Email   Print Page    Text: A A A

Eligible Patients

Prescription Savings for Eligible Patients

The Depakote Co-Pay Card can reduce out-of-pocket costs for eligible patients.*

Click here to view the Depakote Co-Pay Card available to your patients. The Depakote Co-Pay Card will only work with the Depakote brand. Be sure to write “Dispense as Written” or your state’s required language.

You will need Adobe® Reader to display the Depakote Co-Pay Card.
To download the free reader, click here.

Send your
patient info on
Depakote Savings
*Eligibility: Offer not valid in Massachusetts. Available to patients with commercial prescription insurance coverage for DEPAKOTE who meet eligibility criteria. Copay assistance program is not available to patients receiving prescription reimbursement under any federal, state, or government-funded insurance programs (for example, Medicare [including Part D], Medicare Advantage, Medigap, Medicaid, TRICARE, Department of Defense, or Veterans Affairs programs) or where prohibited by law or by the patient's health insurance provider. If at any time a patient begins receiving prescription drug coverage under any such federal, state, or government-funded healthcare program, patient will no longer be able to use the DEPAKOTE Savings Card and patient must call OPUS Health at 800.364.4767 to stop participation. Patients may not seek reimbursement for value received from the DEPAKOTE Savings Program from any third-party payers. Offer subject to change or discontinuance without notice. Restrictions, including monthly maximums, may apply. This is not health insurance. Please see full Terms and Conditions.
  • Summary of
    Important
    Safety Information
  • Indications1-3
  • Indications1-3

IMPORTANT SAFETY INFORMATION1-3

Warning: Life-Threatening Adverse Reactions

Hepatotoxicity

General Population: Hepatic failure resulting in fatalities has occurred in patients receiving valproate and its derivatives. These incidents usually have occurred during the first six months of treatment. Serious or fatal hepatotoxicity may be preceded by non-specific symptoms such as malaise, weakness, lethargy, facial edema, anorexia, and vomiting. In patients with epilepsy, a loss of seizure control may also occur. Patients should be monitored closely for appearance of these symptoms. Serum liver tests should be performed prior to therapy and at frequent intervals thereafter, especially during the first six months.

Children under the age of two years are at a considerably increased risk of developing fatal hepatotoxicity, especially those on multiple anticonvulsants, those with congenital metabolic disorders, those with severe seizure disorders accompanied by mental retardation, and those with organic brain disease. When Depakote (divalproex sodium) tablets, for oral use, Depakote ER (divalproex sodium) extended-release tablets, for oral use, or Depakote Sprinkle Capsules (divalproex sodium delayed release capsules), for oral use, is used in this patient group, it should be used with extreme caution and as a sole agent. The benefits of therapy should be weighed against the risks. The incidence of fatal hepatotoxicity decreases considerably in progressively older patient groups.

Patients With Mitochondrial Disease: There is an increased risk of valproate-induced acute liver failure and resultant deaths in patients with hereditary neurometabolic syndromes caused by DNA mutations of the mitochondrial DNA Polymerase γ (POLG) gene (e.g., Alpers Huttenlocher Syndrome). Depakote, Depakote ER, and Depakote Sprinkle Capsules are contraindicated in patients known to have mitochondrial disorders caused by POLG mutations and in children under two years of age who are clinically suspected of having a mitochondrial disorder. In patients over two years of age who are clinically suspected of having a hereditary mitochondrial disease, Depakote, Depakote ER, or Depakote Sprinkle Capsules should only be used after other anticonvulsants have failed. This older group of patients should be closely monitored during treatment with Depakote, Depakote ER, or Depakote Sprinkle Capsules for the development of acute liver injury, with regular clinical assessments and serum liver testing. POLG mutation screening should be performed in accordance with current clinical practice.

Fetal Risk

Valproate can cause major congenital malformations, particularly neural tube defects (e.g., spina bifida). In addition, valproate can cause decreased IQ scores following in utero exposure.

