Valproic acid capsule delayed release patient counseling information

# Patient Counseling Information
See FDA-Approved patient labeling (Medication Guide)

### 17.1 Hepatotoxicity
Patients and guardians should be warned that nausea, vomiting, abdominal pain, anorexia, diarrhea, asthenia, and/or jaundice can be symptoms of hepatotoxicity and, therefore, require further medical evaluation promptly.

### 17.2 Pancreatitis
Patients and guardians should be warned that abdominal pain, nausea, vomiting, and/or anorexia can be symptoms of pancreatitis and, therefore, require further medical evaluation promptly

### 17.3 Birth Defects and Decreased IQ
Prescribers should inform pregnant women and women of childbearing potential that use of valproate during pregnancy increases the risk of birth defects and decreased IQ in children who were exposed. Prescribers should advise women to use effective contraception while using valproate. Prescribers should counsel these patients about alternative therapeutic options. This is particularly important when valproate use is considered for a condition not usually associated with permanent injury or death (e.g., migraine). Patients should read the Medication Guide, which appears as the last section of the labeling .
Advise women of childbearing potential to discuss pregnancy planning with their doctor and to contact their doctor immediately if they think they are pregnant.
Patients should be encouraged to enroll in the NAAED Pregnancy Registry if they become pregnant. This registry is collecting information about the safety of antiepileptic drugs during pregnancy. To enroll, patients can call the toll free number 1-888-233-2334 

### 17.4 Suicidal Thinking and Behavior
Patients, their caregivers, and families should be counseled that AEDs, including Stavzor, may increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers.

### 17.5 Hyperammonemia
Patients should be informed of the signs and symptoms associated with hyperammonemic encephalopathy and be told to inform the prescriber if any of these symptoms occur.  .

### 17.6 CNS Depression
Since valproate products may produce CNS depression, especially when combined with another CNS depressant (eg, alcohol), patients should be advised not to engage in hazardous activities, such as driving an automobile or operating dangerous machinery, until it is known that they do not become drowsy from the drug.

### 17.7 Multi-Organ Hypersensitivity Reaction
Patients should be instructed that a fever associated with other organ system involvement (rash, lymphadenopathy, etc.) may be drug-related and should be reported to the physician immediately .
Manufactured for:
Noven Therapeutics, LLC
11960 SW 144th Street
Miami, FL 33186
Manufactured by:
Banner Pharmacaps, Inc.
4125 Premier Drive
High Point, NC 27265
Medication Guide
STAVZOR (STAV- ZOR)
(valproic acid)
Delayed Release Capsules
Read this Medication Guide before you start taking STAVZOR and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

### What is the most important information I should know about STAVZOR?
Do not stop taking STAVZOR without first talking to your healthcare provider.
Stopping STAVZOR suddenly can cause serious problems.
STAVZOR can cause serious side effects including:
1. 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.
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
- yellowing of your skin or the whites of your eyes
In some cases, liver damage may continue despite stopping the drug.
2. STAVZOR may harm your unborn baby.
If you take STAVZOR during pregnancy for any medical condition, your baby is at risk for serious birth defects. The most common birth defects with STAVZOR affect the brain and spinal cord and are called spina bifida or neural tube defects. They may occur in up to 5 out of every 100 babies born to mothers who use this medicine at high doses during pregnancy. These defects can begin in the first month, even before you know you are pregnant. Other birth defects can 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 Stavzor during pregnancy for any medical condition, your child is at risk for having a lower IQ.
There may be other medicines to treat your condition that have a lower chance of birth defects and decreased IQ in your child.
Women who are pregnant must not take Stavzor to prevent migraine headaches.
All women of child-bearing age should talk to their healthcare provider about using other possible treatments instead of STAVZOR. If the decision is made to use Stavzor, you should use effective birth control (contraception).
Tell your healthcare provider right away if you become pregnant while taking STAVZOR. You and your healthcare provider should decide if you will continue to take STAVZOR while you are pregnant.
Pregnancy Registry: If you become pregnant while taking STAVZOR, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry.
You can enroll in this registry by calling 1-888-233-2334. The purpose of this registry is to collect information about the safety of antiepileptic drugs during pregnancy.
3. 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
4. Like other antiepileptic drugs, STAVZOR 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 stop Stavzor without first talking to a healthcare provider. Stopping Stavzor suddenly can cause serious problems.Stopping a seizure medicine suddenly in a patient who has epilepsy can cause seizures that do not stop (status epilepticus).
Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.

