IMPORTANT SAFETY INFORMATION

What is the most important information I should know about Trokendi XR?

Take Trokendi XR capsules whole. Do not sprinkle on food, break, crush, dissolve, or chew before swallowing. If you cannot swallow Trokendi XR capsules whole, tell your healthcare provider.

Do not drink alcohol within 6 hours prior to and 6 hours after Trokendi XR administration.

Trokendi XR may cause eye problems. Serious eye problems include any sudden decrease in vision with or without eye pain and redness, and a blockage of fluid in the eye causing increased pressure in the eye (secondary angle closure glaucoma). These eye problems can lead to permanent loss of vision if not treated. Call your healthcare provider right away if you have any new eye symptoms, including any new problems with your vision.

Trokendi XR may cause 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. If a high fever, a fever that does not go away, or decreased sweating develops, call your healthcare provider right away.

Trokendi XR can increase the level of acid in your 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 your baby if you are pregnant. Metabolic acidosis can happen with or without symptoms. Sometimes people with metabolic acidosis will: • feel tired • not feel hungry (loss of appetite) • feel changes in heartbeat • have trouble thinking clearly. Your healthcare provider should do a blood test to measure the level of acid in your blood before and during your treatment with Trokendi XR. If you are pregnant, you should talk to your healthcare provider about whether you have metabolic acidosis.

Like other antiepileptic drugs, Trokendi XR may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:
• thoughts about suicide or dying • attempts to commit suicide • new or worse depression • new or worse anxiety • feeling agitated or restless • panic attacks • trouble sleeping (insomnia) • new or worse irritability • acting aggressive, being angry, or violent • acting on dangerous impulses • an extreme increase in activity and talking (mania) • other unusual changes in behavior or mood.

Do not stop Trokendi XR without first talking to a healthcare provider.

  • Stopping Trokendi XR suddenly can cause serious problems.
  • Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

How can I watch for early symptoms of suicidal thoughts and actions?

  • Pay attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings.
  • Keep all follow-up visits with your healthcare provider as scheduled.
  • Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

Trokendi XR can harm your unborn baby. If you take Trokendi XR during pregnancy, your baby has a higher risk for birth defects including cleft lip and cleft palate. These defects can begin early in pregnancy, even before you know you are pregnant. All women of childbearing age should talk to their healthcare providers about using other possible treatments instead of Trokendi XR. If the decision is made to use Trokendi XR, you should use effective birth control (contraception) unless you are planning to become pregnant. Tell your healthcare provider right away if you become pregnant while taking Trokendi XR. You and your healthcare provider should decide if you will continue to take Trokendi XR while you are pregnant. If you take Trokendi XR during pregnancy, your baby may be smaller than expected at birth. The long-term effects of this are not known. Talk to your healthcare provider if you have questions about this risk during pregnancy. Metabolic acidosis may have harmful effects on your baby. Talk to your healthcare provider if Trokendi XR has caused metabolic acidosis during your pregnancy. Pregnancy Registry: If you become pregnant while taking Trokendi XR, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334. The purpose of this registry is to collect information about the safety of Trokendi XR and other antiepileptic drugs during pregnancy.

Trokendi XR may decrease the density of bones when used over a long period.

Trokendi XR may slow height increase and weight gain in children and adolescents when used over a long period.

Who should not take Trokendi XR?

Do not take Trokendi XR if you are allergic to topiramate, Trokendi XR, or any of the ingredients in Trokendi XR. See end of the Medication Guide for a complete list of ingredients in Trokendi XR.

Before taking Trokendi XR, tell your healthcare provider about all of your medical conditions, including if you:

• have or have had depression, mood problems, or suicidal thoughts or behavior • 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 • are breastfeeding. Trokendi XR passes into your breast milk. Breastfed babies may be sleepy or have diarrhea. It is not known if the Trokendi XR that passes into breast milk can cause other serious harm to your baby. Talk to your healthcare provider about the best way to feed your baby if you take Trokendi XR.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially, tell your healthcare provider if you take:

  • Valproic acid (such as DEPAKOTE).
  • any medicines that impair or decrease your thinking, concentration, or muscle coordination.
  • birth control that contains hormones (such as pills, implants, patches, or injections). Trokendi XR may make your birth control less effective. Tell your healthcare provider if your menstrual bleeding changes while you are using birth control and Trokendi XR.

