DOES LOOK INSIDE for a questionnaire! MIGRAINE HAVE YOU · 3 About 20% of migraine sufferers will experience “aura” before a headache Auras are sensations that signal a migraine

DOES MIGRAINE HAVE YOU

AGAIN?

INDICATION Trokendi XR (topiramate) extended-release capsules are used to prevent migraine headaches in adults. Trokendi XR is not used to stop a migraine headache after it starts.

NEW FOR MIGRAINE PREVENTION: ONCE-A-DAY TROKENDI XR®— an extended-release topiramate that provides continuous 24-hour coverage of migraine prevention medicine may help you get back into the picture!

Please refer to the Important Safety Information (pages 6 and 7) and the enclosed Medication Guide for more information on Trokendi XR, or visit www.TrokendiXR.com.

Visit www.TrokendiXR.com to sign up for the Trokendi XR $0 Co-pay Program.*

ONCE-A-DAY

FOR MIGRAINE PREVENTION IN ADULTS

Capsules shown are not actual size.

FOR MIGRAINEIN ADULTS

PREVENTION

TROKENDI XR NOW APPROVED

MISSING OUT

LOOK INSIDE for a questionnaire!

Actor portrayals. Individual results may vary.

https://www.trokendixr.com/important-safety-information/

https://www.trokendixr.com/assets/TrokendiXRMedGuide.pdf

http://www.TrokendiXR.com

2

MIGRAINE IS NOT “ JUST A BAD HEADACHE” OR “ALL IN YOUR HEAD”

Migraine is an often painful condition that affects about 37 million AmericansMigraine is a serious, often complex condition of the neurologic (nervous) system that can significantly disrupt time with loved ones, education, and careers.

Approximately 1 in 7 Americans 18 years of age and older, an estimated 14% of the US population, suffers from migraine. The World Health Organization categorizes migraine as one of the most disabling medical illnesses worldwide.

Migraine is a recurring, painful attack with a wide variety of potential symptomsIt is believed that various triggers start a complex chain of events that lead to a full-blown migraine attack. The headache of a migraine usually includes severe, recurring, throbbing pain on 1 side of the head. However, migraine sufferers can also experience pain on both sides of their head.

In addition to pain, there are a cluster of other symptoms that can be present and vary from attack to attack. While there are some common symptoms of migraine, each person’s individual experience is unique.

The most common migraine symptoms during the headache phase include:

• Extreme sensitivity to light or sound

• Throbbing pain

• Vomiting

• Sweating

• Scalp tenderness

3

About 20% of migraine sufferers will experience “aura” before a headacheAuras are sensations that signal a migraine is coming. They often cause visual symptoms, such as seeing spots or flashing lights. Auras can also produce other sensations, such as tingling in the arms or face, difficulty speaking, and tunnel vision.

A migraine is usually set off by a triggering factor or conditionMany different factors can bring on migraine headaches in individuals who are sensitive to them. And there is evidence that migraine can run in families. Triggers are different for everyone and can change over time.

The most frequently experienced migraine triggers include:

Lifestyle changes can help lessen the severity and frequency of migraine over timeThere is no cure for migraine. The good news is that there are treatments that can reduce the frequency of migraine, as well as the pain associated with the attacks. There are also simple things that you can do in your daily routine to help with migraine, including:

Keeping regular sleep and meal patterns

Exercising regularly for at least 30 minutes, 3 times per week

Z ZZ

0 10S T R E SS

ZZZ

Z ZZ

0 10S T R E SS

ZZZ

Z ZZ

0 10S T R E SS

ZZZ

Z ZZ

0 10S T R E SS

ZZZ

Z ZZ

0 10S T R E SS

ZZZ

Z ZZ

0 10S T R E SS

ZZZ

Z ZZ

0 10S T R E SS

ZZZ

Z ZZ

0 10S T R E SS

ZZZ

Z ZZ

0 10S T R E SS

ZZZ

Z ZZ

0 10S T R E SS

ZZZ

ZZZ

010 STRESS

Z ZZ

Hormonal changes (e.g., during a woman’s menstrual cycle)

Food allergies or sensitivities (e.g., to alcohol or food additives)

Bright lights or loud noise

Skipping meals

Too little sleep

Weather changes

Stress

Avoiding known triggers

Reducing your stress levels

4 5

Please refer to the Important Safety Information (pages 6 and 7) and the enclosed Medication Guide for more information on Trokendi XR.

