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November 2015 Volume 7, Issue 3 Express Scripts Drug Information & Wellness Center Drug Information Updates Inside this issue: In the News Pharmacy in the News: 6 Key Beers Criteria Updates Pharmacists use, modifying food breakdown, increasing Should Know calorie intake which leads to weight gain. New drug-drug interaction table. Newly Approved Drugs Peripheral alpha-1 blockers & loop diuretics Schwartz BS, Pollak J, Bailey-Davis L, Hirsch AG, Cosgrove SE, Nau C. Antibiotic use and childhood body mass index trajectory. International Journal of Obesity. 2015. increase incontinence in older women. Resource Refresher Influenza Vaccination Review Statins & Flu Vaccination Drug Information Question of the Month ACE-I & amiloride or triamterene can increase hyperkalemia risk. patients with Post-Traumatic Stress Disorder Combination use of anticholinergics increas- Report published by Neuropsychopharmaes risk for cognitive decline. Antidepressants, Antipsychotics, Benzodiaze- cology journal, states methylphenidate is associated with significant declines in PTSD pines, Benzodiazepine-Receptor Agonists & symptoms along with declines in post- two or more CNS drugs increases risk of concussion symptoms. falls. Corticosteroids & NSAIDs increase risk of peptic ulcer disease or GI bleed. Lithium taken with ACE-I and loop diuretics increases lithium toxicity risk. American Geriatrics Society Updated Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. Clinical Guidelines & Recommendations. 2015. Children Who Take Antibiotics Experience Increased Weight Gain Over Time Internal Journal of Obesity; study asserting Thank you to Kaycee Dycus, and Kristin Smith for creating this newsletter Medicine used to treat ADHD may also help Attention tests and capacity to process information quickly were also significantly improved. Improvements were seen early and sustained through the 12 week treatment period. Improvements exceeded current PTSD therapies. McAllister, T, Zafonte, R, Jain S, Flashman L, George M, Grant G. Randomized Placebo-Controlled Trial of Methylphenidate or Galantamine for Persistent Emotional and Cognitive Symptoms Associated with PTSD and/or Traumatic Brain Injury. Neuropsychopharmacology. 2015. antibiotic use and possible aggregate effect Sanofi Recalls All Auvi-Q Epinephrine on BMI in childhood, and into adulthood. Autoinjectors 163,820 children between 3-18 years old over 11 year period. Children with 7 or more antibiotics by age 15 weighed 1.4 kg more than children with no antibiotics, which is 3 pounds more over the 11 year period. Macrolides associated with highest weight gain. Gut microbiota altered by frequent antibiotic Devices may not deliver the correct dose. All 0.15 mg and 0.3 mg autoinjectors with lots 2299596-303720 and expiration dates of March-December 2016 recalled. 26 reports received by Sanofi of “device malfunctions” where patients continued to have hypersensitivity reactions. http://www.fda.gov/Safety/MedWatch/SafetyInformation/Saf etyAlertsforHumanMedicalProducts/ucm470010.htm Express Scripts Drug Information & Wellness Center Page 2 Newly Approved Drugs Praxbind (idarucizumab) Genvoya (a fixed-dose combination tablet containing elvitegravir, cobicistat, emtricitabine, and tenofovir alafen- Indication: Patients taking Pradaxa who require reversal amide) of the anticoagulant effects of dabigatran Indication: HIV infection MOA: Specific reversal agent for dabigatran. Humanized MOA: Fixed dose of 4 antiretroviral drugs; elvitegravir monoclonal antibody fragment (Fab) that neutralizes the boosted by CYP3A inhibitor cobicistat anticoagulant effect of dabigatran by binding to Dosing: 1 tablet (elvitegravir 150 mg/cobicistat 150 dabigatran and its acylglucuronide metabolites with mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg) higher affinity than the binding affinity of dabigatran to orally once daily with food thrombin Dosing: IV use only, 5 g, provided as two separate vials containing 2.5 g/50 mL Nucala (mepolizumab) Valtassa (patiromer) Indication: Add-on maintenance treatment in patients Indication: Treatment of hyperkalemia with severe asthma aged 12 years and older, and with an MOA: Non-absorbed cation exchange polymer containing eosinophilic phenotype calcium-sorbitol counterion which increases fecal potas- MOA: Binds to IL-5, inhibiting the bioactivity of IL-5 