vigabatrin (Rx)

Brand and Other Names:Sabril, Vigadrone
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

tablet

  • 500mg (Sabril, generic)

powder for oral solution

  • 500mg/packet (Sabril, Vigadrone, generic)

Complex Seizures

Indicated for adjunctive therapy in adults with refractory complex partial seizures

500 mg PO q12hr initially, THEN increase by 500-mg increments qWeek to target dose of 1.5 g q12hr

No additional benefit shown with 6 g daily compared with 3 g daily; higher incidence of adverse effects associated with 6 g daily

Dosage Modifications

Renal impairment

  • Mild (CrCl >50 to 80 mL/min): Decrease dose by 25%
  • Moderate (CrCl >30 to 50 mL/min): Decrease dose by 50%
  • Severe (CrCl >10 to 30 mL/min): Decrease dose by 75%
  • Hemodialysis: Clearance not adequately studied

Dosage Forms & Strengths

tablet

  • 500mg (Sabril, generic)

powder for oral solution

  • 500mg/packet (Sabril, Vigadrone, generic)

Partial Seizures

Indicated for adjunctive therapy in children 10-16 years of age with refractory complex partial seizures

<10 years: Safety and efficacy not established

10-16 years

  • 25-60 kg: 250 mg PO q12hr initially, THEN increase qWeek to total maintenance dose of 1000 mg q12hr
  • >60 kg: 500 mg PO q12hr initially, THEN increase by 500-mg increments qWeek to target dose of 1.5 g q12hr

>16 years

  • 500 mg PO q12hr initially, THEN increase by 500-mg increments qWeek to target dose of 1.5 g q12hr

Infantile Spasms

Indicated as monotherapy for pediatric patients with infantile spasms aged 1 month to 2 years for whom the potential benefits outweigh the potential risk of vision loss

<1 month: Not established

1 month to 2 years: 50 mg/kg/day PO divided q12hr initially; if needed, may increase dose by 25-50 mg/kg/day increments every 3 days; not to exceed 150 mg/kg/day  

Dosage Modifications

Renal impairment

  • Infants: Information about how to adjust dose not available
  • ≥10 years
    • Mild (CrCl >50-80 mL/min): Decrease dose by 25%
    • Moderate (CrCl >30-50 mL/min): Decrease dose by 50%
    • Severe (CrCl >10 to 30 mL/min): Decrease dose by 75%
    • Hemodialysis: Clearance not adequately studied

Infantile Spasms (Orphan)

Orphan designation for combination therapy with cosyntropin for treatment of infantile spasms

Sponsor

  • West Therapeutic Development, LLC; 540 Ziegler Drive; Grayslake, Illinois 60030

Initiate at low end of dosing range and consider dose adjustment with renal impairment

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Interactions

Interaction Checker

and vigabatrin

No Results

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    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Weight gain, children (47%)

            Permanent bilateral concentric visual field constriction (>30%)

            Fatigue (28%)

            Somnolence (24%)

            Headache (18%)

            Weight gain, adults (17%)

            Dizziness (15%)

            Convulsion (11%)

            Hyperactivity, in children (11%)

            1-10%

            Nasopharyngitis (10%)

            Weight increased (10%)

            Upper respiratory tract infection (10%)

            Visual field defect (9%)

            Depression (8%)

            Tremor (7%)

            Nystagmus (7%)

            Nausea (7%)

            Diarrhea (7%)

            Memory impairment (7%)

            Insomnia (7%)

            Irritability (7%)

            Coordination abnormal (7%)

            Vision blurred (6%)

            Diplopia (6%)

            Vomiting (6%)

            Influenza (6%)

            Pyrexia (6%)

            Rash (6%)

            Postmarketing Reports

            Birth defects: Congenital cardiac defects, congenital external ear anomaly, congenital hemangioma, congenital hydronephrosis, congenital male genital malformation, congenital oral malformation, congenital vesicoureteric reflux, dentofacial anomaly, dysmorphism, fetal anticonvulsant syndrome, hamartomas, hip dysplasia, limb malformation, limb reduction defect, low set ears, renal aplasia, retinitis pigmentosa, supernumerary nipple, talipes

            Ear disorders: Deafness

            Endocrine disorders: Delayed puberty

            Gastrointestinal disorders: Gastrointestinal hemorrhage, esophagitis

            General disorders: Developmental delay, facial edema, malignant hyperthermia, multiorgan failure

            Hepatobiliary disorders: Cholestasis

            Nervous system disorders: Dystonia, encephalopathy, hypertonia, hypotonia, muscle spasticity, myoclonus, optic neuritis

            Psychiatric disorders: Acute psychosis, apathy, delirium, hypomania, neonatal agitation, psychotic disorder

