Vigpoder

Pronunciation: vig-poe-DARE
Generic name: vigabatrin
Dosage form: vigabatrin powder, for solution
Drug class: Gamma-aminobutyric acid analogs

Medically reviewed by Melisa Puckey, BPharm. Last updated on May 13, 2024.

What is Vigpoder?

Vigpoder is an anticonvulsant used for certain types of seizures, including refractory complex partial seizures in specific patients 2 years and older, and is also used to treat infantile spasms 1 month to 2 years. Vigpoder can cause serious side effects, including vision loss and should only be used if potential benefits outweigh the potential risk of vision loss.  Vigpoder is available as sachets of powder that is made up into an oral solution by adding water.

What is Vigpoder used for?

Vigpoder (vigabatrin) is FDA-approved to treat refractory complex partial seizures in patients 2 years and older who have not responded to other medicines, and the potential benefits outweigh the risk of any loss of vision. It is used together with another anticonvulsant. It is not used as a first-line treatment for complex partial seizures. 

Vigpoder is also FDA-approved to treat infantile spasms in babies and children between the ages of 1 month and 2 years if the potential benefits outweigh the potential risk of vision loss. It can be used as a single therapy for infantile spasms. 

Vigpoder side effects

Common Vigpoder side effects

Common Vigpoder side effects may include:

• blurred vision or other eye problems;
• drowsiness, dizziness, feeling tired;
• problems with walking or coordination;
• tremors or shaking;
• aggressive behavior;
• confusion, problems with thinking or memory;
• weight gain;
• joint pain;
• cold symptoms such as stuffy nose, sneezing, sore throat, or
• (in babies) fussiness, ear infection, cough, breathing problems.

Serious Vigpoder side effects

Get emergency medical help if you have signs of an allergic reaction to Vigpoder (hives, difficulty breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Taking Vigpoder can cause permanent vision loss. Tell your doctor right away about any changes in your vision. If a child is taking this medicine, Tell the doctor right away if the child shows signs of vision changes, such as bumping into things or being easily startled or surprised.

Report any new or worsening symptoms to your doctor, such as mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

• increased or worsening seizures;
• any change in your vision, no matter how mild;
• unusual or involuntary eye movements;
• severe drowsiness, fussiness, or feeding problems (in a baby taking vigabatrin);
• numbness, tingling, or burning pain in your hands or feet;
• weight gain with or without swelling;
• signs of an ear infection - fever, ear pain or full feeling, trouble hearing, drainage from the ear, fussiness in a child, or
• low red blood cells (anemia) - pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.

Some babies treated with Vigpoder have had abnormal brain changes seen on magnetic resonance imaging (MRI). It is not known if these changes are caused by vigabatrin or if they are harmful. Tell any doctor who treats your baby that the child is taking this medicine.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Related/similar drugs

gabapentin, clonazepam, lamotrigine, lorazepam, pregabalin, topiramate, diazepam

Warnings

Taking Vigpoder can cause permanent vision loss, even after you stop using this medicine. Tell your doctor if you have any vision problems, such as retinitis or glaucoma, and advise your doctor right away about any changes in your vision. You must have frequent eye exams before, during, and shortly after taking this medicine.

To be sure Vigpoder is not causing harmful effects on your vision, you will need a thorough eye exam before you start taking the medication and then every 3 months during treatment, even if your vision seems normal. If you ever stop taking this medicine, you may still need to have eye exams every 3 to 6 months after your treatment ends. Do not miss any follow-up visits to your doctor.

Some babies treated with this medicine have had abnormal brain changes seen on magnetic resonance imaging (MRI). Tell any doctor who treats your baby that the child is taking this medicine.

Some people have thoughts about suicide while taking seizure medication. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

Vigpoder should be used only by people who have been unable to control their seizures with several other medications.

Before taking this medicine

Some people taking Vigpoder have developed vision problems within weeks to years after starting treatment. Vision loss caused by vigabatrin may be permanent, and you may notice only mild symptoms at first. Talk to your doctor about this possibility.

Vigpoder is available only from a certified pharmacy under a special program called the Vigabatrin REMS Program. You must be registered in the program and agree to have vision exams before, during, and shortly after taking this medicine. Be sure you understand the risks and benefits of taking this medicine.

You should not use Vigpoder if you are allergic to vigabatrin.

To make sure Vigpoder is safe for you, tell your doctor if you (or the child taking this medicine) have ever had:

• vision problems;
• kidney disease;
• anemia (low red blood cells); or
• depression, a mood disorder, mental illness, or suicidal thoughts or actions.

Some people have thoughts about suicide while taking Vigpoder. Your doctor will need to check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Do not start or stop taking seizure medication during pregnancy without your doctor's advice. Having a seizure during pregnancy could harm both mother and baby. Tell your doctor right away if you become pregnant.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of vigabatrin on the baby.

