Vigabatrin

The most important thing to know

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 y

How to take it

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.

Side effects, and when to stop

VIGADRONE tablets can cause serious side effects, including: sleepiness and tiredness. See " What should I avoid while taking VIGADRONE tablets? " Vigabatrin may cause your baby to be sleepy. Sleepy babies may have a harder time suckling and feeding or may be irritable. weight gain that happens without swelling The following serious side effects happen in adults.

It is not known if these side effects also happen in babies who take VIGADRONE tablets. 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. swelling 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. The most common side effects of VIGADRONE tablets in adults include: blurred vision sleepiness dizziness problems walking feeling uncoordinated shaking (tremor) tiredness The most common side effects of VIGADRONE tablets in children 3 to 16 years of age include: weight gain Also expect side effects like those seen in adults If you are giving vigabatrin to your baby for IS: 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: 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 irritability 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. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What to say before you start

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.

Pregnancy Registry: 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: an allergic reaction to vigabatrin, such as hives, itching, or trouble breathing any vision problems any kidney problems 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.

What to avoid

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.

Storing it

Store at room temperature, between 20° to 25°C (68° to 77°F). Keep VIGADRONE tablets and all medicines out of the reach of children.