Valproate is therefore contraindicated in pregnant women treated for prophylaxis of migraine. Valproate should only be used to treat pregnant women with epilepsy or bipolar disorder if other medications have failed to control their symptoms or are otherwise unacceptable.

Valproate should not be administered to a woman of childbearing potential unless the drug is essential to the management of her medical condition. This is especially important when valproate use is considered for a condition not usually associated with permanent injury or death (e.g., migraine). Women should use effective contraception while using valproate.

Pancreatitis

Cases of life-threatening pancreatitis have been reported in both children and adults receiving valproate. Some of the cases have been described as hemorrhagic with a rapid progression from initial symptoms to death. Cases have been reported shortly after initial use as well as after several years of use. Patients and guardians should be warned that abdominal pain, nausea, vomiting, and/or anorexia can be symptoms of pancreatitis that require prompt medical evaluation. If pancreatitis is diagnosed, valproate should ordinarily be discontinued. Alternative treatment for the underlying medical condition should be initiated as clinically indicated.

  • Valproate should not be administered to patients with hepatic disease or dysfunction. Immediately discontinue drug if significant hepatic dysfunction is suspected or apparent. Progression of dysfunction has occurred in spite of discontinuation of valproate.
  • Valproate is contraindicated in patients known to have mitochondrial disorders caused by mutations in mitochondrial DNA polymerase γ (POLG; e.g., Alpers Huttenlocher Syndrome) and in children under two years of age who are suspected of having a POLG-related disorder. POLG-related disorder symptoms may include unexplained encephalopathy, refractory epilepsy (focal, myoclonic), status epilepticus at presentation, developmental delays, psychomotor regression, axonal sensorimotor neuropathy, myopathy cerebellar ataxia, ophthalmoplegia, or complicated migraine with occipital aura.
  • Depakote and Depakote ER are contraindicated for use in prophylaxis of migraine headaches in pregnant women.
  • Valproate is contraindicated in patients with known hypersensitivity to the drug.
  • Valproate is contraindicated in patients with known urea cycle disorders (UCDs). Hyperammonemic encephalopathy, sometimes fatal, has been reported following initiation of valproate. Symptoms of unexplained hyperammonemic encephalopathy during valproate therapy require prompt treatment (including discontinuation of valproate).
  • Valproate can cause decreased IQ, neural tube defects, and other major congenital malformations (e.g., craniofacial defects, hypospadias, cardiovascular and limb malformations). In epileptic mothers, the rate of congenital malformations with in utero exposure is about four times higher compared to the rate with in utero exposure to other anti-seizure monotherapies. Lower cognitive test scores, including decreased IQ scores, were associated with in utero valproate exposure compared with in utero exposure to either another or no antiepileptic drug. Unless essential to their medical management or failure of other treatments, women of childbearing potential should not receive valproate.
  • Valproate can increase the risk of suicidal thoughts or behavior. Patients treated with any AED should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or unusual changes in mood or behavior. Counsel patients and families to be alert for and to immediately report depression, any unusual changes in mood or behavior, or suicidal thoughts, behavior, or acts of self-harm.
  • Thrombocytopenia is dose-related. Decreases in other cell lines and myelodysplasia have also been associated with valproate. The probability of thrombocytopenia appears to increase significantly at total valproate concentrations of ≥110 ug/mL in females and ≥135 ug/mL in males or at 50 mg/kg/d. Check complete blood counts and coagulation times before starting therapy or surgery, at periodic intervals, and during pregnancy. Reduce dose or discontinue if hemorrhage, bruising, or hemostasis/coagulation disorder occur.
  • Hyperammonemia has been associated with valproate; it may be present despite normal liver function tests and should be considered if hypothermia occurs. Asymptomatic elevations of ammonia are more common and require close monitoring. Discontinue valproate if ammonia increases.
  • Concomitant administration of topiramate and valproate has been associated with hyperammonemia (with or without encephalopathy) in patients who have tolerated either drug alone.
  • Hypothermia has been associated with valproate therapy both in conjunction with, and in the absence of, hyperammonemia. It can occur after starting topiramate treatment or after increasing the daily dose of topiramate. Consider stopping valproate if hypothermia develops.
  • Drug Reaction with Eosinophilia and Systemic Syndrome (DRESS) / multi-organ hypersensitivity reactions have been reported and may be fatal or life-threatening. Patients typically present with fever, rash, and lymphadenopathy associated with other organ system involvement, e.g., hematologic abnormalities. Early symptoms may not include rash. Regardless, immediately evaluate and discontinue therapy for any signs of hypersensitivity.
  • Carbapenem antibiotics (such as ertapenem, imipenem, meropenem) may reduce serum valproate concentrations to subtherapeutic levels, resulting in loss of seizure control.
  • In a clinical trial, somnolence was associated with valproate in some elderly dementia patients along with reduced nutritional intake; weight loss; and a trend to have a lower baseline albumin concentration, higher BUN, and lower valproate clearance. Discontinuation occurred in some patients.
  • Valproate may interact with drugs capable of enzyme induction; check valproate and concomitant drug levels periodically in the early course of therapy.
  • Rare reports of medication residue in the stool have occurred, some in patients with anatomic (ileostomy or colostomy) or functional gastrointestinal disorders with shortened GI transit times or in the context of diarrhea. If medication residue occurs, monitor plasma valproate levels and patient's clinical condition; alternative treatment may be considered.

