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January 2010 Volume 2, issue 1 Drug Information Updates 2010 update to diabetes guidelines The American Diabetes Association have published revisions to their Clinical Practice Recommendations for 2010. One of the more prominent revisions to the Clinical Practice Recommendations is the inclusion of a new diagnosis criteria for diabetes, the use of A1C ≥ 6.5% as a diagnosis for diabetes. Furthermore, an A1C of 5.7—6.4% has been added to the previous impaired fasting glucose and impaired glucose tolerance for criteria of patients at an increased risk of developing diabetes in the future. The antiplatelet agents section has also been revised due to recent data from trials. The ADA now recommends the use of aspirin for primary prevention in patients at increased risk for a cardiovascular event (10-year risk >10%), including men over the age of 50 and women over the age of 60 with at least one other major risk factor. Other sections that have been revised include: detection and diagnosis of GDM, diabetes selfmanagement education, retinopathy screening and treatment, diabetes care in the hospital, and strategies for improving diabetes care. Lastly, a new section on diabetes care in patients with cystic fibrosis has been added. National Influenza Vaccination Week The CDC is sponsoring the National Influenza Vaccination Week (NIVW) to take place from January 10th through January 16th. NIVW was developed to address the importance of vaccination against influenza, even after the holiday season. Each day of the week is set aside to emphasize the importance of certain groups in the community to get vaccinated. For more detail and a schedule of daily events, visit http://www.cdc.gov/h1n1flu/ nivw/. Newly Approved Drugs Tocilizumab (Actemra®) Class: Interleukin-6 (IL-6) receptor inhibitor Indication: Treatment of rheumatoid arthritis MOA: Actemra® is an antagonist of the IL-6 receptor, inhibiting IL-6 signaling. IL-6 plays a part in a variety of immune responses. Inhibition of IL-6 by Actemra® reduces levels of cytokines and production of acute reactants responsible for rheumatoid arthritis. BBW: Risk of serious infection, including tuberculosis Interactions: May increase metabolism of drugs via restoring CYP450 back to higher levels. Doses available - Single-use vials: 80mg/4ml, 200mg/10ml, 400mg/20ml SIUE School of Pharmacy Special points of interest: > DM guidelines update > Newly Approved Drugs > New Formulations > New generics Page 2 Drug Information Updates Capsaicin 8% patch (Qutenza®) Class: TRPV1 channel agonist (topical analgesic) Indication: Management of neuropathic pain associated with postherpetic neuralgia. MOA: Causes initial enhanced stimulation of TRPV1 receptors (may be painful at first). Pain relief is achieved later by reducing the number of TRPV1 receptor containing neurons. Interactions: Studies of drug interactions have not been performed. In vitro studies have shown that capsaicin does not inhibit nor induce CYP450 enzymes. Doses available: Patch 8% capsaicin (179 mg capsaicin) Dalfampridine (Ampyra®) Class: Potassium channel blocker Indication: Improvement of walking in patients with multiple sclerosis. MOA: Mechanism of action is not known. It is thought to increase conduction of action potentials through demyelinated axons by blockage of potassium channels. Interactions: Few drug interaction studies have been performed. No drug interactions have been found thus far. Doses available: Tablet 10 mg Liraglutide (Victoza®) Class: Glucagon-like peptide-1 (GLP-1) receptor agonist Indication: Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. MOA: Increases release of insulin in presence of elevated serum glucose levels. Increased release diminished as serum glucose levels decrease. Also, decreases glucagon secretion and gastric emptying time. Interactions: Limited drug interaction studies have shown low potential for drug interactions related to CYP450 enzymes. Doses available: Prefilled, multi-dose pen (6mg/ml, 3 ml). Ecallantide (Kalbitor®) Class: Plasma kallikrein inhibitor Indication: Treatment of acute attacks of hereditary angioedema in patients > 16 years old. MOA: Selective, reversible inhibitor of plasma kallikrein. Binds to and blocks binding sites of kallikrein, inhibiting the conversion of kininogen to bradykinin. Interactions: No drug interaction studies or in vitro metabolism studies have been performed. Doses Available: Single use vial 10mg/ml Page 3 Volume 2, issue 1 Tranexamic acid (Lysteda®) Class: Antifibrinolytic agent Indication: Treatment of cyclic heavy menstrual bleeding. MOA: Forms reversible bond with fibrin, displacing plasminogen. This results in inhibition of fibrinolysis. Interactions: No drug interaction studies have been performed with Lysteda®. Use caution when prescribing Lysteda® to patients receiving hormonal contraceptives or other medications that increase risk of thrombotic events. Benefit should outweigh risk. Doses available: Tablet 650 mg Ofatumumab (Arzerra®) Class: CD20 directed cytolytic monoclonal antibody Indication: Treatment of refractory chronic lymphocytic leukemia (CLL). MOA: Binds to the CD20 molecule expressed on B lymphocytes. This results in lysis and toxicity in cells overexpressing CD20. Interactions: No formal drug-drug interactions have been performed with Arzerra®. Doses available: Single use vial 100mg/5ml. New Formulations and Indications Generic name: Papillomavirus (Types 6, 11, 16, 18) Vaccine Brand name: Gardasil® New Indication: Prevention of genital warts in men and boys age 9 to 26. Generic name: Pregabalin Brand name: Lyrica® New Dosage Form: Oral solution 20mg/ml. Generic name: Olanzapine Brand name: Zyprexa® Relprevv™ New Dosage Form: Extended release injection of schizophrenia SIUE School of Pharmacy New Generic drugs (since October 2009) Generic Brand October Fentanyl Citrate Troche/Lozenge Buprenorphine sublingual tablet Chlorothiazide injection October Actiq® Subutex® Sodium Diuril® injection November Ketorolac Tromethamine ophthalmic solution Perindopril Erbumine Nicardipine Hydrochloride Ethinyl Estradiol and norethindrone Lansoprazole November Acular® and Acular LS ® December Donepezil ODT December Aricept® ODT January Ibutilide Fumarate January Corvert® Aceon® Cardene® Femhrt® 1/5 Prevacid® .