To help you have more days in the picture, it is important to follow the plan you designed with your doctorPerhaps the most important thing you can do to help reduce the frequency of migraine is to maintain the treatment plan designed by you and your doctor. For patients with frequent migraine attacks, or those who do not respond to acute treatments, preventive medicines can be important. Studies show that about 45% of adults with migraine could see a substantial reduction in migraine with preventive therapy; yet, only about 12 percent of adults with migraine take preventive medicine.

Your doctor has prescribed once-a-day Trokendi XRTrokendi XR is an extended-release version of topiramate. Topamax® (topiramate) is an immediate-release topiramate—a medicine that has been on the market for 2 decades and is approved by the FDA for migraine prevention in adults.

DAYS IN THE PICTURE

TALK TO YOUR DOCTOR ABOUT HOWONCE-A-DAY TROKENDI XR® MAY HELP YOU HAVE MORE




4 5

ONCE-A-DAY



Once-a-day Trokendi XR is an extended-release topiramate that provides continuous 24-hour coverage of migraine prevention medicine with just 1 pill a dayOnce-a-day Trokendi XR is an extended-release formulation of topiramate for adult patients with migraine. Trokendi XR delivers around-the-clock levels of topiramate with a single daily dose of medicine.

For illustration purposes only; does not represent Trokendi XR or the actual time medicine is released.

00

12

0618

Immediate-release beads

Extended-release A beads

Extended-release B beads

24HOURS

Once-a-day Trokendi XR uses Microtrol® technology—3 types of specially coated microbeads that help achieve all-day coverage of your medicine.

DAYS IN THE PICTURE



6

Please refer to the enclosed Medication Guide for more information on Trokendi XR.

INDICATIONTrokendi XR® (topiramate) extended-release capsules are used to prevent migraine headaches in adults. Trokendi XR is not used to stop a migraine headache after it starts.

IMPORTANT SAFETY INFORMATIONWho should not take Trokendi XR?Do not take Trokendi XR if• You have recently consumed or plan to consume alcohol (i.e., within 6 hours prior to

and 6 hours after Trokendi XR use) • You have metabolic acidosis and are also taking metformin (e.g., Glucophage®) Swallow Trokendi XR capsules whole. Do not sprinkle on food, chew, or crush.

What are the possible side effects of Trokendi XR?Trokendi XR can cause serious side effects, including: Eye problems. Serious eye problems include sudden decrease in vision with or without eye pain or redness, a blockage of fluid that may cause increased pressure in the eye (secondary angle closure glaucoma). Call your healthcare provider right away if you have new eye symptoms, including any new problems with your vision. Decreased sweating and increased body temperature (fever). People, especially children, should be watched for signs of decreased sweating and fever, especially in hot temperatures. Some people may need to be hospitalized for this condition. Increased levels of acid in the blood (metabolic acidosis). If left untreated, metabolic acidosis can cause brittle or soft bones (osteoporosis, osteomalacia, osteopenia), kidney stones, can slow the rate of growth in children, and may possibly harm the unborn child of pregnant patients. High levels of ammonia in the blood. High ammonia in the blood can affect mental activities, slow alertness, cause tiredness, or cause vomiting. Blood ammonia levels have been shown to rise when Trokendi XR is taken with a medicine called valproic acid (e.g., DEPAKENE® and DEPAKOTE®).Kidney stones. Drink plenty of fluids when taking Trokendi XR to decrease your chances of getting kidney stones. Low body temperature. Taking Trokendi XR when you are also taking valproic acid may cause a drop in body temperature to less than 95°F, tiredness, confusion, or coma. Effects on thinking and alertness. Trokendi XR may affect how you think, and can cause confusion and problems with concentration, attention, memory, or speech. Trokendi XR may cause depression or mood problems, tiredness, and sleepiness. Dizziness or loss of muscle coordination.

