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DRUG IMAGES
VIGADRONE 500 MG POWDER PACKET
The following indications for VIGADRONE (vigabatrin) have been approved by the FDA:
Indications:
Complex-partial epilepsy
Infantile spasms
Professional Synonyms:
Automatic epilepsy
Complex focal epilepsy
Complex focal seizures
Complex local seizures
Complex partial epilepsy
Complex partial seizures
Complex psychomotor epilepsy
Complex psychomotor seizure
Complex temporal lobe epilepsy
Complex temporal lobe seizures
Infantile spasm
Jackknife seizures
Psychic epilepsy
Psychomotor epilepsy
Psychomotor seizure
Salaam convulsions
Temporal lobe epilepsy
Temporal lobe seizure
West syndrome
Indications:
Complex-partial epilepsy
Infantile spasms
Professional Synonyms:
Automatic epilepsy
Complex focal epilepsy
Complex focal seizures
Complex local seizures
Complex partial epilepsy
Complex partial seizures
Complex psychomotor epilepsy
Complex psychomotor seizure
Complex temporal lobe epilepsy
Complex temporal lobe seizures
Infantile spasm
Jackknife seizures
Psychic epilepsy
Psychomotor epilepsy
Psychomotor seizure
Salaam convulsions
Temporal lobe epilepsy
Temporal lobe seizure
West syndrome
The following dosing information is available for VIGADRONE (vigabatrin):
Since there is no direct correlation between plasma vigabatrin concentrations and efficacy, therapeutic drug monitoring of vigabatrin is not useful.
The manufacturer states that the lowest dosage and shortest duration of therapy with vigabatrin consistent with clinical objectives should be used.
The dosage regimen of vigabatrin depends on the indication, age group, weight, and dosage form (tablets or powder for oral solution).
If therapy is to be discontinued, vigabatrin should be withdrawn gradually.
The manufacturer states that the lowest dosage and shortest duration of therapy with vigabatrin consistent with clinical objectives should be used.
The dosage regimen of vigabatrin depends on the indication, age group, weight, and dosage form (tablets or powder for oral solution).
If therapy is to be discontinued, vigabatrin should be withdrawn gradually.
Vigabatrin is available orally as tablets, a powder for oral solution with a final concentration of 50 mg/mL, and a concentrated 100 mg/mL oral solution that does not require reconstitution or dilution prior to administration. Vigabatrin is administered orally and may be given without regard to meals. When using the powder for oral solution, clinicians should review and discuss the medication guide and instructions on proper reconstitution, administration, and dosing procedures with the patient or caregiver(s) and confirm their understanding.
When using the concentrated 100 mg/mL oral solution, verify the strength and dose of the product before prescribing, dispensing, and administering the product. Vigabatrin powder for oral solution should be prepared and administered according to the manufacturer's directions. The manufacturer states that only water should be used to dissolve the powder.
To prepare the oral solution, the entire contents of the appropriate number of packets of vigabatrin powder for oral solution (500 mg/packet) should be emptied into a clean cup and dissolved with 10 mL of cold or room-temperature water per packet; resultant solutions have a final concentration of 50 mg/mL. For doses between 0 and 500 mg, 1 packet of vigabatrin powder should be dissolved with 10 mL of water; for doses between 501 mg and 1 g, 2 packets of vigabatrin powder should be dissolved with 20 mL of water; and for doses between 1 and 1.5 g, 3 packets of vigabatrin powder should be dissolved with 30 mL of water.
The solution should be mixed thoroughly with a small spoon or other clean utensil until the powder has completely dissolved and the solution is clear. The resulting solution should be discarded if it is not clear (or free of particles) and colorless. Each dose of vigabatrin oral solution should be administered immediately following preparation.
Depending on the dose to be administered, a 3-mL or 10-mL oral syringe supplied by the pharmacy should be used to withdraw the specific volume of solution that will provide the appropriate dose and any remaining solution should be discarded. A calibrated measuring device should be used to measure and deliver the dose of vigabatrin powder for oral solution or oral solution; a household teaspoon or tablespoon is not an appropriate measuring device. Store vigabatrin tablets and powder for oral solution at 20-25degreesC.
Store unopened bottles of vigabatrin 100 mg/mL oral solution between 20-25degreesC (excursions permitted to 15-30degreesC). After opening vigabatrin 100 mg/mL oral solution, store at room temperature or in a refrigerator, between 2-30degreesC; discard any unused medication within 90 days after first opening.
When using the concentrated 100 mg/mL oral solution, verify the strength and dose of the product before prescribing, dispensing, and administering the product. Vigabatrin powder for oral solution should be prepared and administered according to the manufacturer's directions. The manufacturer states that only water should be used to dissolve the powder.