by sium excretion by binding potassium in the GI tract lu- blocking its binding to the alpha chain of the IL-5 recep- men resulting in a decreased serum level of potassium tor complex expressed on the eosinophil cell surface. Dosing: 8.4 g patiromer once daily starting dose. Monitor This action reduces production/survival of eosinophils. serum potassium and adjust dose as needed to achieve The mechanism of mepolizumab action in asthma has not target level. Maximum dose is 25.2 g once daily. Titration been definitively established should be once weekly or longer at 8.4 g increments Dosing: 100 mg administered once every 4 weeks by subcutaneous injection into the upper arm, thigh, or abdomen Resource Refresher Clinicaltrials.gov FDA Orange Book App new! Registry/results database of clinical studies around the world Collection of approved drug products with therapeutic equivalence evaluations list Used when looking for recent studies on drugs, and studies on new drugs not yet approved Information on approved drugs, patents/exclusivity Use Boolean operators to combine search terms (i.e. AND, OR, NOT) Search results will include: condition the drug is being evaluated in, interventions in the trial, trial status (completed/completed with results/terminated, etc) Can search by patent number without specifying market status Unlike full web version, users will be unable to filter results or search for text within results Search by generic name for marketing status of prescription, OTC, and discontinued products Page 3 Express Scripts Drug Information & Wellness Center Influenza Vaccinations Statins Decrease Flu Vaccination For the 2015-2016 Season: Per CDC Effectiveness? What kinds of flu vaccines are available? Trade name Age indications Route Influence of Statins on Influenza Vaccine Response in Elderly Individuals Inactivated influenza vaccine, quadrivalent (IIV4), standard dose Fluarix ≥3 yrs IM FluLaval ≥3 yrs IM Fluzone 6 through 35 mos, ≥36 mos, ≥6 mo de- IM pending on formulation Fluzone In- 18 through 64 yrs ID Inactivated influenza vaccine, trivalent (IIV3), standard dose ≥9 yrs via needle;18 through 64 via jet >5000 trial participants Titers related to different viral strains were 38%, 67%, and 38% lower respectively in subjects receiving chronic statin therapy compared to those who are not Impact of Statins on Influenza Vaccine Effectiveness Against Medically Attended Acute Respiratory Illness tradermal Afluria Post hoc, cross-sectional, observation study IM Retrospective, cohort study over 9 influenza seasons VE against MAARI was lower among statin users; 14.1% vs. 22.9% mean difference for statin and nonstatin users, respectively Impact of vaccine effectiveness (VE) against medically attended acute respiratory illnesses (MAARI) injector Fluvirin ≥4 yrs IM Are any flu vaccines recommended over others? Fluzone ≥6 mos IM The Advisory Committee on Immunization Practices (ACIP) recommends annual influenza vac- Inactivated influenza vaccine, cell-culture-based (ccIIV3), standard dose Flucelvax ≥18 yrs cination for everyone 6 months and older with either live attenuated influenza vaccine (LAIV) or IM inactivated influenza vaccine (IIV) with no prefer- Inactivated influenza vaccine, trivalent (IIV3), high dose ence expressed when either vaccine is available. Fluzone ≥65 yrs IM High-Dose How long is flu season in the Midwest? February, and can last as late as May. Recombinant influenza vaccine, trivalent (RIV3), standard dose; egg free Flublok ≥18 yrs IM Live attenuated influenza vaccine, quadrivalent (LAIV4) FluMist 2 through 49 yrs IN No. It takes about two weeks after vaccination for antibodies to develop. How much vaccine is available during 2015-2016? 171 to 179 million doses of vaccine What does high dose mean? Does the flu vaccine work right away? Starts in October, peaks between December and Four times the amount of antigen is contained. Did You Know? Giving flu vaccines to pregnant women was 92% effective in preventing hospitalization of infants for flu in 2010. (www.cdc.gov) Express Scripts Drug Information & Wellness Center Southern Illinois University Edwardsville Monday — Friday 8 a.m. — 4 p.m. (618) 650-5142 Volume 6, Issue 9 Drug Information Question of the Month: Question: Does a negative hepatitis B antibody (HbsAb) titer warrant revaccination with the HepB vaccine? HBsAB or anti-HBs test for a successful response to the