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:

Par Pharmaceutical, Inc.

INN (International Name):

VIGABATRIN

Composition:

VIGABATRIN 50 mg in 1 mL

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, 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-

Product summary:

Vigabatrin for Oral Solution, USP 500 mg packets contain a white to off-white powder. NDC 49884-358-03         Carton of 50 unit dose packets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

VIGABATRIN- vigabatrin powder, for solution
Par Pharmaceutical, Inc.
----------
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 10 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):
•
might not be seeing as well as before starting vigabatrin for oral
solution
•
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 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 fo

Summary of Product characteristics

VIGABATRIN- VIGABATRIN POWDER, FOR SOLUTION
PAR PHARMACEUTICAL, INC.
----------
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 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 IS AVAILABLE ONLY THROUGH A RESTRICTED PROGRAM CALLED THE
VIGABATRIN REMS
PROGRAM (5.2).
RECENT MAJOR CHANGES
Indications and Usage (1.1)
1/2020
Dosage and Administration (2.1, 2.2, 2.4, 2.5)1/2020
Warnings and Precautions (5.3)
1/2020
Warnings and Precautions (5.4)
7/2019
INDICATIONS AND USAGE
Vigabatrin for oral solution is indicated for the treatment of: (1)
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 (2)
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 in