RUFINAMIDE tablet, film coated

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

RUFINAMIDE (UNII: WFW942PR79) (RUFINAMIDE - UNII:WFW942PR79)

Dostupné z:

Glenmark Pharmaceuticals Inc., USA

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

Rufinamide tablets are indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year of age and older and in adults. Rufinamide is contraindicated in patients with Familial Short QT syndrome [see Warnings and Precautions (5.3) ]. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to AEDs, such as rufinamide, during pregnancy. Encourage women who are taking Rufinamide during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org. Risk Summary There are no adequate data on the developmental risks associated with use of rufinamide in pregnant women. In animal reproduction studies, oral administration of rufinamide resulted in developmental toxicity in pregnant rats and rabbits at clinically relevant doses [see Data] . In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown. Data Animal data Oral administration of rufinamide (0, 20, 100, or 300 mg/kg/day) to pregnant rats throughout organogenesis resulted in decreased fetal weight and increased incidence of fetal skeletal abnormalities at 100 and 300 mg/kg/day, which were associated with maternal toxicity. The maternal plasma exposure (AUC) at the no- adverse effect dose (20 mg/kg/day) for developmental toxicity was less than that in humans at the maximum recommended human dose (MRHD) of 3200 mg/day. Oral administration of rufinamide (0, 30, 200, or 1000 mg/kg/day) to pregnant rabbits throughout organogenesis resulted in embryofetal death, decreased fetal body weight, and increased incidence of fetal visceral and skeletal abnormalities at doses of 200 and 1000 mg/kg/day. The high dose (1000 mg/kg/day) was associated with abortion. Plasma exposure (AUC) at the no-adverse effect dose (30 mg/kg/day) was less than that in humans at the MRHD. When rufinamide was orally administered (0, 5, 30, or 150 mg/kg/day) to pregnant rats throughout pregnancy and lactation, decreased offspring growth and survival were observed at all doses tested. A no-effect dose for adverse effects on pre- and postnatal development was not established. At the lowest dose tested (5 mg/kg/day), plasma exposure (AUC) was less than that in humans at the MRHD. Risk Summary There are no data on the presence of rufinamide in human milk, the effects on the breastfed infant, or the effects of the drug on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for rufinamide and any potential adverse effects on the breastfed infant from rufinamide or from the underlying maternal condition. Contraception Use of rufinamide may reduce the effectiveness of hormonal contraceptives containing ethinyl estradiol or norethindrone. Advise women of reproductive potential taking rufinamide who are using a contraceptive containing ethinyl estradiol and norethindrone to use an additional non-hormonal form of contraception [see Drug Interactions (7.3) and Clinical Pharmacology (12.3)] . Infertility The effect of rufinamide on fertility in humans has not been established. Oral administration of rufinamide (20, 60, 200, and 600 mg/kg/day) to male and female rats prior to mating, during mating, and during early gestation (females only) resulted in the impairment of fertility at all dose levels tested. The no-effect dose was not established. The plasma exposure level at 20 mg/kg was approximately 0.2 times the human plasma AUC at the MRHD [see Nonclinical Toxicology ( Error! Hyperlink reference not valid. )]. Safety and effectiveness have been established in pediatric patients 1 to 17 years of age. The effectiveness of rufinamide in pediatric patients 4 years of age and older was based upon an adequate and well-controlled trial of rufinamide that included both adults and pediatric patients, 4 years of age and older, with Lennox Gastaut Syndrome. The effectiveness in patients 1 to less than 4 years was based upon a bridging pharmacokinetic and safety study [see Dosage and Administration (2.1), Adverse Reactions ( Error! Hyperlink reference not valid. ), and Clinical Studies ( Error! Hyperlink reference not valid. ) ]. The pharmacokinetics of rufinamide in the pediatric patients, ages 1 to less than 4 years of age is similar to children older than 4 years of age and adults [see Clinical Pharmacology (12.3)] . Safety and effectiveness in pediatric patients below the age of 1 year has not been established. Oral administration of rufinamide (0, 15, 50, or 150 mg/kg) to young rats for 10 weeks starting on postnatal day 7 resulted in decreased brain weights at the mid and high doses and neurobehavioral impairment (learning and memory deficit, altered startle response, decreased locomotor activity) and decreased growth (decreased body weight) at the highest dose tested. The no-effect dose for adverse effects on postnatal development in rats (15 mg/kg) was associated with a plasma exposure (AUC) lower than that in humans at the maximum recommended human dose (MRHD) of 3200 mg/day. Clinical studies of rufinamide did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Pharmacokinetics of rufinamide in the elderly are similar to that in the young subjects [see Clinical Pharmacology (12.3) ]. Rufinamide pharmacokinetics in patients with severe renal impairment (creatinine clearance < 30 mL/min) was similar to that of healthy subjects. Dose adjustment in patients undergoing dialysis should be considered [see Clinical Pharmacology (12.3) ]. Use of rufinamide in patients with severe hepatic impairment (Child-Pugh score 10 to 15) is not recommended. Caution should be exercised in treating patients with mild (Child-Pugh score 5 to 6) to moderate (Child-Pugh score 7 to 9) hepatic impairment.

