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STAVZOR® Easy Save Pharmacy Card Program Designed to Eliminate Your Insurance Co-pay What is STAVZOR® and how can it help me?
STAVZOR® is a brand of valproic acid (also cal ed valproate).
Important Safety Information for STAVZOR®(valproic acid delayed release capsules)
What is unique about STAVZOR®?
STAVZOR® (valporic acid delayed release capsules) is used:
STAVZOR® is an innovative form of valproate that comes in the type of soft gel capsule that is
easy to swal ow. And, STAVZOR® 500 mg is 40% smal er than Depakote®/Depakote ER®* 500 mg
To treat manic episodes associated with bipolar disorder tablets. STAVZOR® is also available in 250 mg capsules.
- complex partial seizures in adults and children 10 years of age and older In a recent survey, 85% of Depakote®/Depakote ER®* patients said they would have preferred a small soft gel like STAVZOR® if it had been available when they started therapy.
Only with other medicines to treat other seizure types that include absence seizures Is STAVZOR
® as effective as Depakote?
Yes. Since STAVZOR® 500 mg capsules are bioequivalent to Depakote 500 mg tablets, they are
IMPORTANT SAFETY INFORMATION
How can STAVZOR
STAVZOR® (valproic acid delayed release capsules) can cause serious side effects including:
® help me?
The smal , easy-to-swal ow STAVZOR® capsule is designed to help you start and stay on your
Serious liver damage that can cause death, especially in children younger than 2 years old.
therapy. Being able to take your medications daily, exactly as your doctor instructed, can help The risk of serious liver damage is more likely to happen within the first 6 months of treatment. keep the il ness under control and reduce the chance of symptoms coming back.
Your doctor should check your liver function before you start this medication and at frequent intervals thereafter. Before taking this medication, tell your doctor if you have liver disease. In Instructions for Patients:
some cases, liver damage may continue despite stopping the drug.
Present this printout to your pharmacist. It is good for the first $50 off every STAVZOR®
prescription, including refills.
Call your healthcare provider right away if you get any of the fol owing symptoms: 1. Give your prescription for STAVZOR®, along with the Easy Save Pharmacy Card, to your retail
2. If the co-pay cost from your insurance company is $50 or less, you will pay nothing ($0). If the pain on the right side of your stomach (abdomen) cost is more than $50, you only pay the difference to your pharmacy.
3. Present this printout to your pharmacist and you can use it for every refill as long as you yel owing of your skin or the whites of your eyes continue taking STAVZOR®.
STAVZOR® may harm your unborn baby. Although birth defects may occur in children born to
women who are not taking any medicines, using STAVZOR carries special risks for unborn babies:
Instructions for Prescribers:
If you take STAVZOR during pregnancy for any medical condition, your baby is at risk 1. Give your eligible patient a valid prescription for STAVZOR®. Be sure to mark “dispense as
for serious birth defects. These defects can begin in the first month, even before you written,” “do not substitute,” “medical y necessary,” or as required in your state.
The most common birth defects with STAVZOR affect the brain and spinal cord and 2. Instruct your patient to take the prescription for STAVZOR®, along with the attached Easy Save
are cal ed spina bifida or neural tube defects, a condition in which the baby’s spinal Pharmacy Card, to any retail pharmacy. Remind your patient that the Easy Save Pharmacy Card is good for each and every prescription for STAVZOR®, including refil s.
Taking STAVZOR during pregnancy for any medical condition can put your child at risk for having a lower IQ.
3. Please refer to the Eligibility Criteria for more information.
There may be other medicines to treat your condition that have a lower chance of birth defects. All women of child-bearing age should talk to their healthcare provider Pharmacy instructions:
about using other possible treatments instead of STAVZOR. STAVZOR should not Good for patients with authorized third-party coverage only. Not valid for individuals enrol ed in be used by a woman of child-bearing age unless STAVZOR is essential to the Medicare, Medicaid, or any other federal or state health care plan. Please submit the claim to the management of her mania or epilepsy, and rarely for migraines. If the decision is Primary Payor first, then submit the balance due to Therapy First as a Secondary Payor as a co-
made to use STAVZOR, you should use effective birth control (contraception) unless pay bil ing. The payor amount will be reduced by UP TO $50 and you receive this plus a handling you are planning to become pregnant.
fee in your next reimbursement. Other Coverage Code required. The patient is responsible for Tell your healthcare provider right away if you become pregnant while taking the balance if the co-pay amount exceeds $50. This printout is limited to 1 per patient and is not STAVZOR. You and your healthcare provider should decide if you will continue to take For reimbursement, use the following information:
Taking folic acid supplements before getting pregnant and during early pregnancy can lower the chance of having a baby with a neural tube defect.
