Important Safety Information
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. Stopping a seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus).
DEPAKOTE can cause serious side effects, including:
Serious liver damage that can cause death, especially in children younger than 2 years old and patients with mitochondrial disorders. 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 even though the medicine is stopped. Your healthcare provider will do blood tests to check your liver before and during treatment with DEPAKOTE. Call your healthcare provider right away if you get any of the following symptoms: feeling very weak, tired, or uncomfortable (malaise); swelling of your face; not feeling hungry; nausea or vomiting that does not go away; diarrhea; pain on the right side of your stomach (abdomen); dark urine; yellowing of your skin or the whites of your eyes; or loss of seizure control in people with epilepsy.
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 (such as spina bifida or neural tube defects). 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. Decreased hearing or hearing loss 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 (NAAED) 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.
Swelling (inflammation) and bleeding (hemorrhaging) 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, or not feeling hungry.
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; suicide attempt; 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); or 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 such as Alpers-Huttenlocher syndrome
are allergic to divalproex sodium, valproic acid, sodium valproate, or any of the ingredients in DEPAKOTE
have a genetic problem called a 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 about all your medical conditions, including if you:
have or have had liver problems
have or think you have a genetic liver problem caused by a mitochondrial disorder such as Alpers-Huttenlocher syndrome
drink alcohol
have or have had depression, suicidal thoughts or behavior, unusual changes in mood, or thoughts about self-harm
are male and plan to father a child. DEPAKOTE may cause fertility problems, which may affect your ability to father a child. Talk to your healthcare provider if this is a problem for you.
are pregnant or may become pregnant. DEPAKOTE may harm your unborn baby. See “DEPAKOTE may harm your unborn baby” above for more information.
are breastfeeding. DEPAKOTE can pass into breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you take DEPAKOTE.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
DEPAKOTE may affect the way other medicines work, and other medicines may affect how DEPAKOTE works. Using DEPAKOTE with other medicines can cause serious side effects. Do not start or stop other medicines without talking to your healthcare provider.
Especially tell your healthcare provider if you take:
medicines that can affect how the liver breaks down other medicines (such as phenytoin, carbamazepine, felbamate, phenobarbital, primidone, or rifampin)
aspirin, carbapenem antibiotics, or estrogen-containing hormonal contraceptives
methotrexate
topiramate
cannabidiol
You can ask your healthcare provider or pharmacist for a list of these medicines if you are not sure.
DEPAKOTE can cause other serious side effects, including:
Bleeding problems: Problems may include bruising or red or purple spots on your skin, bleeding from your mouth or nose, coughing up blood or blood clots, vomiting blood or vomit that looks like coffee grounds, blood in your stools or black stools (looks like tar), or pain and swelling in your joints.
Increased ammonia levels in your blood: High ammonia levels can seriously affect your mental activities, slow your alertness, make you feel tired, or cause vomiting (encephalopathy). This has happened when DEPAKOTE is taken alone or with a medicine called topiramate. Call your healthcare provider if you have any of these symptoms.
Low body temperature (hypothermia): A drop in your body temperature to less than 95ºF can happen during treatment with DEPAKOTE. Call your healthcare provider if you have any of the following symptoms: feeling tired, confusion, memory loss, drowsiness, coma, or shivering.
Severe multiorgan or skin reactions: Treatment with DEPAKOTE may cause serious or life-threatening allergic reactions that may affect your skin or other parts of your body. Stop taking DEPAKOTE and contact your healthcare provider or get medical help right away, if you develop any of these symptoms: skin rash; hives; blistering and peeling of your skin; sores in your mouth; swelling of your lymph nodes; swelling of your face, eyes, lips, tongue, or throat; or 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 healthcare provider if you are not able to eat or drink as you normally do. Your healthcare provider may start you at a lower dose of DEPAKOTE.
Medicine residue in your stool: Tell your healthcare provider if you have or think you may have medicine residue in your stool.
Common side effects of DEPAKOTE include: headache, weakness, sleepiness, dizziness, tremors, difficulty falling or staying asleep, double vision, hair loss (alopecia), low blood platelet count, stomach burning, fullness or bloating after eating, nausea, vomiting, stomach pain, diarrhea, and infection.
INDICATIONS:
DEPAKOTE comes in different dosage forms for oral use. DEPAKOTE® (divalproex sodium) delayed-release tablets, DEPAKOTE® ER (divalproex sodium) extended-release tablets, and DEPAKOTE® Sprinkle Capsules (divalproex sodium delayed release capsules) are prescription medicines 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 other medications to treat:
– patients with multiple seizure types that include absence seizures
DEPAKOTE ER and DEPAKOTE are also used to prevent migraine headaches.
DEPAKOTE ER is also used to treat acute manic or mixed episodes associated with bipolar disorder with or without psychotic features.
DEPAKOTE is also used to treat manic episodes associated with bipolar disorder.
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/PatientAccessSupport to learn more.
Please see the full Prescribing Information, including Boxed Warnings, for:
DEPAKOTE, including Medication Guide
DEPAKOTE ER, including Medication Guide
DEPAKOTE Sprinkle Capsules, including Medication Guide
