Sabril Powder

The active ingredient in Sabril is vigabatrin. Vigabatrin is an anticonvulsant that increases levels of gamma-aminobutyric acid (GABA), a naturally occurring chemical in the brain that helps calm overactive nerve signals. This helps reduce the frequency and severity of certain types of seizures, especially infantile spasms and hard-to-treat complex partial seizures.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Sabril. However, the following is a synopsis of the general guidelines for the use of Sabril:

• Take Sabril exactly as prescribed, at the same time each day.
• Tablets should be swallowed whole.
• Powder packets must be mixed with the correct amount of water before giving the dose. Measure using an approved oral syringe.
• For infantile spasms, doses are based on the child’s body weight and adjusted over time.
• Do not miss doses. If a dose is missed, take it as soon as possible unless it is nearly time for the next dose.
• Because Sabril can cause permanent vision loss, regular eye exams and visual assessments are required.
• Caregivers should monitor infants for changes in alertness, increased sleepiness, or continued spasms.

Some mild or common side effects of Sabril seen in clinical trials as compared to placebo include:

• Drowsiness.
• Sleepiness.
• Weight gain.
• Swelling of the hands, legs, or feet (edema).
• Joint pain.
• Irritability or mood changes.
• Blurred vision.
• Anemia.
• Headache.
• Increased appetite.

Some individuals may experience serious side effects while using Sabril. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Vision problems, including tunnel vision, blind spots, or sudden vision changes.
• Signs of permanent vision loss.
• Suicidal thoughts or unusual mood changes.
• Severe allergic reactions, such as hives, swelling, or difficulty breathing.
• Worsening seizures or episodes of status epilepticus.
• Numbness or tingling that may suggest peripheral neuropathy.
• Unusual bleeding, pale skin, or extreme weakness (possible anemia).

These are not all of the possible side effects of Sabril. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Sabril, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including:

• Any history of vision problems.
• Kidney disease or kidney problems.
• A history of anemia.
• A history of depression or suicidal thoughts.
• Previous allergic reactions to seizure medications.
• Any neurological conditions affecting alertness or muscle control.
• Concerns about weight gain or metabolic conditions.

Boxed Warning

Sabril carries an FDA boxed warning due to the risk of permanent vision loss. Vision damage can occur at any time during treatment, may worsen even after the medication is stopped, and may be irreversible. Because of this, Sabril is only available through the FDA’s Risk Evaluation and Mitigation Strategy (REMS) program. Regular vision testing is required.

Sabril should not be used in individuals who:

• Have a known allergy to vigabatrin or any inactive ingredient in the product.
• Are unable to undergo required vision testing or REMS program monitoring (unless treating infantile spasms, where testing is done as feasible).

The response depends on the condition being treated:

• Infantile spasms: Many infants show improvement within 1 to 2 weeks of starting therapy.
• Refractory complex partial seizures: Some adults and children may notice changes within several weeks, but it may take longer to assess the full benefit.
• If seizures or infantile spasms do not improve after an adequate trial period, your healthcare provider may discontinue Sabril.

When Sabril is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Phenytoin. Sabril may reduce phenytoin levels.
• Other antiepileptic drugs. Combined use may increase drowsiness.

Sabril comes in several dosage forms:

• Tablets (500 mg).
• Powder packets for oral solution (500 mg).
• Oral solution (vigabatrin mixed with water to a specific concentration).

Dosing depends on body weight for infants and is individualized for older children and adults. Your healthcare provider will determine the correct starting dose and maintenance dose.

Store at room temperature, away from the reach of children or pets.

Sabril is manufactured by Lundbeck, a company specializing in neurological and psychiatric medicines.

Yes, there are generic name versions available of Sabril.

Do not stop taking Sabril without speaking to your healthcare provider. Suddenly stopping anticonvulsants may cause seizures to worsen or trigger status epilepticus.

If vision problems, mood changes, or other serious side effects occur, your healthcare provider may gradually lower your dose or switch you to another medicine.

Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. Sabril may pose risks to an unborn baby, but uncontrolled seizures are also dangerous during pregnancy. Patients may be encouraged to enroll in a pregnancy registry to help track outcomes. Your healthcare provider will determine what is safest for you.

Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. It is unknown how much vigabatrin passes into breast milk, and caution is advised. Your healthcare provider will help weigh potential risks and benefits.