Vigabatrin (Vigabatrin)

Trade Name : Vigabatrin

Actavis Pharma, Inc.

TABLET, FILM COATED

Strength 500 mg/1

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VIGABATRIN Anti-epileptic Agent [EPC]

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No data

u00a0
Because of the risk of permanent vision loss, n- vigabatrinu00a0n- is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the n- Vigabatrinu00a0n- REMS Program . Further information is available at www.vigabatrinREMS.com or 1-866-244-8175.
WARNING: PERMANENT VISION LOSS
See full prescribing information for complete boxed warning.

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 tablets are available only through a restricted program called the Vigabatrin n- REMS Program ().

Warnings and Precautions, Neurotoxicity (5.4) u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a07/2019
Warnings and Precautions, Neurotoxicity () u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a07/2019

Vigabatrin tablets are indicated as adjunctive therapy for adults and pediatric patients 10 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 . Vigabatrin tablets are not indicated as a first line agent for complex partial seizures.
Vigabatrin tablets are indicated for the treatment of:

Refractory Complex Partial Seizures as adjunctive therapy in patients greater than or equal to 10 years of age who have responded inadequately to several alternative treatments; Vigabatrin tablets are not indicated as a first line agent ()

Refractory Complex Partial Seizures

Pediatric (10 to 16 years of age): Initiate at 500 mg/day (250 mg twice daily); increase total daily dose weekly in 500 mg/day increments, to recommended maintenance dose of 2,000 mg/day (1,000 mg twice daily); dose patients weighing more than 60 kg according to adult recommendations ()n- Array

Vigabatrin Tablets, USP are available for oral administration and are supplied as follows:n
500 mg u2014 Each white to off-white, film-coated, oval biconvex tablet functionally-scored on one side and debossed with A314 on the other side contains 500 mg of vigabatrin, USP.

u00a0Tablet: 500 mg ()

None.
None ()

No data

Abnormal MRI signal changes and intramyelinic edema have been reported in some infants with Infantile Spasms receiving vigabatrin (, )

The following serious and otherwise important adverse reactions are described elsewhere in labeling:
Refractory Complex Partial Seizures
Most common adverse reactions in controlled studies include (incidence greater than or equal to 5% over placebo):
To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals USA, Inc. at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Adults: in addition to permanent vision loss, fatigue, somnolence, nystagmus, tremor, blurred vision, memory impairment, weight gain, arthralgia, abnormal coordination, and confusional state ()
Pediatric patients (10 to 16 years of age): weight gain, upper respiratory tract infection, tremor, fatigue, aggression, and diplopia ()

Decreased phenytoin plasma levels: dosage adjustment may be needed ()

No data

No data

No data

Vigabatrin Tablets, USP are an oral antiepileptic drug and are available as white film-coated 500 mg tablets.
The chemical name of vigabatrin, USP, a racemate consisting of two enantiomers, is (u00b1) 4-amino-5-hexenoic acid. The molecular formula is CHNO and the molecular weight is 129.16. It has the following structural formula:
Vigabatrin, USP is a white to off-white powder which is freely soluble in water, slightly soluble in methyl alcohol, very slightly soluble in ethyl alcohol and chloroform, and insoluble in toluene and hexane. The pH of a 1% aqueous solution is about 6.9. The n-octanol/water partition coefficient of vigabatrin, USP is about 0.011 (log =-1.96) at physiologic pH. Vigabatrin, USP melts with decomposition in a 3-degree range within the temperature interval of 171u00b0C to 176u00b0C. The dissociation constants (pK) of vigabatrin, USP are 4 and 9.7 at room temperature (25u00b0C).
Each Vigabatrin Tablet, USP contains 500 mg of vigabatrin, USP. The inactive ingredients are hypromellose 2910, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, polyethylene glycol 8000, polysorbate 80, povidone, sodium starch glycolate, and titanium dioxide.

No data

Vigabatrin showed no carcinogenic potential in mouse or rat when given in the diet at doses up to 150 mg/kg/day for 18 months (mouse) or at doses up to 150 mg/kg/day for 2 years (rat). These doses are less than the maximum recommended human dose (MRHD) for refractory complex partial seizures (3 g/day) on a mg/m basis.
Vigabatrin was negative in (Ames, CHO/HGPRT mammalian cell forward gene mutation, chromosomal aberration in rat lymphocytes) and in (mouse bone marrow micronucleus) assays.
No adverse effects on male or female fertility were observed in rats at oral doses up to 150 mg/kg/day (approximately 1/2 the MRHD of 3 g/day on a mg/m basis) for adults treated with refractory complex partial seizures.

