VIGABATRIN tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

VIGABATRIN (UNII: GR120KRT6K) (VIGABATRIN - UNII:GR120KRT6K)

Available from:

Actavis Pharma, Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. None. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to AEDs, including vigabatrin, during pregnancy. Encourage women who are taking vigabatrin during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. This can be done by calling the toll-free number 1-888-233-2334 or visiting the website, http://www.aedpregnancyregistry.org/. This must be done by the patient herself. Risk Summary There are no adequate data on the developmental risk associated with the use of vigabatrin in pregnant women. Limi

Product summary:

Vigabatrin Tablets, USP are available for oral administration and are supplied as follows:  500 mg — 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. Tablets are supplied in bottles of 100 (NDC 0591-3851-01). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure. Keep this and all drugs out of the reach of children.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Actavis Pharma, Inc.
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MEDICATION GUIDE
Vigabatrin (vye ga' ba trin) Tablets
What is the most important information I should know about vigabatrin?
Vigabatrin can cause serious side effects, including:
•
Permanent vision loss
•
Risk of suicidal thoughts or actions
1. Permanent vision loss:
Vigabatrin can damage the vision of anyone who takes it. Some people
can have severe loss particularly to their ability to see to the side
when they look
straight ahead (peripheral vision). With severe vision loss, you may
only be able to see things straight in front of you (sometimes called
“tunnel vision”).
You may also have blurry vision. If this happens, it will not get
better.
•
Vision loss and use of vigabatrin in adults and children 2 years and
older: Because of the risk of vision loss, vigabatrin is used to treat
complex
partial seizures (CPS) only in people who do not respond well enough
to several other medicines.
Tell your healthcare provider right away if you (or your child):
•
might not be seeing as well as before starting vigabatrin.
•
start to trip, bump into things, or are more clumsy than usual.
•
are surprised by people or things coming in front of you that seem to
come out of nowhere.
•
These changes can mean that you (or your child) have damage to your
vision.
•
It is recommended that your healthcare provider test your (or your
child’s) vision (including peripheral vision) and visual acuity
(ability to read an
eye chart) before you (or your child) start vigabatrin or within 4
weeks after starting vigabatrin, and at least every 3 months after
that until
vigabatrin is stopped. It is also recommended that you (or your child)
have a vision test about 3 to 6 months after vigabatrin is stopped.
Your vision loss may get worse after you stop taking vigabatrin.
•
Some people are not able to complete testing of vision. Your
healthcare provider will determine if you (or your child) can be
tested. If you (or your
child) cannot complete vision testing, your healthcare provider may
continu

Summary of Product characteristics

VIGABATRIN- VIGABATRIN TABLET, FILM COATED
ACTAVIS PHARMA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VIGABATRIN TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
VIGABATRIN TABLETS.
VIGABATRIN TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2009
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 (5.1).
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
(5.1).
RISK OF NEW AND WORSENING VISION LOSS CONTINUES AS LONG AS VIGABATRIN
IS USED, AND
POSSIBLY AFTER DISCONTINUING VIGABATRIN (5.1).
BASELINE AND PERIODIC VISION ASSESSMENT IS RECOMMENDED FOR PATIENTS ON
VIGABATRIN.
HOWEVER, THIS ASSESSMENT CANNOT ALWAYS PREVENT VISION DAMAGE (5.1).
VIGABATRIN TABLETS ARE AVAILABLE ONLY THROUGH A RESTRICTED PROGRAM
CALLED THE
VIGABATRIN REMS PROGRAM (5.2).
INDICATIONS AND USAGE
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)
DOSAGE AND ADMINISTRATION
Refractory Complex Partial Seizures
Adults (17 years of age and older): Initiate at 1,000 mg/day (500 mg
twice daily); increase total daily
dose weekly in 500 mg/day increments, to the recommended dose of 3,000
mg/day (1,500 mg twice
daily) (2.2)
Pediatric (2 to 16 years of age): The recommended dosage is based on
body weight and administered
as two divided doses (2.2)
The dosage may be increased in weekly intervals, depending on response
(2.2)
Dose patients weighing more than 60 kg according to adult
recommendations (2.2)
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