Ask your healthcare provider if you are not sure if your medicine is listed above.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist each time you get a new medicine. Do not start a new medicine without talking with your healthcare provider.

What should I avoid while taking Trokendi XR?

  • Do not drink alcohol within 6 hours before or 6 hours after taking Trokendi XR capsules. Trokendi XR and alcohol can cause serious side effects such as severe sleepiness and dizziness and an increase in seizures.
  • 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.

What are the possible side effects of Trokendi XR?

Trokendi XR may cause serious side effects, including:

  • Effects on thinking and alertness. Trokendi XR may affect how you think, and cause confusion, problems with concentration, attention, memory, or speech. Trokendi XR may cause depression or mood problems, tiredness, and sleepiness.
  • Dizziness or loss of muscle coordination.
  • Severe multiorgan reactions. Treatment with Trokendi XR may cause a serious allergic reaction that may affect your skin or other parts of your body such as your liver, kidneys, heart, or blood cells. This allergic reaction can be life-threatening and can cause death, particularly if it is not treated as early as possible. Contact your healthcare provider or get medical help right away if you have: • blistering and peeling of your skin or skin rash • fever or swollen glands that do not go away • hives • swelling of your face, eyes, lips, tongue, or throat • sores in your mouth • trouble swallowing or breathing • dark urine • yellowing of the skin or whites of the eyes.
  • Serious skin reactions. Trokendi XR may cause a severe rash with blisters and peeling skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome). Trokendi XR may also cause a rash with blisters and peeling skin over much of the body that may cause death (toxic epidermal necrolysis). Call your healthcare provider right away if you develop a skin rash or blisters.
  • Allergic reactions. Serious allergic reactions can happen after you take Trokendi XR. Get emergency help right away if you have swelling of the face, lips, eyes, tongue, or throat, or trouble swallowing or breathing.
  • High blood ammonia levels. High ammonia in the blood can affect your mental activities, slow your alertness, make you feel tired, or cause vomiting. This has happened when Trokendi XR is taken with a medicine called valproic acid (DEPAKOTE). Call your healthcare provider right away if you develop unexplained tiredness, vomiting, slowing of your thinking or reaction time, or changes in your mental activities.
  • 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 can cause a drop in body temperature to less than 95°F, feeling tired, confusion, or coma.

Call your healthcare provider right away if you have any of the symptoms above.
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 • diarrhea • upper respiratory tract infection • decreased feeling or sensitivity, especially on the skin • fever • tiredness • sleepiness/drowsiness • difficulty with memory • pain in abdomen.

Tell your healthcare provider about any side effect that bothers you or that does not go away. These are not all the possible side effects of Trokendi XR.

What is Trokendi XR®?

Trokendi XR® (topiramate) extended-release capsules is a prescription medicine used to prevent migraine headaches in adults and adolescents 12 years of age and older.

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.

Please refer to the Medication Guide.

Here to Help

Streamlined coverage and payment support for patients prescribed once-a-day Trokendi XR

ACTIVATE MY CO-PAY CARD

How to Register in Our Co-Pay Savings Program

This program is intended for non-government funded, commercially insured patients to help lower out-of-pocket costs.

1

Get a Trokendi XR prescription from your healthcare provider

2

Download and activate your Trokendi XR co-pay savings card

3

Print and show your co-pay savings card to your pharmacist and begin saving on your Trokendi XR prescription

BEGIN HERE
Image: Copay Card

Already received your Trokendi XR co-pay savings card?

ACTIVATE CARD

Supernus Support

Supernus Support provides a single point of contact for all of your questions regarding Trokendi XR, including medication access and insurance coverage.

Call 1-866-398-0833

Benefit verification

Claims and appeals support

Prior authorization assistance

Pharmacy locator service provided for patients and providers, trade, wholesale, stocking

Adverse event reporting

Product complaints

Medical inquiries

Savings and Support Program FAQs

Trokendi XR is covered by most prescription plans. If you have any questions about prescription coverage, call your insurance provider or call Supernus Support toll-free at 1-866-398-0833.

The Supernus Patient Savings and Support Program may help patients who meet eligibility requirements lower the cost of their prescriptions. For more information on eligibility requirements, call Supernus Support toll-free at 1-866-398-0833.

