Protein Supplementation For Athletes

Do athletes need to eat diets that are very

high in protein to help gain muscle? Proba-

bly not. Eating protein can help people lose

weight because it gives a sense of fullness

during and after eating, which leads to less

food consumption. A common thought is that,

since muscles are made of protein, the diet

should be high in protein to build muscle.

However, too much protein can keep athletes

from eating carbohydrates, which are a major

source of energy.

Eating a diverse diet can help you get the fat,

carbohydrates, and protein needed to build and

maintain a healthy body. Plus, eating a variety

of foods will help you get the nutrients (like

vitamins and minerals) to allow your body to

perform at its peak.

The problem with using protein supplements

is that, while they may supply protein, they

often do not supply any other nutrients like

food does. Protein supplements are “empty”

proteins, but real food is more “complete”.

Reports differ on the consequences of a high-

protein diet. Although high-protein diets may

hurt the kidneys, there is currently no proof to

support this claim. Proteins require more wa-

ter to be digested properly, and too much pro-

tein might make an athlete prone to dehydra-

tion. Muscles are about 75% water, so it is

very important for athletes to be well hydrated

to maintain or build muscle.

Why do people who take protein supple-

ments seem to have more muscle than other

Volume

January 2016

We welcome any comments

and suggestions for future

newsletter topics.

Editors in Chief:

Sherrill Brown, DVM, Pharm.D, BCPS

Micah Miller, PharmD

Patient Information: Stroke

2

Vraylar® (cariprazine)

3

Treatment of RSV 4

Patient Information: Pneumococcal Vac-cination

7

Updates to Clozap-ine REMS Program

8

Inside this issue:

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

Drug Informa tion Service

athletes? We know that it is not the protein

supplement that is responsible for the large mus-

cles. It may be a placebo effect, when the belief

that a treatment will work results in the treat-

ment working.

An excellent web site to help determine a

healthy diet is www.choosemyplate.gov. Most

adults need between five and six ounces of pro-

tein daily. Three ounces of protein is equivalent

to:

1 small chicken breast

three eggs

1 can of tuna

1 small, lean hamburger patty

1 ½ cups of bean, pea, or lentil soup

If an athlete eats more calories in a day for their

training program, they may need to eat more

protein than a non-athlete.

By Tim Polacheck, PharmD Candidate

REFERENCES:

1. All about the protein food group

(3/28/2016). USDA Web site. Available at:

http://www.choosemypla te.gov/protein-

foods. Accessed October 12, 2015.

2. Newnham M. Sports nutrition and perfor-

mance-enhancing nutrients and supple-

ments. In: Krinsky DL, Berardi RR, Ferreri

SP, et. al editors. Handbook of Nonpre-

scription Drugs: An Interactive Approach to

Self-care. 17th ed. Washington (DC):

American Pharmacists Association;

2012:437-454.

3. Sánchez Oliver A1, Miranda León MT,

Guerra-Hernández E. Prevalence of protein

supplement use at gyms. Nutr Hosp

2011;26(5):1168-1174.

4. Tipton KD. Efficacy and consequences of

very-high-protein diets for athletes and ex-

ercisers. Proc Nutr Soc 2011;70(2):205-

214.

Page 2

How do you recognize a stroke?

Remember the word FAST to recognize a

stroke quickly.

F for Face – Face drooping or laziness on

one side can occur when a strokes happens.

A for Arm – Arm weakness on one side can

occur when a stroke happens.

S for Speech – Trouble speaking or slurred

speech can occur when a stroke happens.

T for Time – Getting help as fast as possi-

ble by calling 9-1-1 is very important.

Recognizing the signs of a stroke is very

important. Quickly recognizing a stroke and

calling 9-1-1 could prevent serious disability

or even death.

How can you help prevent a stroke from

happening to you?

Regular exercise can help lower stroke

risk in several ways, including losing body

weight, lowering blood pressure, and im-

proving cholesterol.

Eating a healthy diet that consists of plenty

of fresh fruit and vegetables, and less satu-

rated fats, trans fats, and salt.

Quitting tobacco use will lower r isk of

stroke and improve health in many other

ways.

Drinking less alcohol and limiting the

amount of drinks to one per day for women

and two per day for men can also help lower

risk of stroke.