ADVERSE EVENTS1-3

  • Most common adverse reactions (reported >5%) are abdominal pain, abnormal thinking, alopecia, amblyopia/blurred vision, amnesia, anorexia, asthenia, ataxia, back pain, bronchitis, constipation, depression, diarrhea, diplopia, dizziness, dyspepsia, dyspnea, ecchymosis, emotional lability, fever, flu syndrome, headache, increased appetite, infection, insomnia, nausea, nervousness, nystagmus, peripheral edema, pharyngitis, rash, rhinitis, somnolence, thrombocytopenia, tinnitus, tremor, vomiting, weight gain, and weight loss.

Keep Depakote and all other medications where children cannot reach them.

References:
  1. Depakote [package insert]. North Chicago, IL: AbbVie Inc.
  2. Depakote ER [package insert]. North Chicago, IL: AbbVie Inc.
  3. Depakote Sprinkle Capsules [package insert]. North Chicago, IL: AbbVie Inc.
  4. Data on file, AbbVie Inc. Amundsen Group Analysis, May 2016.
  5. Data on file, AbbVie Inc. Depakote Pharmacy Audit. June 29, 2016.
  6. US Food and Drug Administration. Orange book: approved drug products with therapeutic equivalence evaluations. http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm. Accessed June 27, 2017.
  7. US Food and Drug Administration Orange Book Preface. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ucm079068.htm#TEC. Accessed June 27, 2017.
  8. US Food and Drug Administration, Drug Approvals and Databases, Drugs@FDA Glossary of Terms. http://www.fda.gov/drugs/informationondrugs/ucm079436.htm#TE. Accessed June 27, 2017.
  9. IMS Health FIA Dataset; Amundsen Group Analysis.
  10. Data on file, AbbVie Inc. Amundsen Group Analysis, May 2016.

SAFETY CONSIDERATIONS

Life-threatening adverse reactions have been reported with Depakote:

  • Hepatotoxicity, including fatalities, usually during the first 6 months of treatment. Children under the age of two years and patients with mitochondrial disorders are at higher risk. Monitor patients closely, and perform serum liver testing prior to therapy and at frequent intervals thereafter.
  • Fetal Risk, particularly neural tube defects, other major malformations and decreased IQ.
  • Pancreatitis, including some hemorrhagic cases.
  • Contraindicated for use in patients with: hepatic disease or significant hepatic dysfunction, mitochondrial disorders (POLG e.g. Alpers) and children under 2 years of age suspected of having a POLG-related disorder, known urea cycle disorders (UCD), particularly ornithine transcarbamylase deficiency, known hypersensitivity or pregnant patients treated for prophylaxis of migraine headaches.
  • In the presence of significant hepatic dysfunction, suspected or apparent, discontinue therapy immediately. Hepatic dysfunction can progress despite discontinuation of therapy.
  • Should not be administered to a women of childbearing potential unless essential to treatment as other treatment options have failed or are otherwise unacceptable.
  • In the presence of pancreatitis, discontinue therapy.