To prepare the oral solution, the entire contents of the appropriate number of packets of vigabatrin powder for oral solution (500 mg/packet) should be emptied into a clean cup and dissolved with 10 mL of cold or room-temperature water per packet; resultant solutions have a final concentration of 50 mg/mL. For doses between 0 and 500 mg, 1 packet of vigabatrin powder should be dissolved with 10 mL of water; for doses between 501 mg and 1 g, 2 packets of vigabatrin powder should be dissolved with 20 mL of water; and for doses between 1 and 1.5 g, 3 packets of vigabatrin powder should be dissolved with 30 mL of water.
The solution should be mixed thoroughly with a small spoon or other clean utensil until the powder has completely dissolved and the solution is clear. The resulting solution should be discarded if it is not clear (or free of particles) and colorless. Each dose of vigabatrin oral solution should be administered immediately following preparation.
Depending on the dose to be administered, a 3-mL or 10-mL oral syringe supplied by the pharmacy should be used to withdraw the specific volume of solution that will provide the appropriate dose and any remaining solution should be discarded. A calibrated measuring device should be used to measure and deliver the dose of vigabatrin powder for oral solution or oral solution; a household teaspoon or tablespoon is not an appropriate measuring device. Store vigabatrin tablets and powder for oral solution at 20-25degreesC.
Store unopened bottles of vigabatrin 100 mg/mL oral solution between 20-25degreesC (excursions permitted to 15-30degreesC). After opening vigabatrin 100 mg/mL oral solution, store at room temperature or in a refrigerator, between 2-30degreesC; discard any unused medication within 90 days after first opening.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| VIGADRONE 500 MG POWDER PACKET | Maintenance | Adults take 1 packet (500 mg) dissolved in 10 mL water by oral route 2 times per day |
| VIGADRONE 500 MG TABLET | Maintenance | Adults take 1 tablet (500 mg) by oral route 2 times per day |
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| VIGABATRIN 500 MG TABLET | Maintenance | Adults take 1 tablet (500 mg) by oral route 2 times per day |
| VIGABATRIN 500 MG POWDER PACKT | Maintenance | Adults take 1 packet (500 mg) dissolved in 10 mL water by oral route 2 timesper day |
The following drug interaction information is available for VIGADRONE (vigabatrin):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for VIGADRONE (vigabatrin):
Drug contraindication overview.
*None.
*None.
There are 0 contraindications.
There are 9 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Chronic kidney disease stage 2 (mild) GFR 60-89 ml/min |
| Chronic kidney disease stage 3A (moderate) GFR 45-59 ml/min |
| Chronic kidney disease stage 3B (moderate) GFR 30-44 ml/min |
| Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min |
| Chronic kidney disease stage 5 (failure) GFr<15 ml/min |
| Pregnancy |
| Reduced visual acuity |
| Suicidal ideation |
| Visual field defect |
There are 4 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Anemia |
| Edema |
| Peripheral neuropathy |
| Weight gain |
The following adverse reaction information is available for VIGADRONE (vigabatrin):
Adverse reaction overview.
Vigabatrin causes permanent damage to vision in a high percentage of patients. The most common adverse effects reported (incidence >=5% over placebo) in adolescents and adults >=16 years of age with refractory CPS included blurred vision, somnolence, dizziness, abnormal coordination, tremor, and fatigue. In controlled clinical studies in pediatric patients 3 to 16 years of age with refractory CPS receiving vigabatrin, adverse effects occurring at an incidence >=5% over placebo included weight gain. In a placebo-controlled study in pediatric patients with IS, adverse effects occurring in >5% of vigabatrin-treated patients and more frequently than in placebo recipients included somnolence, bronchitis, ear infection, and acute otitis media.
Vigabatrin causes permanent damage to vision in a high percentage of patients. The most common adverse effects reported (incidence >=5% over placebo) in adolescents and adults >=16 years of age with refractory CPS included blurred vision, somnolence, dizziness, abnormal coordination, tremor, and fatigue. In controlled clinical studies in pediatric patients 3 to 16 years of age with refractory CPS receiving vigabatrin, adverse effects occurring at an incidence >=5% over placebo included weight gain. In a placebo-controlled study in pediatric patients with IS, adverse effects occurring in >5% of vigabatrin-treated patients and more frequently than in placebo recipients included somnolence, bronchitis, ear infection, and acute otitis media.