PATIENT INFORMATION:

Stroke

Be aware of other health conditions that

may add to stroke risk, such as:

Atrial fibrillation (A-Fib) or other

heart diseases

High blood pressure

High cholesterol

Diabetes

What is a stroke? AN EMERGENCY!

A stroke happens when blood supply is

cut off to part of the brain. Then brain

tissue dies from lack of oxygen. Two

types of stroke can occur:

Ischemic stroke – when blood clots

block vessels in the brain.

Hemorrhagic stroke – when blood

vessels burst causing bleeding in the

brain.

How common are strokes?

Strokes are common—about 800,000

people will have a stroke per year in the

US. Strokes are the number 1 cause of

disability and 4th leading cause of death

in adults in the

United States.

Ask your doctor

or pharmacist

about strokes

and ways to

lower your risk

of stroke.

Visit the following Web sites for more

information about strokes:

https://www.nlm.nih.gov/medlineplus/

stroke.html

http://www.cdc.gov/stroke/index.htm

http://www.strokeassociation.org/

STROKEORG/

By Luke Schonsberg, PharmD Candi-

date

REFERENCES: 1. Spot a stroke (n.d.). American

Stroke Association Web site.

Available at: http://

www.strokeassociation.org/

STROKEORG/WarningSigns/

Stroke-Warning-Signs-and-

Symptoms_UCM_30852

8_SubHomePage.jsp. Accessed

November 3, 2015.

2. Stroke (10/28/2015). Medline Plus

Web site. Available at: https://

www.nlm.nih.gov/medlineplus/

stroke.html. Accessed November

3, 2015.

3. Stroke (3/24/2015). CDC Web site.

Available at: http://www.cdc.gov/

stroke/about.htm. Accessed No-

vember 3, 2015.

4. Koton S, Schneider ALC, Rosa-

mond WD, et al. Stroke incidence

and mortality trends in US commu-

nities, 1987 to 2011. JAMA

2014;312(3):259-268.

Image from: http://www.strokeassociation.org/STROKEORG/WarningSigns/Stroke-Warning-Signs-and-

Symptoms_UCM_308528_SubHomePage.jsp

Image from: http://www.neurodoc.in/stroke

Page 3

Vraylar® (cariprazine) was approved by the

FDA on September 17, 2015, for treatment

of schizophrenia and bipolar I disorder with

acute mixed or manic episodes.1 Cariprazine

is believed to be a potent partial agonist of

D3, D2, and 5-HT1A receptors in the brain

as well as an antagonist for 5-HT2B, 5-

HT2A, and H1 receptors.1-3,5 Current anti-

psychotic medications do not have a strong

affinity for D3 receptors.2 Cariprazine is

unique because it is 10 times more potent

for D3 receptors than D2 in vitro.2,3 D3 re-

ceptors are thought to have a role in mood

regulation and cognition function.2 There-

fore, cariprazine may have a broader effect

on patients with bipolar and schizophrenia

due its unique mechanism of action.2

Current antipsychotic therapies mainly tar-

get positive symptoms including hallucina-

tions, delusions, and disorganized speech.3

However, better quality of life is associated

with decreased negative (social withdrawal,

decreased motivation, lack of emotion) and

cognitive symptoms (lack of attention or

memory deficit).3 In clinical trials, caripra-

zine not only improved positive symptoms,

but also had some benefit on negative symp-

toms. 3

Cariprazine was more effective than placebo

in patients with bipolar disorder and in study

participants with schizophrenia in multiple

trials.1-3

Cariprazine significantly decreased the se-

verity of mania symptoms after three weeks

in 312 participants with bipolar disorder.2

The randomized, double-blind study evalu-

ated various cariprazine doses between 3 mg

and 12 mg. The use of benzodiazepines as a

rescue medication in the study did not sig-

nificantly decrease in any of the treatment

groups. Because the use of benzodiazepines

was similar between placebo and caripra-

zine, this drug may not decrease agitation in

patients. The study results may not be gener-

alizable to all populations since 57% of par-

ticipants were Asian. Additionally, partici-

pants were excluded if they had received

electroconvulsive therapy within the last

three months, a depot neuroleptic within the

last three months or had been previous

clozapine treatment within the last ten

years.2

Vraylar® (cariprazine)