INDICATIONS1-3

Mania

Depakote® ER (divalproex sodium) extended-release tablets, for oral use, is a valproate and is indicated for the treatment of acute manic or mixed episodes associated with bipolar disorder, with or without psychotic features.

Depakote® (divalproex sodium) tablets, for oral use, is a valproate and is indicated for the treatment of the manic episodes associated with bipolar disorder.

A manic episode is a distinct period of abnormally and persistently elevated, expansive, or irritable mood. Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, poor judgment, aggressiveness, and possible hostility. A mixed episode is characterized by the criteria for a manic episode in conjunction with those for a major depressive episode (depressed mood, loss of interest or pleasure in nearly all activities).

The efficacy of Depakote ER is based in part on studies of Depakote (divalproex sodium) tablets, for oral use, in this indication, and was confirmed in a 3-week trial with patients meeting DSM-IV-TR criteria for bipolar I disorder, manic or mixed type, who were hospitalized for acute mania.

The efficacy of Depakote was established in 3-week trials with patients meeting DSM-III-R criteria for bipolar disorder who were hospitalized for acute mania.

The effectiveness of valproate for long-term use in mania, i.e., more than 3 weeks, has not been demonstrated in controlled clinical trials. Therefore, healthcare providers who elect to use Depakote or Depakote ER for extended periods should continually reevaluate the long-term risk-benefits of the drug for the individual patient.

Epilepsy

Depakote ER is indicated as monotherapy and adjunctive therapy in the treatment of adult patients and pediatric patients down to the age of 10 years with complex partial seizures that occur either in isolation or in association with other types of seizures. Depakote ER is also indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures in adults and children 10 years of age or older, and adjunctively in adults and children 10 years of age or older with multiple seizure types that include absence seizures.

Depakote is indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures. Depakote is also indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures, and adjunctively in patients with multiple seizure types that include absence seizures.

Depakote® Sprinkle Capsules (divalproex sodium delayed release capsules), for oral use, are indicated as monotherapy and adjunctive therapy in the treatment of adult patients and pediatric patients down to the age of 10 years with complex partial seizures that occur either in isolation or in association with other types of seizures. Depakote Sprinkle Capsules are also indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures, and adjunctively in patients with multiple seizure types that include absence seizures.

Simple absence is defined as very brief clouding of the sensorium or loss of consciousness accompanied by certain generalized epileptic discharges without other detectable clinical signs. Complex absence is the term used when other signs are also present.

Migraine

Depakote and Depakote ER are indicated for prophylaxis of migraine headaches. There is no evidence that Depakote ER or Depakote is useful in the acute treatment of migraine headaches.

Important Limitations

Because of the risk to the fetus of decreased IQ, neural tube defects, and other major congenital malformations, which may occur very early in pregnancy, valproate should not be administered to a woman of childbearing potential unless the drug is essential to the management of her medical condition.

Depakote and Depakote ER are contraindicated for prophylaxis of migraine headaches in women who are pregnant.

References:
1.
Depakote [package insert]. North Chicago, IL: AbbVie Inc.
2. Depakote ER [package insert]. North Chicago, IL: AbbVie Inc.
3. Depakote Sprinkle Capsules [package insert]. North Chicago, IL: AbbVie Inc.

744-1914146

Patient Support

Patients need support.
We have the tools to help.

Access resources and tools
Dispense as Written

No matter which Depakote
formulation you prescribe,
make sure your patients get it.