Adults
The effectiveness of vigabatrin as adjunctive therapy in adult patients was established in two U.S. multicenter, double-blind, placebo-controlled, parallel-group clinical studies. A total of 357 adults (age 18 to 60 years) with complex partial seizures, with or without secondary generalization were enrolled (Studies 1 and 2). Patients were required to be on an adequate and stable dose of an anticonvulsant, and have a history of failure on an adequate regimen of carbamazepine or phenytoin. Patients had a history of about 8 seizures per month (median) for about 20 years (median) prior to entrance into the study. These studies were not capable by design of demonstrating direct superiority of vigabatrin over any other anticonvulsant added to a regimen to which the patient had not adequately responded. Further, in these studies, patients had previously been treated with a limited range of anticonvulsants.
The primary measure of efficacy was the patientu2019s reduction in mean monthly frequency of complex partial seizures plus partial seizures secondarily generalized at end of study compared to baseline.
Study 1
Study 1 (N=174) was a randomized, double-blind, placebo-controlled, dose-response study consisting of an 8-week baseline period followed by an 18-week treatment period. Patients were randomized to receive placebo or 1, 3, or 6 g/day vigabatrin administered twice daily. During the first 6 weeks following randomization, the dose was titrated upward beginning with 1 g/day and increasing by 0.5 g/day on days 1 and 5 of each subsequent week in the 3 g/day and 6 g/day groups, until the assigned dose was reached.
Results for the primary measure of effectiveness, reduction in monthly frequency of complex partial seizures, are shown in Table 8. The 3 g/day and 6 g/day dose groups were statistically significantly superior to placebo, but the 6 g/day dose was not superior to the 3 g/day dose.u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0
Figure 1 presents the percentage of patients (X-axis) with a percent reduction in seizure frequency (responder rate) from baseline to the maintenance phase at least as great as that represented on the Y-axis. A positive value on the Y-axis indicates an improvement from baseline (i.e., a decrease in complex partial seizure frequency), while a negative value indicates a worsening from baseline (i.e., an increase in complex partial seizure frequency). Thus, in a display of this type, a curve for an effective treatment is shifted to the left of the curve for placebo. The proportion of patients achieving any particular level of reduction in complex partial seizure frequency was consistently higher for the vigabatrin 3 and 6 g/day groups compared to the placebo group. For example, 51% of patients randomized to vigabatrin 3 g/day and 53% of patients randomized to vigabatrin 6 g/day experienced a 50% or greater reduction in seizure frequency, compared to 9% of patients randomized to placebo. Patients with an increase in seizure frequency greater than 100% are represented on the Y-axis as equal to or greater than -100%.
Study 2
Study 2 (N=183 randomized, 182 evaluated for efficacy) was a randomized, double-blind, placebo-controlled, parallel study consisting of an 8-week baseline period and a 16-week treatment period. During the first 4 weeks following randomization, the dose of vigabatrin was titrated upward beginning with 1 g/day and increased by 0.5 g/day on a weekly basis to the maintenance dose of 3 g/day.
Results for the primary measure of effectiveness, reduction in monthly complex partial seizure frequency, are shown in Table 9. Vigabatrin 3 g/day was statistically significantly superior to placebo in reducing seizure frequency.
Figure 2 presents the percentage of patients (X-axis) with a percent reduction in seizure frequency (responder rate) from baseline to the maintenance phase at least as great as that represented on the Y-axis. A positive value on the Y-axis indicates an improvement from baseline (i.e., a decrease in complex partial seizure frequency), while a negative value indicates a worsening from baseline (i.e., an increase in complex partialu00a0seizure frequency). Thus, in a display of this type, a curve for an effective treatment is shifted to the left of the curve for placebo. The proportion of patients achieving any particularu00a0level of reduction in seizure frequency was consistently higher for the vigabatrin 3 g/day group compared to the placebo group. For example, 39% of patients randomized to vigabatrin (3 g/day) experienced a 50% or greater reduction in complex partial seizure frequency, compared to 21% of patients randomized to placebo. Patients with an increase in seizure frequency greater than 100% are represented on the Y-axis as equal to or greater than -100%.
For both studies, there was no difference in the effectiveness of vigabatrin between male and female patients. Analyses of age and race were not possible as nearly all patients were between the ages of 18 to 65 and Caucasian.
Pediatric patients 10 to 16 years of age
Vigabatrin was studied in three double-blind, placebo-controlled, parallel-group studies in 269 patients who received vigabatrin and 104 patients who received placebo. No individual study was considered adequately powered to determine efficacy in pediatric patients age 10 years and above. The data from all three pediatric studies were pooled and used in a pharmacometric bridging analysis using weight-normalized doses to establish efficacy and determine appropriate dosing. All three studies were randomized, double-blind, placebo-controlled, parallel-group, adjunctive-treatment studies in patients aged 3 to 16 years with uncontrolled complex partial seizures with or without secondary generalization. The study period included a 6 to 10 week baseline phase and a 14 to 17 week treatment phase (composed of a titration and maintenance period).
The pharmacometric bridging approach consisted of defining a weight-normalized dose-response, and showing that a similar dose-response relationship exists between pediatric patients and adult patients when vigabatrin was given as adjunctive therapy for complex partial seizures. Dosing recommendations in pediatric patients 10 to 16 years of age were derived from simulations utilizing these pharmacometric dose-response analyses .

