|What is the most important information I should know about VIGADRONE tablets?
VIGADRONE tablets can cause serious side effects, including:
Permanent vision loss
Magnetic resonance imaging (MRI) changes in babies with infantile spasms (IS)
Risk of suicidal thoughts or actions
Permanent vision loss:
- VIGADRONE tablets can damage the vision of anyone who takes it. Some people can have severe loss particularly to 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.
Vision loss and use of VIGADRONE tablets in adults and children 2 years and older:
Because of the risk of vision loss, VIGADRONE tablets are used to treat complex partial seizures (CPS) only in people who do not respond well enough to several other medicines.
Tell your healthcare provider right away if you (or your child):
- might not be seeing as well as before starting VIGADRONE tablets
- start to trip, bump into things, or are more clumsy than usual
- are surprised by people or 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 (including peripheral vision) and visual acuity (ability to read an eye chart) before you (or your child) start VIGADRONE tablets or within 4 weeks after starting VIGADRONE tablets, and at least every 3 months after that until VIGADRONE tablets are stopped. It is also recommended that you (or your child) have a vision test about 3 to 6 months after VIGADRONE tablets are stopped. Your vision loss may get worse after you stop taking VIGADRONE tablets.
- Some people are not able to complete testing of vision. Your healthcare provider will determine if you (or your child) can be tested. If you (or your child) cannot complete vision testing, your healthcare provider may continue prescribing VIGADRONE tablets, but your healthcare provider will not be able to watch for any vision loss you (or your child) may get.
- Even if your vision (or your child's vision) seems fine, it is important that you (or your child) get these regular vision tests because vision damage can happen before you (or your child) notice any changes.
- These vision tests cannot prevent the vision damage that can happen with VIGADRONE tablets, but they do allow the healthcare provider to decide if you (or your child) should stop VIGADRONE tablets if vision has gotten worse.
- Vision testing may not detect vision loss before it is severe.
- If you do not have these vision tests regularly, your healthcare provider may stop prescribing VIGADRONE tablets.
- If you drive and your vision is damaged by VIGADRONE tablets, driving might be more dangerous, or you may not be able to drive safely at all. Talk about this with your healthcare provider.
Vision loss in babies: Because of the risk of vision loss, vigabatrin is used in babies 1 month to 2 years of age with infantile spasms (IS) only when you and your healthcare provider decide that the possible benefits of vigabatrin are more important than the risks.
- Parents or 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.
- It is difficult to test vision in babies, but, to the extent possible, all babies should have their vision tested before starting vigabatrin or within 4 weeks after starting vigabatrin, and every 3 months after that until vigabatrin is stopped. Your baby should also have a vision test about 3 to 6 months after vigabatrin is stopped.
- Your baby may not be able to be tested. Your healthcare provider will determine if your baby can be tested. If your baby cannot be tested, your healthcare provider may continue prescribing vigabatrin, but your healthcare provider will not be able to watch for any vision loss.
Tell your healthcare provider right away if you think that your baby is:
- not seeing as well as before taking vigabatrin
- acting differently than normal
- Even if your baby's vision seems fine, it is important to get regular vision tests because damage can happen before your baby acts differently. Even these regular vision exams may not show the damage to your baby's vision before it is severe and permanent.
|All people who take VIGADRONE tablets:
- You are at risk for permanent vision loss with any amount of VIGADRONE tablets.
- Your risk of vision loss may be higher the more VIGADRONE tablets you take daily and the longer you take it.
- It is not possible for your healthcare provider to know when vision loss will happen. It could happen soon after starting VIGADRONE tablets or any time during treatment. It may even happen after treatment has stopped.
- Because VIGADRONE tablets might cause permanent vision loss, it is available to healthcare providers and patients only under a special program called the Vigabatrin Risk Evaluation and Mitigation Strategy (REMS) Program. VIGADRONE tablets can only be prescribed to people who are enrolled in this program. As part of the Vigabatrin REMS Program, it is recommended that your healthcare provider test your (or your child's) vision from time to time (periodically) while you (or your child) are being treated with VIGADRONE tablets, and even after you (or your child) stop treatment. Your healthcare provider will explain the details of the Vigabatrin REMS Program to you. For more information, go to www.vigabatrinREMS.com or call 1-866-244-8175.
Magnetic resonance imaging (MRI) changes in babies with infantile spasms:
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.
Suicidal thoughts or actions can be caused by things other than medicines. If you or your child have suicidal thoughts or actions, your healthcare provider may check for other causes.
Risk of suicidal thoughts or actions:
Like other antiepileptic drugs, VIGADRONE tablets may cause suicidal thoughts or actions in a very small number of people, about 1 in 500 people taking it. Call a healthcare provider right away if you or your child 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 VIGADRONE tablets without first talking to a healthcare provider.
- Stopping VIGADRONE 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.
|What are VIGADRONE tablets?
- VIGADRONE tablets are a prescription medicine used along with other treatments to treat adults and children 2 years and older with complex partial seizures (CPS) if:
VIGADRONE tablets should not be the first medicine used to treat CPS.
- The CPS does not respond well enough to several other treatments, and
- You and your healthcare provider decide the possible benefit of taking VIGADRONE tablets is more important than the risk of vision loss.
- Vigabatrin is also used to treat babies 1 month to 2 years of age who have infantile spasms (IS) if you and your healthcare provider decide the possible benefits of taking vigabatrin are more important than the possible risk of vision loss.
|What should I tell my healthcare provider before starting VIGADRONE tablets?