Often antipsychotics are linked to weight

gain, cardiovascular events or metabolic

changes.2 In a three-week clinical trial,

the effects of cariprazine were similar to

placebo in weight gain, QTc prolonga-

tion, metabolic changes, and changes in

prolactin, which may suggest cariprazine

as an alternative to other antipsychotic

medications to avoid these side effects.2

Cariprazine 3 mg to 9 mg significantly

decreased positive schizophrenia symp-

toms in 446 participants compared to

placebo.3 In this double-blind, six-week

study, doses of 3 mg to 6 mg of caripra-

zine and 6 mg to 9 mg of cariprazine

were compared to placebo. Regardless of

cariprazine dose, positive symptoms im-

proved compared to placebo. Participants

on higher doses of cariprazine also had a

significant decrease in negative symp-

toms, but this was not seen with lower

cariprazine doses. Schizophrenia Quality

of Life Scale (SQLS-R4) scores and vi-

tality scores significantly improved in

participants taking lower doses of

cariprazine, but the improvement was

not significant with higher doses. Study

participants were excluded if they had

treatment-resistant schizophrenia, elec-

troconvulsive therapy in the past 3

months, or used clozapine within the last

ten years, which may limit the generali-

zability of the results.3

Adverse effects of akathisia, extrapyram-

idal symptoms, somnolence, restlessness,

indigestion, and vomiting were common-

ly seen in clinical trials. It is important

to note that full effects from dose in-

creases do not develop in patients for

several weeks since cariprazine has a

long half-life (2 – 4 days) and multiple

metabolites.1-5 Therefore the relatively

short clinical trials may not be an ade-

quate representation of long-term ad-

verse effects of cariprazine.4,5

The initial starting dose for cariprazine

is 1.5 mg per day. The dose can be in-

creased by 1.5 mg as needed to see ef-

fect. The maximum dose of cariprazine

is 6 mg per day.4,5 The maintenance

dose for treatment of schizophrenia is

1.5 mg to 6 mg daily, and the mainte-

nance dose for treatment of bipolar dis-

order is 3 mg to 6 mg daily.4,5

When used in conjunction with a strong

CYP3A4 inhibitor (ketoconazole, clar-

ithromycin, etc.), cariprazine dose

should be decreased by 50% due to de-

creased metabolism and elimination of

cariprazine. Cariprazine is also partially

metabolized by CYP2D6 so it may in-

teract with medications such as celecox-

ib or amiodarone.4,5

The use of cariprazine in patients with

severe hepatic impairment or creatinine

clearance less than 30 mL/min has not

studied, and it is not recommended to

use cariprazine in these populations.4,5

Cariprazine is a novel agent with the

effects on D3 receptors as well as D2

receptors. Since D3 receptors promote

mood regulation and cognition function,

cariprazine may help advance therapy in

patients with schizophrenia and bipolar

disorder. Cariprazine clinical trials did

not include an active control, which

limits the ability to evaluate caripra-

zine’s therapeutic advantages compared

to other agents. The clinical trials for

both bipolar and schizophrenia allowed

use of rescue benzodiazepine therapy,

which did not decrease with use of

cariprazine. Therefore, cariprazine

should not be expected to reduce agita-

tion.

By Valerie Nauditt, PharmD Candi-

date

References on Page 6

Page 4

RSV infections can cause bronchiolitis, pneumonia, inflammatory disorders, and secondary infections of the lungs.1,2 In-

fection with RSV can occur at any time of year, but the incidence of infection increases in the winter months (Figure 1).1 RSV is

the most common cause of bronchiolitis in children less than one year of age.2 By the age of 2, nearly all children will have been

infected with RSV. Reinfection is common throughout life.1,2 As the time from first infection increases, occurrence becomes less

common and symptoms are usually less severe.2 Most RSV infections are not life-threatening and do not require health care inter-

ventions.1 However, interventions may be warranted in those with severe disease or in high risk groups.1

Treatment of Respiratory Syncytial Virus (RSV) Infection

Figure 1: RSV seasons in US and Western regions (Adapted from the Center for Disease Control Web site 13)

Treatment Recommendations by Patient Population

Treatment for RSV in all groups Supportive care is the mainstay of treatment, which includes supplemental oxygen,

fluids, mucus removal and, in severe cases, intubation.1

Routine bronchodilator use has not shown a clear benefit in the treatment of RSV for

any group.1,3

Infants and young children (less than

24 months)