Prehľad produktov:

Rufinamide Tablets, USP 200 mg (containing 200 mg rufinamide, USP) are pink, film-coated, oblong-shaped tablets with functional scoring, embossed with ‘713’ and a ‘G’ on either side of a break line on one side and plain with a break line on the other side. They are available in: Rufinamide Tablets, USP 400 mg (containing 400 mg rufinamide, USP) are pink, film-coated, oblong-shaped tablets with functional scoring, embossed with ‘714’ and a ‘G’ on either side of a break line on one side and plain with a break line on the other side. They are available in: Store the tablets at 20°C to 25°C (68°F to 77°F); excursions permitted to 15ºC to 30°C (59ºF to 86°F) [see USP Controlled Room Temperature]. Protect from moisture. Replace cap securely after opening.

Stav Autorizácia:

Abbreviated New Drug Application

Príbalový leták

RUFINAMIDE- rufinamide tablet, film coated
Glenmark Pharmaceuticals Inc., USA
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Medication Guide
Rufinamide (roo fin' a mide) Tablets
Read this Medication Guide before you start taking rufinamide tablets
and each time you get a refill. There
may be new information. This information does not take the place of
talking to your healthcare provider
about your medical condition or treatment.
What is the most important information I should know about rufinamide
tablets?
Do not stop taking rufinamide tablets without first talking to your
healthcare provider.
Stopping rufinamide tablets suddenly can cause serious problems.
Rufinamide tablets can cause serious side effects, including:
1. Like other antiepileptic drugs, rufinamide tablets may cause
suicidal thoughts or actions in a very small
number of people, about 1 in 500.
Call a healthcare provider right away if you have any of these
symptoms, especially if they are new, worse,
or worry you:
•
thoughts about suicide or dying
•
attempt to commit suicide
•
new or worse depression
•
new or worse anxiety
•
feeling agitated or restless
•
panic attacks
•
trouble sleeping (insomnia)
•
new or worse irritability
•
acting aggressive, being angry, or violent
•
acting on dangerous impulses
•
an extreme increase in activity and talking (mania)
•
other unusual changes in behavior or mood
•
Suicidal thoughts or actions can be caused by things other than
medicines. If you have suicidal
thoughts or actions, your healthcare provider may check for other
causes.
How can I watch for early symptoms of suicidal thoughts and actions?
•
Pay attention to any changes, especially sudden changes, in mood,
behaviors, thoughts, or feelings.
•
Keep all follow-up visits with your healthcare provider as scheduled.
Call your healthcare provider between visits as needed, especially if
you are worried about symptoms.
Do not stop rufinamide tablets without first talking to a healthcare
provider.
•
Stopping rufinamide tablets suddenly can cause serious problems.
Stopp

Súhrn charakteristických

RUFINAMIDE- RUFINAMIDE TABLET, FILM COATED
GLENMARK PHARMACEUTICALS INC., USA
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
RUFINAMIDE TABLETS
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
RUFINAMIDE TABLETS.
RUFINAMIDE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2008
INDICATIONS AND USAGE
Rufinamide tablets are indicated for adjunctive treatment of seizures
associated with Lennox-Gastaut
Syndrome (LGS) in pediatric patients 1 year of age and older, and in
adults (1)
DOSAGE AND ADMINISTRATION
Rufinamide tablets should be given with food. Tablets can be
administered whole, as half tablets, or
crushed (2.2)
Pediatric patients 1 year and older:
•
•
Adults:
•
•
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
•
WARNINGS AND PRECAUTIONS
•
•
•
•
•
ADVERSE REACTIONS
Most common adverse reactions (≥ 10% and greater than placebo) were
headache, dizziness, fatigue,
somnolence, and nausea (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT GLENMARK
PHARMACEUTICALS INC., USA AT
1 [phone] OR FDA AT 1-800-FDA-1088 OR www.fda.gov/medwatch.
DRUG INTERACTIONS
•
•
USE IN SPECIFIC POPULATIONS
Starting daily dose: 10 mg/kg per day in two equally divided doses
(2.1)
Increase by 10 mg/kg increments every other day to maximum dose of 45
mg/kg per day, not to
exceed 3,200 mg per day, in two divided doses (2.1)
Starting daily dose: 400 mg per day to 800 mg per day in two equally
divided doses (2.1)
Increase by 400 mg to 800 mg every other day until a maximum dose of
3,200 mg per day, in two
divided doses, is reached (2.1)
200 mg tablets: pink, film-coated, oblong-shaped with functional
scoring; 400 mg tablets: pink, film-
coated, oblong-shaped with functional scoring (3)
Rufinamide is contraindicated in patients with Familial Short QT
syndrome (4)
Monitor patients for new or worsening depression, suicidal
thoughts/behavior, and unusual changes in
mood or behavior (5.1)
Central nervous system reactions can occur (5.2)
Use