No data

Advise patients and caregivers to read the FDA-approved patient labeling (Medication Guide).
Permanent Vision Loss
Inform patients and caregivers of the risk of permanent vision loss, particularly loss of peripheral vision, from vigabatrin tablets, and the need for monitoring vision .
Monitoring of vision, including assessment of visual fields and visual acuity, is recommended at baseline (no later than 4 weeks after starting vigabatrin tablets), at least every 3 months while on therapy, and about 3 to 6 months after discontinuation of therapy. In patients for whom vision testing is not possible, treatment may continue without recommended testing according to clinical judgment with appropriate patient or caregiver counseling. Patients or caregivers should be informed that if baseline or subsequent vision is not normal, vigabatrin tablets should only be used if the benefits of vigabatrin tablet treatment clearly outweigh the risks of additional vision loss.
Advise patients and caregivers that vision testing may be insensitive and may not detect vision loss before it is severe. Also advise patients and caregivers that if vision loss is documented, such loss is irreversible. Ensure that both of these points are understood by patients and caregivers.
Patients and caregivers should be informed that if changes in vision are suspected, they should notify their physician immediately.
Vigabatrin REMS Program
Vigabatrin tablets are available only through a restricted program called the Vigabatrin REMS Program . Inform patients/caregivers of the following:
Suicidal Thinking and Behavior
Counsel patients, their caregiver(s), and families that AEDs, including vigabatrin tablets, may increase the risk of suicidal thoughts and behavior. Also advise patients and caregivers of the need to be alert for the emergence or worsening of symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts of self-harm. Behaviors of concern should be reported immediately to healthcare providers .
Use in Pregnancy
Instruct patients to notify their physician if they become pregnant or intend to become pregnant during therapy, and to notify their physician if they are breast feeding or intend to breast feed during therapy .
Encourage patients to enroll in the NAAED Pregnancy Registry if they become pregnant. This registry is collecting information about the safety of antiepileptic drugs during pregnancy. To enroll, patients can call the toll free number 1-888-233-2334. Information on the registry can also be found at the website http://www.aedpregnancyregistry.org/ .
Withdrawal of n- Vigabatrin Tablet Therapy
Instruct patients and caregivers not to suddenly discontinue vigabatrin tablet therapy without consulting with their healthcare provider. As with all AEDs, withdrawal should normally be gradual .
Manufactured in India by:Watson Pharma Private LimitedVerna, Salcette Goa 403 722 INDIA
Manufactured for: Teva Pharmaceuticals USA, Inc.North Wales, PA 19454
Rev. A 8/2019

This Medication Guide has been approved by the U.S. Food and Drug Administration.n
Rev. A 8/2019

NDC 0591-3851-01
Vigabatrin Tablets, USP
500 mg
PHARMACIST: Dispense the accompanying Medication Guide to each patient.
Rx only
100 Tablets
TEVA

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Vigabatrin (Vigabatrin)

Trade Name : Vigabatrin

TABLET, FILM COATED

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Vigabatrin (Vigabatrin)

Trade Name : Vigabatrin

TABLET, FILM COATED

Storage and handling for Vigabatrin

Disclaimer

Delivery Process

Product information is meant for

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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