Bin #:004682
RxPCN: CN
Group#: LCWSP276
ID#: WSP929485440
STAVZOR® may cause a serious life-threatening inflamed pancreas. This can occur shortly
after initial use and can progress rapidly to death. Call your doctor immediately if you experience
For Pharmacists’ Questions: please call Therapy First at 1-800-422-5604.
severe stomach pain or nausea and vomiting that does not go away.
* Depakote is a registered trademark of Abbott Laboratories Eligibility Criteria: 1. This offer is not available for individuals enrol ed in Medicare, Medicaid, or any other federal or state health care plan. This offer is valid only up to $50 for the patients out-of-pocket cost for the prescription. 2. Card is limited to
one (1) per patient and is not transferable. Offer valid only for prescriptions of STAVZOR®. Any other use may constitute fraud. CARD CANNOT BE BOUGHT, TRANSFERRED OR SOLD. CARD CANNOT BE COMBINED WITH ANY OTHER OFFER. 3. This
offer is restricted for “al -payor” states (eg, Massachusetts). 4. Customer is responsible for any sales tax. Tax charged on pre-coupon price where required. No cash back. Offer good only in the U.S. Noven Therapeutics, LLC, reserves the right to
rescind, revoke, or amend this offer without notice at any time. Void where prohibited, taxed, or otherwise restricted by law. 5. The sel ing, purchasing, trading, or counterfeiting of this card is prohibited by federal law, and such activities may result in
imprisonment for not more than 10 years or fines of not more than $250,000, or both.
Taking STAVZOR® may increase the risk of thoughts or behaviors of suicide in patients
taking it for any illness or disorder.
Patients, their caregivers and family need to be alert for new
or worsening signsor symptoms of depression, thoughts or behaviors of suicide, or for any unusual
changes in behavior or mood. Call a healthcare provider right away if you have thoughts about
suicide or dying, attempts to commit suicide, new or worse depression, anxiety, agitation, panic
attacks, irritability, aggressiveness, dangerous impulses, increased activity or talking, unusual
changes in behavior or mood.
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). Do not change your dose of
STAVZOR® without talking to your healthcare provider.
are al ergic to valproic acid, divalproex sodium, sodium valproate, or any of the ingredients in STAVZOR® have a genetic problem cal ed a urea cycle disorder 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.
Some people on STAVZOR may experience low blood platelet counts. Your doctor should order blood tests to check your platelets while you are taking this medication, as well as prior to surgery. Tell your doctor if you have any unexplained bleeding or bruising.
Elevated ammonia levels and hypothermia (an unintentional drop in body temperature) have been reported in some patients receiving valproate. Contact your doctor immediately if you experience abnormal drowsiness and vomiting or changes in mental status.
A fever associated with other symptoms such as rash or enlargement of the lymph nodes should be reported to your doctor immediately, as this may be a sign of a serious reaction.
STAVZOR can affect other medications. Your doctor may need to perform certain blood tests while taking this medication. Tell your doctor about all medicines you are taking or planning to take, including those without a prescription, vitamins, and herbal products.
Some older patients with dementia have experienced extreme drowsiness. Let your doctor know if you become too tired or if your appetite changes.
You may experience drowsiness when you start this medication. You should not drive or operate dangerous machinery until you know how this medication will affect you.
The most common side effects reported in clinical studies were nausea, vomiting, extreme drowsiness, dizziness, weakness, abdominal pain, stomach upset, rash, diarrhea, increased appetite, pain, tremor, weight gain, back pain, hair loss, headache, fever, loss of appetite, constipation, double/blurred vision, side-to-side eye movements, staggering, emotional upset, abnormal thinking, amnesia, flu syndrome, infection, bronchitis, runny nose, bruising, swel ing of the arms or legs, insomnia, nervousness, depression, sore throat, shortness of breath, and ringing of the ears. This is not a complete list of reported side effects.
This is important information to know about STAVZOR. For more information, talk with your health care provider.
These are not all the side effects that may occur. You will find a complete list of side effects in the full Prescribing Information.
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.
For medical inquiries specific to STAVZOR, please call 1-800-455-8070 STAVZOR® is a registered trademark of Noven Therapeutics, LLC. For information visit www.STAVZOR.com 2013 Noven Therapeutics, LLC. All rights reserved. Printed in USA STVZR-1001 02/13 Efficacy that’s easy to swallow

Source: http://www.stavzor.com/pdfs/STAVZOR-copaycard.pdf

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