You Could Save More On Your Generic Vigabatrin Prescription

Eligible patients pay as little as $0* for generic Vigabatrin with Hikma’s copay assistance program.

Generic Vigabatrin Tablets USP, 500 mg

Product rendering for illustrative purposes only.

For the Treatment of Seizures in Adults and Pediatric Patients with Epilepsy

Vigabatrin tablets is a prescription medicine used with other treatments in adults and children 2 years of age and older with refractory complex partial seizures (CPS) who have not responded well enough to several other treatments. Vigabatrin tablets should not be the first medicine used to treat CPS.

Vigabatrin tablets is a prescription medicine that may be used without other medicines in babies, 1 month to 2 years of age, with infantile spasms (IS), if the possible benefits outweigh the possible risk of vision loss.

Product Image NDC Number Strength Unit Size/Quantity Downloads
0054-0652-25 500 mg Bottle – 100 tablets

While film coated, modified oval, bi-convex with “54 444” debossed on one side and scored on the other.

You Could Save More With Hikma Generic Vigabatrin Tablets

For Your Pharmacist

BIN: 018844
PCN: 3F
Group: FCGBTRN
Member ID: BATW1384598

How It Works

* Maximum value of $500 per prescription. The Vigabatrin copay card is not health insurance. See below for Eligibility and Restrictions.

This card is not transferable. You must be enrolled in a commercial drug insurance plan to be eligible for the Vigabatrin Savings Program. You are not eligible if you are enrolled in any state or federally funded healthcare program including, but not limited to, Medicare, Medicare Part D, Medicaid (including Medicaid managed care), Medigap, VA, FEHB, DOD, TRICARE or a state pharmacy assistance program. In addition, you must be a legal resident of the US or Puerto Rico. Offer void where prohibited by law, taxed or restricted. May not be used with any other discount, trial offer, or other offer. Hikma Pharmaceuticals USA Inc. reserves the right to rescind, revoke, or amend this program without notice. Your participation in this program confirms that this offer is consistent with your insurance coverage, if any, and that you will report the value received if required by your insurance provider. When you use this card, you are certifying that you understand and will comply with the terms and conditions. Other conditions may apply.

Eligible patients may pay as little as $0 for out-of-pocket expenses with use of this offer, up to a maximum dollar value of $500 per prescription per 30 day period. Maximum benefit of 12 prescriptions per calendar year, not to exceed $6,000 in total benefit per calendar year. Remaining balance after application of copay card and any commercial insurance shall be the responsibility of the patient. This offer is valid only for Hikma Pharmaceuticals’ vigabatrin tablets USP, 500 mg, NDC# 00054-0652-25.

TO THE PHARMACY: Copay card must be adjudicated using the claim type of 8. For claims processing under OCC 8, patients must have a commercial drug insurance plan. For pharmacy assistance filing this claim, please call the Pharmacy Help Desk at 1-855-282-4888. By using this card, you certify that the patient meets the eligibility requirements described herein and that you have not submitted and will not submit a claim for reimbursement under any federal, state, or other governmental program for this prescription. As a condition of payment, you certify that you are in compliance with the terms, and conditions set forth herein, as well as with any obligations to provide notice of your participation in this savings program to third-party payers as required by law, contract, or otherwise.

DOD=US Department of Defense; FEHB=Federal Employees Health Benefits; VA=US Department of Veterans Affairs.

How to Get Generic Vigabatrin

The process for filling, receiving and using your generic Vigabatrin prescription is different than most other medications. Due to the risk of vision loss associated with the use of this medication, it is only available through a restricted distribution program called the Vigabatrin Risk Evaluation and Mitigation Strategy (REMS). You must be enrolled in this REMS program to receive your generic medication and it can only be dispensed by certified heathcare providers and pharmacies. For more on the Vigabatrin REMS program, visit vigabatrinrems.com.

Receiving Your Prescription

  • Your healthcare provider enrolls you in the Vigabatrin REMS Program and sends your prescription to the a certified pharmacy (based on your insurance and preferences).

  • A case manager from the pharmacy calls you to explain the program, answer questions and review your insurance information.

  • A pharmacist from the pharmacy calls you to counsel you on the safety information, review your current medications, medical history, allergies, and arranges your first shipment. You must take this call in order to receive your first shipment.

  • The pharmacy confirms your shipping address, date of delivery, and arranges for your prescription to be shipped overnight. You or an adult are required to sign for your medication.

Important Safety Information for Vigabatrin Tablets USP, 500 mg

WARNING: PERMANENT VISION LOSS
See Medication Guide and Full Prescribing Information for complete information.

Vigabatrin can cause permanent vision loss.

  • Vision loss caused by vigabatrin can occur soon after starting treatment, at any time during treatment and even after treatment has stopped.
  • Vision loss from vigabatrin may not be noticeable before it becomes severe.
  • The risk of vision loss increases when you (or your child) take a larger dose of vigabatrin or take it for a long time. Vision loss can occur even if you (or your child) take a smaller dose of vigabatrin or take it for a short time. No dose of vigabatrin is known to be free of the risk of vision loss.
  • Vision loss due to vigabatrin is not reversible.

Because vigabatrin can cause permanent vision loss, it is available only through a restricted program called the Vigabatrin Risk Evaluation and Mitigation Strategy (REMS) Program. Your healthcare provider will explain the details of this program to you.