### What is STAVZOR?
STAVZOR is a prescription medicine 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

### Who should not take STAVZOR?
Do not take STAVZOR if you:
- have liver problems
- are allergic to valproic acid, divalproex sodium, sodium valproate, or any of the ingredients in STAVZOR. See the end of this leaflet for a complete list of ingredients in STAVZOR.
- have a genetic problem called a urea cycle disorder
- are pregnant for the prevention of migraine headaches

### What should I tell my healthcare provider before taking STAVZOR?
Before you take STAVZOR, tell your healthcare provider if you:
- drink alcohol
- are pregnant or breastfeeding. STAVZOR can pass into breast milk. Talk to your healthcare provider about the best way to feed your baby if you take STAVZOR.
- have or have had depression, mood problems, or suicidal thoughts or behavior
- have any other medical conditions
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, herbal supplements, and medicines that you take for a short period of time.
Taking STAVZOR with certain other medicines can cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider.
Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist each time you get a new medicine.

### How should I take STAVZOR?
Take STAVZOR exactly as your healthcare provider tells you. Your healthcare provider will tell you how much STAVZOR to take and when to take it.
Your healthcare provider may change your dose.
Do not change your dose of STAVZOR without talking to your healthcare provider.
Do not stop taking STAVZOR without first talking to your healthcare provider.Stopping STAVZOR suddenly can cause serious problems.
Swallow STAVZOR whole. Do not crush, chew, or break STAVZOR. Tell your healthcare provider if you can not swallow STAVZOR whole.You may need a different medicine.
If you take too much STAVZOR, call your healthcare provider or local Poison Control Center right away.

### What should I avoid while taking STAVZOR?
STAVZOR can make you sleepy or dizzy. Do not drink alcohol or take other drugs that make you sleepy or dizzy while taking STAVZOR, until you talk to your doctor. Taking STAVZOR with alcohol or drugs that cause sleepiness or dizziness may make your sleepiness or dizziness worse.
Do not drive, operate heavy machinery, or do other dangerous activities until you know how STAVZOR affects you. STAVZOR can slow your thinking and motor skills.

### What are the possible side effects of STAVZOR?
See What is the most important information I should know about STAVZOR?.
STAVZOR may cause other serious side effects including:
- Low blood count: red or purple spots on your skin, bruising, bleeding from your mouth, teeth or nose.
- High ammonia levels in your blood: feeling tired, vomiting, changes in mental status.
- Low body temperature (hypothermia): drop in body temperature to less than 95F, feeling tired, confusion, coma
- Allergic (hypersensitivity) reactions: fever, skin rash, hives, sores in your mouth, blistering and 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 Stavzor
Call your healthcare provider right away, if you have any of the symptoms listed above.
The most common side effects of STAVZOR include:
- Nausea
- headache
- sleepiness
- vomiting
- weakness
- tremor
- dizziness
- stomach pain
- blurry vision
- double vision
- diarrhea
- increased appetite
- weight gain
- hair loss
- loss of appetite
- problems with walking coordination
These are not all of the possible side effects of STAVZOR. For more information, ask your healthcare provider or pharmacist.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store STAVZOR?
Store STAVZOR between 59oF to 86oF (15oC to 30oC)
Keep STAVZOR and all medicines out of the reach of children.
General Information about STAVZOR
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use STAVZOR for a condition for which it was not prescribed. Do not give STAVZOR to other people, even if they have the same symptoms that you have. It may harm them.
This Medication Guide summarizes the most important information about STAVZOR. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about STAVZOR that is written for health professionals
For more information, go to www. STAVZOR.com or call 1-800-455-8070

### What are the ingredients in STAVZOR?
Active ingredient: valproic acid
Inactive ingredient: ammonium hydroxide, gelatin, glycerin, methacrylic acid copolymer, triethyl citrate, water, and FD&C Yellow No. 6 as the colorant