Most Trokendi XR patients with commercial insurance are eligible for the Trokendi XR Patient Savings and Support Program. See full Terms and Conditions if you have questions about eligibility, or call Supernus Support toll-free at 1-866-398-0833.

You can access co-pay savings cards by visiting Patient Savings on this website to download a co-pay savings card online.

Activate your Trokendi XR co-pay savings card here.

TERMS AND CONDITIONS

*This offer is good for commercially insured and cash-paying patients purchasing Trokendi XR® (topiramate) extended-release capsules and may not be used for any other product. Maximum benefits apply. This offer is not valid for prescriptions purchased under Medicaid, Medicare, or other federal or state programs (such as medical assistance programs). Offer not valid where prohibited by law, taxed, or restricted. It is not transferable and may not be combined with any other offer. The amount of the rebate cannot exceed the patient’s actual out-of-pocket expenses. Offer must be presented along with a valid prescription for Trokendi XR® at the time of purchase. By enrolling into this program you are consenting to the collection and use of certain personal information including your phone number and/or email address and elements of pharmacy claim information. This information will be collected and used by service providers of Supernus Pharmaceuticals, Inc. (“Supernus”), in order to administer this program. This information is not provided to Supernus directly. If you do not consent, please do not enroll into the program. If you require additional assistance, please call 1-866-398-0833. Supernus reserves the right to rescind, revoke, or amend this offer without notice at any time.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about Trokendi XR?

Take Trokendi XR capsules whole. Do not sprinkle on food, break, crush, dissolve, or chew before swallowing. If you cannot swallow Trokendi XR capsules whole, tell your healthcare provider.

Do not drink alcohol within 6 hours prior to and 6 hours after Trokendi XR administration.

Trokendi XR may cause eye problems. Serious eye problems include any sudden decrease in vision with or without eye pain and redness, and a blockage of fluid in the eye causing increased pressure in the eye (secondary angle closure glaucoma). These eye problems can lead to permanent loss of vision if not treated. Call your healthcare provider right away if you have any new eye symptoms, including any new problems with your vision.

Trokendi XR may cause 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. If a high fever, a fever that does not go away, or decreased sweating develops, call your healthcare provider right away.

Trokendi XR can increase the level of acid in your 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 your baby if you are pregnant. Metabolic acidosis can happen with or without symptoms. Sometimes people with metabolic acidosis will: • feel tired • not feel hungry (loss of appetite) • feel changes in heartbeat • have trouble thinking clearly. Your healthcare provider should do a blood test to measure the level of acid in your blood before and during your treatment with Trokendi XR. If you are pregnant, you should talk to your healthcare provider about whether you have metabolic acidosis.

Like other antiepileptic drugs, Trokendi XR may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:
• thoughts about suicide or dying • attempts to commit suicide • new or worse depression • new or worse anxiety • feeling agitated or restless • panic attacks • trouble sleeping (insomnia) • new or worse irritability • acting aggressive, being angry, or violent • acting on dangerous impulses • an extreme increase in activity and talking (mania) • other unusual changes in behavior or mood.

Do not stop Trokendi XR without first talking to a healthcare provider.

  • Stopping Trokendi XR suddenly can cause serious problems.
  • Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

How can I watch for early symptoms of suicidal thoughts and actions?

  • Pay attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings.
  • Keep all follow-up visits with your healthcare provider as scheduled.
  • Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

Trokendi XR can harm your unborn baby. If you take Trokendi XR during pregnancy, your baby has a higher risk for birth defects including cleft lip and cleft palate. These defects can begin early in pregnancy, even before you know you are pregnant. All women of childbearing age should talk to their healthcare providers about using other possible treatments instead of Trokendi XR. If the decision is made to use Trokendi XR, you should use effective birth control (contraception) unless you are planning to become pregnant. Tell your healthcare provider right away if you become pregnant while taking Trokendi XR. You and your healthcare provider should decide if you will continue to take Trokendi XR while you are pregnant. If you take Trokendi XR during pregnancy, your baby may be smaller than expected at birth. The long-term effects of this are not known. Talk to your healthcare provider if you have questions about this risk during pregnancy. Metabolic acidosis may have harmful effects on your baby. Talk to your healthcare provider if Trokendi XR has caused metabolic acidosis during your pregnancy. Pregnancy Registry: If you become pregnant while taking Trokendi XR, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334. The purpose of this registry is to collect information about the safety of Trokendi XR and other antiepileptic drugs during pregnancy.

