Download Express Scripts Drug Information & Wellness Center Pharmacy in the News:

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.