POTIGA- ezogabine tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

EZOGABINE (UNII: 12G01I6BBU) (EZOGABINE - UNII:12G01I6BBU)

Available from:

GlaxoSmithKline LLC

INN (International Name):

EZOGABINE

Composition:

EZOGABINE 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

POTIGA® is indicated as adjunctive treatment of partial-onset seizures in patients aged 18 years and older who have responded inadequately to several alternative treatments and for whom the benefits outweigh the risk of retinal abnormalities and potential decline in visual acuity [see Warnings and Precautions (5.1)] . None. Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. POTIGA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In animal studies, doses associated with maternal plasma exposures (AUC) to ezogabine and its major circulating metabolite, N-acetyl metabolite of ezogabine (NAMR), similar to or below those expected in humans at the maximum recommended human dose (MRHD) of 1,200 mg per day produced developmental toxicity when administered to pregnant rats and rabbits. The maximum doses evaluated were limited by maternal toxicity (acute neurotoxicity). Treatment of pregnant rats with ezogabine (oral doses

Product summary:

POTIGA is supplied as film-coated immediate-release tablets for oral administration containing 50 mg, 200 mg, 300 mg, or 400 mg of ezogabine in the following packs: Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature.]

Authorization status:

New Drug Application

Patient Information leaflet

POTIGA- EZOGABINE TABLET, FILM COATED
GlaxoSmithKline LLC
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MEDICATION GUIDE
POTIGA® (po-TEE-ga) tablets, CV
(ezogabine)
Read this Medication Guide before you start taking POTIGA and each
time you get a refill. There may be
new information. This Medication Guide does not take the place of
talking to your healthcare provider
about your medical condition or treatment. If you have questions about
POTIGA, ask your healthcare
provider or pharmacist.
What is the most important information I should know about POTIGA?
Do not stop POTIGA without first talking to a healthcare provider.
Stopping POTIGA suddenly can cause
serious problems. Stopping POTIGA suddenly can cause you to have more
seizures more often.
1.
POTIGA can cause changes to your retina, which is located in the back
of your eye and is needed
for vision. These types of changes can cause vision loss.
•
If a decrease in your vision happens, it is not known if it will get
better.
•
You and your healthcare provider should decide if the benefit of
taking POTIGA is more important
than the possible risk of vision loss.
•
You should have a complete eye exam if you are currently taking POTIGA
or before starting
treatment, and then every 6 months while taking POTIGA.
•
Tell your healthcare provider right away if you notice any changes in
your vision.
2.
POTIGA can make it hard for you to urinate (empty your bladder) and
may cause you to be unable
to urinate. Call your healthcare provider right away if you:
•
are unable to start urinating.
•
have trouble emptying your bladder.
•
have a weak urine stream.
•
have pain with urination.
3.
POTIGA can cause changes in the color of your skin, nails, lips, roof
of your mouth, and whites of
your eyes or insides of your eyelids.
•
The changes in color may be blue, grey-blue, or brown.
•
Most changes in color have happened in people who have taken POTIGA
for at least 2 years, but
may happen earlier.
•
It is not known if the changes in color go away after stopping POTIGA.
•
Tell your healthcare pro

Summary of Product characteristics

POTIGA- EZOGABINE TABLET, FILM COATED
GLAXOSMITHKLINE LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
POTIGA SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR POTIGA.
POTIGA (EZOGABINE) TABLETS, FOR ORAL USE, CV
INITIAL U.S. APPROVAL: 2011
WARNING: RETINAL ABNORMALITIES AND POTENTIAL VISION LOSS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
•
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RECENT MAJOR CHANGES
Boxed Warning
5/2016
Dosage and Administration (2.3)
5/2016
Warnings and Precautions (5.1)
5/2016
INDICATIONS AND USAGE
POTIGA is a potassium channel opener indicated as adjunctive treatment
of partial-onset seizures in patients aged 18
years and older who have responded inadequately to several alternative
treatments and for whom the benefits outweigh
the risk of retinal abnormalities and potential decline in visual
acuity. (1)
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Tablets: 50 mg, 200 mg, 300 mg, and 400 mg. (3)
POTIGA CAN CAUSE RETINAL ABNORMALITIES WITH FUNDUSCOPIC FEATURES
SIMILAR TO THOSE SEEN IN RETINAL
PIGMENT DYSTROPHIES, WHICH ARE KNOWN TO RESULT IN DAMAGE TO THE
PHOTORECEPTORS AND VISION LOSS.
MACULAR ABNORMALITIES CHARACTERIZED AS VITELLIFORM LESIONS HAVE ALSO
BEEN OBSERVED. (5.1)
SOME PATIENTS WITH RETINAL ABNORMALITIES HAVE BEEN FOUND TO HAVE
ABNORMAL VISUAL ACUITY. IT IS NOT
POSSIBLE TO DETERMINE WHETHER POTIGA CAUSED THIS DECREASED VISUAL
ACUITY. (5.1)
THE RATE OF PROGRESSION AND REVERSIBILITY ARE UNKNOWN. (5.1)
PATIENTS WHO FAIL TO SHOW SUBSTANTIAL CLINICAL BENEFIT AFTER ADEQUATE
TITRATION SHOULD BE DISCONTINUED
FROM POTIGA. (5.1)
ALL PATIENTS TAKING POTIGA SHOULD HAVE BASELINE AND PERIODIC (EVERY 6
MONTHS) SYSTEMATIC VISUAL
MONITORING BY AN OPHTHALMIC PROFESSIONAL. TESTING SHOULD INCLUDE
VISUAL ACUITY, DILATED FUNDUS
PHOTOGRAPHY, AND OPTICAL COHERENCE TOMOGRAPHY. (5.1)
IF RETINAL PIGMENTARY ABNORMALITIES OR VISION CHANGES ARE DETECTED,
POTIGA SHOULD BE DISCONTINUED