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Clinical Rx Forum Volume 4 Issue 2

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Clinical Rx Forum Volume 4 Issue 2 In This Issue Sugammadex: Is the Third Time the Charm? From the Department of Pharmacy Incretin-based Therapies and the Risk of Pancreatic Disease March/April Issue 2016, Volume 4, Issue 2 FDA Medication Safety Alert: Risk of VTE with TestSugammadex: Is the Third Time the Charm? osterone By: Jamie Eckardt , Pharm.D. ® Marcia J. Wyman, Pharm.D., BCPS Background: Sugammadex (Bridion ; Pharmacokinetics: Cyclodextrins have Drug Information Pharmacist Merck & Co., Inc.), a novel agent for the a lipophilic interior and a hydrophilic Editor reversal of neuromuscular blockade exterior surface. As a result, these drugs (NMB) with rocuronium or vecuronium, are used as hydrophilic carriers for hy- Mandy C. Leonard, Pharm.D., BCPS System Director, Drug Use Policy and was previously denied approval by the drophobic drugs. Sugammadex selec- Formulary Management Food and Drug Administration (FDA) tively binds to the free rocuronium mol- Editor twice; the Lirst time was in 2008 and ecules with a high afLinity. It encapsu- then more recently in April of 2015. lates or chelates this free molecule Meghan K. Lehmann, Pharm.D., BCPS Denial was due to concerns about thereby inactivating it. 4 The resulting Drug Information Specialist Editor hypersensitivity/anaphylaxis and cardi- complex is then eliminated from the ac dysrhythmias. 1 This injectable prod- body. The structural similarity of rocu- Marigel Constantiner, MSc, BCPS, CGP, CPh uct is currently sold in over 50 coun- ronium and vecuronium allows sugam- Drug Information Specialist tries worldwide. 2 Sugammadex, a mod- madex to also encapsulate vecuronium. Associate Editor iLied γ-cyclodextrin, is the Lirst selective Sugammadex demonstrates linear phar- Christopher Snyder, B.S., R.Ph. relaxant-binding agent that has been macokinetics over the dosing range of Drug Information Pharmacist shown to rapidly and completely re- 1-16 mg/kg/dose. 4 Its steady state vol- Associate Editor verse the effects of the neuromuscular ume of distribution is ~11-14 L. There blocking agents rocuronium and vecu- is no apparent metabolism and excre- Kara J. Sink, B.S., R.Ph. 3 Drug Information Pharmacist ronium. Currently, the most common tion is primarily unchanged drug in the Associate Editor NMB reversal regimens include acetyl- urine. Its elimination half-life is cholinesterase inhibitors (e.g., neostig- 1.8 hours. 3,4 Brian Hoffmaster, Pharm.D., BCPS mine, pyridostigmine, and edrophoni- Student Education Pharmacist Associate Editor um) given intravenously in combina- Therapeutic EfLicacy: EfLicacy of tion with antimuscarinic agents (e.g., sugammadex 2mg/kg has been shown Maya Wai, Pharm.D. atropine and glycopyrrolate). (Continued on page 2) Drug Information Pharmacist Associate Editor Incretin-based Therapies and the Risk of Pancreatic Disease Scott Knoer, MS, Pharm.D., FASHP Chief Pharmacy OfPicer By: Meghan Wilson, Pharm.D. Introduction: Incretin-based therapies receptor agonists. Dipeptidyl pepti- are a class of medications used to treat dase-4 inhibitors bind the enzyme DPP- type 2 diabetes mellitus (T2DM). In- 4, which is responsible for inactivating cretins are peptide hormones released circulating incretins. As a result, DPP-4 by the small intestines in response to inhibitors lead to increased levels of eating meals. 1 These hormones increase active GLP-1 and GIP. The DPP-4 inhibi- From the Department of Pharmacy insulin secretion and decrease tors include alogliptin (Nesina ®), Drug Information Service glucagon secretion. Glucagon-like pep- linagliptin (Tradjenta ®), saxagliptin (216) 444-6456, option #1 tide-1 (GLP-1) and glucose-dependent (Onglyza ®), and sitagliptin (Januvia ®). 2 insulinotropic polypeptide (GIP) are The GLP-1 receptor agonists have a dif- Comprehensive information about two known incretins. The two classes ferent mechanism of action as they bind medications, biologics, nutrients, of incretin-based medications are di- to GLP-1 receptors on the pancreas and drug therapy peptidyl peptidase-4 (DPP-4) inhibitors and thereby mimic the actions of and glucagon-like peptide-1 (GLP-1) (Continued on page 3) (Continued from page 1) in a pivotal trial comparing sugammadex to neostig- On December 15, 2015, suggamadex received Linal mine 50 mcg/kg plus glycopyrrolate 10 mcg/kg for the FDA approval. 8 reversal of rocuronium 0.6 mg/kg and vecuronium 0.1 mg/kg. 5,6 This study was a multi-center, random- Formulary Status: Sugammadex was added to the ized, active-controlled, parallel-group, safety-assessor- CCHS Formulary in March 2016. It will be available for blinded trial with the rocuronium treated group re- use in early May 2016. ported separately from the vecuronium treated group. Subjects were randomly assigned to receive rocuroni- References um or vecuronium for intubation and either neostig- 1. Brown, T. FDA Panel Backs Sugammadex for General Anesthe- sia Reversal. Medscape. Nov 06, 2015. mine/glycopyrrolate or sugammadex for reversal of 2. Aniskevich A, Leone BJ, Brull SJ. Sugammadex: a novel ap- neuromuscular blockade. The primary endpoint was proach to reversal of neuromuscular blockade. Expert Rev the time from administration of reversal agent to the Neurother 2011;11(2): 185-98. recovery of a TOF (train-of-four) ratio of 0.9. 