Pronunciation:

vye-GA-ba-trin

Brand Names:

• Sabril
• Vigadrone

Dosage Forms:

• Powder for Solution
• Tablet

Warnings:

Vigabatrin can cause permanent bilateral concentric visual field constriction, including tunnel vision that can result in disability. In some cases, vigabatrin may also decrease visual acuity.Risk increases with increasing dose and cumulative exposure, but there is no dose or exposure to vigabatrin known to be free of risk of vision loss.Risk of new and worsening vision loss continues as long as vigabatrin is used, and possibly after discontinuing vigabatrin.Baseline and periodic vision assessment is recommended for patients on vigabatrin. However, this assessment cannot always prevent vision damage.Vigabatrin is available only through a restricted program called the Vigabatrin REMS Program. Further information is available at www.vigabatrinREMS.com or 1-866-244-8175 .

Classifications:

Therapeutic—

Anticonvulsant

Pharmacologic—

Gamma Aminobutyric Acid Transaminase Inhibitor

Chemical—

Gamma Aminobutyric Acid (class)

Uses of This Medicine:

Vigabatrin is used alone or together with other medicines to treat refractory complex partial seizures in adults and children 2 years of age and older, and infantile spasms in children. It is used in patients who have already been treated with other medicines that did not work well.

Vigabatrin is an anticonvulsant. It increases the amount of the chemical called gamma amino butyric acid (GABA) in the brain. Some seizures are caused by low levels of GABA. When vigabatrin increases GABA, it reduces the likelihood of a seizure.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of vigabatrin oral liquid to treat infantile spasms in children 1 month to 2 years of age. Safety and efficacy have been established.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of vigabatrin oral liquid and tablets to treat refractory complex partial seizures in children 2 to 16 years of age. However, safety and efficacy have not been established in children younger than 2 years of age.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of vigabatrin in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving vigabatrin.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Calcifediol
• Carbamazepine
• Orlistat

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Fosphenytoin
• Ginkgo
• Phenytoin

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Anemia or
• Depression, history of or
• Eye or vision problems or
• Mental illness, history of—Use with caution. May make these conditions worse.

• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

Vigabatrin is only available through a restricted program called the Vigabatrin REMS program. It is very important that you understand the Vigabatrin REMS program and become familiar with the Medication Guide. Talk to your doctor about the program before starting treatment with vigabatrin.

You may take this medicine with or without food.

To use the oral liquid:

• Open the packet and empty the contents into a clean cup.
• Dissolve it with 10 milliliters (mL) of cold or room temperature water.
• Do not use the liquid if it is not clear (or free of particles) and colorless.
• Measure the dose with the oral syringe in the package.
• Throw away any unused liquid after the dose is given.

Vigabatrin may be used together with other seizure medicines. Keep using all of your medicines unless your doctor tells you to stop.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (solution):
  • For infantile spasms:
    • Children 1 month to 2 years of age—Dose is based on body weight and must be determined by your doctor. The starting dose is 50 milligrams (mg) per kilogram (kg) of body weight per day, divided and given 2 times a day. Your doctor may adjust the dose as needed. However, the dose is usually not more than 150 mg per kg per day.
    • Children younger than 1 month of age—Use and dose must be determined by your doctor.
• For oral dosage forms (solution or tablets):
  • For seizures:
    • Adults and children 17 years of age and weighs more than 60 kilograms (kg)—At first, 500 milligrams (mg) two times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 3000 mg per day.
    • Children 2 to 16 years of age and weighs 10 to 15 kg—Dose is based on body weight and must be determined by your doctor. At first, 175 milligrams (mg) given two times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 1050 mg per day.
    • Children 2 to 16 years of age and weighs 15 to 20 kg—Dose is based on body weight and must be determined by your doctor. At first, 225 milligrams (mg) given two times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 1300 mg per day.
    • Children 2 to 16 years of age and weighs 20 to 25 kg—Dose is based on body weight and must be determined by your doctor. At first, 250 milligrams (mg) given two times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 1500 mg per day.
    • Children 2 to 16 years of age and weighs 25 to 60 kg—Dose is based on body weight and must be determined by your doctor. At first, 250 milligrams (mg) given two times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 2000 mg per day.
    • Children younger than 10 years of age and weighs less than 10 kg—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

This medicine may cause permanent vision loss. Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. It is very important that your ophthalmologist (eye doctor) check your child's or your eyes within 4 weeks after starting treatment, every 3 months during treatment, and about 3 to 6 months after stopping treatment with this medicine.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine (eg, magnetic resonance imaging or MRI).

This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Make sure the doctor knows if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell the doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. If you, your child, or your caregiver notice any of these side effects, tell your doctor right away.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away. Your doctor may want you to join a pregnancy registry for patients taking a seizure medicine.

This medicine may cause some people to become drowsy, sleepy, tired, or weak than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are drowsy or not alert.

Check with your doctor right away if you or your child are having burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet. These could be symptoms of a condition called peripheral neuropathy.

This medicine may increase your weight and cause swelling in your hands, ankles, or feet. Your doctor may need to check your weight on a regular basis while you are using this medicine. Talk to your doctor about ways to prevent weight gain.

Do not suddenly stop taking this medicine without checking first with your doctor. Your doctor may want to gradually reduce the amount you are using before stopping it completely. Stopping this medicine suddenly may cause seizures.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Blue-yellow color blindness

blurred vision

decreased vision or other vision changes

eye pain

increase in seizures

loss of memory

problems with memory

Less common or rare

Uncontrolled rolling eye movements

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Change in or loss of consciousness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Agitation

burning, tingling, or prickly sensations

clumsiness or unsteadiness

confusion

constipation

diarrhea

dizziness

double vision or seeing double

increased movement

joint pain

mental depression

sleepiness or unusual drowsiness

stomach pain

trembling

tremor

trouble sitting still

Less common

Aggression

headache

increased saliva

muscle weakness

nausea

poor concentration

speech disorder

trouble sleeping

unusual thoughts

vomiting

weight gain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.