PATIENT INFORMATION:

Swimmer’s Itch

What is Swimmer’s Itch?

Swimmer’s itch is a rash that appears as red,

itchy bumps on the skin after swimming. It

can occur hours or days after someone has

been swimming in certain bodies of water,

such as lakes. Swimmer’s itch is caused by

the human body’s reaction to a parasite that

lives in the water. The parasite does not sur-

vive in humans, and the rash will clear up

within a couple of weeks.

Who is at Risk for Swimmer’s Itch?

Anyone who swims in non-chlorinated water

that is home to large groups of birds (such as

ducks or gulls) and a specific type of snail is at

risk. The parasite lives in shallow shore areas

with warmer water temperatures. Water

known to be a source of the parasite will often

have signs posted by public health officials to

warn swimmers of the risk.

How to Prevent Swimmer’s Itch

Avoid water that is known to contain the para-

site. If you don’t know if the water contains

the parasite, rinse with clean water or towel

off immediately after exiting the water.

How to Treat Swimmer’s Itch

Treatment is focused on relieving the discom-

fort caused by swimmer’s itch. It is very im-

portant not to scratch the rash to avoid an in-

fection.1

Cold compresses can be applied to affect-

ed areas.

Colloidal oatmeal or Epsom salt baths can

relieve discomfort. Use lukewarm (not

hot) water in the bath.

Baking soda and water can be mixed into

a paste and applied to the itchy skin.

Topical anti-itch creams or lotions (such

as calamine) are available over-the-

counter.

Volume 19, Issue 9

September 2015

We welcome any comments

and suggestions for future

newsletter topics.

Editors in Chief:

Sherrill Brown, DVM, Pharm.D, BCPS

Micah Miller, PharmD

Patient Information: PCSK9 Inhibitors

2

Savaysa™ 3

Patient Information: Mirena® IUD

5

Patient Information: Belsomra®

6

Inside this issue:

DIS News Col lege of Heal th Professions and Biomedica l Sc iences

Drug Informa tion Service

Topical steroid creams are also available

over-the-counter. Use with caution on large

areas in children for extended periods.

When to Contact Your Medical Provider

Talk to your medical provider if the rash skin

does not improve or if it worsens after 3 days of

treatment. If signs of infection (fever, pus,

swelling) develop, contact your medical provider

as soon as possible.

By Kaylyn DesRosier, PharmD Candidate

REFERENCES:

1. Swimmer’s itch FAQs (1/10/2012). CDC

Web site. Available at: http://

www.cdc.gov/parasites/

swimmersitch/faqs.html. Accessed Septem-

ber 8, 2015.

2. Swimmer’s itch (n.d.). American Osteo-

pathic College of Dermatology Web Site.

Available at: http://www.aocd.org/?

page=SwimmersItch. Accessed September

8, 2015.

Nearly 73 million Americans have hy-

percholesterolemia (high cholesterol), a

condition which can double the risk of

heart disease. Less than one-third of

people with high cholesterol have their

low-density lipoprotein (LDL), or bad

cholesterol, well managed. For years,

the standard of therapy has been the

statins, which include Lipitor®

(atorvastatin) and Crestor®

(rosuvastatin). Unfortunately, a disease

called familial hypercholesterolemia

results in highly elevated LDL and re-

sistance to statin therapy for a small

group of patients. Recently, a new class

of drugs called the PCSK9 inhibitors

were approved by the FDA to help treat

this condition. Two drugs, Repatha™

(evolocumab) and Praluent®

(alirocumab), are currently available.

Who may benefit from the PCSK9

inhibitors?

Both Praluent® and Repatha™ are used

as add-on therapy to diet and maximally

tolerated statin therapy in patients with

clinical cardiovascular disease or hetero-

zygous hypercholesterolemia, when

LDL reduction has not been successful

with previous treatments.

Who should not take a PCSK9 inhibi-

tor?

Patients who have had severe hypersen-

sitivity or anaphylactic allergic reactions

to either Praluent® or Repatha™ should

not take these medications.

Which conditions should I tell my doc-

tor about before I start a PCSK9 in-

hibitor?