The most common side effects include tingling of the arms and legs (paresthesia), not feeling hungry, nausea, weight loss, abnormal vision, a change in the way foods taste, nervousness, speech problems, dizziness, slow reactions, difficulty with concentration/attention, sleepiness, and difficulty with memory. These are not all the possible side effects of Trokendi XR. For more information, ask your healthcare provider or pharmacist.


7

ONCE-A-DAY



Like other antiepileptic drugs, Trokendi XR may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Before you take Trokendi XR, tell your healthcare provider if you have or have had depression, mood problems, or suicidal thoughts or behavior. Call a healthcare provider right away if you have thoughts about suicide or dying; have attempted to commit suicide; have new or worsening depression or anxiety; feel agitated or restless; experience panic attacks, trouble sleeping (insomnia), or new or worsening irritability; feel or act more aggressive, angry, or violent; act on dangerous impulses; have an extreme increase in activity and talking (mania); or experience other unusual changes in behavior or mood. Before taking Trokendi XR, tell your healthcare provider about any other medical conditions, including if you have kidney problems, kidney stones, or are getting kidney dialysis; have a history of metabolic acidosis (too much acid in the blood); have liver problems; have weak, brittle, or soft bones (osteomalacia, osteoporosis, osteopenia, or decreased bone density); have lung or breathing problems; have eye problems, especially glaucoma; have diarrhea; have a growth problem; are on a diet high in fat and low in carbohydrates, which is called a ketogenic diet; are having surgery; are pregnant or plan to become pregnant; or if you are breastfeeding. Trokendi XR passes into your breast milk. It is not known if the Trokendi XR that passes into breast milk can harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take Trokendi XR. Trokendi XR can harm your unborn baby. If you take Trokendi XR during pregnancy, your baby has a higher risk for the birth defects cleft lip, cleft palate, and being smaller than expected at birth. These defects can begin early in pregnancy, even before you know you are pregnant. Tell your healthcare provider about any other medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Trokendi XR and other medicines may affect each other, causing side effects. Especially tell your healthcare provider if you take metformin (e.g., Glucophage); valproic acid (e.g., DEPAKENE or DEPAKOTE); any medicines that impair or decrease your thinking, concentration, or muscle coordination; or birth control pills. Trokendi XR may make your birth control pills less effective.Do not stop Trokendi XR without first talking to a healthcare provider. If you have epilepsy and you stop taking Trokendi XR suddenly, you may have seizures that do not stop. Your healthcare provider will tell you how to stop taking Trokendi XR slowly. Do not drive a car or operate heavy machinery until you know how Trokendi XR affects you. Trokendi XR can slow your thinking and motor skills, and may affect vision.

Please refer to the enclosed Medication Guide for additional important patient information.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.


8 9

It was determined that a total daily dose of Trokendi XR given once a day provided the same medicine levels as Topamax twice a day

Part 2:

• After the 10 days were completed, all the adults took a break from the treatment for 32 days to clear the medicine from their bodies

• They were then switched to the opposite treatment and the same procedures were repeated

There were 2 main parts to the study: Part 1:

• 39 healthy adults were randomly assigned to take 200 mg of Trokendi XR once a day or 100 mg of Topamax twice a day†

• Over the course of 3 weeks, the 39 adults in the study were adjusted up to their full 200-mg dose of medicine and were maintained on this full dose for 10 days

†Recommended dose of Trokendi XR for migraine prophylaxis is 100 mg/day.

