Description
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 under a restricted distribution program called Vigabatrin REMS (Risk Evaluation and Mitigation Strategy) Program.
This product is available in the following dosage forms:
- Solution
- Powder for Solution
- Tablet
Before Using
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.
Pediatric
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.
Geriatric
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.
Breastfeeding
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.
Drug Interactions
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
- Fosphenytoin
- Hydroxychloroquine
- Orlistat
- Phenytoin
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.
- Ginkgo
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
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.
It is very important that you understand the Vigabatrin REMS program and become familiar with the Medication Guide and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions. Ask your pharmacist for the medication guide if you do not have one.
You may take this medicine with or without food.
To use the Sabril® 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.
To use Vigafyde™ oral liquid:
- Press and turn the child-resistant cap counterclockwise. Insert the bottle adapter. While holding the bottle firmly on a flat surface, push the ribbed end of the bottle adapter all the way into the neck of the bottle. Make sure that the bottle adapter is fully inserted.
- Use the oral syringe to draw the prescribed dose. Push the plunger all the way up towards the tip of the syringe to remove air. Place the bottle on a flat surface, insert the tip of the syringe into the opening of the bottle adapter and push down gently.
- While holding the oral syringe firmly into the bottle, turn the bottle upside down. Slowly pull back the plunger of the syringe until you reach the prescribed dose. Hold the plunger to keep it from moving.
- If there are large air bubbles, slowly push up on the plunger until the bubbles are removed.
- Remove the syringe from the bottle adapter by gently pulling it straight up.
- Make sure your child is sitting upright when giving this medicine. Place the tip of the syringe into your child's mouth and point the syringe towards either cheek. Push on the plunger slowly.
Vigabatrin may be used together with other seizure medicines. Keep using all of your medicines unless your doctor tells you to stop.
Measure the Vigafyde™ oral liquid with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.
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 infantile spasms:
- For oral dosage form (Sabril® powder for solution):
- 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 form (Vigafyde™ solution):
- 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.
- Weighing 16 kilograms (kg)—At first, 4 milliliters (mL) 2 times a day. However, the dose is usually not more than 12 mL 2 times a day.
- Weighing 15 kg—At first, 3.75 mL 2 times a day. However, the dose is usually not more than 11.25 mL 2 times a day.
- Weighing 14 kg—At first, 3.5 mL 2 times a day. However, the dose is usually not more than 10.5 mL 2 times a day.
- Weighing 13 kg—At first, 3.25 mL 2 times a day. However, the dose is usually not more than 9.75 mL 2 times a day.
- Weighing 12 kg—At first, 3 mL 2 times a day. However, the dose is usually not more than 9 mL 2 times a day.
- Weighing 11 kg—At first, 2.75 mL 2 times a day. However, the dose is usually not more than 8.25 mL 2 times a day.
- Weighing 10 kg—At first, 2.5 mL 2 times a day. However, the dose is usually not more than 7.5 mL 2 times a day.
- Weighing 9 kg—At first, 2.25 mL 2 times a day. However, the dose is usually not more than 6.75 mL 2 times a day.
- Weighing 8 kg—At first, 2 mL 2 times a day. However, the dose is usually not more than 6 mL 2 times a day.
- Weighing 7 kg—At first, 1.75 mL 2 times a day. However, the dose is usually not more than 5.25 mL 2 times a day.
- Weighing 6 kg—At first, 1.5 mL 2 times a day. However, the dose is usually not more than 4.5 mL 2 times a day.
- Weighing 5 kg—At first, 1.25 mL 2 times a day. However, the dose is usually not more than 3.75 mL 2 times a day.
- Weighing 4 kg—At first, 1 mL 2 times a day. However, the dose is usually not more than 3 mL 2 times a day.
- Weighing 3 kg—At first, 0.75 mL 2 times a day. However, the dose is usually not more than 2.25 mL 2 times a day.
- Children younger than 1 month of age—Use and dose must be determined by your doctor.
- 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.
- For oral dosage form (Sabril® powder for solution):
- For seizures:
- For oral dosage forms (Sabril® solution or tablets):
- Adults and children 17 years of age weighing 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 weighing 60 kg or less—Dose is based on body weight and must be determined by your doctor.
- Weighing 25 kg to 60 kg—At first, 250 mg given 2 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 2000 mg per day.
- Weighing 20 kg to 25 kg— At first, 250 mg given 2 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 1500 mg per day.
- Weighing 15 kg to 20 kg—At first, 225 mg given 2 times a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 1300 mg per day.
- Weighing 10 kg to 15 kg—At first, 175 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 younger than 10 years of age weighing less than 10 kg—Use and dose must be determined by your doctor.
- For oral dosage forms (Sabril® solution or tablets):
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
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.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
You may store opened Vigafyde™ oral liquid in the refrigerator. Throw away unused medicine 90 days after opening the bottle.
Precautions
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
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 or loss of consciousness
- sleepiness
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.
DRG-20066675