There are 28 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Vision impairment Visual field defect |
Anemia Chest pain Influenza |
| Rare/Very Rare |
|---|
|
Accidental fall Acquired dystonia Acute respiratory failure Angioedema Cholestasis Drug-induced psychosis Dyskinesia Encephalopathy Gastrointestinal hemorrhage Hearing loss Hypomania Intramyelinic edema Laryngeal edema Malignant hyperthermia Multiple organ failure Myoclonus Optic neuritis Peripheral motor neuropathy Pulmonary thromboembolism Stevens-johnson syndrome Suicidal Suicidal ideation Toxic epidermal necrolysis |
There are 57 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Acute bacterial otitis media Acute cognitive impairment Arthralgia Ataxia Blurred vision Depression Diarrhea Diplopia Disturbance of attention Dizziness Drowsy Fatigue Headache disorder Insomnia Irritability Memory impairment Nausea Nystagmus Tremor Upper respiratory infection Weight gain |
Abdominal distension Acute abdominal pain Asthenopia Back pain Bronchitis Dyspepsia Edema Fever Hyporeflexia Lethargy Muscle fasciculation Myalgia Ocular pain Peripheral sensory neuropathy Pharyngitis Urinary tract infection Vertigo |
| Rare/Very Rare |
|---|
|
Acne vulgaris Aggressive behavior Alopecia Cough Delirium Dysmenorrhea Erectile dysfunction Esophagitis Facial edema Hypertonia Hypoesthesia Hypotonia Indifference Maculopapular rash Muscle spasm Pruritus of skin Skin rash Stridor Tinnitus |
The following precautions are available for VIGADRONE (vigabatrin):
Safety and efficacy of vigabatrin tablets and powder for oral solution, as adjunctive therapy for refractory CPS in pediatric patients 2 to 16 years of age have been established. The drug is indicated as adjunctive therapy for refractory CPS in pediatric patients 2 years of age and older who have not responded adequately to several alternative treatments. The dosage recommendation in this population depends on the age group and is based on weight .
Adverse effects in this pediatric population are similar to those observed in adults. Safety and efficacy of vigabatrin have not been established in pediatric patients younger than 2 years with refractory CPS. Safety and efficacy of vigabatrin (all formulations) as monotherapy for IS have been established in pediatric patients 1 month to 2 years of age, and the drug is indicated in such patients when the potential benefits of vigabatrin therapy outweigh the potential risk of developing permanent vision loss.
Safety and efficacy of the drug have not been established in patients with IS outside this age group. Abnormal MRI signal changes and IME have been observed in infants and young children treated with vigabatrin. The elimination half-life of vigabatrin is approximately 5.7
hours in infants (5 months to 2 years of age) , 6.8 hours for children (3 to 9 years of age), 9.5 hours in children and adolescents 10 to 16 years of age, and 10.5 hours in adults.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Adverse effects in this pediatric population are similar to those observed in adults. Safety and efficacy of vigabatrin have not been established in pediatric patients younger than 2 years with refractory CPS. Safety and efficacy of vigabatrin (all formulations) as monotherapy for IS have been established in pediatric patients 1 month to 2 years of age, and the drug is indicated in such patients when the potential benefits of vigabatrin therapy outweigh the potential risk of developing permanent vision loss.
Safety and efficacy of the drug have not been established in patients with IS outside this age group. Abnormal MRI signal changes and IME have been observed in infants and young children treated with vigabatrin. The elimination half-life of vigabatrin is approximately 5.7
hours in infants (5 months to 2 years of age) , 6.8 hours for children (3 to 9 years of age), 9.5 hours in children and adolescents 10 to 16 years of age, and 10.5 hours in adults.
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
There are no adequate data on the developmental risk associated with use of vigabatrin in pregnant patients. Limited data from case reports and cohort studies in pregnant patients have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. However, animal data suggest use of vigabatrin in pregnancy may result in fetal harm.
Vigabatrin produced developmental toxicity, including teratogenic, neurobehavioral, and neurohistopathologic effects, when administered to pregnant animals in clinically relevant dosages. Developmental neurotoxicity was observed in animals given vigabatrin during a period of postnatal development corresponding to the third trimester of human pregnancy. The North American Antiepileptic Drug (NAAED) Pregnancy Registry may be contacted at 888-233-2334 (for patients); NAAED registry information also is available on the website https://www.aedpregnancyregistry.org.
Vigabatrin produced developmental toxicity, including teratogenic, neurobehavioral, and neurohistopathologic effects, when administered to pregnant animals in clinically relevant dosages. Developmental neurotoxicity was observed in animals given vigabatrin during a period of postnatal development corresponding to the third trimester of human pregnancy. The North American Antiepileptic Drug (NAAED) Pregnancy Registry may be contacted at 888-233-2334 (for patients); NAAED registry information also is available on the website https://www.aedpregnancyregistry.org.