Supportive care is the mainstay of treatment for this group.1,3

Avoid corticosteroids, bronchodilators, ribavirin and immunoglobulins.1

One to two bronchodilator administrations may be warranted in severe disease, but

routine use is not supported by the current literature. 1,5

Older children and adults (over 24

months)

Consider use of methylprednisolone.1

Provide supportive care as needed, though severity of symptoms is usually less than

with younger patients.1-3

Special populations Immunocompromised patients: Consider ribavirin therapy1,3 Ribavirin may be particularly beneficial when combined with passive immuno-

therapy and/or corticosteroids1,5,6

Pregnant patients: Pregnant patients should receive management similar to other adults1 Ribavirin is contraindicated in this group of patients.1 Male partners of pregnant patients should not receive ribavirin.1

By Kyle Ann Spinner, PharmD Candidate

Continued on Page 5

Page 5

Treatment of Respiratory Syncytial Virus (RSV) Infection (cont.)

Recommendations for Specific Therapies

Supplemental oxygen Indication: Arterial oxygen saturations of < 90%1

Delivery systems Masks or nasal cannula are recommended over other administration systems.

Infants or children may also require enclosure systems. In severe cases, me-

chanical ventilation may be required.4

Discontinuation Discontinue upon consistent oxygen saturation of >90% and cessation of se-

vere respiratory symptoms.3

Corticosteroids (methylprednisolone)

Adults 500 mg oral methylprednisolone once daily for 3 days8

Children >24 months No dose is currently established. Standard dosing for patients with inflamma-

tory conditions are: Pediatrics: 0.5 to 1.7 mg/kg/day orally in 2-4 divided doses 9 Adults: 2 to 60 mg/day in 1-4 divided doses9

Bronchodilators (albuterol and epineph-

rine)

Short term use Short term bronchodilator use has been found ineffective in all groups except

those less than 24 months of age. 5 A single study demonstrated a limited short

term benefit of 0.1 mg/kg nebulized albuterol when given no more than 1-2

times, 30 minutes apart. All patients included in the study were under 24

months of age. Improvement occurred only in subjective clinical scores. Oxy-

gen saturation was unaffected by this treatment.6

Prolonged use No benefit of long-term albuterol or epinephrine use has been found for all

age groups.1

Ribavirin Formulations Nebulizer solutions have demonstrated efficacy in a greater number of trials

than other formulations. Ribavirin is also supplied as a capsule, tablet and oral

solution.10 No formulations have been directly compared or clearly estab-

lished as the treatment of choice for RSV.7,8,10

Dosing Dosing of ribavirin for RSV has not been established. Treatment regimens

that have shown success in trials have included: 2000 mg of inhaled ribavirin given over 2 hours and repeated every 8 hours

for 4 to 10 days7,8 15 to 20 mg/kg/day oral ribavirin in three divided doses for 7-10 days11 10 mg/kg loading dose or oral or IV ribavirin, followed by 400 mg three times

per day on day 2, and 600 mg three times per day on day 3. Treatment is

discontinued when the patients become asymptomatic and RSV is unde-

tectable by RT-PCR.12

Concomitant treat-

ments

In most studies, ribavirin was used concomitantly with both 500 mg/kg RSV

IVIG and 15 mg/kg palivizumab. Both medications were given as a single

dose at admission for treatment.1,7,8 Several studies demonstrated efficacy when ribavirin was administered with

500 mg of methylprednisolone daily for 3 days.1,7,8

References on Page 6

Page 6

1. Barr F, Graham B. Respiratory syncyti-

al virus infection: treatment. In: Up-

ToDate, Post TW (Ed), UpToDate,

Waltham, MA. (Accessed November

13, 2015.)

2. Respiratory syncytial virus infection

(RSV): infection and incidence

(12/4/2014). CDC Web site. Available

at: http://www.cdc.gov/rsv/about/

infection.html. Accessed October 28,

2015.

3. Respiratory syncytial virus infection

treatment and management (6/25/2015).

Medscape Web site. Available at: http://

emedicine.medscape.com/

article/971488-treatment. Accessed

November 12, 2015.

4. Baily P. Continuous oxygen delivery

systems for infants, children, and adults.

In: UpToDate, Post TW (Ed), Up-

ToDate, Waltham, MA. (Accessed No-

vember 14, 2015.)

5. Eiland LS. Respiratory syncytial virus:

diagnosis, treatment and prevention. J

Pediatr Pharmacol Ther 2009;14(2):75-

85.