Tips to help patients
get the brand

IMPORTANT SAFETY INFORMATION1-3

Warning: Life-Threatening Adverse Reactions

Hepatotoxicity

General Population: Hepatic failure resulting in fatalities has occurred in patients receiving valproate and its derivatives. These incidents usually have occurred during the first six months of treatment. Serious or fatal hepatotoxicity may be preceded by non-specific symptoms such as malaise, weakness, lethargy, facial edema, anorexia, and vomiting. In patients with epilepsy, a loss of seizure control may also occur. Patients should be monitored closely for appearance of these symptoms. Serum liver tests should be performed prior to therapy and at frequent intervals thereafter, especially during the first six months.

Children under the age of two years are at a considerably increased risk of developing fatal hepatotoxicity, especially those on multiple anticonvulsants, those with congenital metabolic disorders, those with severe seizure disorders accompanied by mental retardation, and those with organic brain disease. When Depakote (divalproex sodium) tablets, for oral use, Depakote ER (divalproex sodium) extended-release tablets, for oral use, or Depakote Sprinkle Capsules (divalproex sodium delayed release capsules), for oral use, is used in this patient group, it should be used with extreme caution and as a sole agent. The benefits of therapy should be weighed against the risks. The incidence of fatal hepatotoxicity decreases considerably in progressively older patient groups.

Patients With Mitochondrial Disease: There is an increased risk of valproate-induced acute liver failure and resultant deaths in patients with hereditary neurometabolic syndromes caused by DNA mutations of the mitochondrial DNA Polymerase γ (POLG) gene (e.g., Alpers Huttenlocher Syndrome). Depakote, Depakote ER, and Depakote Sprinkle Capsules are contraindicated in patients known to have mitochondrial disorders caused by POLG mutations and in children under two years of age who are clinically suspected of having a mitochondrial disorder. In patients over two years of age who are clinically suspected of having a hereditary mitochondrial disease, Depakote, Depakote ER, or Depakote Sprinkle Capsules should only be used after other anticonvulsants have failed. This older group of patients should be closely monitored during treatment with Depakote, Depakote ER, or Depakote Sprinkle Capsules for the development of acute liver injury, with regular clinical assessments and serum liver testing. POLG mutation screening should be performed in accordance with current clinical practice.

Fetal Risk

Valproate can cause major congenital malformations, particularly neural tube defects (e.g., spina bifida). In addition, valproate can cause decreased IQ scores following in utero exposure.

Valproate is therefore contraindicated in pregnant women treated for prophylaxis of migraine. Valproate should only be used to treat pregnant women with epilepsy or bipolar disorder if other medications have failed to control their symptoms or are otherwise unacceptable.

Valproate should not be administered to a woman of childbearing potential unless the drug is essential to the management of her medical condition. This is especially important when valproate use is considered for a condition not usually associated with permanent injury or death (e.g., migraine). Women should use effective contraception while using valproate.

Pancreatitis

Cases of life-threatening pancreatitis have been reported in both children and adults receiving valproate. Some of the cases have been described as hemorrhagic with a rapid progression from initial symptoms to death. Cases have been reported shortly after initial use as well as after several years of use. Patients and guardians should be warned that abdominal pain, nausea, vomiting, and/or anorexia can be symptoms of pancreatitis that require prompt medical evaluation. If pancreatitis is diagnosed, valproate should ordinarily be discontinued. Alternative treatment for the underlying medical condition should be initiated as clinically indicated.

