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:

Dr. Reddy’s Laboratories Inc.,

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

Product summary:

Vigabatrin for oral solution USP, 500 mg packets contain a white to off-white powder.   They are supplied in packages of 50 (NDC 43598-697-50). 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
Dr. Reddy’s Laboratories 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 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):
•
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
viga

Summary of Product characteristics

VIGABATRIN- VIGABATRIN POWDER, FOR SOLUTION
DR. REDDY’S LABORATORIES INC.,
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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 FOR ORAL SOLUTION (5.1).
• BASELINE AND PERIODIC VISION ASSESSMENT IS RECOMMENDED FOR
PATIENTS ON VIGABATRIN.
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
daily) (2.2) ·
Pediatric (2 to 16 years of age): The recommend