6. Klassen TP, Rowe PC, Sutcliffe T,

RSV Treatement References

1. Walsh S. FDA approves new drug to

treat schizophrenia and bipolar disor-

der. FDA Web Site. Available at: http://

www.fda.gov/NewsEvents/Newsroom/

PressAnnouncements/ucm463103.htm.

Accessed November 16, 2015.

2. Sachs G, Greenberg W, Starace A, et

al. Cariprazine in treatment of acute

mania in bipolar I disorder: a double-

blind, placebo controlled, phase III

trial. J Affect Disord 2015;174:296-

302.

3. Kane J, Zukin S, Wang Y, et al. Effica-

cy and safety of cariprazine in acute

exacerbation of schizophrenia: Results

from an international, phase III clinical

trial. J Clin Psychopharmacol 2015; 35

(4):367-373.

4. Micromedex[Internet Database].

Greenwood Village, Colo:Truven

Health Analytics, 2015.

programs/asp/ribavirin-for-rsv-

guidelines_literature-

review_2014.pdf. Accessed No-

vember 13, 2015.

12. Khanna N, Widmer AF, Decker M,

et al. Respiratory syncytial virus

infection in patients with hemato-

logical diseases: single-center

study and review of the literature.

Clin Infect Dis 2008;46(3):402-

412.

13. Haynes AK, Prill MM, Iwane MK,

Gerber SI, Centers for Disease

Control and Prevention (CDC).

Respiratory syncytial virus —

United States, July 2012–June

2014. MMWR Morb Mortal Wkly

Rep 2014;63(48):1133-1136.

Cariprazine References

Ropp L, McDowell IW, Li MM.

Randomized trial of salbutamol in

acute bronchiolitis. J Pediatr

1991;118(5):807-811.

7. Boeckh M, Englund J, Li Y, et al.

Randomized controlled multicenter

trial of aerosolized ribavirin for res-

piratory syncytial virus upper respir-

atory tract infection in hematopoiet-

ic cell transplant recipients. Clin

Infect Dis 2007;44(2):245-249.

8. Iu V, Dhillon GS, Weill D. A multi-

drug regimen for respiratory syncyt-

ial virus and parainfluenza virus

infections in adult lung and heart-

lung transplant recipients. Transpl

Infect Dis 2010;12(1):38-44.

9. Lexicomp Online® , Methylpredni-

solone, Hudson, Ohio: Lexi-Comp,

Inc.; November 16, 2015.

10. Lexicomp Online® , Ribavirin,

Hudson, Ohio: Lexi-Comp, Inc.;

November 16, 2015.

11. Oral ribavirin (2014). Nebraska

Medicine Web site. Available at:

http://www.nebraskamed.com/

app_files/pdf/careers/education-

www.micromedexsolution

s.com. Accessed Novem-

ber 16, 2015.

5. Vraylar [Package Insert].

Parsippany, NJ: Actavis

Pharma, Inc; September

2015.

Page 7

What is the concern about pneumonia?2

“Pneumonia” is a common term used to

describe a general lung infection. One cause

of pneumonia is Streptococcal pneumoniae

bacteria. There are more than 90 types of S.

pneumoniae, and they are commonly found

in the upper respiratory tract. Five to seven-

ty percent of healthy adults are “carriers” of

S. pneumoniae.

Exposure to these bacteria can occur from

an infected person expelling water droplets

(coughing, sneezing). S. pneumoniae bacte-

ria is also found in healthy people and can

cause pneumonia if you are already ill or

have a weakened immune system.

Who is at risk?

People most at risk for S. pneumoniae infec-

tions are the young (< 5 years old) and the

elderly (> 65 years old). People who have a

weakened immune system (cancer, HIV/

AIDS), lung disease (including asthma and

smoking), or liver disease are also at risk.

How S. pneumoniae becomes deadly is not

completely known, but lung diseases, such

as asthma and COPD, are thought to play a

PATIENT INFORMATION:

Pneumococcal Vaccination Recommendations

role.

What is the pneumonia vaccine?

There are 2 vaccines which protect

against the most common types of S.

pneumoniae bacteria that cause pneumo-

nia.

Prevnar 13®—the “conjugate” vac-

cine was approved in 2010

Pneumovax® 23—the

“polysaccharide” vaccine was ap-

proved in 1983

The table below has information about

who should get which pneumonia vac-

cine.