You should not breastfeed while you are using Vigpoder.

Do not give this medicine to a child without medical advice.

How should I take Vigpoder?

Take Vigpoder exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

You may take Vigpoder with or without food, usually twice a day.

Vigpoder powder for oral solution should be mixed with water prior to administration. Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions. A calibrated measuring device is recommended to measure and deliver the prescribed dose accurately. A household teaspoon or tablespoon is not an adequate measuring device. Throw away any mixture that is left over. Do not save or reuse any leftover mixture.

Your healthcare provider will tell you:

• how many packets of Vigpoder you will need for each dose
• how many milliliters (mL) of water to use to mix one dose of Vigpoder
• how many milliliters (mL) of the powder and water mixture you will need for each dose of medicine

Anyone taking Vigpoder can develop vision problems that could get worse, even after you stop using this medicine. The more you take this medicine, the more likely you are to develop severe vision problems.

You will need a thorough eye exam before you start taking this medicine and then every 3 months during treatment, even if your vision seems normal. Eye exams may not fully prevent vision damage, but they will help your doctor decide whether to change your treatment plan. Stay alert to any changes in your vision and report them to your doctor right away.

If you stop taking Vigpoder, you should have another eye exam about 3 to 6 months after your last dose.

It may be more difficult to test vision in a baby or young child. However, your doctor may still prescribe Vigpoder for the child if the benefit of preventing seizures outweighs any risk. Tell the doctor right away if you think your child's vision may be changing.

Call your doctor if your complex partial seizures do not improve after 3 months of treatment, or if your baby's infantile spasms do not improve after 2 to 4 weeks of treatment.

Do not stop using Vigpoder suddenly, even if you feel fine. Stopping suddenly may cause increased seizures. Follow your doctor's instructions about tapering your dose.

Store in the original container at room temperature, away from moisture and heat.

Dosing information

Usual Adult Vigpoder Dose for Refractory Complex Partial Seizures (17 years and older)

Initial dose: 1 g orally daily (administered as one 500 mg orally 2 times daily) with or without food. The total daily dose may be increased in 500 mg increments at weekly intervals depending on response.

Recommended dose: 3 g orally daily (1.5 g orally 2 times daily)

A 6 g daily dose has not been shown to confer additional benefit compared to the 3 g daily dose and is associated with an increased incidence of adverse events.

Usual Pediatric Vigpoder Dose for Refractory Complex Partial Seizures

Initial dose: by body weight

The recommended dosage is based on body weight and administered as two divided doses. The dosage may be increased in weekly intervals to the total daily maintenance dosage, depending on response.

Pediatric patients weighing more than 60 kg should be dosed according to adult recommendations.

• 10kg to 15kg: total daily dose 350mg per day
• 16kg to 20kg: total daily dose 450mg per day
• 21kg to 25 kg: total daily dose 500mg per day
• 25kg to 60 kg: total daily dose 500mg per day

Maintenance dose:

• 10kg to 15kg: total daily dose 1,050mg per day
• 16kg to 20kg: total daily dose 1,300mg per day
• 21kg to 25 kg: total daily dose 1,500mg per day
• 25kg to 60 kg: total daily dose 2,000mg per day

Approved indication: For adults and children 2 years of age and older as adjunctive therapy for refractory complex partial seizures (CPS) who have inadequately responded to several alternative treatments and for whom the potential benefits outweigh the risk of vision loss. Vigpoder is not indicated as a first-line agent for complex partial seizures.

Usual Pediatric Vigpoder Dose for Infantile Spasms:

Dose: The initial daily dosing is 50 mg/kg/day given in two divided doses (25 mg/kg twice daily); subsequent dosing can be titrated by 25 mg/kg/day to 50 mg/kg/day increments every 3 days, up to a maximum of 150 mg/kg/day given in 2 divided doses (75 mg/kg twice daily).

Approved indication: Use as monotherapy for pediatric patients with infantile spasms 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss.

Comments: Patients with impaired renal function require dose adjustment.

Vigpoder is available as a powder, for solution. The concentration after reconstitution is 50 mg/mL.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Call your doctor for instructions if your baby is taking Vigpoder and misses a dose, takes only part of a dose, or spits up or vomits after taking the medicine.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include severe drowsiness or dizziness, confusion, trouble speaking, feeling agitated or irritable, unusual thoughts or behavior, increased seizures, slow heart rate, weak or shallow breathing, or fainting.

What to avoid

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired.

What other drugs will affect Vigpoder?

Other drugs may interact with vigabatrin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Storage 

Store at 20° to 25°C (68° to 77°F).

Ingredients

Active Ingredient: vigabatrin, USP

Inactive Ingredient: povidone

Company

Manufactured for PYROS PHARMACEUTICALS, INC

Parsippany, NJ 07054, U.S.A.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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