Vigabatrin tablets can damage the vision of anyone who takes them. Some people can have severe loss particularly in their ability to see to the side when they look straight ahead (peripheral vision). With severe vision loss, you may only be able to see things straight in front of you (sometimes called “tunnel vision”). You may also have blurry vision. If this happens, it will not get better.

Tell your healthcare provider right away if you (or your child):

  • Might not be seeing as well as before starting vigabatrin tablets
  • Start to trip, bump into things or are more clumsy than usual
  • Are surprised by people and things coming in front of you that seem to come out of nowhere

These changes can mean that you (or your child) have damage to your vision.

It is recommended that your healthcare provider test your (or your child’s) vision before or within 4 weeks after starting vigabatrin tablets and at least every 3 months after that until vigabatrin tablets are stopped. It is also recommended that you (or your child) have a vision test about 3 to 6 months after vigabatrin is stopped. Vision loss may get worse after you (or your child) stop taking vigabatrin tablets.

It is difficult to test vision in babies, but to the extent possible, all babies should have their vision tested. Your healthcare provider will determine if your baby’s vision can be tested. Parents and caregivers are not likely to recognize the symptoms of vision loss in babies until it is severe. Healthcare providers may not find vision loss in babies until it is severe.

Even if your (or your child’s) vision seems fine, get routine vision tests because vision damage can happen before it becomes noticeable. If you do not have vision tests regularly, your healthcare provider may stop prescribing vigabatrin tablets.

Vision testing cannot prevent the vision damage that can happen with vigabatrin tablets, but they do allow your healthcare provider to decide if you (or your child) should stop vigabatrin tablets if vision has gotten worse. Even these regular vision tests may not show vision damage until it is severe and permanent.

Some people are unable to complete vision tests. Your healthcare provider will determine if you (or your child) can be tested. If you (or your child) cannot be tested, your healthcare provider may continue prescribing vigabatrin tablets. However, your healthcare provider will not be able to watch for vision loss.

Brain pictures taken by magnetic resonance imaging (MRI) show changes in some babies after they are given vigabatrin. It is not known if these changes are harmful.

Like other antiepileptic drugs, vigabatrin tablets may cause suicidal thoughts or actions in a very small number of people. Call your healthcare provider if you or your child have these symptoms, especially if they are new, worsen or worry you.

Do not stop taking vigabatrin tablets without first talking to your healthcare provider. Stopping vigabatrin tablets suddenly can cause serious problems. Stopping a seizure medicine suddenly can cause seizures that will not stop (status epilepticus) in people who are being treated for seizures.

Before taking vigabatrin tablets, tell your healthcare provider about all of your (or your child’s) medical conditions, especially if you or your child have or had an allergic reaction to vigabatrin tablets, any vision problems, any kidney problems, low red blood cell counts (anemia) or any nervous or mental illnesses. Tell your healthcare provider about all the medicines you or your child take.

Tell your healthcare provider if you are breastfeeding or planning to breastfeed. Vigabatrin can pass into breast milk and may harm your baby. Vigabatrin may cause your baby to be sleepy. Sleepy babies may have a harder time suckling and feeding, or may be irritable. Talk to your healthcare provider about the best way to feed your baby if you take vigabatrin tablets.

Tell your healthcare provider if you are pregnant or planning to become pregnant. Vigabatrin tablets can harm your unborn baby. You and your healthcare provider will need to decide if you should take vigabatrin tablets while you are pregnant.

If you become pregnant while taking vigabatrin tablets, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll by calling 1-888-233-2334. You can find information about the registry at http://www.aedpregnancyregistry.org/. The purpose of this registry is to collect information about the safety of antiepileptic medicine during pregnancy.

Vigabatrin tablets can cause serious side effects, including anemia, tiredness and fatigue, nerve problems, weight gain and swelling. Vigabatrin may cause your baby to be sleepy. Sleepy babies may have a harder time suckling and feeding, or may be irritable. Adults taking vigabatrin tablets should not drive, operate machinery or perform any hazardous task unless you and your healthcare provider have decided that you can do these things safely.

The most common side effects of vigabatrin tablets in adults include blurred vision, sleepiness, dizziness, problems walking or feeling uncoordinated, shaking and tiredness. The most common side effect of vigabatrin tablets in children 3 to 16 years of age is weight gain. Also expect side effects like those seen in adults. The most common side effects of vigabatrin in babies include sleepiness, ear infection, swelling in the bronchial tubes (bronchitis) and irritability.

If you or your child has complex partial seizures (CPS), vigabatrin may make certain types of seizures worse. Tell your healthcare provider right away if your (or your child’s) seizures get worse. If you are giving vigabatrin to your baby for infantile spasms (IS), vigabatrin may make certain types of seizures worse. Tell your baby’s healthcare provider right away if your baby’s seizures get worse or if you see any changes in your baby’s behavior.

Tell your healthcare provider if you or your child have any side effect that bothers you or that does not go away. These are not all the possible side effects of vigabatrin tablets.

For more information, please see the Full Prescribing Information, including the Boxed Warning, and the Medication Guide.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit https://www.fda.gov/medwatch or call 1-800-FDA-1088.

Distributed by: Hikma Pharmaceuticals USA Inc., Berkeley Heights, NJ 07922

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