The medical letter on drugs and therapeutics february 27 2017

The Medical Letter ® on Drugs and Therapeutics Volume 59 ISSUE ISSUE No 1433 1515 Volume 56 February 27, 2017 ALSO IN THIS ISSUE Auvi-Q Epinephrine Auto-Injector Returns p 33 Crisaborole (Eucrisa) for Atopic Dermatitis p 34 Anticoagulation of Elderly Patients at High Risk for Falls with Atrial Fibrillation p 35 Extended-Release Calcifediol (Rayaldee) for Secondary Hyperparathyroidism p 36 Kyleena – Another Hormonal IUD p 38 Drug Interaction: Clopidogrel and PPIs p 39 Atezolizumab (Tecentriq) for Bladder Cancer and NSCLC online only Important Copyright Message FORWARDING OR COPYING IS A VIOLATION OF U.S AND INTERNATIONAL COPYRIGHT LAWS The Medical Letter, Inc publications are protected by U.S and international copyright laws Forwarding, copying or any distribution of this material is prohibited Sharing a password with a non-subscriber or otherwise making the contents of this site available to third parties is strictly prohibited By accessing and reading the attached content I agree to comply with U.S and international copyright laws and these terms and conditions of The Medical Letter, Inc For further information click: Subscriptions, Site Licenses, Reprints or call customer service at: 800-211-2769 Published by The Medical Letter, Inc • A Nonprofit Organization The Medical Letter publications are protected by US and international copyright laws Forwarding, copying or any other distribution of this material is strictly prohibited For further information call: 800-211-2769 The Medical Letter ® on Drugs and Therapeutics Volume 59 February 27, 2017 Take CME Exams ISSUE ISSUE No 1433 1515 Volume 56 ▶ ALSO IN THIS ISSUE Crisaborole (Eucrisa) for Atopic Dermatitis p 34 Anticoagulation of Elderly Patients at High Risk for Falls with Atrial Fibrillation p 35 Extended-Release Calcifediol (Rayaldee) for Secondary Hyperparathyroidism p 36 Kyleena – Another Hormonal IUD p 38 Drug Interaction: Clopidogrel and PPIs p 39 Atezolizumab (Tecentriq) for Bladder Cancer and NSCLC online only Auvi-Q Epinephrine Auto-Injector Returns Auvi-Q (Kaléo; previously manufactured and marketed by Sanofi), the epinephrine auto-injector approved by the FDA in 2012 for emergency treatment of anaphylaxis and voluntarily withdrawn in 2015 due to potential inaccurate dosage delivery,1 has become available once more According to Kaléo, improvements in the manufacturing process have addressed the concerns that led to its recall Table Epinephrine Auto-Injectors Drug Epinephrine injection, USP – generic (Mylan)3 EpiPen Jr (Mylan) EpiPen Epinephrine injection, USP4 – generic (Impax) Adrenaclick (Impax)7 Epinephrine injection, USP – Auvi-Q (Kaléo)8 Formulations1 Cost2 0.15 mg/0.3 mL, 0.3 mg/0.3 mL 0.15 mg/0.3 mL 0.3 mg/0.3 mL $300.00 300.00 608.60 608.60 0.15 mg/0.15 mL, 0.3 mg/0.3 mL 0.15 mg/0.15 mL, 0.3 mg/0.3 mL 395.205,6 460.905 4500.009 4500.009 The dose of epinephrine is 0.15 mg for patients who weigh 15-30 kg and 0.3 mg for those who weigh ≥30 kg Approximate WAC for one package containing two auto-injectors WAC = wholesaler acquisition cost or manufacturer’s published price to wholesalers; WAC represents a published catalogue or list price and may not represent an actual transactional price Source: AnalySource® Monthly February 5, 2017 Reprinted with permission by First Databank, Inc All rights reserved ©2017 www.fdbhealth.com/policies/drug-pricing-policy Interchangeable with EpiPen and EpiPen Jr Adrenaclick and its generic equivalent are similar to EpiPen and EpiPen Jr in size and functionality, but they are not considered interchangeable due to differences in device design and instructions for use Both strengths cost the same Both strengths are available at CVS for a cash price of $110.00 for two auto-injectors Adrenaclick is no longer being manufactured; its generic equivalent will continue to be marketed after supplies of Adrenaclick are depleted Auvi-Q is not interchangeable with other currently available epinephrine auto-injectors Manufacturer's list price for insurers Insurers and pharmacy benefit managers may negotiate with the manufacturer for a lower price or decide not to pay for Auvi-Q at all According to the manufacturer, the out-ofpocket cost is $0 for all commercially insured patients, whether or not their insurer covers the device The cash price for patients without government or commercial insurance is $360 for those with a household income ≥$100,000/year and $0 for those with a household income 80 years old c he should not take an anticoagulant because he is at risk for falls d a study in Medicare patients with atrial fibrillation and a high risk for falls found that those with risk factors other than age who took warfarin had a lower risk of death, stroke, MI, or any hemorrhage Calcifediol is: a a prohormone of calcitriol b a calcimimetic agent c an inactive form of vitamin D d all of the above In clinical trials in patients with stage or chronic kidney disease, secondary hyperparathyroidism, and vitamin