Vigabatrin distributes into milk; the effects on the breast-fed infant and on milk production are not known Because of the potential for serious adverse reactions to vigabatrin in nursing infants , the manufacturer recommends against breast-feeding while taking vigabatrin. In the event that a decision is made to continue breastfeeding during vigabatrin therapy, the nursing infant should be monitored for potential adverse effects.
Clinical studies of vigabatrin did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adults. Vigabatrin is known to be substantially excreted by the kidney, and the risk of toxic reactions to the drug may be greater in patients with impaired renal function. Because geriatric patients are more likely to have reduced renal function, careful dosage selection is advised and renal function monitoring may be useful.
Administration of single oral doses of vigabatrin to 5 patients older than 65 years of age with reduced renal function (creatinine clearance (ClCr) less than 50 mL/minute) resulted in moderate to severe sedation and confusion in 4 out of 5 patients lasting up to 5 days. Renal clearance of vigabatrin is reduced by 36% in healthy individuals 65 years of age or older compared with healthy younger individuals; an adjustment in vigabatrin dosage or frequency of administration should be considered in patients in this age group. Other reported clinical experience has not identified differences in responses to vigabatrin between geriatric and younger patients.
Administration of single oral doses of vigabatrin to 5 patients older than 65 years of age with reduced renal function (creatinine clearance (ClCr) less than 50 mL/minute) resulted in moderate to severe sedation and confusion in 4 out of 5 patients lasting up to 5 days. Renal clearance of vigabatrin is reduced by 36% in healthy individuals 65 years of age or older compared with healthy younger individuals; an adjustment in vigabatrin dosage or frequency of administration should be considered in patients in this age group. Other reported clinical experience has not identified differences in responses to vigabatrin between geriatric and younger patients.
The following prioritized warning is available for VIGADRONE (vigabatrin):
WARNING: Serious vision problems may occur while taking this medication and may be permanent even after you stop taking the medication. To prevent vision problems from getting worse, your doctor must find any eye problems as early as possible. Also, tell your doctor if you have a history of vision problems.
It is very important that you have an eye exam before or within 4 weeks of starting this medication, then every 3 months thereafter while you are taking this medication. You should also have an eye exam 3 to 6 months after stopping this medication. Follow your doctor's directions carefully and keep all medical/eye/lab appointments.
Tell your doctor right away if you have any changes in vision (such as loss of vision, blurred vision, double vision, sensitivity to light, eye pain). To receive vigabatrin in the United States, you must understand, agree to, and carefully follow the requirements of the REMS Program for this medication. If you live in Canada or any other country, consult your doctor and pharmacist for your country's regulations.
WARNING: Serious vision problems may occur while taking this medication and may be permanent even after you stop taking the medication. To prevent vision problems from getting worse, your doctor must find any eye problems as early as possible. Also, tell your doctor if you have a history of vision problems.
It is very important that you have an eye exam before or within 4 weeks of starting this medication, then every 3 months thereafter while you are taking this medication. You should also have an eye exam 3 to 6 months after stopping this medication. Follow your doctor's directions carefully and keep all medical/eye/lab appointments.
Tell your doctor right away if you have any changes in vision (such as loss of vision, blurred vision, double vision, sensitivity to light, eye pain). To receive vigabatrin in the United States, you must understand, agree to, and carefully follow the requirements of the REMS Program for this medication. If you live in Canada or any other country, consult your doctor and pharmacist for your country's regulations.
The following icd codes are available for VIGADRONE (vigabatrin)'s list of indications:
| Complex-partial epilepsy | |
| G40.0 | Localization-related (focal) (partial) idiopathic epilepsy and epileptic syndromes with seizures of localized onset |
| G40.00 | Localization-related (focal) (partial) idiopathic epilepsy and epileptic syndromes with seizures of localized onset, not intractable |
| G40.009 | Localization-related (focal) (partial) idiopathic epilepsy and epileptic syndromes with seizures of localized onset, not intractable, without status epilepticus |
| G40.01 | Localization-related (focal) (partial) idiopathic epilepsy and epileptic syndromes with seizures of localized onset, intractable |
| G40.019 | Localization-related (focal) (partial) idiopathic epilepsy and epileptic syndromes with seizures of localized onset, intractable, without status epilepticus |
| G40.2 | Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with complex partial seizures |
| G40.20 | Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with complex partial seizures, not intractable |
| G40.209 | Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with complex partial seizures, not intractable, without status epilepticus |
| G40.21 | Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with complex partial seizures, intractable |
| G40.219 | Localization-related (focal) (partial) symptomatic epilepsy and epileptic syndromes with complex partial seizures, intractable, without status epilepticus |
| Infantile spasms | |
| G40.82 | Epileptic spasms |
| G40.822 | Epileptic spasms, not intractable, without status epilepticus |
| G40.824 | Epileptic spasms, intractable, without status epilepticus |
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