Depakote formulations

WHAT IS DEPAKOTE USED FOR?^1-3

DEPAKOTE comes in different dosage forms. DEPAKOTE^® (divalproex sodium) delayed-release tablets, for oral use, and DEPAKOTE^® ER (divalproex sodium) extended-release tablets, for oral use, are prescription medications used:

• to treat manic episodes associated with bipolar disorder
• alone or with other medicines to treat:
  • complex partial seizures in adults and children 10 years of age and older
  • simple and complex absence seizures, with or without other seizure types
• to prevent migraine headaches

DEPAKOTE^® Sprinkle Capsules (divalproex sodium delayed release capsules), for oral use, is a prescription medicine used alone or with other medicines to treat:

• complex partial seizures in adults and children 10 years of age and older
• simple and complex absence seizures, with or without other seizure types

IMPORTANT SAFETY INFORMATION^1-3

The most important information about DEPAKOTE is:

Do not stop taking DEPAKOTE without first talking to your healthcare provider. Stopping DEPAKOTE suddenly can cause serious problems.

DEPAKOTE can cause serious side effects, including:

• Serious liver damage that can cause death, especially in children younger than 2 years old. The risk of getting this serious liver damage is more likely to happen within the first 6 months of treatment. In some cases, liver damage may continue despite stopping the drug. Call your healthcare provider right away if you get any of the following symptoms: nausea or vomiting that does not go away, loss of appetite, pain on the right side of your stomach (abdomen), dark urine, swelling of your face, or yellowing of your skin or the whites of your eyes.
• DEPAKOTE may harm your unborn baby. If you take DEPAKOTE during pregnancy for any medical condition, your baby is at risk for serious birth defects that affect the brain and spinal cord and are called spina bifida or neural tube defects. These defects occur in 1 to 2 out of every 100 babies born to mothers who use this medicine during pregnancy. These defects can begin in the first month, even before you know you are pregnant. Other birth defects that affect the structures of the heart, head, arms, legs, and the opening where the urine comes out (urethra) on the bottom of the penis can also happen. Birth defects may occur even in children born to women who are not taking any medicines and do not have other risk factors. Taking folic acid supplements before getting pregnant and during early pregnancy can lower the chance of having a baby with a neural tube defect. If you take DEPAKOTE during pregnancy for any medical condition, your child is at risk for having a lower IQ and may be at risk for developing autism or attention-deficit/hyperactivity disorder. There may be other medicines to treat your condition that have a lower chance of causing birth defects, decreased IQ, or other disorders in your child. Women who are pregnant must not take DEPAKOTE to prevent migraine headaches. All women of childbearing age (including girls from the start of puberty) should talk to their healthcare provider about using other possible treatments instead of DEPAKOTE. If the decision is made to use DEPAKOTE, you should use effective birth control (contraception). Tell your healthcare provider right away if you become pregnant while taking DEPAKOTE. You and your healthcare provider should decide if you will continue to take DEPAKOTE while you are pregnant. Pregnancy Registry: If you become pregnant while taking DEPAKOTE, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling toll-free 1-888-233-2334 or by visiting the website, www.aedpregnancyregistry.org. The purpose of this registry is to collect information about the safety of antiepileptic drugs during pregnancy.
• Inflammation of your pancreas that can cause death. Call your healthcare provider right away if you have any of these symptoms: severe stomach pain that you may also feel in your back, nausea or vomiting that does not go away.
• Like other antiepileptic drugs, DEPAKOTE 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. 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.

Do not take DEPAKOTE if you:

• have liver problems
• have or think you have a genetic liver problem caused by a mitochondrial disorder (e.g., Alpers Huttenlocher Syndrome)
• are allergic to divalproex sodium, valproic acid, sodium valproate, or any of the ingredients in DEPAKOTE
• have a genetic problem called urea cycle disorder
• are taking it to prevent migraine headaches and are either pregnant or may become pregnant because you are not using effective birth control (contraception)

Before taking DEPAKOTE, tell your healthcare provider if you:

• have a genetic liver problem caused by a mitochondrial disorder (e.g., Alpers Huttenlocher Syndrome)
• drink alcohol
• are pregnant or breastfeeding since DEPAKOTE can pass into breast milk. Ask your healthcare provider about the best way to feed your baby.
• have or have had depression, mood problems, or suicidal thoughts or behavior
• have any other medical condition

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, herbal supplements.

Taking DEPAKOTE with certain other medicines, even for a short period of time, can cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider.

DEPAKOTE can cause other serious side effects, including:

• Bleeding problems: red or purple spots on your skin, bruising, pain and swelling into your joints due to bleeding or bleeding from your mouth or nose.
• High ammonia levels in your blood: feeling tired, vomiting, changes in mental status.
• Low body temperature (hypothermia): drop in your body temperature to less than 95º F, feeling tired, confusion, coma.
• Allergic (hypersensitivity) reactions: fever, skin rash, hives, sores in your mouth, blistering and peeling of your skin, swelling of your lymph nodes, swelling of your face, eyes, lips, tongue, or throat, trouble swallowing or breathing.
• Drowsiness or sleepiness in the elderly. This extreme drowsiness may cause you to eat or drink less than you normally would. Tell your doctor if you are not able to eat or drink as you normally do. Your doctor may start you at a lower dose of DEPAKOTE.

Common side effects of DEPAKOTE include:

Please see the full Prescribing Information, including Medication Guide, for additional information about DEPAKOTE. Talk to your healthcare provider if you have questions.

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.

If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit Abbvie.com/myAbbVieAssist to learn more.