            Respiratory disorders: Laryngeal edema, pulmonary embolism, respiratory failure, stridor

            Skin and subcutaneous tissue disorders: Angioedema, maculopapular rash, pruritus, Stevens-Johnson syndrome, toxic epidermal necrolysis, alopecia

            Vision disorders: Permanent vision loss

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            Warnings

            Black Box Warnings

            Causes permanent vision loss in infants, children, and adults and includes progressive and permanent bilateral concentric visual field constriction in >30% of patients and ranges in severity from mild to severe, including tunnel vision to within 10 degrees of visual fixation, and can result in disability

            May damage the central retina and decrease visual acuity

            Vision loss onset is unpredictable and can occur within weeks of starting treatment, or sooner, or at any time during treatment (even after months or years), and possibly after vigabatrin is discontinued

            Vision assessment is recommended at baseline (no later than 4 weeks after initiating therapy), at least every 3 months during therapy, and about 3-6 months after discontinuation of therapy

            Consider drug discontinuation, balancing benefit and risk, if vision loss documented

            Symptoms of vision loss are unlikely to be recognized by patients or caregivers before vision loss is severe

            Risk of new or worsening vision loss continues throughout therapy; it is possible that vision loss can worsen despite discontinuation of therapy

            Therapy should not be administered to patients with, or at high risk of, other types of irreversible vision loss unless benefits of treatment clearly outweigh risks

            Use lowest dosage and shortest exposure to therapy

            Because of risk of permanent vision loss, therapy is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the SABRIL REMS Program; www.vigabatrinREMS.com or 1-866-244-8175

            Contraindications

            Hypersensitivity

            Cautions

            P450 CYP2C inducer; coadministration with CYP2C substrates (eg, phenytoin) result in decreased plasma levels, phenytoin levels decreased 16-20% when coadministered and therefore may require dosage adjustments

            When coadministration with other AEDs, serum concentration of phenobarbital was reduced 8-16% and sodium valproate concentration was reduced by 8%

            Vigabatrin increased clonazepam Cmax by 30% and decreased Tmax by 45%

            May cause severe visual changes requiring regular ophthalmic monitoring (see Black Box Warnings)

            May cause somnolence and fatigue

            Abnormal MRI signal changes reported in some infants

            Antiepileptic drugs may increase risk of suicidal thoughts and behavior

            Taper dose gradually when discontinuing to avoid withdrawal seizures; if withdrawal needed because of serious adverse event, rapid discontinuation can be considered

            Anemia reported

            Peripheral neuropathy reported

            Weight gain reported in adults and children

            Edema reported in adults

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            Pregnancy & Lactation

            Pregnancy

            No adequate and well-controlled studies in pregnant women

            Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus

            Advised pregnant patients taking vigabatrin to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry; 1-888-233-2334 or http://www.aedpregnancyregistry.org/

            Animal studies

            • Vigabatrin produced developmental toxicity, including teratogenic and neurohistopathological effects, when administered to pregnant animals at clinically relevant doses
            • In addition, developmental neurotoxicity was observed in rats treated with vigabatrin during a period of postnatal development corresponding to the third trimester of human pregnancy

            Lactation

            Excreted in human milk

            Because of the potential for serious adverse reactions from vigabatrin in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Irreversible inhibitor of gamma aminobutyric acid (GABA) transaminase, thereby increases the level of the inhibitory neurotransmitter GABA within the brain

            Pharmacokinetics

            Half-Life: 5.7 hr in infants; 5-8 hr in young adults; 7.5 hr in adults; 12-14 hr in geriatric patients

            Absorption: 100% (solution and tablets are bioequivalent to one another and may be interchanged)

            Vd: 1.1 L/kg

            Peak Plasma Time: [fasting] 2.5 hr; [with food] 2 hr

            Protein Bound: Negligible

            Metabolism: Not extensively metabolized

            Clearance: [adults] 7 L/hr; [infants] 2.4 L/hr; [children] 5.7 L/hr

            Excretion: Urine: 95%

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            Administration

            Oral Solution Preparation

            Dissolve powder content from each 500 mg packet in 10 mL cold or room temp water (final concentration 50 mg/mL)

            Pepare immediately before use

            Oral Administration

            May take with or without food

            Discontinue gradually

            • Infantile spasms: Taper by decreasing daily dose at a rate of 25-50 mg/kg q3-4 days
            • Pediatric patients aged 10-16 yr with complex partial seizures: Taper by decreasing daily dose by one-third qWeek for 3 wk
            • >16 yr with complex partial seizures: Taper by decreasing daily dose 1000 mg/day on a weekly basis until discontinued
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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.