Vigabatrin

What is Vigabatrin?

• Vigabatrin (Sabril) is an oral antiepileptic drug used in combination with other agents as therapy of refractory complex partial seizures and as monotherapy for infantile spasms.

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What are the uses of this medicine?

Vigabatrin (Sabril) is a prescription medicine used along with other treatments to treat adults and children 2 years and older with complex partial seizures (CPS) if:

• the CPS do not respond well enough to several other treatments, and
• you and your healthcare provider decide the possible benefit of taking SABRIL is more important than the risk of vision loss.

• SABRIL should not be the first medicine used to treat CPS.
• SABRIL is also used to treat babies 1 month to 2 years of age who have infantile spasms (IS) if you and your healthcare provider decide the possible benefits of taking SABRIL are more important than the possible risk of vision loss.

How does this medicine work?

• Vigabatrin (vye ga' ba trin) is a vinyl derivative of gamma-aminobutyric acid (GABA) that acts as a competitive inhibitor of GABA transaminase.
• Vigabatrin prevents the breakdown of GABA and thus may increase GABAergic, neuroinhibitory activity.
• Vigabatrin has been shown to be effective in reducing seizure activity as add on therapy in patients with refractory partial onset seizures.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• SABRIL may cause a moderate reduction in total phenytoin plasma levels. dosage adjustment may be needed.
• SABRIL may moderately increase the Cmax of clonazepam resulting in an increase of clonazepam-associated adverse reactions.

Is this medicine FDA approved?

• It has been available in other countries for more than a decade, but was first approved for use in the United States in 2009.
• Current indications include as adjuvant therapy in patients with refractory complex partial seizures and as monotherapy for infantile spasms in children ages 1 month to 2 years.

How should this medicine be used?

Recommended dosage: Refractory Complex Partial Seizures Adults (17 years of age and older):

• Initiate at 1000 mg/day (500 mg twice daily); increase total daily dose weekly in 500 mg/day increments, to the recommended dose of 3000 mg/day (1500 mg twice daily).

Pediatric (2 to 16 years of age):

• The recommended dosage is based on body weight and administered as two divided doses.
• The dosage may be increased in weekly intervals, depending on response.
• Dose patients weighing more than 60 kg according to adult recommendations.

Infantile Spasms

• Initiate at a daily dose of 50 mg/kg (25 mg/kg twice daily); increase total daily dose every 3 days, in increments of 25 mg/kg/day to 50mg/kg/day up to a maximum daily dose of 150 mg/kg (75 mg/kg twice daily).

Renal Impairment: Dose adjustment recommended.

• Mild renal impairment (CLcr >50 to 80 mL/min): dose should be decreased by 25%
• Moderate renal impairment (CLcr >30 to 50 mL/min): dose should be decreased by 50%
• Severe renal impairment (CLcr >10 to 30 mL/min): dose should be decreased by 75%

Administration:

• SABRIL comes as tablets or as packets containing powder for mixing with water to make an oral solution.
• You or your child will receive SABRIL from a specialty pharmacy.
• Take SABRIL exactly as your healthcare provider tells you to. SABRIL is usually taken 2 times each day.
• SABRIL may be taken with or without food.
• Before starting to take SABRIL, talk to your healthcare provider about what you or your child should do if a SABRIL dose is missed.
• If you or your child are taking SABRIL for CPS and the seizures do not improve enough within 3 months, your healthcare provider will stop prescribing SABRIL.
• If your child is taking SABRIL for IS and the seizures do not improve within 2 to 4 weeks, your healthcare provider will stop prescribing SABRIL.
• Do not stop taking SABRIL suddenly. This can cause serious problems. Stopping SABRIL or any seizure medicine suddenly can cause seizures that will not stop (status epilepticus) in people who are being treated for seizures. You should follow your healthcare provider’s instructions on how to stop taking SABRIL.
• Tell your healthcare provider right away about any increase in seizures when SABRIL treatment is being stopped. Before your child starts taking SABRIL, speak to your child’s healthcare provider about what to do if your baby misses a dose, vomits, spits up, or only takes part of the dose of SABRIL.
• Do not stop taking SABRIL without talking to your healthcare provider. If SABRIL improves your (or your child’s) seizures, you and your healthcare provider should talk about whether the benefit of taking SABRIL is more important than the risk of vision loss, and decide if you (or your child) will continue to take SABRIL.
• If you are giving SABRIL for oral solution to your child, it can be given at the same time as their meal. SABRIL powder should be mixed with water only.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablet: 500 mg
• For oral solution: 500 mg per packet

This medicine is available in fallowing brand namesː

• SABRIL

What side effects can this medication cause?