Prior to starting a PCSK9 inhibitor, tell

your provider if you have a latex allergy,

are pregnant or planning to become

pregnant, or are breastfeeding. The nee-

dle cover of Repatha™ contains dry nat-

ural rubber, so an allergic reaction to

latex may occur. Latex allergies are not

a concern with Praluent®. Though signif-

icant drug interactions have not been

identified with either drug, inform your

doctor about all of your prescription and

over-the-counter medications and sup-

plements.

What are adverse events may occur

while taking PCSK9 inhibitors?

Common side effects include upper res-

piratory infections, influenza, injection

site reactions, muscle pain, urinary tract

infections, and diarrhea.

How do I take my PCSK9 inhibitor?

Both Praluent® and Repatha™ are

administered by the patient as sub-

cutaneous injections into the abdo-

men, thigh, or upper-arm.

Each injection needs to warm up to

room temperature for 30 minutes

prior to administration.

Rotate injection sites.

Repatha™ is given either every two

weeks (140 mg dose) or once a

month (420 mg dose). The once-

monthly 420 mg dose is given as

three 140 mg injections within 30

minutes. Each injection is with a

new syringe or auto-injector.

Praluent® is given every two weeks

and is available in 75 mg and 150

mg doses.

How do I store my PCSK9 inhibitor?

Protect both medications from light

exposure.

Store both medications in the refrig-

Page 2 DIS News

erator at 36-46° F.

Do NOT allow either medication

to freeze or be exposed to temper-

atures above 77° F.

Praluent® should not be exposed

to room temperature (77° F) for

more than 24 hours.

Repatha™ may be kept at room

temperature for up to 30 days.

How much do PCSK9 inhibitors

cost?

Praluent® is estimated to cost $14,600

annually, or $560 per injection. Re-

patha™ has an annual cost of $14,100,

or $542.31 per injection. Although

copays are determined by individual

insurance companies, both drugs have

copay assistance programs.

The patient assistance program for

Repatha™ allows eligible patients cov-

ered by non-government insurance

programs to pay no more than $5 for

each prescription refill.

Praluent® patient support allows eligi-

ble patients with commercial insurance

to receive the first 6 months of therapy

for a $0 copay. After the first 6

months, the copay becomes $10. As-

sistance for eligible patients without

insurance provides 12 months of

Praluent® free of charge.

By Matt Slagle, PharmD Candidate

PATIENT INFORMATION: PCSK9 Inhibitors: New Big Guns in the Arsenal Against High Cholesterol

References on Page 4

Cholesterol Reductions in Heterozygous Familial Hypercholesterolemia with the PCSK9 Inhibitors

LDL Reduction (%) Total Cholesterol Reduction (%)

Repatha™ (evolocumab) 61-71% 38-42%

Praluent® (alirocumab) 58% 36%

What is the reduction in cholesterol with PCSK9 inhibitors?

Volume 19, Issue 9 Page 3

Savaysa™ (edoxaban) is a new antico-

agulant agent approved in January 2015

by the FDA1

Routine coagulation monitoring is not

needed because edoxaban is a factor Xa

(FXa) inhibitor2-5

Edoxaban is indicated for stroke pre-

vention in nonvalvular atrial fibrillation,

deep vein thrombosis (DVT), and pul-

monary embolism (PE)2

Edoxaban can also be used prophylacti-

cally for postoperative DVT prevention

in patients undergoing total knee arthro-

plasty2

Dosing:

The typical adult dose of edoxaban is 60 mg

by mouth daily for atrial fibrillation, DVT,

and PE.2 Dosing for other different indica-

tions is described in Table 1.

Dose adjustments for creatinine clearance:

>95 mL/min: do not use in patients

with atrial fibrillation due to increased

risk of ischemic stroke

15-50 mL/min: reduce dose to 30 mg

daily

<15 mL/min: not recommended

Patients with hepatic impairment:

Not recommended for patients with

Child-Pugh score B or C

Patients with low body weight (≤60 kg):

Reduce dose to 30 mg daily

Drug Interactions:

Edoxaban is a p-glycoprotein substrate and

can interact with other drugs that use the p-

glycoprotein transport system. These drugs

include azithromycin, clarithromycin, keto-

conazole, and verapamil.2,6 In patients with

a DVT or PE who are taking other drugs that

are p-glycoprotein substrates, the edoxaban

dose should be reduced to 30 mg daily.2,4,5

Unlike rivaroxaban and apixaban, edoxaban

does not interact with cytochrome P450 en-

zymes. This makes edoxaban a good alter-

Savaysa™ (edoxaban)

native for patients on many medica-

tions.2,5 See Table 2 (page 4) for a phar-

macokinetic comparison of anticoagulant

agents.