Look at how once-a-day Trokendi XR and twice-a-day Topamax® (topiramate) are absorbed into your bloodstream and available throughout your body over a full 24-hour day

TALK TO YOUR DOCTOR ABOUT HOWONCE-A-DAY TROKENDI XR® MAY HELP YOU HAVE MORE DAYS


0 h 4 h 8 h 12 h 16 h 20 h 24 h

8

6

4

0

Topi

ram

ate

conc

entr

atio

n (m

g/L)

Time (hours)Topamax 100 mg

twice a dayTrokendi XR 200 mg

once a day

Slow Rate of Rise

Low Fluctuation (Peaks and Drops)Low Fluctuation (Peaks and Drops)

Slow Rate of Rise

Delivery of topiramate for a full 24 hours in just 1 pill a day



8 9

What does this medical study mean for you?

When the level of medicine in your body fluctuates, you may not have appropriate coverage during the high peaks and low drops

At these times, you may be at greater risk for symptoms or side effects while you are going about your day

Once-a-day Trokendi XR, represented by the blue line, rises slowly in your body and maintains a relatively steady level to ensure that you are covered with your medicine throughout the day with a single dose

Twice-a-day Topamax, represented by the purple line, rises very quickly in your body and then drops down over the course of 12 hours before the second dose is taken

Taking just 1 pill a day and getting the same total daily dose of topiramate is an important option. Many patients may find it less difficult to remember to take their medicine once a day rather than twice a day.

Equally important is the fact that these 2 medicines enter your body at different rates throughout the day, despite the fact that they offer the same total daily dose of medicine.

ONCE-A-DAY



TALK TO YOUR DOCTOR ABOUT HOWONCE-A-DAY TROKENDI XR® MAY HELP YOU HAVE MORE DAYS IN THE PICTURE


10

Once-a-day Trokendi XR— an extended-release topiramate that

9 out of 10 patients with epilepsy (93.4%) preferred over twice-a-day Topamax® (topiramate) in a medical study

In the medical study, 61 patients with epilepsy took a stable dose of immediate-release topiramate for 2 weeks followed by Trokendi XR for 2 weeks

6.6%Twice-a-day topiramate

(n=4)

93.4%Once-a-day Trokendi XR

(n=57)

In addition to the fact that 93.4% of patients with epilepsy chose once-a-day Trokendi XR over immediate-release topiramate, over 90% of those patients also felt that once-a-day dosing with Trokendi XR helped them to take their medicine every day






11

ONCE-A-DAY



How the study was conducted:• Patients with epilepsy on a stable dose of immediate-release topiramate

took their current dose of medicine for 2 weeks

• At 2 weeks, patients were switched to the same total daily dose of Trokendi XR and remained on this dose for another 2 weeks

• Blood samples were drawn to determine levels of medication

• At day 28 of the study, patients were asked which medicine they preferred through questions that were noted in study report forms. The questions that patients answered were:

➊ Were you asked which medicine you preferred at day 28? ❏ Yes ❏ No

➋ Which treatment do you prefer? ❏ Once a day ❏ Twice a day



• I am currently taking immediate-release Topamax® (topiramate) twice a day Yes_____ No______

• Someone I know switched to Trokendi XR and recommended I talk to my doctor about it Yes_____ No______

• I am interested in talking to my doctor about side effects Yes_____ No______

• I like the idea of a steady concentration of medicine in my system, which may mean fewer ups and downs in coverage over 24 hours Yes_____ No______

• I am interested in paying $0 for my topiramate therapy* Yes_____ No______

• Other topics not listed here: ____________________________ ________________________________________________ ________________________________________________

Print this page and bring to your appointment to guide your talk with your doctor.

I don't want to miss my opportunity to try Trokendi XR®—

I'll talk to my doctor today

ONCE-A-DAY




* For full terms and conditions, please see the Trokendi XR Co-pay Card, or visit www.TrokendiXR.com.




