Download Express Scripts Drug Information & Wellness Center Drug Information Updates

August 2011
Volume 3 Issue 6
Express Scripts Drug Information & Wellness Center
Drug Information Updates
In the News:
Special points of interest:
Extra Strength TYLENOL® to update labeled dosing.
McNeill Consumer Healthcare, the manufacturer of TYLENOL® is slated to
change the current labeled dosing of Extra Strength TYLENOL® from 2 pills every 4-6 hours
(4000 mg) to 2 pills every 6 hours (3000 mg) to help reduce the potential for accidental overdose
in this product. This updated packaging should hit the shelves sometime in Fall 2011.
 In the News

This move is part of the Get Relief Responsibly™ campaign which is designed to promote safety
in acetaminophen use among consumers.
 New Generic Approvals

Additional changes to labeling, including featured dosing on the bottle cap, are expected to be
rolled out in 2012.

For more information, visit the website: http://www.tylenol.com/getreliefresponsibly

Pioglitazone-containing products to receive updated FDA labeling regarding safety concerns.

On August 4th the FDA approved an update to the product safety information stating that patients who use pioglitazone products for longer than a year are at a higher risk for developing
bladder cancer.

The new labeling recommends that health care providers should not use this medication in patients with active bladder cancer and use the medication cautiously in patients who have a positive history for bladder cancer.