5,6 In the 3. Martindale: The Complete Drug Reference, Lexi-Drugs Online, rocuronium group, mean time to reversal with sugam- Hudson, OH: Lexi-Comp Inc.;2015: November 6, 2015. 4. Yang LP, Keam SJ. Sugammadex: a review of its use in anaes- madex was signiLicantly faster than with neostigmine, thetic practice. Drugs 2009;69(7):919-42. 1.5 minutes versus 18.6 minutes, respectively. 5 Mean 5. Blobner M, Erikson LI, Scholz J, Motsch J, Della Rocca G, Prims time to recovery of TOF ratio of 0.9 in the vecuronium ME. Reversal of sugammadex compared with neostigmine group was 6.6 times faster with sugammadex versus during sevoLlurane anesthesia: results of a randomized con- trolled trial. Eu J Anaesthesiol 2010;27:874-81. neostigmine, 2.7 minutes versus 17.9 minutes, 6. Khuenl-Brady KS, Wattwil M, Vanacker BF, Lora-Tamayo JI, respectively. 6 Rietbergen H, Alvarez-Gomez JA. Sugammadex provides faster reversal of vecuronium-induced neuromuscular blockade Safety: Pooled data from phase I-III placebo- compared to neostigmine: a multi-center, randomized, con- trolled trial. Anesth Analg 2010; 110:64-73. controlled trials demonstrated the following adverse 7. NDA 22225: Sugammadex Injection. Food and Drug Admin- events with an incidence greater than placebo and istration Anesthetic and Analgesic Drug Products Advisory greater than 2%: vomiting, pain, procedural hypoten- Committee Meeting: http://www.fda.gov/downloads/ sion, chills, back pain, QTc prolongation, and ab- AdvisoryCommitteesMeetingMaterials/Drugs/ 1,7 AnestheticAndAnalgesicDrugProductsAdvisoryCommittee/ dominal pain. Data analysis of 56 clinical trials con- UCM470718.pdf. Accessed: February 23, 2016. ducted in Europe and the United States was performed 8. FDA approves Bridion to reverse effects of neuromuscular by the FDA, including scrutiny of European post- blocking drugs used during surgery. Available from: http:/ marketing reports from a safety database, the Merck www.fda.gov/NewsEvents/NewsroomPressAnnouncements/ Adverse Event Reporting and Review System ucm477512.htm. Accessed: February 17, 2016. (MARRS), to evaluate the true risk of serious adverse reactions/events. 7 This detailed investigation by the FDA provided evidence that sugammadex is associated with hypersensitivity reactions, including anaphylaxis, with an estimated frequency of less than 0.1%. The FDA also required further clinical trials designed to analyze the effect of sugammadex on the QT/QTc inter- val. These three studies found no evidence of clinically relevant QT prolongation. Dysguesia is uncommon at recommended doses; however this is the most fre- quent adverse event at higher doses. 4 Adverse events in patients who received neostigmine plus glyco- pyrrolate included dry mouth, anxiety, and prolonged neuromuscular blockade; this is an incidence of at least two times that of sugammadex. 4 Approval Status: On November 6, 2015, the FDA’s Anesthetic and Analgesic Drug Products Advi- sory Committee voted unanimously to approve sugammadex for the reversal of neuromuscular 1 blockade induced by rocuronium or vecuronium. 2 (Continued from page 1) endogenous GLP -1. 3 The GLP-1 receptor agonists con- placebo. 8,9 The median duration of therapy for these sist of albiglutide (Tanzeum ®), dulaglutide (Trulicity ®), trials were 2.1 years and 18 months, respectively. The exenatide (Byetta ®), and liraglutide (Victoza ®). 2 In ad- association of pancreatitis with exenatide was also dition to the indication for T2DM, liraglutide evaluated in a retrospective cohort using claims from a (Saxenda ®) is also indicated for use in chronic weight US healthcare database. 10 The study included patients management. who had a claim for a new antidiabetic medication on or after June 1, 2005. The primary outcome was the Safety Warnings and REMS: In 2007, the U.S. Food Lirst occurrence of acute pancreatitis as identiLied by and Drug Administration (FDA) released a statement ICD-9 CM codes. The incidence rate of acute pancreati- regarding 30 reports of pancreatitis associated with tis in the exenatide arm was not signiLicantly different exenatide, leading to the addition of acute pancreatitis from the control group (p=0.9383). The mean time for risk to the product’s labeling. 4 Similarly, the FDA re- follow-up was 1.4 years for the exenatide group. leased a medication safety communication for sitagliptin in 2009 concerning 88 post-market case re- Bottom Line: Based on the current evidence, it seems ports of acute pancreatitis associated with sitagliptin there is no short-term risk of pancreatitis and pancre- and sitagliptin/metformin (Janumet ®). 5 As a result, atic cancer with the use of DPP-4 inhibitors and ex- labeling of all DPP-4 inhibitors now includes warnings enatide. Long-term studies are needed to evaluate the about pancreatitis. Following these safety communica- risk beyond 2 years of use with these agents. tions, an examination of the FDA’s adverse event re- porting database also found these agents were associ- References 1.
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