TODAY IS THE DAY!

I WANT TO TALK TO MY DOCTOR ABOUT TAKING

ONCE-A-DAY TROKENDI XR® — EVERY DAY.

Print this page and bring to your appointment to guide your talk with your doctor.


IN THE PICTURE

25 mg 50 mg 100 mg 200 mg


12

Switching to once-a-day Trokendi XR from immediate-release topiramate is simple

You can switch to once-a-day Trokendi XR from Topamax® (topiramate) as soon as your next dose Switching to once-a-day Trokendi XR from twice-a-day Topamax allows you to take the same medicine you are already taking, but less often. For example, if you are taking 50 mg of Topamax twice a day (100 mg total per day), you would only have to take a single 100 mg capsule of Trokendi XR once a day.

Once-a-day Trokendi XR is available in 4 convenient dosage strengths

Trokendi XR provides mg-to-mg conversion from twice-a-day TopamaxThis means that your doctor prescribes the same total daily dose of medicine, but it is only taken once a day instead of being split into twice-a-day doses.






15

Example of same-day conversion for patients taking twice-a-day Topamax†

13

ONCE-A-DAY



Tablets and capsule shown are not actual size.†Recommended dose of Trokendi XR for migraine prophylaxis is 100 mg/day.

=ONCE A DAY

TROKENDI XR100 mg

Daily

+TWICE A DAY

TOPAMAX50 mg

EveningMorning



154164/

512/ 51

8/ 5164/

912/

2

334/

334/

Please see the Important Safety Information and Medication Guide for more information on Trokendi XR, or visit www.TrokendiXR.com.

*For full terms and conditions, please see the Trokendi XR Co-pay Card, or visit www.TrokendiXR.com.


ONCE-A-DAY


ONCE-A-DAY TROKENDI XR®

EVERY DAY!

Please refer to the Important Safety Information and the enclosed Medication Guide for more information on Trokendi XR, or visit www.TrokendiXR.com.

DON’T FORGET!

15

41

64

/

51

2 /5

18 /

51

64

/

91

2 /

233

4 /

33

4 /



Once-a-day Trokendi XR® every day— an important part of your

new treatment plan

Tips to help you remember to take your medicine every day:

• Take your medicine at the same time every day• Take your medicine regardless of whether you’re feeling well or not• Mark your calendar to fill and refill your prescription on time• Check with your pharmacist to see if there are refill programs to help

you with monthly refills• Set a daily reminder on your cell phone or computer• Check your insurance policy for mail order capability• Use daily pill boxes• Take your medicine when you do another daily activity• Use the enclosed door hanger on a cabinet or door near where you

store your medicine

15

41

64

/

51

2 /5

18 /

51

64

/

91

2 /

233

4 /

33

4 /


14

Study Details: • In both medical studies, patients with 3-12 migraines (but no more than

15 headache days) per month were observed for 6 months• Patients were maintained on placebo or 1 of 3 different doses (50, 100, or

200 mg/day) of topiramate • The goal of the medical studies was to measure the reduction in number of

migraines per month

Placebo(# of patients:115/114)

0.8 1.1 1.3 1.4 2.1 2.1 2.2 2.4

*Dose group was statistically different than placebo group.

Topiramate 50 mg/day(# of patients:117/117)

Topiramate 100 mg/day(# of patients:125/120)

Topiramate 200 mg/day(# of patients: 112/117)

Study 2(467 patients)

Study 1(469 patients)

Perc

ent r

educ

tion

in n

umbe

r of m

igra

ines

per

mon

th

50

45

40

35

30

25

20

15

10

5

0

15%

20%

24% 25%

*38% *38%*40%

*44%

Average number of migraines reduced permonth compared to baseline

Starting on topiramate for the first time: what you can expect from once-a-day Trokendi XR

In medical studies, topiramate was proven to be effective in reducing the number of migraines

Patients started with an average of approximately 5.5 migraines a month


154164 /

512/51

8/5164 /

912/

2

334/

334/




S

15

It is important to take your daily dose of medicine as prescribed. Do not stop taking once-a-day Trokendi XR without talking to your doctor.