By Chris Migliaccio, PharmD Candi-

date

REFERENCES:

1. Epidemiology and Prevention of

Vaccine-Preventable Diseases.The

Pink Book. 13th edition. 2015. Cen-

ter for Disease Control and Preven-

tion Web site. Available at: http://

www.cdc.gov/vaccines/pubs/

pinkbook/index.html. Accessed

December 2, 2015.

2. Pneumonia (n.d.). American Lung

Association Web site. Available at:

http://www.lung.org/lung-health-

and-diseases/lung-disease-lookup/

pneumonia. Accessed December 2,

2015.

2015 Pneumococcal Vaccination Guidelines from the Advisory Committee on Immunization Practices (ACIP)

Prevnar 13® Pneumovax® 23

Vaccine type Conjugate Polysaccharide

Patient ages for vaccine use

> 65 years old*

2-59 months old

> 65 years old*

Special populations

≤ 64 years old§

+ asplenia

+ cochlear implant

+ cerebral spinal fluid leaks

+ decreased immunity (transplant,

cancer, HIV)

2-64 years old§

+ chronic heart disease

+ asplenia

+ lung disease

+ asthma

(if > 19 years old)

+ liver disease

+ alcoholism

+ cigarette smoker

(if > 19 years old)

* Prevnar 13® should be given at least 1 year before receiving Pneumovax® 23

§ Prevnar 13® should be given at least 8 weeks before receiving Pneumovax® 23

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

Updates to Clozapine REMS Program

Previously, each manufacturer of

clozapine had their own risk evaluation

mitigation strategy (REMS) program,

resulting in six independent programs.

In an effort to reduce potential sources

of error, the FDA has released a central

REMS program, consolidating the pre-

vious programs into one program.

Patients enrolled in previous programs

have been transferred to the new

REMS program. This update changes

prescriber and pharmacist duties and

eliminates the National Non-

Rechallenge Master File (NNRMF).

Prescriber duty changes:

Prescribers are required to be reg-

istered and certified with the new

clozapine REMS program before

they can dispense.

Only prescribers or their registered

designees can enroll patients into

the program.

Monitoring must be done with

absolute neutrophil count (ANC);

white blood cell (WBC) counts are

no longer accepted.

Notable updates to treatment

guidelines include lower ANC

thresholds, new guidelines for

patients with benign ethnic neutro-

penia, removal of the NNRMF,

and flexibility to continue treat-

ment if benefits outweigh risks.

Pharmacist duty changes:

Pharmacies must have a designated

authorized representative who is reg-

istered with the program. This can be

a pharmacist, pharmacy director, or

corporate executive.

Pharmacists can no longer enroll pa-

tients, unless they are a prescriber’s

registered designee.

A pre-dispense authorization (PDA)

must be obtained before a pharmacy

may dispense clozapine, to ensure all

checks have been passed. PDAs can

be obtained through the pharmacy

management program (if your pro-

gram is set up to interact with the

registry) online through

www.clozapinerems.com or by

phone.

Inpatient pharmacies do not need a

PDA.

May 20, 2016 Update:

The initial PDA launch was implemented

on May 20, 2016. If the prescriber and/or

pharmacy is not certified with the REMS

program, then a warning message will

appear. However, dispensing will still be

authorized. Dispensing will still be au-

thorized if the patient’s ANC is not cur-

rent.

Once the second phase of the PDA imple-

mentation goes into effect, clozapine dis-

pensing will NOT be authorized if the

prescriber and/or pharmacy is not certified

or if the patient’s ANC is not current.

Pharmacies and prescribers should have

received letters from the clozapine REMS

program concerning the PDA launch.

More details about the PDA and the

REMS program are available at

www.clozapinerems.com.

By Doua Vang, PharmD Candidate

REFERENCES:

1. Risk evaluation and mitigation strate-

gy (REMS) single shared system for

clozapine. FDA Web site. Available

at: http://www.accessda ta.fda.gov/

drugsatfda_docs/rems/clozapine

_2015-09-15_REMS_f ull.pdf. Ac-

cessed November 12, 2015.

2. Important program update (as of

05/20/2016). Clozapine REMS Web

site. Available at: https://

www.clozapinerems.com/

CpmgClozapineUI/home.u#. Ac-

cessed May 23, 2016.