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Mrx CLINICAL ALERT MRx NOVEMBER 2018 CLINICAL ALERT YOUR MONTHLY SOURCE FOR DRUG INFORMATION HIGHLIGHTS HOT TOPIC: While yearly vaccination is the primary NEW FLU MED APPROVED means of preventing and controlling EDITORIAL flu outbreaks, treatment with antiviral Influenza places a considerable burden agents can lessen symptoms, shorten STAFF on the United States (US) healthcare duration of illness, and prevent serious system, with up to 35 million cases complications. reported each year. As the 2018- EDITOR IN CHIEF 2019 flu season gets underway, the UPDATED CONSENSUS ON Maryam Tabatabai Food and Drug Administration (FDA) DIABETES MANAGEMENT PharmD granted Priority Review and approval for Genentech/Shionogi’s baloxavir The American Diabetes Association marboxil (Xofluza™), the first new (ADA) and the European Association for EXECUTIVE EDITOR novel influenza antiviral in nearly 20 the Study of Diabetes (EASD) updated Carole Kerzic years. The new agent is indicated to their 2015 joint position statement on RPh treat acute uncomplicated influenza the management of type 2 diabetes in people ≥ 12 years of age with flu mellitus (T2DM). It includes a new DEPUTY EDITORS symptoms for ≤ 48 hours. Baloxavir decision cycle for patient-centered Stephanie Christofferson marboxil uses a unique mechanism glycemic management with a goal PharmD of action to block the replication of to prevent diabetes complications influenza A and B viruses, including and enhance quality of life (QOL). Jessica Czechowski Avian strains (H7N9, H5N1). In clinical Greater focus is placed on lifestyle PharmD studies, it was well tolerated and management and diabetes self- eased flu symptoms in about the management education and support. Lara Frick same amount of time as the market Weight loss strategies include lifestyle, PharmD, BCPS, BCPP leader, oral oseltamivir (Tamiflu®), and medical nutrition therapy (MNT), significantly less time compared to medication, and surgical interventions. Leslie Pittman placebo (54 versus 80 hours). Duration When T2DM is not controlled with PharmD of viral shedding was shorter with metformin plus lifestyle management, baloxavir marboxil compared to the ADA/EASD recommends addition oseltamivir and placebo (24, 72, and of a sodium-glucose cotransporter 96 hours, respectively). Furthermore, 2 inhibitor (SGLT2i) or glucagon-like baloxavir marboxil demonstrated peptide 1 receptor agonist (GLP1RA) efficacy against select oseltamivir- with proven benefit in select patients, resistant strains. Baloxavir marboxil, such as those with atherosclerotic which is approved as 20 mg and 40 mg cardiovascular disease (ASCVD) or tablets, is administered as a single oral chronic kidney disease (CKD), or in dose (weight-based, 40 mg or 80 mg), patients with clinical heart failure and while oseltamivir requires twice-daily ASCVD (SGLT2i preferred). An SGLT2i dosing for 5 days to treat the flu. In or GLP1RA is recommended when contrast, oseltamivir has a broader weight management is key. Adjunct indication for influenza treatment treatment with an SLGT2i, GLP1RA, in patients ≥ 2 weeks of age and dipeptidyl peptidase 4 inhibitor Download at: prophylaxis in patients aged ≥ 1 year. (DPP4i), or thiazolidinedione (TZD) is magellanrx.com | NOVEMBER 2018 recommended to minimize hypoglycemia. Further, in who have switched from another insurer during PSO most patients with T2DM, ADA/EASD recommends use of treatment. a GLP1RA over insulin as the first injectable medication. The committee also issued a report evaluating 2 GUIDANCE UPDATE ON RESISTANT medications recently FDA-approved for hereditary transthyretin amyloidosis (hATTR), a rare, often fatal HYPERTENSION genetic disorder, characterized by neurologic and cardiac The American Heart Association (AHA) updated the 2008 dysfunction. An estimated 3,000 to 3,500 Americans Scientific Statement on resistant hypertension (RH). The may be candidates for hATTR treatment. The 2 new AHA defines RH as above-goal elevated blood pressure agents, patisiran (Onpattro™) and inotersen (Tegsedi™), (BP) despite concurrent use of 3 antihypertensive demonstrated significant improvement in neuropathy drug classes at maximally tolerated doses or BP that and QOL. Patisiran is given by a healthcare professional requires ≥ 4 medications to achieve a target level. (HCP) as an intravenous (IV) infusion every 3 weeks, and Hypertension is typically treated with a diuretic, a long- inotersen can be self-administered SC once weekly. Until acting calcium channel blocker, and a renin-angiotensin approval of these agents, hATTR treatments in the US system blocker (angiotensin-converting enzyme inhibitor only included liver transplantation and off-label use of [ACEI] or angiotensin receptor blocker [ARB]). The the oral non-steroidal anti-inflammatory