi- Mechanism of Action. Tination of aspirin plus a PY cagrelor and its major metabolite 1 antagonist (i.e., clopidogrel) has reversibly interact with the platelet death worldwide. The term refers demonstrated greater efficacy than ADP PY receptors to prevent 1 to a spectrum of conditions that either drug alone, and aspirin plus ADP-induced platelet activation. result from myocardial ischemia, clopidogrel is considered the gold Ticagrelor and its active metaboand includes unstable angina and standard over single-agent therapy lite are very similar pharmacokimyocardial infarction. ACS may in blocking the platelet response. netically and are approximately develop slowly over many years Patients receiving dual antiplate- equipotent. by the buildup of atherosclerotic let therapy remain at substantial Adverse Effects. The most plaque. ACS usually occur due risk of ischemic events because common adverse reactions are to rupture of an atherosclerotic these agents do not interfere with bleeding (1 percent) and dyspnea plaque with superimposed throm- all platelet activation pathways (14 percent). botic occlusion of one or more coro- including the one mediated by Warnings, Precautions and nary arteries. Plaque disruption is thrombin. Moreover, because plate- Contraindications. The followaccompanied by resultant platelet let activation initiated by TXA ing warnings and precautions activation and aggregation at the and ADP is critical to hemostasis; are listed: site of the rupture, and thrombosis aspirin and clopidogrel target these As with other antiplatelet agents, The Georgia Pharmacy Journal February 01 8

6 Table 4 M a j o r c o u n s e l i n g p o i n t s f o r B r i l i n t a ( t i c a g r e l o r ) tablets* Brilinta is used with aspirin (not more than 100 mg) to lower your chance of having a heart attack or dying from a heart attack or stroke. Read the Medication Guide before you start taking Brilinta and each time you get a refill. Tell your doctor: -if you have ever had bleeding problems in the past, recent injury or surgery or plan to have surgery or dental work, a history of stomach ulcers or colon polyps, or lung problems; -if you are bleeding now, have a history of bleeding in your brain, have severe liver problems; -if you have bleeding that is severe or that you cannot control; pink, red or brown urine; vomit blood or your vomit looks like coffee grounds; red or black bowel movements; coughing up blood or blood clots; -if you have new or unexpected shortness of breath when you are at rest, or when you are doing any activity; -about all other prescription and nonprescription (OTC) medicines, vitamin/mineral supplements, natural products and herbal remedies you are taking. Do not take more than 100 mg of aspirin a day. WOMEN: Notify your doctor if you become or intend to become pregnant, or are breastfeeding. Brilinta is usually taken at around the same time each day, with or without food. Store Brilinta at room temperature in its tightly closed container. Do not use after the expiration date on the label. Properly discard unused medicine. *Excerpted from the FDA-approved Medication Guide Brilinta increases the risk of bleeding. In general, risk factors for bleeding include older age, a history of bleeding disorders, performance of percutaneous invasive procedures and concomitant use of medications that increase the risk of bleeding (e.g., anticoagulant and fibrinolytic therapy, higher doses of aspirin, and chronic nonsteroidal anti-inflammatory drugs). Moderate hepatic impairment: Risks versus benefits of treatment, noting the probable increase in exposure to ticagrelor should be considered. Dyspnea: Dyspnea was reported more frequently with Brilinta (14 percent of patients) than with clopidogrel (8 percent of patients). Dyspnea resulting from Brilinta is self-limiting. Other causes should be ruled out. Discontinuation of Brilinta: Premature discontinuation increases the risk of myocardial infarction, stent thrombosis, and death. Contraindications include a history of intracranial hemorrhage, active pathological bleeding and severe hepatic impairment. Drug Interactions. Ticagrelor is predominantly metabolized by CYP3A4, and to a lesser extent by CYP3A5. It is an inhibitor of CYP3A4/5 and P-gp. Avoid use of strong inhibitors of CYP3A4 (e.g., ketoconazole, itraconazole, voriconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir and telithromycin). CYP3A inducers (e.g., rifampin, dexamethasone, phenytoin, carbamazepine and phenobarbital). Aspirin: Use of Brilinta with aspirin maintenance doses above 100 mg reduced the effectiveness of Brilinta. Digoxin: Because of inhibition of the P-gp transporter, digoxin levels should be monitored with initiation of or any change in Brilinta therapy. Dosage and Availability. The initial (loading) dose is 180 mg, followed with 90 mg twice daily. After an initial loading dose of aspirin (usually 35 mg), Brilinta should be used with a daily maintenance dose of aspirin of 75 to 100 mg. Brilinta is available as tablets containing 90 mg of ticagrelor. The tablets must be kept in the container they come in, and the tablets kept dry. Patient Information. Ex- cerpts from the FDA-approved Medication Guide are shown in Table 4. O v e r v i e w a n d S u m m a r y Treatment of COPD, DVT and ACS are targeted with therapy involving the three new drugs presented in this lesson. Patients should receive benefit from the drugs when used correctly. The authors, the Ohio Pharmacists Foundation and the Ohio Pharmacists Association disclaim any liability to you or your patients resulting from reliance solely upon the information contained herein. Bibliography for additional reading and inquiry is available upon request. This lesson is a knowledge-based CE activity and is targeted to pharmacists in all practice settings. Program H01-P Release date: Expiration date: CE Hours: 1.5 (0.15 CEU) The Ohio Pharmacists Foundation Inc. is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. The Georgia Pharmacy Journal February 01 9