Adverse Effects:

Bleeding, including in mouth, phar-

ynx, gastrointestinal tract, and skin

Rash

Abnormal liver function tests

Edoxaban Compared to Warfarin:

Edoxaban is comparable in efficacy and

safety to warfarin, the oldest anticoagu-

lant agent.3-6 Warfarin has its peak effect

within four to five days. This time

frame, along with its many drug interac-

tions, make warfarin dosing difficult.

For this reason, coagulation monitoring

of INR is crucial for patient safety and

efficacy.2

Unlike warfarin, edoxaban has fewer

drug interactions. Instead of 4-5 days,

edoxaban reaches its peak effect in ap-

proximately one to two hours. Fewer

interactions and a shorter time to peak

effect makes monitoring less crucial with

edoxaban. However, edoxaban’s half-

life is much shorter than warfarin’s, so

compliance is an important topic to dis-

cuss with patients before starting edoxa-

ban. See Table 3 (page 4) for infor-

mation on switching patients between

edoxaban and warfarin.3,5

Edoxaban was non-inferior to warfarin in

a major study.3,4 The ENGAGE AF-

TIMI 48 study focused on individuals

with moderate-to-high risk atrial fibril-

lation. Primary endpoints included all-

cause stroke events, systemic embo-

lism, and mortality. This study also

looked at safety related to increased

bleeding risk.3,4

In this randomized, double-blind, dou-

ble-dummy trial, 21105 patients were

given either warfarin adjusted to INR

2.0-3.0, edoxaban 60 mg daily, or

edoxaban 30 mg daily. Stroke or sys-

temic embolic events per year were

decreased with edoxaban 60 mg com-

pared to warfarin (1.18% vs. 1.50%).

According to the study results, 197

people need to be treated with edoxa-

ban 60 mg daily instead of warfarin to

prevent one stroke or systemic embolic

event per year. The incidence of major

bleeds was also reduced in patients

treated with edoxaban compared to

patients treated with warfarin.3,4

By Ka Zoua Moua, PharmD Candi-date

Continued on Page 5

Table 1: Edoxaban Dosing

References and Tables on Page 4

Volume 19, Issue 9 Page 4

1. High cholesterol facts (3/17/2015). CDC

Web site. Available at: http://www.cdc.go

v/cholesterol/facts.htm. Accessed Septem-

ber 7, 2015.

2. Weinrauch LA. Familial hypercholesterol-

emia (5/20/2014). Medline Plus Web site.

Available at: https://www.nlm.nih.gov/

medlineplus/ency/article/000392.htm.

Accessed September 7, 2015.

3. Repatha [package insert and patient infor-

mation]. Thousand Oaks, CA: Amgen

Inc.; 2015 August.

4. Praluent [package insert]. Bridgewater,

NJ: Sanofi-Aventis U.S. LLC; 2015 July.

5. Pollack A. New drug sharply lowers cho-

lesterol, but it’s costly (7/24/2015). New

York Times Web site. Available at: http://

www.nytimes.com/2015/07/25/business/

us-approves-drug-that-can-sharply-lower-

Edoxaban (from page 3)

cholesterol-levels.html. Accessed Sep-

tember 7, 2015.

6. Davis K, Hawkins T, Sood A. FDA

approves Amgen’s new cholesterol-

lowering medication Repatha

(evolocumab) (8/27/2015). Amgen

Web site. Available at: http://ww

w.amgen.com/media/media_pr_deta

il.jsp?releaseID=2082837. Accessed

September 7, 2015.

7. Patient assistance and support services

(2015). Repatha Web site. Available

at: https://www.rep atha.com/patient-

services-and-copay-registration/. Ac-

cessed September 9, 2015.