D insufficiency, ER calcifediol: a reduced parathyroid hormone levels, but did not correct vitamin D insufficiency b corrected vitamin D insufficiency, but did not reduce parathyroid hormone levels c reduced parathyroid hormone levels and corrected vitamin D insufficiency d did not reduce parathyroid hormone levels or correct vitamin D insufficiency Kyleena – Another Hormonal IUD A 25-year-old nulliparous woman with heavy menstrual bleeding and dysmenorrhea asks you whether the Kyleena IUD would be a good choice for her because she has trouble remembering to take her oral contraceptive every day She plans to have children someday, but probably not for 4-5 years You could tell her that: a Kyleena is convenient and effective and can reduce her menstrual symptoms b Kyleena is not recommended for women who have not had any children c Kyleena will make her dysmenorrhea worse d she won’t be able to have children after Kyleena is removed Drug Interaction: Clopidogrel and PPIs 10 Which of the following best describes the mechanism by which PPIs such as omeprazole may reduce the antiplatelet activity of clopidogrel? a omeprazole reduces the absorption of clopidogrel by increasing gastric pH b omeprazole is thrombogenic c omeprazole induces CYP2C19, lowering serum concentrations of clopidogrel d omeprazole inhibits CYP2C19, limiting the conversion of clopidogrel to its active form ACPE UPN: Per Issue Exam: 0379-0000-17-515-H01-P; Release: February 27, 2017, Expire: February 27, 2018 Comprehensive Exam 76: 0379-0000-17-076-H01-P; Release: July 2017, Expire: July 2018 PRESIDENT: Mark Abramowicz, M.D.; VICE PRESIDENT AND EXECUTIVE EDITOR: Gianna Zuccotti, M.D., M.P.H., F.A.C.P., Harvard Medical School; EDITOR IN CHIEF: Jean-Marie Pflomm, Pharm.D.; ASSOCIATE EDITORS: Susan M Daron, Pharm.D., Amy Faucard, MLS, Corinne Z Morrison, Pharm.D., Michael P Viscusi, Pharm.D.; CONSULTING EDITORS: Brinda M Shah, Pharm.D., F Peter Swanson, M.D CONTRIBUTING EDITORS: Carl W Bazil, M.D., Ph.D., Columbia University College of Physicians and Surgeons; Vanessa K Dalton, M.D., M.P.H., University of Michigan Medical School; Eric J Epstein, M.D., Albert Einstein College of Medicine; Jane P Gagliardi, M.D., M.H.S., F.A.C.P., Duke University School of Medicine; David N Juurlink, BPhm, M.D., Ph.D., Sunnybrook Health Sciences Centre; Richard B Kim, M.D., University of Western Ontario; Franco M Muggia, M.D., New York University Medical Center; Sandip K Mukherjee, M.D., F.A.C.C., Yale School of Medicine; Dan M Roden, M.D., Vanderbilt University School of Medicine; Esperance A.K Schaefer, M.D., M.P.H., Harvard Medical School; F Estelle R Simons, M.D., University of Manitoba; Neal H Steigbigel, M.D., New York University School of Medicine; Arthur M F Yee, M.D., Ph.D., F.A.C.R., Weill Medical College of Cornell University MANAGING EDITOR: Susie Wong; ASSISTANT MANAGING EDITOR: Liz Donohue; EDITORIAL ASSISTANT: Cheryl Brown FULFILLMENT AND SYSTEMS MANAGER: Cristine Romatowski; SITE LICENSE SALES: Gene Carbona, Elaine Reaney-Tomaselli; EXECUTIVE DIRECTOR OF MARKETING AND COMMUNICATIONS: Joanne F Valentino; VICE PRESIDENT AND PUBLISHER: Yosef Wissner-Levy Founded in 1959 by Arthur Kallet and Harold Aaron, M.D Copyright and Disclaimer: The Medical Letter, Inc is an independent nonprofit organization that provides healthcare professionals with unbiased drug prescribing recommendations The editorial process used for its publications relies on a review of published and unpublished literature, with an emphasis on controlled clinical trials, and on the opinions of its consultants The Medical Letter, Inc does not sell advertising or receive any commercial support No part of the material may be reproduced or transmitted by any process in whole or in part without prior permission in writing The editors not warrant that all the material in this publication is accurate and complete in every respect The editors shall not be held responsible for any damage resulting from any error, inaccuracy, or omission Subscription Services Address: The Medical Letter, Inc 145 Huguenot St Ste 312 New Rochelle, NY 10801-7537 www.medicalletter.org Get Connected: Customer Service: Call: 800-211-2769 or 914-235-0500 Fax: 914-632-1733 E-mail: custserv@medicalletter.org Permissions: To reproduce any portion of this issue, please e-mail your request to: permissions@medicalletter.org Copyright 2017 ISSN 1523-2859 Subscriptions (US): year - $159; 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NSCLC www.medicalletter.org/TML-article-1515g The Medical Letter ® on Drugs and Therapeutics Volume 59 (Issue 1515) ▶ February 27, 2017 Atezolizumab (Tecentriq) for Bladder Cancer and NSCLC The FDA... to pass the exam ACCREDITATION INFORMATION: ACCME: The Medical Letter is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians... information presented in materials contained in The Medical Letter The Medical Letter will strive to continually improve the CME program through periodic assessment of the program and activities The Medical