7 con tinuin g education quiz New Drugs : Arcapta, Brilinta an d Xarelto Please print. Name Address City, State, Zip Program H01-P 0.15 CEU 1. Arcapta is effective for treating: a. acute asthma. c. chronic asthma. b. acute COPD. d. chronic COPD.. Arcapta is a: a. short-acting bronchodilator. b. short-acting corticosteroid. c. long-acting bronchodilator. d. long-acting corticosteroid. 3. The overall prevalence of COPD has increased more rapidly in: a. men. b. women. 4. The pharmacologic effects of Arcapta are attributed to its being an adrenergic receptor: a. agonist. b. antagonist. 5. Arcapta stimulates adenyl: a. cyclase. c. oxidase. b. glucuronidase. d. reductase. 6. The Medication Guide for Arcapta advises patients to tell their doctor if they have: a. allergic rhinitis. c. glaucoma. b. cystic fibrosis. d. heart problems. 7. When beginning therapy with Arcapta, patients who have been taking an inhaled short-acting β -agonist on a regular basis should be advised to continue its regular use. a. True b. False Completely fill in the lettered box corresponding to your answer. 1. [a] [b] [c] [d] 6. [a] [b] [c] [d] 11. [a] [b] [c] [d]. [a] [b] [c] [d] 7. [a] [b] 1. [a] [b] [c] [d] 3. [a] [b] 8. [a] [b] [c] [d]] 13. [a] [b] [c] [d] 4. [a] [b] 9. [a] [b] 14. [a] [b] 5. [a] [b] [c] [d] 10. [a] [b] [c] [d] 15. [a] [b] [c] [d] I am enclosing $5 for this month s quiz made payable to: Ohio Pharmacists Association. 1. Rate this lesson: (Excellent) (Poor). Did it meet each of its objectives? yes no If no, list any unmet 3. Was the content balanced and without commercial bias? yes no 4. Did the program meet your educational/practice needs? yes no 5. How long did it take you to read this lesson and complete the quiz? 6. Comments/future topics welcome. NABP e-profile ID* *Obtain NABP e-profile number at Birthdate (MMDD) Return quiz and payment (check or money order) to Correspondence Course, OPA, 674 Federated Blvd, Columbus, OH Xarelto is an inhibitor of factor a. Ta. c. Xa. b. Va. d. Za. 9. By inhibiting the factor referred to in question 8, the generation of thrombin from prothrombin is: a. increased. b. decreased. 10. The most common adverse reaction with Xarelto noted in clinical trials was: a. anaphylaxis. c. hemorrhage. b. dyspepsia. d. tachycardia. 11. The recommended dose for Xarelto is 10 mg: a. once a day. c. three times a day. b. twice a day. d. four times a day. 1. The key platelet agonist is thromboxane: a. G. c. C. b. E. d. A. 13. The gold-standard over single-agent therapy in blocking the platelet response in acute coronary syndrome is aspirin plus: a. ticagrelor. c. clopidogrel. b. prasugrel. d. warfarin. 14. Brilinta and its major metabolite reversibly interact with the platelet ADP PY receptors to: 1 a. increase platelet activation. b. decrease platelet activation. 15. Brilinta should be used with a daily maintenance dose of: a. aspirin. c. prednisone. b. clopidogrel. d. warfarin. To receive CE credit, your quiz must be postmarked no later than November 15, 014. A passing grade of 80% must be attained. CE statements of credit are mailed February, April, June, August, October, and December until the CPE Monitor Program is fully operational. Send inquiries to The Georgia Pharmacy Journal 31 February 01 November 011

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