8. Patient support(2015). Praluent Web

site. Available at: https://www.pra

luenthcp.com/cost-support. Accessed

September 9, 2015.

REFERENCES:

1. FDA approves anti-clotting drug Savaysa (1/8/2015). FDA Web site. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm429523.htm. Accessed August 10, 2015.

2. Micromedex® Healthcare Series [internet database]. Greenwood Village, Colo: Truven Health Ana-lytics, 2015. www.micromedexsolutions.com. Accessed August 10, 2015.

3. Giugliano RP, Ruff CT, Braunwalk E, et al. Edoxaban versus warfarin in patients with atrial fibrillation. New Engl J Med 2013;369(22):2093-2104.

4. Ruff CT, Giugliano RP, Braunwalkd E, et al. Association between edox-aban dose, concentration, anti-factor Xa activity, and outcomes: an analysis of data from the ran-domized, double-blind ENGAGE AF-TIMI 48 trial. Lancet 2015;385:2288-2295.

5. Niebecker R, Jonsson S, Karisson MO, et al. Population pharmacoki-netics of edoxaban in patients with symptomatic deep-vein throm-bosis and/or pulmonary embo-lism—the Hokusai-VTE phase 3 study. Br J Clin Pharmacol 2015; 80(6):1374-1387.

6. Lip GYH, Merino J, Ezekowitz M, et al. A prospective evaluation of edoxaban compared to warfarin in subjects undergoing cardioversion of atrial fibrillation: the edoxaban vs. warfarin in subjects undergoing cardioversion of atrial fibrillation (ENSURE-AF) study. Am Heart J 2015;169:597-604.e5.

Warfarin → Edoxaban Discontinue warfarin

Start edoxaban when INR is ≤2.5

Edoxaban → Warfarin Decrease edoxaban dose by 50% and start warfarin

Discontinue edoxaban when INR is stable (≥2) Monitor INR at least weekly once on warfarin therapy

Edoxaban → Warfarin

(With Parenteral

Bridge)

Discontinue edoxaban and start warfarin and parenteral

anticoagulant at next scheduled edoxaban dose Discontinue parenteral anticoagulant once INR is stable (≥2)

Table 2: Anticoagulant Comparison

Table 3: Switching between Warfarin and Edoxaban

PCSK9 Inhibitors References (from page 2)

Volume 19, Issue 9 Page 5

The Mirena® (levonorgestrel) intrauterine

device (IUD) is used for up to 5 years of

contraception and is 99% effective. Mire-

na® is also FDA approved to treat menor-

rhagia.

Mirena® contains synthetic progestin that

inhibits pregnancy by:

Slowing the transport of the sperm

Preventing the implantation of a ferti-

lized egg

Do not use Mirena® if you are pregnant or if

you have any of the following conditions:

Pelvic Inflammatory Disease (PID) or

history of PID

Cervical or uterine cancer

Breast cancer or other progestin sensi-

tive cancer

History of pelvic infections

Hypersensitivity to levonorgestrel or

any component of the IUD

Liver cancer or disease

Precautions:

If pregnancy occurs, IUD must be re-

moved

Bleeding patterns may change and be-

come irregular or amenorrhea (absence

of menstrual bleeding) may occur

Expulsion of IUD may occur

PATIENT INFORMATION:

Mirena® (levonorgestrel) IUD

Adverse Effects:

Bacterial Vaginitis (13.6%)

Vaginal Candidiasis (13.3%)

Acne (12.3%)

Headache (9.8%)

Nausea/Vomiting (7.9%)

Abdominal discomfort or pain

(6.1%)

Pelvic discomfort or pain (6.1%)

Depression (5.4%)

After Mirena® is inserted, your provider

will want to do an exam 4-6 weeks later

and every year while the IUD is in place.

Mirena® was highly effective for up to 3

years in one study. The Mirena® IUD

was associated with a low occurrence of

side effects. Expulsion of the IUD with-

in the first year after placement occurred

in 3.5% of women in the study. Pelvic

infections were not more common in the

first 20 days after IUD insertion. In the

3-year study, only 6 pregnancies oc-

curred in the 1751 women.