Additionally, the new information suggests that patients should contact their physician if they
have blood present in their urine (red coloration), or symptoms of pain or increased urgency
after starting on pioglitazone, as these are potential signs of bladder cancer.
 New Formulations and Indications
 Newly Approved Drugs
 Drug Information Question
 When do you reimmunize when
titers are low?
 Apps of the Month
New Formulations and Indications:
Omnitrope (somatropin recombinant) Injection by Sandoz Inc.
Class: Recombinant human growth hormone
Indication: Adult and pediatric patients with growth hormone deficiency, and pediatric patients with
Prader-Willi Syndrome, small gestational age, or idiopathic short stature
MOA: Stimulates growth of bones, skeletal muscle, and organs
New Indication: Pediatric patients with short stature due to Turner Syndrome
Topamax (topiramate) by Ortho-McNeil-Janssen Pharmaceuticals, Inc.
Class: Antiepileptic agent
Indication: Monotherapy and adjunctive therapy for epilepsy, and migraine prophylaxis
MOA: Unknown; possibly due to voltage-dependant sodium channel blockade, gamma-aminobutyrate
augmentation, glutamate receptor antagonism, and inhibition of the carbonic anhydrase enzyme
New Indication: Monotherapy for epilepsy patients at least two years of age, down from 10 years
Rosuvastatin Zinc by Watson Labs Inc. (tentative approval)
Class: HMG-CoA reductase inhibitor
Indication: Hypertriglyceridemia and homozygous familial hypercholesterolemia
MOA: Inhibiting HMG-CoA reductase reduces cholesterol production in the liver
New Formulation: Rosuvastatin as a zinc salt; 5, 10, 20, and 40 mg tablets
August is…
New Generic Approvals:
Alfuzosin hydrochloride
Tranexamic acid injection
Paricalcitol injection
Paricalcitol capsule (Tentative approval)
Candesartan cilexetil/HCTZ (Tentative approval)
Risedronate sodium 150 mg (Tentative approval)
UroXatral
Cyklokapron
Zemplar
Zemplar
Atacand HCT
Actonel
National Immunization
Awareness Month!
Page 2
Express Scripts Drug Information & Wellness Center
Volume 3 Issue 6
Newly Approved Drugs
Brilinta (ticagrelor) oral tablet by AstraZeneca (approved 7/20/2011)
Class: Antiplatelet agent, cyclopentyltriazolopyrimidine
Indication: Acute coronary syndrome– thrombosis prophylaxis and Percutaneous coronary intervention– thrombosis prophylaxis
MOA: Reversibly binds to adenoside diphosphate P2y 12 receptor on the platelet surface. This prevents signal transductions and platelet activation and aggregation.
Dosing: Initial: 180 mg by mouth loading dose with a loading dose of aspirin 325 mg (if not previously on).
Maintenance: 90 mg by mouth twice daily with low dose aspirin 75-100 mg daily
Conversion from clopidogrel: 90 mg by mouth twice daily beginning 24 hours after clopidogrel dose
Complera (Emtricitabine, Rilpivirine, and Tenofovir) oral tablet by (approved 8/11/11)
Class: Antiretroviral agent, Nonnucleoside Reverse Transcriptase Inhibitor, and Nucleoside Reverse Transcriptase Inhibitor Indication: Treatment of human immunodiefiency virus type 1 infection in antiretroviral treatment naive adult patients
MOA: inhibits HIV viral replication
Dosing: One tablet once by mouth with a meal (200mg/25mg/300mg of emtricitabine/rilpivirine/tenofovir)
Zelboraf (vemurafenib) oral tablet by Hoffman-La Roche (approved 08/17/2011)
Class: Antineoplastic agent, BRAF Kinase Inhibiitor
Indication: Unresectable or metastatic melanoma in patients with a BRAF V600E mutation
MOA: selectively inhibits BRAF protein
Dosing: 960 mg orally twice daily
Adectris (brentuximab vedotin) intravenous infusion by Seattle Genetics (approved 08/19/2011)
Class: monoclonal antibody, antineoplastic agent
Indication: Hodgkin lymphoma after failure of 2 prior chemotherapy regimens or after stem cell transplant failure and systemic anaplastic large cell
lymphoma after failure of 1 prior regimen
MOA: IgG1 antibody directed against CD30
Dosing: 1.8 mg/kg administered IV infusion over 30 minutes every 3 weeks for a maximum of 16 cycles
Recent Guideline Updates
Institute for Clinical Symptoms Improvement (ICSI)-Diagnosis and Treatment of Headache
Health care guideline: diagnosis and treatment of headache. January 2011. Available from: http://www.icsi.org/
headache/headache__diagnosis_and_treatment_of_2609.html.
American Heart Association (AHA)-Hypertension in the Elderly
ACCF/AHA 2011 expert consensus document on hypertension in the elderly: A report of the American
College of Cardiology Foundation Task Force on Clinical Expert Consensus Documents. Circulation.
2011 April 25. Available from: http://circ.ahajournals.org/content/123/21/2434.
Recommendations: For most patients who are 80 years or older, a systolic blood pressure between 140
and 145 mmHg is acceptable.
Centers for Disease Control (CDC)-Morbidity and Mortality Weekly Report (MMWR) Early Release
Prevention and Control of Influenza with Vaccines: Recommendations of the Advisory Committee on
Immunization Practices (ACIP), 2011. MMWR. 2011 August 18. Available from: http://www.cdc.gov/
mmwr/pdf/wk/mm60e0818.pdf.
Recommendations: Patients who are 6 months or older are recommended to receive the 2011-2012
U.S. influenza vaccine, regardless of receiving an influenza vaccine for 2010-2011.
Patients between 6 months and 8 years of age may only receive one 2011-2011
vaccine instead of two if they have received at least one 2010-2011 vaccine.
“When will the Eighth Report of the Joint National Committee on Prevention, Detection,
