Safety

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.

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.

What should I tell my neurologist before starting Keppra XR®?
Tell your neurologist about all of your medical conditions, including if you:

  • have or have had depression, mood problems or suicial thoughts or behavior.
  • have kidney problems.
  • are pregnant or planning to become pregnant. It is not known if Keppra XR® will harm your unborn baby. If you become pregnant while taking Keppra XR®, talk to your doctor about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334. You can also enroll in the UCB AED Pregnancy Registry by calling 1-888-537-7734. The purpose of these registries is to collect information about the safety of Keppra XR® and other antiepileptic medicine during pregnancy.
  • are breast feeding. Keppra XR® can pass into your milk and may harm your baby. You and your doctor should discuss whether you should take Keppra XR® or breast feed; you should not do both.

Tell your neurologist about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Do not start a new medicine without first talking with your doctor.

Know the medicines you take. Keep a list of them to show your neurologist and pharmacist each time you get a new medicine.

What should I avoid while taking Keppra XR®?
Do not drive, operate machinery, or do other dangerous activities until you know how Keppra XR® affects you. Keppra XR® may make you dizzy or sleepy.

General information about Keppra XR®.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Keppra XR® for a condition for which it was not prescribed. Do not give Keppra XR® to other people, even if they have the same symptoms that you have. It may harm them.

INDICATIONS

KEPPRA XR (levetiracetam) is a prescription medicine taken by mouth that is used with other medicines to treat partial onset seizures in people 12 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.

Do not take KEPPRA or KEPPRA XR if you are allergic to levetiracetam.

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. Discontinue KEPPRA or KEPPRA XR and contact your healthcare provider right away if you have allergic reactions such as swelling of the face, lips, eyes, tongue and throat, trouble swallowing or breathing, and hives. 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.

The coupon must be accompanied by a valid, signed prescription.

This program is not valid for prescriptions that are reimbursed, in whole or in part, under Medicare (including Medicare Part D), Medicaid, similar federal- or state-funded programs (including any state prescription drug assistance programs and the Government Health Insurance Plan available in Puerto Rico), or where otherwise prohibited by law. Product dispensed pursuant to program rules and federal and state laws. Claims should not be submitted to any public payor (i.e., Medicare, Medicaid, Medigap, Tricare, VA, and DoD) for reimbursement. Patients and pharmacists are responsible for notifying insurance carriers or any other third party who pays for or reimburses any part of the prescription filled using this coupon as may be required by the insurance carrier's terms and conditions and applicable law. The parties reserve the right to amend or end this program at any time without notice. This language may be subject to change in the future.

The coupon may not be reproduced and has no cash value. Offer expires on 12/31/2017.