Keppra XR<sup>®</sup> FAQs

What is Keppra XR®?
What is the most important information I should know about Keppra XR®?
How can I watch for early symptoms of suicidal thoughts and actions?
What does XR stand for?
How does Keppra XR® work?
How should I take Keppra XR®?
What are the possible side effects of Keppra XR®?
Does Keppra XR® offer a patient savings program?

What is Keppra XR®
Keppra XR® is a unique treatment made specifically to help control seizures. It is used with other medicines to treat partial-onset seizures in patients with epilepsy who are 16 years of age and older.

Keppra XR® starts working at the first dose to control seizures. Studies have shown that patients who had already tried many other epilepsy medicines saw improvement when Keppra XR® was added to their treatment. And Keppra XR® has been proven to provide seizure control in patients with difficult-to-treat epilepsy.
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What is the most important information I should know about Keppra XR®?

Like other antiepileptic drugs, Keppra XR® may cause suicidal thoughts or actions in a very small number of people, about 1 in 500 people taking it.

Call a doctor 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 Keppra XR® without first talking to a doctor.

  • Stopping Keppra XR® suddenly can cause serious problems. Stopping a seizure medicine suddenly can cause seizures that will not stop (status epilepticus).
  • Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your doctor may check for other causes.

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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 doctor as scheduled.
  • Call your doctor between visits as needed, especially if you are worried about symptoms.

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What does XR stand for?
Most people take Keppra XR® once a day. “XR” stands for “extended release,” which means Keppra XR® provides a constant flow of medicine all day long. Because Keppra XR® is a once-a-day medicine, it may be easier to remember to take it daily.
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How does Keppra XR® work?
During a seizure, electrical signals in the brain cause the release of chemicals called neurotransmitters. These neurotransmitters help send messages between nerve cells (known as neurons). If the release of neurotransmitters happens too often or goes on for too long, there may be an overload in these electrical signals. This overload can result in a seizure.

Keppra XR® acts by targeting structures in the brain that are not affected directly by most other epilepsy medicines.

Within the neurons, Keppra XR® attaches to specific molecules (called SV2A). These molecules are found on the surfaces of tiny structures in the neurons called vesicles. The attachment of Keppra XR® to the SV2A molecules may help reduce the abnormal spread of signals that can lead to a seizure.
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How should I take Keppra XR®?
Keppra XR® can help make treatment more convenient. It can be taken at any time, day or night, with or without food—so it fits into any schedule.

Once you’ve chosen the schedule that’s best for you, be sure to take Keppra XR® at the same time each day. And when you take it, swallow the tablets whole, without chewing, breaking, or crushing them. Your doctor may change your dose. Do not change your dose without talking to your doctor.

Always take Keppra XR® exactly as prescribed. If you sometimes forget or fail to take Keppra XR®, you won’t achieve the level of seizure control that’s possible. However, if you do forget to take Keppra XR®, follow these instructions:

  • If you miss a dose, take it as soon as your remember. Do not take two doses at the same time.
  • If it is almost time for your next dose, just skip the missed dose and take the next dose at your regular schedule.

Talk to your neurologist for more detailed instructions.

Do not stop taking Keppra XR® or any other seizure medicine unless instructed by your doctor. Stopping medication all at once can cause seizures that will not stop (status epilepticus), a very serious problem. Discontinuing seizure medication without a doctor's guidance is one of the major reasons people who have been seizure-free begin having new seizures.
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What are the possible side effects of Keppra XR®?
See the Safety section for the most important information you should know about Keppra XR®.

Keppra XR® can cause serious side effects. Call your doctor right away if you get any of these symptoms:

  • mood and behavior changes such as aggression, agitation, anger, anxiety, apathy, mood swings, depression, hostility, and irritability. A few people may get psychotic symptoms such as hallucinations (seeing or hearing things that are really not there), delusions (false or strange thoughts or beliefs) and unusual behavior.
  • extreme sleepiness, tiredness, and weakness
  • problems with muscle coordination (problems walking and moving)

Common side effects seen in people who take Keppra XR® and other formulations of Keppra® include:

  • sleepiness
  • weakness
  • dizziness
  • infection

These side effects could happen at any time but happen most often within the first four weeks of treatment.

These are not all the possible side effects of Keppra XR®. For more information, ask your neurologist or pharmacist. If you get any side effects that concern you, call your neurologist. Call your doctor for medical advice about side effects. You may also report side effects to FDA at 1-800-FDA-1088.
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Does Keppra XR® offer a patient savings program?
Yes. With the Patient Savings Card, you pay the first $25 of your Keppra XR® or Keppra® co-pay, and we pay the remaining out-of-pocket expense up to $30.* Get your Patient Savings Card.
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INDICATION

KEPPRA XR (levetiracetam) is a prescription medicine taken by mouth that is used with other medicines to treat partial onset seizures in people 16 years of age and older with epilepsy. KEPPRA XR is available in two dosage strengths: 500mg and 750mg tablets.

KEPPRA (levetiracetam) is a prescription medicine taken by mouth that is used with other medicines to treat primary generalized tonic-clonic seizures in people 6 years of age and older with certain types of generalized epilepsy, myoclonic seizures in people 12 years of age and older with juvenile myoclonic epilepsy, and partial onset seizures in people 1 month of age and older with epilepsy. KEPPRA is available in tablet strengths of 250mg, 500mg, 750mg, and 1000mg, and 100mg of levetiracetam per mL oral solution.

IMPORTANT SAFETY INFORMATION

KEPPRA and KEPPRA XR may not be for everyone. Ask your healthcare provider if KEPPRA or KEPPRA XR is right for you.

Warnings and Precautions

Antiepileptic drugs, including KEPPRA and KEPPRA XR, may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call your healthcare provider right away if you have new or worsening symptoms of depression, any unusual changes in mood or behavior, or suicidal thoughts, behavior, or thoughts about self harm that you have never had before or may be worse than before. KEPPRA and KEPPRA XR may cause extreme sleepiness, tiredness, and weakness, and problems with muscle coordination. You should not drive, operate machinery or do other dangerous activities until you know how KEPPRA or KEPPRA XR affects you. Call your healthcare provider right away if you have a skin rash. Serious skin rashes can happen after you start taking KEPPRA and KEPPRA XR. There is no way to tell if a mild rash will become a serious reaction. Do not stop taking KEPPRA or KEPPRA XR unless instructed by your healthcare provider. Stopping a seizure medication all at once can cause seizures that will not stop, a very serious problem.

Common Adverse Reactions

In clinical trials, the most common side effects seen with KEPPRA XR and other formulations of KEPPRA include sleepiness, weakness, dizziness, and infection.

In clinical trials, the most common side effects seen in people who take KEPPRA include sleepiness, weakness, dizziness, and infection. In addition to those previously listed, the most common side effects seen in children who take KEPPRA include tiredness, acting aggressive, nasal congestion, decreased appetite, and irritability.

Talk to your healthcare provider about other possible side effects with KEPPRA or KEPPRA XR. 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 see additional patient information in the KEPPRA Patient Medication Guide and KEPPRA XR Patient Medication Guide at the end of the full prescribing information. This information does not take the place of talking with your healthcare provider about your condition or your treatment.

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