hepatitis B vaccine (HBV). (1) A positive or reactive result means the patient is immune to future hepatitis B (hepB) infection. It is of importance to note, that per CDC guidelines titers should be drawn 1 -2 months after the third vaccination in the series. (2) Per CDC achieving an anti-HB concentration of ≥ 10 mIU/mL after pre-exposure vaccination confers nearly complete protection both acutely and chronically even if the anti-HB titer declines to ≤10 mIU/mL. In the case that anti-HBs decrease to less than the desired 10 mIU/mL, nearly all vaccinated persons will remain protected against infection. This is thought to be mediated by persistence of vaccine-induced immune memory through selective expansion and cloning of antigen-specific T and B lymphocytes. (2) Serologic testing for immunity is not required post vaccination in adults, but is recommended in high risk persons whose immune status is more imperative, such as health care workers, hemodialysis patients, HIV infected persons, and sex or needle sharing partners of HBsAG positive persons. (2) HBV three dose series consists of doses at 0, 1, and 6 months and produces a protective antibody response in ~30-55% of healthy adults aged ≤40 years after one dose, 75% after the second dose, and >90% after the third dose. By age 60 years, protective levels of antibody develop in only 75% of vaccinated persons. In addition to age, other patient specific factors such as obesity, smoking, genetics, and immune suppression can contribute to a decreased vaccine response. (2) For non-responders confirmed by anti-HB titer <10mIU/mL, after the primary vaccine series, an additional 3 dose series should be repeated per the appropriate schedule. (2) Receiving extra doses of hepB vaccine is not harmful, and was shown in previous clinical trials to have minimal adverse effects. For example, a single blind, randomized, controlled trial of 116 patients evaluated the use of Engerix-B 20 mcg given at 0, 1, and 6 months to patients who did not initially respond (<10 mIU/mL anti-HB after 2-5 months, and at least 4 previous doses of HBV) to HBV series. After one month had passed since revaccination, 68% of the patients achieved seroprotection (anti-HBs ≥10 mIU/mL). (3) Local adverse events included pain (21.1%), redness (4.8%), and swelling (3.4%). General adverse events included fatigue (12.2%), headache (7.5%), malaise (4.8%), GI symptoms (4.1%), and fever (1.4%). There were 3 serious adverse events reported which were gastrointestinal (GI) symptoms/arthralgia (n=1), rheumatism relapse (n=1), and fever/malaise/GI disorder/diarrhea (n=1) that were considered to be possibly-related to vaccination by the investigator. (3) Additionally, per the CDC in persons who did not respond to the original 3 doses of vaccine 44-100% of patients responded to a 3 dose revaccination series. (2) Booster doses (single dose administration) of HBV are only recommended for hemodialysis patients and other immunocompromised patients, not for immunocompetent adults. Patients who do not respond after revaccination are considered primary nonresponders or may be infected with HBV, and should be tested for HBsAg. (2) In summary, revaccination is considered safe and recommended per the CDC for non-responders. A 3 dose revaccination regimen with either Engerix-B or Recombivax-HB could be considered as no immunogenicity differences are observed with vaccines from different manufacturers when used to complete a series. (2) References: 1. Hepb.org [Internet]. Hepatitis B foundation: Cause for a Cure Hepatitis B Blood Tests: FAQ [updated March 2014; cited 2015 Oct. 22] Available from: http://www.hepb.org/patients/hepatitis_b_blood_tests.htm 2. Mast EE, Weinbaum CM, Fiore AE, Alter MJ, Bell BP, Finelli L, et al. Advisory Committee on Immunization Practices (ACIP) Centers for Disease Control and Prevention (CDC). A comprehensive immunization strategy to eliminate transmission of hepatitis B virus infection in the United States: recommendations of the Advisory Committee on Immunization Practices (ACIP) Part II: immunization of adults. MMWR Recomm Rep. 2006 Dec 8;55(RR-16):1-33; quiz CE1-4. Erratum in: MMWR Morb Mortal Wkly Rep. 2007 Oct 26;56(42):1114. 3. Jacques P, Moens G, Desombere I et al. The immunogenicity and reactogenicity profile of a candidate hepatitis B vaccine in an adult vaccine non-responder population. Vaccine 2002;20(31-32):3644-9.