S

M

M

T

T

W

W

T

T

F

F

S

S

WEEK 1

Once a day

WEEK 2

S M T W T F SWEEK 3

S M T W T F SWEEK 4

25 mg/day

50 mg/day

100 mg/day

75 mg/day

ONCE-A-DAY




Your doctor will start you on once-a-day Trokendi XR with a plan to increase your daily dose over time Gradually increasing the dosage over a period of 4 weeks will help your body adapt to the medicine and reduce the risk of side effects. Your doctor will work with your individual needs to help you achieve the right dose for migraine prevention.

The recommended daily dose of Trokendi XR for migraine prevention in adults is 100 mg/day achieved over a 4-week dosing schedule:

IN THE PICTURE


16

You’re not alone—there are many resources and places to go for more information on migraineYou should always talk to your doctor about any questions you may have, and for information about the migraine treatment plan specifically designed for you. But there are also many websites and resources where you can find additional information.

Below is a list of trusted resources you may find helpful:

Organization web sites:Alliance for Headache Disorders Advocacy allianceforheadacheadvocacy.wordpress.com

American Migraine Foundation americanmigrainefoundation.org

American Headache and Migraine Association ahma.memberclicks.net

Migraine Awareness Group migraines.org

Migraine Research Foundation www.migraineresearchfoundation.org

National Headache Foundation (NHF) www.headaches.org

National Institute of Neurological Disorders and Stroke (NIH) www.ninds.org

NHF Head Wise Online Magazine www.headaches.org/headwise-magazine

Other web sites and blogs:AccuWeather.com For a "migraine headache forecast," enter your location, move (don't click) your cursor over the forecast, then roll to the "Health" column and click "Migraine headache" www.accuweather.com

Migraine.com An online community dedicated exclusively to migraine headache. Features articles, discussion boards, interactive polls, and more migraine.com

Putting Our Heads Together Educational support and advocacy information for those who suffer from migraine www.puttingourheadstogether.com

The web sites and/or blogs listed above are not affiliated with, controlled, or endorsed by Supernus Pharmaceuticals, Inc.

LOCATING INFORMATION AND RESOURCES THAT MAY HELP YOU HAVE MORE DAYS


http://allianceforheadacheadvocacy.wordpress.com

http://americanmigrainefoundation.org

http://ahma.memberclicks.net

http://migraines.org

http://www.migraineresearchfoundation.org

http://www.headaches.org

http://www.headaches.org/headwise-magazine

http://www.accuweather.com

http://migraine.com



https://www.ninds.nih.gov/

http://www.puttingourheadstogether.com/

17

ONCE-A-DAY



LOCATING INFORMATION AND RESOURCES THAT MAY HELP YOU HAVE MORE DAYS IN THE PICTURE


* For full terms and conditions, please see the Trokendi XR Co-pay Card, or visit www.TrokendiXR.com.

Trokendi XR and Microtrol are registered trademarks of Supernus Pharmaceuticals, Inc. All other trademarks are the property of their respective owners. ©2017 Supernus Pharmaceuticals, Inc. All rights reserved. SPN.TRO.2017-0089

Once-a-day, FDA-approved, extended-release Trokendi XR for the prevention of migraine in adults

Please refer to the Important Safety Information (pages 6 and 7) and the enclosed Medication Guide for more information on Trokendi XR, or visit www.TrokendiXR.com.


DAYS IN THE PICTUREActor portrayals. Individual results may vary.


ONCE-A-DAY






Documents

DOES LOOK INSIDE for a questionnaire! MIGRAINE HAVE YOU · 3 About 20% of migraine sufferers will experience “aura” before a headache Auras are sensations that signal a migraine