VIGABATRIN powder, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Ascend Laboratories, LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Vigabatrin for oral solution is 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 for oral solution is not indicated as a first line agent for complex partial seizures. Vigabatrin for oral solution is indicated as monotherapy for pediatric patients with infantile spasms 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss [see Warnings and Precautions (5.1)]. None. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to AEDs, including vigabatrin for oral solution, during pregnancy. Encourage women who are taking vigabatrin for oral solution during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registr

Product summary:

Vigabatrin for oral solution, USP is available as 500 mg packets containing a white to off-white granular powder. They are supplied in packages of 50 (NDC 67877-674-63). The oral syringes are provided separately by the pharmacy. Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

VIGABATRIN - VIGABATRIN POWDER, FOR SOLUTION
Ascend Laboratories, LLC
----------
MEDICATION GUIDE
Vigabatrin for Oral Solution, USP
(vye-GA-ba-trin)
What is the most important information I should know about vigabatrin
for oral solution? vigabatrin for
oral solution can cause serious side effects, including:
•
Permanent vision loss
•
Magnetic resonance imaging (MRI) changes in babies with infantile
spasms (IS)
•
Risk of suicidal thoughts or actions
1. Permanent vision loss:
Vigabatrin for oral solution 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 for oral solution in adults and
children 2 years and older:
Because of the risk of vision loss, vigabatrin for oral solution 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):
o might not be seeing as well as before starting vigabatrin for oral
solution.
o start to trip, bump into things, or are more clumsy than usual.
o 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 for oral solution or within 4 weeks after starting
vigabatrin for oral solution, and at least
every 3 months after that until vigabatrin for oral solution is
stopped. It is also recommended that
you (or your child) have a vision test about 3 to 6 months after
vigabatrin for ora

Summary of Product characteristics

VIGABATRIN - VIGABATRIN POWDER, FOR SOLUTION
ASCEND LABORATORIES, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VIGABATRIN
FOR ORAL SOLUTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR VIGABATRIN
FOR ORAL SOLUTION
VIGABATRIN FOR ORAL SOLUTION
INITIAL U.S. APPROVAL: 2009
WARNING: PERMANENT VISION LOSS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
VIGABATRIN FOR ORAL SOLUTION CAN CAUSE PERMANENT BILATERAL CONCENTRIC
VISUAL FIELD
CONSTRICTION, INCLUDING TUNNEL VISION THAT CAN RESULT IN DISABILITY.
IN SOME CASES,
VIGABATRIN FOR ORAL SOLUTION MAY ALSO DECREASE VISUAL ACUITY (5.1).
RISK INCREASES WITH INCREASING DOSE AND CUMULATIVE EXPOSURE, BUT THERE
IS NO DOSE
OR EXPOSURE TO VIGABATRIN FOR ORAL SOLUTION KNOWN TO BE FREE OF RISK
OF VISION LOSS
(5.1).
RISK OF NEW AND WORSENING VISION LOSS CONTINUES AS LONG AS VIGABATRIN
FOR ORAL
SOLUTION IS USED, AND POSSIBLY AFTER DISCONTINUING VIGABATRIN FOR ORAL
SOLUTION (5.1).
BASELINE AND PERIODIC VISION ASSESSMENT IS RECOMMENDED FOR PATIENTS ON
VIGABATRIN
FOR ORAL SOLUTION. HOWEVER, THIS ASSESSMENT CANNOT ALWAYS PREVENT
VISION DAMAGE
(5.1).
VIGABATRIN FOR ORAL SOLUTION IS AVAILABLE ONLY THROUGH A RESTRICTED
PROGRAM CALLED THE
VIGABATRIN REMS PROGRAM (5.2).
INDICATIONS AND USAGE
Vigabatrin for oral solution is 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 for oral solution is not
indicated as a first line agent (1.1)
Infantile Spasms -monotherapy in infants 1 month to 2 years of age for
whom the potential benefits
outweigh the potential risk of vision loss (1.2)
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
da