  • Valproate should not be administered to patients with hepatic disease or dysfunction. Immediately discontinue drug if significant hepatic dysfunction is suspected or apparent. Progression of dysfunction has occurred in spite of discontinuation of valproate.
  • Valproate is contraindicated in patients known to have mitochondrial disorders caused by mutations in mitochondrial DNA polymerase γ (POLG; e.g., Alpers Huttenlocher Syndrome) and in children under two years of age who are suspected of having a POLG-related disorder. POLG-related disorder symptoms may include unexplained encephalopathy, refractory epilepsy (focal, myoclonic), status epilepticus at presentation, developmental delays, psychomotor regression, axonal sensorimotor neuropathy, myopathy cerebellar ataxia, ophthalmoplegia, or complicated migraine with occipital aura.
  • Depakote and Depakote ER are contraindicated for use in prophylaxis of migraine headaches in pregnant women.
  • Valproate is contraindicated in patients with known hypersensitivity to the drug.
  • Valproate is contraindicated in patients with known urea cycle disorders (UCDs). Hyperammonemic encephalopathy, sometimes fatal, has been reported following initiation of valproate. Symptoms of unexplained hyperammonemic encephalopathy during valproate therapy require prompt treatment (including discontinuation of valproate).
  • Valproate can cause decreased IQ, neural tube defects, and other major congenital malformations (e.g., craniofacial defects, hypospadias, cardiovascular and limb malformations). In epileptic mothers, the rate of congenital malformations with in utero exposure is about four times higher compared to the rate with in utero exposure to other anti-seizure monotherapies. Lower cognitive test scores, including decreased IQ scores, were associated with in utero valproate exposure compared with in utero exposure to either another or no antiepileptic drug. Unless essential to their medical management or failure of other treatments, women of childbearing potential should not receive valproate.
  • Valproate can increase the risk of suicidal thoughts or behavior. Patients treated with any AED should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or unusual changes in mood or behavior. Counsel patients and families to be alert for and to immediately report depression, any unusual changes in mood or behavior, or suicidal thoughts, behavior, or acts of self-harm.
  • Thrombocytopenia is dose-related. Decreases in other cell lines and myelodysplasia have also been associated with valproate. The probability of thrombocytopenia appears to increase significantly at total valproate concentrations of ≥110 ug/mL in females and ≥135 ug/mL in males or at 50 mg/kg/d. Check complete blood counts and coagulation times before starting therapy or surgery, at periodic intervals, and during pregnancy. Reduce dose or discontinue if hemorrhage, bruising, or hemostasis/coagulation disorder occur.
  • Hyperammonemia has been associated with valproate; it may be present despite normal liver function tests and should be considered if hypothermia occurs. Asymptomatic elevations of ammonia are more common and require close monitoring. Discontinue valproate if ammonia increases.
  • Concomitant administration of topiramate and valproate has been associated with hyperammonemia (with or without encephalopathy) in patients who have tolerated either drug alone.
  • Hypothermia has been associated with valproate therapy both in conjunction with, and in the absence of, hyperammonemia. It can occur after starting topiramate treatment or after increasing the daily dose of topiramate. Consider stopping valproate if hypothermia develops.
  • Drug Reaction with Eosinophilia and Systemic Syndrome (DRESS) / multi-organ hypersensitivity reactions have been reported and may be fatal or life-threatening. Patients typically present with fever, rash, and lymphadenopathy associated with other organ system involvement, e.g., hematologic abnormalities. Early symptoms may not include rash. Regardless, immediately evaluate and discontinue therapy for any signs of hypersensitivity.
  • Carbapenem antibiotics (such as ertapenem, imipenem, meropenem) may reduce serum valproate concentrations to subtherapeutic levels, resulting in loss of seizure control.
  • In a clinical trial, somnolence was associated with valproate in some elderly dementia patients along with reduced nutritional intake; weight loss; and a trend to have a lower baseline albumin concentration, higher BUN, and lower valproate clearance. Discontinuation occurred in some patients.
  • Valproate may interact with drugs capable of enzyme induction; check valproate and concomitant drug levels periodically in the early course of therapy.
  • Rare reports of medication residue in the stool have occurred, some in patients with anatomic (ileostomy or colostomy) or functional gastrointestinal disorders with shortened GI transit times or in the context of diarrhea. If medication residue occurs, monitor plasma valproate levels and patient's clinical condition; alternative treatment may be considered.

ADVERSE EVENTS1-3

  • Most common adverse reactions (reported >5%) are abdominal pain, abnormal thinking, alopecia, amblyopia/blurred vision, amnesia, anorexia, asthenia, ataxia, back pain, bronchitis, constipation, depression, diarrhea, diplopia, dizziness, dyspepsia, dyspnea, ecchymosis, emotional lability, fever, flu syndrome, headache, increased appetite, infection, insomnia, nausea, nervousness, nystagmus, peripheral edema, pharyngitis, rash, rhinitis, somnolence, thrombocytopenia, tinnitus, tremor, vomiting, weight gain, and weight loss.