The most common side effects of this medicine include:

• sleepiness - SABRIL may cause your baby to be sleepy.
• swelling in the bronchial tubes (bronchitis)
• ear infection
• irritability

SABRIL can cause serious side effects, including:

• Permanent vision loss
• Magnetic resonance imaging (MRI) changes in babies with infantile spasms
• Risk of suicidal thoughts or actions
• sleepiness and tiredness
• weight gain that happens without swelling
• anemia
• nerve problems
• swelling

What special precautions should I follow?

• SABRIL can cause permanent vision loss. Because of this risk and because, when it is effective, SABRIL provides an observable symptomatic benefit; patient response and continued need for treatment should be periodically assessed.
• SABRIL is available only through a restricted distribution program called the Vigabatrin REMS Program, because of the risk of permanent vision loss.
• Abnormal MRI signal changes and intra myelinic edema have been reported in some infants with Infantile Spasms receiving SABRIL.
• Intra myelinic Edema (IME) has been reported in postmortem examination of infants being treated for infantile spasms with vigabatrin.
• Antiepileptic drugs, including SABRIL, increase the risk of suicidal thoughts and behavior. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.
• As with all AEDs, SABRIL should be withdrawn gradually. However, if withdrawal is needed because of a serious adverse event, rapid discontinuation can be considered. Patients and caregivers should be told not to suddenly discontinue SABRIL therapy. Taper dose to avoid withdrawal seizures.
• Anemia may occur. Monitor for symptoms of anemia.
• SABRIL causes somnolence and fatigue. Advise patients not to drive or operate machinery until they have gained sufficient experience on SABRIL.
• Vigabatrin has not been convincingly linked to cases of clinically apparent liver injury, but was linked to a fatal case of Reye syndrome in a child with severe developmental delay.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• Coma
• unconsciousness
• drowsiness
• vertigo
• psychosis
• apnea or respiratory depression
• bradycardia
• agitation
• irritability
• confusion
• headache
• hypotension
• abnormal behavior
• increased seizure activity
• status epilepticus
• speech disorder

Treatment of overdosage:

• There is no specific antidote for SABRIL overdose.
• Standard measures to remove unabsorbed drug should be used, including elimination by emesis or gastric lavage.
• Supportive measures should be employed, including monitoring of vital signs and observation of the clinical status of the patient.
• The effectiveness of hemodialysis in the treatment of SABRIL overdose is unknown.

Can this medicine be used in pregnancy?

• There are no adequate data on the developmental risk associated with the use of SABRIL in pregnant women.
• Limited available data from case reports and cohort studies pertaining to SABRIL use in pregnant women have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

Can this medicine be used in children?

• The safety and effectiveness of SABRIL as adjunctive treatment of refractory complex partial seizures in pediatric patients 2 to 16 years of age have been established.
• Safety and effectiveness as adjunctive treatment of refractory complex partial seizures in pediatric patients below the age of 2 and as monotherapy for the treatment of infantile spasms in pediatric patients below the age of 1 month have not been established.

What are the active and inactive ingredients in this medicine?

• Active Ingredient: vigabatrin
• Inactive Ingredients:
• Tablets: hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycols, povidone, sodium starch glycolate, and titanium dioxide
• For oral solution: povidone

Who manufactures and distributes this medicine?

Marketed by:

• Lundbeck, Deerfield, IL 60015, U.S.A.
• SABRIL is a registered trademark of Lundbeck

What should I know about storage and disposal of this medication?

• Store SABRIL tablets and SABRIL packets at room temperature between 68ºF to 77ºF (20ºC to 25ºC).

• Dailymed label info on Vigabatrin
• FDA Vigabatrin

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