Evaluation, and Treatment of High Blood Pressure (JNC 8) be released?”
According to the National Heart, Lung, and Blood Institute (NHLBI) website, the expected release date for reviewing the JNC 8 will be in
Fall 2011 with the final version expected to be released in Spring 2012. Unfortunately, a representative from the NHLBI could not provide specific
dates for the JNC 8 review and release, and said that the review release may not occur until early 2012.
The best suggestion? Periodically check the NHLBI website for more information at: http://www.nhlbi.nih.gov/guidelines/hypertension/
jnc8/index.htm.
Volume 3 Issue 6
Page 3
Drug Information Question
Is there a need to revaccinate with MMR or Varicella when low titers are found in healthcare workers?
A healthcare worker had received 2 doses of MMR at the appropriate age and time frame. Titers
were drawn to prove immunity. Immunity was demonstrated for rubeola and varicella but was negative
for mumps (levels was 0.7; > 0.9 shows immunity).
The question was: Is there any evidence to support the need for an additional mumps booster or
another MMR series in a healthcare worker? We searched ImmunoFacts, cdc.gov, and immunize.org.
Immunize.org (from the Immunization Action Coalition linked from CDC) included an ‘Ask the Experts’
document which answered this exact question. They stated that, according to the Advisory Committee on
Immunization Practices, having proof of receiving the 2 MMR vaccine series itself proves immunity to
MMR. However, in many cases a healthcare worker or student is required to show immunity via a titer. If
the healthcare worker has documentation of receiving the 2 MMR vaccines, it is likely that the negative
titer result was a false negative.
In summary, it was found that this student would not need to be revaccinated with MMR or receive a booster dose of the
mumps vaccine. Since the student has 2 documented doses of MMR, it seems that the test could have illustrated a false negative
and the antibody titer was too low to detect with commercial testing1.
Regarding varicella, the following question was posed: If a healthcare student who has had chickenpox and not had a vaccine that had a titer of 0.34 (normal = 0.90), should they be recommended to receive the varicella vaccine? The CDC only considers a health-care worker immune to varicella if they meet any of the following three criteria:
1. Two doses of varicella vaccine (documented)
2. A laboratory test confirming immunity
3. A positive diagnosis of either chicken pox or shingles from a health-care provider (documented).2
There was no information available correlating a titer to an individual’s immunity status. Because of this, since the student
in question did not meet the CDC criteria for immunity (a confirmatory laboratory test), they recommend that the individual receive
the entire varicella immunization series. According to the Immunization Action Coalition’s immunization guidelines for healthcare
professionals, a varicella vaccine series consists of two total injections with a four week separation between the doses.3 Upon receiving both doses, the student would then be considered to have lifelong immunity and would not need any subsequent titers in
the future.4
References:
1.
Immunize.org [Internet]. St. Paul (MN): Immunization Action Coalition, [updated Mar 2011; cited 2011 Jul 25]. Available from: http://
www.immunize.org/askexperts/experts_mmr.asp.
2.
Varicella (chickenpox) In-Short. CDC.gov [Internet]. Atlanta (Ga): Centers for Disease Control and Prevention; [updated 2008 Sept 24,
cited 2011 July 29]. Available from: http://www.cdc.gov/vaccines/vpd-vac/varicella/in-short-adult.htm#who.
3.
Healthcare Professional Vaccination Recommendations. Immunize.org [Internet]. St. Paul (Mn): Immunization Action Coalition; [updated
2011 Mar, cited 2011 July 29]. Available from: http://www.immunize.org/catg.d/p2017.pdf.
4.
Varicella Vaccine – Q&As about Health Care Providers. CDC.gov [Internet]. Atlanta (Ga): Centers for Disease Control and Prevention;
[updated 2011 June 27, cited 2011 July 29]. Available from: http://www.cdc.gov/vaccines/vpd-vac/varicella/vac-faqs-clinic-hcp.htm.
Page 4
Express Scripts
Drug Information & Wellness Center
Southern Illinois University Edwardsville
Volume 3 Issue 6
Monday — Friday
8 a.m. — 4 p.m.
(618) 650-5142
Apps of the Month The following applications for smartphones have been reviewed and critiqued by students and pharmacists:
Name
Cost
Eponyms
NEJM
This Week
US
Pharmacist
Shots
Free

Provides basic definitions of
a vast array of medical terms,
tests, and labs.
Free

Provides full-text of recent
articles published in the
NEJM. Also includes some
pictures and videos.
Free

Contains the latest and past
full-text issues of US Pharmacist.

Contains the CDC’s schedule
for 2011 vaccines for adults,
children, and by disease
states.

A user friendly medication
reminder app which makes
adherence interactive and
easy.

A quick an easy way to see
the current ASHP and FDA
reported shortages. Also links
you to the original post.
Free

Contains the latest two issues
of Pharmacist’s Letter, and
other unbiased drug and disease information.
$0.99

Contains descriptive information for drug identification
with links to DailyMed.
Free

Contains basic disease information, and features a GPS
enabled pharmacy or health
care provider search.
Free
Pillboxie
Free
Rx
Shortages
Free
Pharmacist’s
Letter
NLM Drugs and
Meds
iTriage
Content
Rating (1-5)