Mirena® can also be used to treat abnor-

mal uterine bleeding. In 70 women, use

of Mirena® decreased menstrual blood

loss and improved quality of life.

By Mandy Major, PharmD Candidate

REFERENCES:

1. Mirena® [package insert]. Whip-

peny, NJ: Bayer Healthcare Phar-

maceuticals; May 2014.

2. Micromedex [Internet database].

Greenwood Village, Colo: Truven

Health Analytics, 2015.

www.micromedexsolutions.com

Accessed July 15, 2015.

3. Eisenber DL, Schreiber CA, Turok

DL, et al. Three-year efficacy and

safety of a new 52 mg levonorg-

estrel-releasing intrauterine sys-

tem. Contraception 2015;92(1):10

-16.

4. Dhamangasnkar PC, Anurandha K,

Saxena A. Levonorgestrel intrau-

terine system (Mirena®): an

emerging tool for conservative

treatment of abnormal uterine

bleeding. J Mid-life Health

2015;6:26-30.

The University of Montana

Skaggs School of Pharmacy

32 Campus Drive

Missoula, MT 59812-1522

College of Health Professions and Biomedical Sciences

Drug Information Service

Phone: 406-243-5254

Fax: 406-243-5256

Email: druginfo@umontana.edu

www.health.umt.edu/DIS

PATIENT INFORMATION:

Belsomra® (suvorexant): A Different Look at Treating Insomnia

What is Belsomra®?

Belsomra® (suvorexant) is a new medi-

cation that treats insomnia with fewer

side effects than traditional sleep medi-

cines.

Suvorexant acts differently than other

sleep medications. Suvorexant blocks

hormones called orexins which play a

role in waking you up and keeping you

awake throughout the day.

Researchers believe that people with

insomnia have higher levels of orexins

in their brains. By blocking the orex-

ins in the brain from working, su-

vorexant may help some people get to

sleep and stay asleep.

How do I take suvorexant?

Some people might need more or less

suvorexant depending on how well it

works for them. Suvorexant comes in

three different sized tablets, so you and

your doctor can find which strength

may work best for you.

Take suvorexant a half hour before you

plan to go to bed at night. Suvorexant

may take longer to work if you take it

with food.

Suvorexant is intended to help you get

a full night’s sleep, so you should plan

on having at least seven hours of sleep

before you take suvorexant.

Taking more than one dose of suvorexant

before bed can increase the chances of

side effects and make you very drowsy, so

it is important to take it as prescribed by

your doctor.

What are the side effects of suvorexant?

Suvorexant has fewer side effects than

other available sleep medications. How-

ever, side effects can still happen. Nor-

mal side effects include diarrhea, dry

mouth, and higher risk of flu or strep in-

fection.

Serious side effects can happen with su-

vorexant. You should call your doctor

right away if you:

Feel sleepier than normal during the day

Have problems concentrating

Have episodes of sleep-walking, sleep-

eating, sex while asleep, or sleep-talking

What are the warnings with suvorexant?

Suvorexant can interact with alcohol and

some medications that also make you

tired. When using suvorexant:

Avoid drinking alcohol with suvorexant

Have someone else drive if you have

recently taken suvorexant

Avoid taking other medications at night

that make you drowsy, like pain medi-

cations, anti-anxiety medications, and

some antidepressants

By Barry Bodle, PharmD Candidate

REFERENCES:

1. Belsomra® [package insert].

Whitehouse Station, NJ: Merck &

Co.; 2014 August.

2. Michelson D, Snyder E, Paradis E, et

al. Safety and efficacy of suvorexant

during 1-year treatment of insomnia

with subsequent abrupt treatment

discontinuation: a phase 3 random-

ised, double-blind, placebo-controlled

trial. Lancet 2014;13:461-471.

3. Sun H, Kennedy WP, Wilbraham D,

et al. Effects of suvorexant, an orexin

receptor antagonist, on sleep parame-

ters as measured by polysomnogra-

phy in healthy men. Sleep 2013;36

(2):259-267.

4. Herring JW, Snyder E, Budd K, et al.

Orexin receptor antagonism for treat-

ment of insomnia: a randomized clini-

cal trial of suvorexant. Neurology

2012;79:2265-2274.