Keep Depakote and all other medications where children cannot reach them.

References:
  1. Depakote [package insert]. North Chicago, IL: AbbVie Inc.
  2. Depakote ER [package insert]. North Chicago, IL: AbbVie Inc.
  3. Depakote Sprinkle Capsules [package insert]. North Chicago, IL: AbbVie Inc.
  4. Data on file, AbbVie Inc. Amundsen Group Analysis, May 2016.
  5. Data on file, AbbVie Inc. Depakote Pharmacy Audit. June 29, 2016.
  6. US Food and Drug Administration. Orange book: approved drug products with therapeutic equivalence evaluations. http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm. Accessed June 27, 2017.
  7. US Food and Drug Administration Orange Book Preface. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ucm079068.htm#TEC. Accessed June 27, 2017.
  8. US Food and Drug Administration, Drug Approvals and Databases, Drugs@FDA Glossary of Terms. http://www.fda.gov/drugs/informationondrugs/ucm079436.htm#TE. Accessed June 27, 2017.
  9. IMS Health FIA Dataset; Amundsen Group Analysis.
  10. Data on file, AbbVie Inc. Amundsen Group Analysis, May 2016.

SAFETY CONSIDERATIONS

Life-threatening adverse reactions have been reported with Depakote:

  • Hepatotoxicity, including fatalities, usually during the first 6 months of treatment. Children under the age of two years and patients with mitochondrial disorders are at higher risk. Monitor patients closely, and perform serum liver testing prior to therapy and at frequent intervals thereafter.
  • Fetal Risk, particularly neural tube defects, other major malformations and decreased IQ.
  • Pancreatitis, including some hemorrhagic cases.
  • Contraindicated for use in patients with: hepatic disease or significant hepatic dysfunction, mitochondrial disorders (POLG e.g. Alpers) and children under 2 years of age suspected of having a POLG-related disorder, known urea cycle disorders (UCD), particularly ornithine transcarbamylase deficiency, known hypersensitivity or pregnant patients treated for prophylaxis of migraine headaches.
  • In the presence of significant hepatic dysfunction, suspected or apparent, discontinue therapy immediately. Hepatic dysfunction can progress despite discontinuation of therapy.
  • Should not be administered to a women of childbearing potential unless essential to treatment as other treatment options have failed or are otherwise unacceptable.
  • In the presence of pancreatitis, discontinue therapy.
2046689-1916145   ©2017 AbbVie Inc.   North Chicago, IL 60064

Conversion from Depakote to Depakote ER1,2

Depakote


Total Daily Dose (mg)

500 – 625
1000 – 1125
1500 – 1625
1875 – 2000
2500 – 2750
3000 – 3125

Depakote ER


Total Daily Dose (mg)

750
1250
1750
2250
3000
3500
  • Depakote and Depakote ER tablets are not interchangeable.
  • Use Depakote if smaller dose adjustments than those available with Depakote ER are required.
  • Depakote ER tablets are administered orally once a day and must be swallowed whole.
  • Depakote ER should be administered once daily using a dose 8%-20% higher than the total daily dose of Depakote.
  • If satisfactory clinical response has not been achieved, monitor plasma levels.

Click here for full Prescribing Information.

These total daily doses of Depakote cannot be directly converted to an 8% to 20% higher total daily dose of Depakote ER because the required dosing strengths of Depakote ER are not available. Consideration may be given at the clinician’s discretion to increase the patient’s total daily doses of Depakote to the next higher dosage before converting to the appropriate total daily dose of Depakote ER.

References:
1. Depakote [package insert]. North Chicago, IL: AbbVie Inc.
2. Depakote ER [package insert]. North Chicago, IL: AbbVie Inc.