ZURAMPIC- lesinurad tablet, film coated

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

lesinurad (UNII: 09ERP08I3W) (lesinurad - UNII:09ERP08I3W)

Beszerezhető a:

Ironwood Pharmaceuticals, Inc.

INN (nemzetközi neve):

lesinurad

Összetétel:

lesinurad 200 mg

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

ZURAMPIC is indicated in combination with a xanthine oxidase inhibitor for the treatment of hyperuricemia associated with gout in patients who have not achieved target serum uric acid levels with a xanthine oxidase inhibitor alone [see Clinical Studies (14) ]. ZURAMPIC is not recommended for the treatment of asymptomatic hyperuricemia. ZURAMPIC should not be used as monotherapy [see Warnings and Precautions (5.1) ]. The use of ZURAMPIC is contraindicated in the following conditions: - Severe renal impairment (eCLcr less than 30 mL/min), end stage renal disease, kidney transplant recipients, or patients on dialysis [see Use in Specific Populations (8.6) ] - Tumor lysis syndrome or Lesch-Nyhan syndrome [see Use in Specific Populations (8.8) ]. Risk Summary There are no available human data on use of ZURAMPIC in pregnant women to inform a drug-associated risk. No teratogenicity or effects on fetal development were observed in embryo-fetal development studies with oral administration of lesinurad to pregnant rats

Termék összefoglaló:

ZURAMPIC Tablets, 200 mg are blue in color, oval shaped, debossed with "LES200" and are supplied as follows: Protect from light. Store at 20° to 25°C (68° to 77°F); excursions permitted from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature ].

Engedélyezési státusz:

New Drug Application

Betegtájékoztató

Ironwood Pharmaceuticals, Inc.
----------
This Medication Guide has been approved by the U.S. Food and
Drug Administration
Revised:January 2018
MEDICATION GUIDE
ZURAMPIC (zer-AM-pik)
(lesinurad)
tablets
What is the most important information I should know about ZURAMPIC?
Some patients taking ZURAMPIC may have kidney problems such as a
sudden decrease in kidney
function (acute kidney failure). This is more common when you take
ZURAMPIC without a xanthine
oxidase inhibitor. You should always take ZURAMPIC with a xanthine
oxidase inhibitor.
What is ZURAMPIC?
•
ZURAMPIC is a prescription medicine used together with a xanthine
oxidase inhibitor to lower
uric acid levels in the blood in adult patients with gout.
•
ZURAMPIC should not be taken without a xanthine oxidase inhibitor such
as allopurinol or
febuxostat.
•
ZURAMPIC helps the kidneys remove uric acid from the body and is added
to a xanthine oxidase
inhibitor, which decreases the amount of uric acid your body makes.
•
It is not known if ZURAMPIC is safe and effective in children under 18
years of age.
Who should not take ZURAMPIC?
Do not take ZURAMPIC if you have:
•
severe kidney problems, received a kidney transplant or you are on
dialysis
•
a fast breakdown of cancer cells that can lead to high uric acid
(Tumor lysis syndrome)
•
a rare inherited condition that causes too much uric acid in the blood
(Lesch Nyhan syndrome)
Before taking ZURAMPIC, tell your healthcare provider about all of
your medical conditions, including
if you:
•
are pregnant or plan to become pregnant. It is not known if ZURAMPIC
will harm your unborn
baby.
•
are breastfeeding or plan to breastfeed. It is not known if ZURAMPIC
passes into your breast
milk. You and your healthcare provider should decide if you should
take ZURAMPIC while
breastfeeding.
Tell your healthcare provider about all the medicines you take,
including prescription and over-the-
counter medicines, vitamins, and herbal supplements.
ZURAMPIC may affect the way other medicines work, and other medicines
may

Termékjellemzők

ZURAMPIC- LESINURAD TABLET, FILM COATED
IRONWOOD PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZURAMPIC SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR ZURAMPIC.
ZURAMPIC (LESINURAD) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2015
WARNING: RISK OF ACUTE RENAL FAILURE, MORE COMMON WHEN USED WITHOUT A
XANTHINE
OXIDASE INHIBITOR
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
ACUTE RENAL FAILURE HAS OCCURRED WITH ZURAMPIC AND WAS MORE COMMON
WHEN ZURAMPIC WAS GIVEN
ALO NE .
ZURAMPIC SHOULD BE USED IN COMBINATION WITH A XANTHINE OXIDASE
INHIBITOR. (1.1, 5.1, 6.1)
INDICATIONS AND USAGE
ZURAMPIC is a URAT1 inhibitor indicated in combination with a xanthine
oxidase inhibitor for the treatment of
hyperuricemia associated with gout in patients who have not achieved
target serum uric acid levels with a xanthine oxidase
inhibitor alone. (1)
Limitations of Use:
ZURAMPIC is not recommended for the treatment of asymptomatic
hyperuricemia. (1.1)
ZURAMPIC should not be used as monotherapy. (1.1, 5.1)
DOSAGE AND ADMINISTRATION
ZURAMPIC is recommended at 200 mg once daily in combination with a
xanthine oxidase inhibitor, including
allopurinol or febuxostat. The maximum daily dose of ZURAMPIC is 200
mg. (2.1)
Failure to take ZURAMPIC with a xanthine oxidase inhibitor may
increase the risk of renal adverse reactions. (2.1, 5.1)
ZURAMPIC tablets should be taken in the morning with food and water.
(2.1)
Patients should be instructed to stay well hydrated. (2.1)
Assess renal function before initiating ZURAMPIC. Do not initiate
ZURAMPIC if eCLcr is below 45 mL/min. (2.2)
Discontinue ZURAMPIC if eCLcr persistently falls below 45 mL/min.
(2.2)
DOSAGE FORMS AND STRENGTHS
Tablet: 200 mg. (3)
CONTRAINDICATIONS
Severe renal impairment, end stage renal disease, kidney transplant
recipients, or patients on dialysis. (4, 8.6)
Tumor lysis syndrome or Lesch-Nyhan syndrome. (4)
WARNINGS AND PRECAUTIONS
_Renal events_: Adverse rea