Vigabatrin — Membership Pricing

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What Vigabatrin is approved for (FDA label)

Vigabatrin tablets are indicated for the treatment of: • Refractory Complex Partial Seizures as adjunctive therapy in patients 2 years of age and older who have responded inadequately to several alternative treatments; Vigabatrin tablets are not indicated as a first line agent ( 1.1 ) • Infantile Spasms - monotherapy in infants 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss ( 1.2 ) 1.1 Refractory Complex Partial Seizures (CPS) Vigabatrin tablets are indicated as adjunctive therapy for adults and pediatric patients 2 years of age and older with refractory complex partial seizures who have inadequately responded to several alternative treatments and for whom the potential benefits outweigh the risk of vision loss [see Warnings and Precautions ( 5.1 ) ]. Vigabatrin tablets are not indicated as a first line agent for complex partial seizures. 1.2 Infantile Spasms (IS) Vigabatrin tablets are indicated 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 [ see Warnings and Precautions ( 5.1 ) ]

Source: Read the full FDA label on DailyMed. Label effective date: August 12, 2026.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Boxed warning for Vigabatrin (FDA label)

WARNING: PERMANENT VISION LOSS • Vigabatrin can cause permanent bilateral concentric visual field constriction, including tunnel vision that can result in disability. In some cases, vigabatrin also can damage the central retina and may decrease visual acuity [ see Warnings and Precautions ( 5.1 ) ]. • The onset of vision loss from vigabatrin is unpredictable, and can occur within weeks of starting treatment or sooner, or at any time after starting treatment, even after months or years. • Symptoms of vision loss from vigabatrin are unlikely to be recognized by patients or caregivers before vision loss is severe. Vision loss of milder severity, while often unrecognized by the patient or caregiver, can still adversely affect function. • The risk of vision loss increases with increasing dose and cumulative exposure, but there is no dose or exposure known to be free of risk of vision loss. • Vision assessment is recommended at baseline (no later than 4 weeks after starting vigabatrin), at least every 3 months during therapy, and about 3 to 6 months after the discontinuation of therapy. • Once detected, vision loss due to vigabatrin is not reversible. It is expected that, even with frequent monitoring, some patients will develop severe vision loss. • Consider drug discontinuation, balancing benefit and risk, if vision loss is documented. • Risk of new or worsening vision loss continues as long as vigabatrin is used.

Source: FDA prescribing information (DailyMed). Set ID: 93ba3894-fd97-4432-9f2d-e7050371e91f. SPL document ID: f96ecebb-fe76-4332-85ec-60303d6c8c99. Label effective date: August 12, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Dosage forms and strengths for Vigabatrin (FDA label)

Vigabatrin Tablets, USP: 500 mg oval-shaped tablets, white, film-coated, biconvex, scored on one side and debossed with "D500" on the other side. • Tablets: 500 mg ( 3 )

Source: FDA prescribing information (DailyMed). Set ID: 93ba3894-fd97-4432-9f2d-e7050371e91f. SPL document ID: f96ecebb-fe76-4332-85ec-60303d6c8c99. Label effective date: August 12, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Adverse reactions for Vigabatrin (FDA label)

The following serious and otherwise important adverse reactions are described elsewhere in labeling: • Permanent Vision Loss [ see BOXED WARNING and Warnings and Precautions ( 5.1 ) ] • Magnetic Resonance Imaging (MRI) Abnormalities in Infants [ see Warnings and Precautions ( 5.3 ) ] • Neurotoxicity [ see Warnings and Precautions ( 5.4 )] • Suicidal Behavior and Ideation [ see Warnings and Precautions ( 5.5 ) ] • Withdrawal of Antiepileptic Drugs (AEDs) [ see Warnings and Precautions ( 5.6 )] • Anemia [ see Warnings and Precautions ( 5.7 ) ] • Somnolence and Fatigue [ see Warnings and Precautions ( 5.8 ) ] • Peripheral Neuropathy [ see Warnings and Precautions ( 5.9 ) ] • Weight Gain [ see Warnings and Precautions ( 5.10 ) ] • Edema [ see Warnings and Precautions ( 5.11 ) ] Refractory Complex Partial Seizures Most common adverse reactions in controlled studies include (incidence ≥5% over placebo): • Adults: blurred vision, somnolence, dizziness, abnormal coordination, tremor, and fatigue ( 6.1 ) • Pediatric patients (3 to 16 years of age): weight gain ( 6.1 ) Infantile Spasms (incidence >5% and greater than on placebo) • Somnolence, bronchitis, ear infection, and acute otitis media ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Edenbridge Pharmaceuticals, LLC. at 877-381-3336 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Source: FDA prescribing information (DailyMed). Set ID: 93ba3894-fd97-4432-9f2d-e7050371e91f. SPL document ID: f96ecebb-fe76-4332-85ec-60303d6c8c99. Label effective date: August 12, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Contraindications for Vigabatrin (FDA label)

None. None ( 4 )

Source: FDA prescribing information (DailyMed). Set ID: 93ba3894-fd97-4432-9f2d-e7050371e91f. SPL document ID: f96ecebb-fe76-4332-85ec-60303d6c8c99. Label effective date: August 12, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Warnings and precautions for Vigabatrin (FDA label)

• Abnormal MRI signal changes and intramyelinic edema have been reported in some infants with Infantile Spasms receiving vigabatrin ( 5.3 , 5.4 ) • Suicidal behavior and ideation: Antiepileptic drugs, including vigabatrin, increase the risk of suicidal thoughts and behavior ( 5.5 ) • Withdrawal of AEDs: Taper dose to avoid withdrawal seizures ( 5.6 ) • Anemia: Monitor for symptoms of anemia ( 5.7 ) • Somnolence and fatigue: Advise patients not to drive or operate machinery until they have gained sufficient experience on vigabatrin ( 5.8 ) 5.1 Permanent Vision Loss Vigabatrin can cause permanent vision loss. Because of this risk and because, when it is effective, vigabatrin provides an observable symptomatic benefit; patient response and continued need for treatment should be periodically assessed.

Source: FDA prescribing information (DailyMed). Set ID: 93ba3894-fd97-4432-9f2d-e7050371e91f. SPL document ID: f96ecebb-fe76-4332-85ec-60303d6c8c99. Label effective date: August 12, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Drug interactions for Vigabatrin (FDA label)

Decreased phenytoin plasma levels: dosage adjustment may be needed ( 7.1 ) 7.1 Antiepileptic Drugs Phenytoin Although phenytoin dose adjustments are not routinely required, dose adjustment of phenytoin should be considered if clinically indicated, since vigabatrin may cause a moderate reduction in total phenytoin plasma levels [ see Clinical Pharmacology ( 12.3 ) ]. Clonazepam Vigabatrin may moderately increase the Cmax of clonazepam resulting in an increase of clonazepam-associated adverse reactions [ see Clinical Pharmacology ( 12.3 ) ]. Other AEDs There are no clinically significant pharmacokinetic interactions between vigabatrin and either phenobarbital or sodium valproate.

Source: FDA prescribing information (DailyMed). Set ID: 93ba3894-fd97-4432-9f2d-e7050371e91f. SPL document ID: f96ecebb-fe76-4332-85ec-60303d6c8c99. Label effective date: August 12, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.