Trokendi XR may decrease the density of bones when used over a long period.

Trokendi XR may slow height increase and weight gain in children and adolescents when used over a long period.

Who should not take Trokendi XR?

Do not take Trokendi XR if you are allergic to topiramate, Trokendi XR, or any of the ingredients in Trokendi XR. See end of the Medication Guide for a complete list of ingredients in Trokendi XR.

Before taking Trokendi XR, tell your healthcare provider about all of your medical conditions, including if you:

• have or have had depression, mood problems, or suicidal thoughts or behavior • 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 • are breastfeeding. Trokendi XR passes into your breast milk. Breastfed babies may be sleepy or have diarrhea. It is not known if the Trokendi XR that passes into breast milk can cause other serious harm to your baby. Talk to your healthcare provider about the best way to feed your baby if you take Trokendi XR.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially, tell your healthcare provider if you take:

  • Valproic acid (such as DEPAKOTE).
  • any medicines that impair or decrease your thinking, concentration, or muscle coordination.
  • birth control that contains hormones (such as pills, implants, patches, or injections). Trokendi XR may make your birth control less effective. Tell your healthcare provider if your menstrual bleeding changes while you are using birth control and Trokendi XR.

Ask your healthcare provider if you are not sure if your medicine is listed above.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist each time you get a new medicine. Do not start a new medicine without talking with your healthcare provider.

What should I avoid while taking Trokendi XR?

  • Do not drink alcohol within 6 hours before or 6 hours after taking Trokendi XR capsules. Trokendi XR and alcohol can cause serious side effects such as severe sleepiness and dizziness and an increase in seizures.
  • 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.

What are the possible side effects of Trokendi XR?

Trokendi XR may cause serious side effects, including:

  • Effects on thinking and alertness. Trokendi XR may affect how you think, and cause confusion, problems with concentration, attention, memory, or speech. Trokendi XR may cause depression or mood problems, tiredness, and sleepiness.
  • Dizziness or loss of muscle coordination.
  • Severe multiorgan reactions. Treatment with Trokendi XR may cause a serious allergic reaction that may affect your skin or other parts of your body such as your liver, kidneys, heart, or blood cells. This allergic reaction can be life-threatening and can cause death, particularly if it is not treated as early as possible. Contact your healthcare provider or get medical help right away if you have: • blistering and peeling of your skin or skin rash • fever or swollen glands that do not go away • hives • swelling of your face, eyes, lips, tongue, or throat • sores in your mouth • trouble swallowing or breathing • dark urine • yellowing of the skin or whites of the eyes.
  • Serious skin reactions. Trokendi XR may cause a severe rash with blisters and peeling skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome). Trokendi XR may also cause a rash with blisters and peeling skin over much of the body that may cause death (toxic epidermal necrolysis). Call your healthcare provider right away if you develop a skin rash or blisters.
  • Allergic reactions. Serious allergic reactions can happen after you take Trokendi XR. Get emergency help right away if you have swelling of the face, lips, eyes, tongue, or throat, or trouble swallowing or breathing.
  • High blood ammonia levels. High ammonia in the blood can affect your mental activities, slow your alertness, make you feel tired, or cause vomiting. This has happened when Trokendi XR is taken with a medicine called valproic acid (DEPAKOTE). Call your healthcare provider right away if you develop unexplained tiredness, vomiting, slowing of your thinking or reaction time, or changes in your mental activities.
  • 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 can cause a drop in body temperature to less than 95°F, feeling tired, confusion, or coma.

Call your healthcare provider right away if you have any of the symptoms above.
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 • diarrhea • upper respiratory tract infection • decreased feeling or sensitivity, especially on the skin • fever • tiredness • sleepiness/drowsiness • difficulty with memory • pain in abdomen.

Tell your healthcare provider about any side effect that bothers you or that does not go away. These are not all the possible side effects of Trokendi XR.

What is Trokendi XR®?

Trokendi XR® (topiramate) extended-release capsules is a prescription medicine used to prevent migraine headaches in adults and adolescents 12 years of age and older.

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.

Please refer to the Medication Guide.