If you or your child has CPS, before taking VIGADRONE tablets tell your healthcare provider about all of your medical conditions, including, if you or your child:
- have or had an allergic reaction to VIGADRONE tablets, such as hives, itching, or trouble breathing
- have or had any vision problems
- have or had any kidney problems
- have or had low red blood cell counts (anemia)
- have or had any nervous or mental illnesses, such as depression, mood problems, thoughts of suicide, or attempts at suicide
- are breastfeeding or planning to breastfeed. VIGADRONE 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 VIGADRONE tablets.
- are pregnant or plan to become pregnant. VIGADRONE tablets can cause harm to your unborn baby. You and your healthcare provider will have to decide if you should take VIGADRONE tablets while you are pregnant.
If you become pregnant while taking VIGADRONE tablets, 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. Information on the registry can also be found on the website http://www.aedpregnancy.org/. The purpose of this registry is to collect information about the safety of antiepileptic medicine during pregnancy.
If you are a parent or caregiver whose baby has IS, before giving vigabatrin to your baby, tell your healthcare provider about all of your baby's medical conditions, including if your baby has or ever had:
Tell your healthcare provider about all the medicines you or your child take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Vigabatrin and other medicines may affect each other causing side effects.
- an allergic reaction to vigabatrin, such as hives, itching, or trouble breathing
- any vision problems
- any kidney problems
|How should I take VIGADRONE tablets?
- You or your child will receive VIGADRONE tablets from a specialty pharmacy.
- Take VIGADRONE tablets exactly as your healthcare provider tells you to. VIGADRONE tablets are usually taken 2 times each day.
- VIGADRONE tablets may be taken with or without food.
- Before starting to take VIGADRONE tablets, talk to your healthcare provider about what you or your child should do if a VIGADRONE tablets dose is missed.
- If you or your child are taking VIGADRONE tablets for CPS and the seizures do not improve enough within 3 months, your healthcare provider will stop prescribing vigabatrin.
- If your child is taking vigabatrin for IS and the seizures do not improve within 2 to 4 weeks, your healthcare provider will stop prescribing vigabatrin.
Do not stop taking VIGADRONE tablets suddenly. This can cause serious problems. Stopping VIGADRONE tablets or any seizure medicine suddenly can cause seizures that will not stop (status epilepticus) in people who are being treated for seizures. You should follow your healthcare provider's instructions on how to stop taking vigabatrin.
Tell your healthcare provider right away about any increase in seizures when VIGADRONE tablets treatment is being stopped. Before your child starts taking vigabatrin, speak to your child's healthcare provider about what to do if your baby misses a dose, vomits, spits up, or only takes part of the dose of vigabatrin.
Do not stop taking VIGADRONE tablets without talking to your healthcare provider. If VIGADRONE tablets improves your (or your child's) seizures, you and your healthcare provider should talk about whether the benefit of taking VIGADRONE tablets is more important than the risk of vision loss and decide if you (or your child) will continue to take VIGADRONE tablets.
|What should I avoid while taking VIGADRONE tablets?
VIGADRONE tablets causes sleepiness and tiredness. Adults taking VIGADRONE 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.
|What are the possible side effects of VIGADRONE tablets?
VIGADRONE tablets can cause serious side effects, including:
The following serious side effects happen in adults. It is not known if these side effects also happen in babies who take VIGADRONE tablets.
If you or your child has CPS, VIGADRONE tablets may make certain types of seizures worse. Tell your healthcare provider right away if your (or your child's) seizures get worse.
low red blood cell counts (anemia)
nerve problems. Symptoms of a nerve problem can include numbness and tingling in your toes or feet. It is not known if nerve problems will go away after you stop taking VIGADRONE tablets.
The most common side effects of VIGADRONE tablets in adults include:
The most common side effects of VIGADRONE tablets in children 3 to 16 years of age include:
- blurred vision
- problems walking
- feeling uncoordinated
- shaking (tremor)
If you are giving vigabatrin to your baby for IS:
- weight gain
- Also expect side effects like those seen in adults
Vigabatrin may make certain types of seizures worse. You should tell your baby's healthcare provider right away if your baby's seizures get worse. Tell your baby's healthcare provider if you see any changes in your baby's behavior.
The most common side effects of vigabatrin in babies include:
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 VIGADRONE tablets.
- sleepiness – vigabatrin may cause your baby to be sleepy. Sleepy babies may have a harder time suckling and feeding or may be irritable.
- swelling in the bronchial tubes (bronchitis)
- ear infection
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 VIGADRONE tablets?
Keep VIGADRONE tablets and all medicines out of the reach of children.
- Store at room temperature, between 20° to 25°C (68° to 77°F).
|General information about the safe and effective use of VIGADRONE tablets.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your pharmacist or healthcare provider for information about VIGADRONE tablets that is written for health professionals. Do not use VIGADRONE tablets for a condition for which it was not prescribed. Do not give VIGADRONE tablets to other people, even if they have the same symptoms that you have. It may harm them.
|What are the ingredients in VIGADRONE tablets?
Active Ingredient: vigabatrin
Inactive Ingredients: isopropyl alcohol, magnesium stearate, microcrystalline cellulose, povidone and sodium starch glycolate (potato). Coating ingredients are hydroxypropyl methylcellulose, polyethylene glycol and titanium dioxide.
For Medication Guides, please visit www.upsher-smith.com or call 1-888-650-3789.
UPSHER-SMITH LABORATORIES, LLC
Maple Grove, MN 55369
VIGADRONE is a registered trademark of Upsher-Smith Laboratories, LLC.
Made in India