drug (NSAID), update complements the AHA’s revised target BP of diflunisal. ICER determined that while the new agents ≤ 130/80 mm Hg in patients on antihypertensive therapy; provide a substantial net health benefit compared to this lower threshold increases the number of patients best supportive care alone, their pricing greatly exceeds considered to have RH. Diagnosis of RH should be cost-effectiveness thresholds; therefore, use of prior made based on a 24-hour ambulatory BP measured authorization strategies is reasonable. after medication adherence has been confirmed. RH assessment should consider lifestyle, drug-drug interactions, secondary hypertension, and presence of end BEHAVIORAL HEALTH CORNER organ damage. Recommended treatment for confirmed RH includes optimization of lifestyle interventions, use of a long-acting thiazide-like diuretic (e.g., chlorthalidone, FDA CONTINUES TO FIGHT OPIOID CRISIS indapamide), and addition of a mineralocorticoid receptor In an effort to combat the US opioid crisis, the antagonist (e.g., spironolactone, eplerenone). If BP remains FDA will apply new safety measures for outpatient above target levels, addition of agents with different use of opioid analgesics. Steps taken include the mechanisms, and possibly referral to a hypertension addition of immediate-release formulations to specialist, are advised. the opioid Risk and Evaluation Mitigation Strategy (REMS). The FDA is expanding the availability of ICER SPOTLIGHT opioid education programs to all HCPs involved in managing a patients pain, including pharmacists and The Institute for Clinical and Economic Review (ICER) nurses. Information covered will also include use of updated the report on targeted immunomodulators for non-opioid alternatives. Roll-out of this enhanced the treatment of moderate-to-severe plaque psoriasis program is expected by March 2019. While training (PSO). The tumor necrosis factor-alpha (TNFα) inhibitor is not required to prescribe opioids, the FDA is certolizumab pegol (Cimzia™), and the interleukin (IL)-23 considering mandating it in select circumstances. In inhibitors, guselkumab (Tremfya®), tildrakizumab-asmn addition, the FDA is adding information to all opioid (Ilumya™), and risankizumab (investigational) were product labels regarding HCP pain management added. ICER determined guselkumab and risankizumab, education and new Patient Counseling Guides but not tildrakizumab-asmn and certolizumab pegol, to assist in patient discussions around risks, safe offer a superior net health benefit compared to all use, storage, and disposal of opioids. Lastly, the subcutaneously (SC) administered TNFα inhibitors. ICER agency is creating a framework to help medical does, however, acknowledge that certolizumab pegol professional societies develop evidence-based, is an important option in pregnant or breastfeeding indication-specific guidelines on appropriate opioid women. It also states that the mechanism of action of prescribing for acute pain, including appropriate the IL-23 inhibitors may be effective in patients when duration of therapy. other therapies have failed. To hasten improved QOL, ICER recommends removing or limiting step therapy around medication coverage, particularly in patients 2 | NOVEMBER 2018 DRUG INFORMATION HIGHLIGHTS • The intermittent shortage of epinephrine auto-injectors, • Endo Pharmaceuticals announced a voluntary recall of used for the emergency treatment of allergic reactions, 2 lots of Robaxin® (methocarbamol) 750 mg tablets, 100 including anaphylaxis, persists nationwide in the count bottle to the consumer level due to a labeling US. Impax’s authorized generic (AG) version of the error that misstates the daily dose as 2 to 4 tablets 4 discontinued Adrenaclick® continues to be on backorder times daily instead of 2 tablets 3 times daily. The error with additional supply expected in November. Mylan could lead to drug toxicity. ® ® reports that they are shipping Epipen 0.3 mg, Epipen Jr • After reviewing all available postmarketing reports of 0.15 mg, and their respective AG to some distributors; death and serious adverse events related to the use supply stabilization is expected by the end of 2018. of the antipsychotic, pimavanserin (Nuplazid®), the ® No shortages are reported for Kaleo’s Auvi-Q 0.3 mg, FDA did not find any new or unexpected safety risks. 0.15 mg, and 0.1 mg. Teva’s generic versions of Epipen The agency did, however, identify potentially harmful TM and Epipen Jr and Adamis’ Symjepi (0.3 mg and prescribing patterns, such as concomitant use with 0.15 mg) have not entered the US market. other antipsychotic drugs or drugs that can cause QT • The FDA issued a Safety Communication to alert prolongation and is reminding HCPs of the potential patients, caregivers, and HCPs
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