ELEPSIA XR 1000 MG- levetiracetam tablet, extended release ELEPSIA XR 1500 MG- levetiracetam tablet, extended release

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

LEVETIRACETAM (UNII: 44YRR34555) (LEVETIRACETAM - UNII:44YRR34555)

Beschikbaar vanaf:

TRIPOINT THERAPEUTICS, LLC

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

ELEPSIA XR is indicated as adjunctive therapy for the treatment of partial-onset seizures in patients 12 years of age and older. ELEPSIA XR is contraindicated in patients with a hypersensitivity to levetiracetam. Reactions have included anaphylaxis and angioedema [see Warnings and Precautions (5.4)]. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), including ELEPSIA XR, during pregnancy. Encourage women who are taking ELEPSIA XR 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 Prolonged experience with levetiracetam in pregnant women has not identified a drug-associated risk of major birth defects or miscarriage, based on published literature, which includes data from pregnancy registries and reflects experience over two decades [see Human Data] . In animal studies, levetiracetam produced developmental toxicity (increased embryofetal and offspring mortality, increased incidences of fetal structural abnormalities, decreased embryofetal and offspring growth, neurobehavioral alterations in offspring) at doses similar to human therapeutic doses [see Animal Data] . In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown. Clinical Considerations Levetiracetam levels may decrease during pregnancy [see Warnings and Precautions (5.9)] . Physiological changes during pregnancy may affect levetiracetam concentration. Decrease in levetiracetam plasma concentrations has been observed during pregnancy. This decrease is more pronounced during the third trimester. Dose adjustments may be necessary to maintain clinical response. Data Human Data While available studies cannot definitively establish the absence of risk, data from the published literature and pregnancy registries have not established an association with levetiracetam use during pregnancy and major birth defects or miscarriage. Animal Data When levetiracetam (0, 400, 1200, or 3600 mg/kg/day) was administered orally to pregnant rats during the period of organogenesis, reduced fetal weights and increased incidence of fetal skeletal variations were observed at the highest dose tested. There was no evidence of maternal toxicity. The no-effect dose for adverse effects on embryofetal development in rats (1200 mg/kg/day) is approximately 4 times the maximum recommended human dose (MRHD) of 3000 mg on a body surface area (mg/m2 ) basis. Oral administration of levetiracetam (0, 200, 600, or 1800 mg/kg/day) to pregnant rabbits during the period of organogenesis resulted in increased embryofetal mortality and incidence of fetal skeletal variations at the mid and high dose and decreased fetal weights and increased incidence of fetal malformations at the high dose, which was associated with maternal toxicity. The no-effect dose for adverse effects on embryofetal development in rabbits (200 mg/kg/day) is approximately equivalent to the MRHD on a mg/m2 basis. Oral administration of levetiracetam (0, 70, 350, or 1800 mg/kg/day) to female rats throughout pregnancy and lactation led to an increased incidence of fetal skeletal variations, reduced fetal body weight, and decreased growth in offspring at the mid and high doses and increased pup mortality and neurobehavioral alterations in offspring at the highest dose tested. There was no evidence of maternal toxicity. The no-effect dose for adverse effects on pre- and postnatal development in rats (70 mg/kg/day) is less than the MRHD on a mg/m2 basis. Oral administration of levetiracetam to rats during the latter part of gestation and throughout lactation produced no adverse developmental or maternal effects at doses of up to 1800 mg/kg/day (6 times the MRHD on a mg/m2 basis). Risk Summary Levetiracetam is excreted in human milk. There are no data on the effects of ELEPSIA XR on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for ELEPSIA XR and any potential adverse effects on the breastfed infant from ELEPSIA XR or from the underlying maternal condition. Safety and effectiveness of ELEPSIA XR in pediatric patients 12 years of age and older has been established based on pharmacokinetic data in adults and adolescents using levetiracetam extended-release tablets and efficacy and safety data in controlled pediatric studies using immediate-release levetiracetam tablets [see Adverse Reactions (6.1), Clinical Pharmacology (12.3), and Clinical Studies (14.1)]. Safety and effectiveness in pediatric patients below the age of 12 years have not been established. A 3-month, randomized, double-blind, placebo-controlled study was performed to assess the neurocognitive and behavioral effects of immediate-release levetiracetam tablets as adjunctive therapy in 98 pediatric patients with inadequately controlled partial seizures, ages 4 to 16 years (levetiracetam N=64; placebo N=34). The target dose of immediate-release levetiracetam tablets was 60 mg/kg/day. Neurocognitive effects were measured by the Leiter-R Attention and Memory (AM) Battery, which assesses various aspects of a child's memory and attention. Although no substantive differences were observed between the placebo-and levetiracetam-treated groups in the median change from baseline in this battery, the study was not adequate to assess formal statistical non-inferiority between the drug and placebo. The Achenbach Child Behavior Checklist (CBCL/6-18), a standardized validated tool used to assess a child's competencies and behavioral/emotional problems, was also assessed in this study. An analysis of the CBCL/6-18 indicated a worsening in aggressive behavior, one of the eight syndrome scores, in patients treated with levetiracetam [see Warnings and Precautions (5.1)]. Juvenile Animal Toxicity Data Studies of levetiracetam in juvenile rats (dosing from day 4 through day 52 of age) and dogs (dosing from week 3 through week 7 of age) at doses of up to 1,800 mg/kg/day (approximately 7 and 24 times, respectively, the maximum recommended pediatric dose of 60 mg/kg/day on a mg/m2 basis) did not indicate a potential for age-specific toxicity. There were insufficient numbers of elderly subjects in controlled trials of epilepsy to adequately assess the effectiveness of levetiracetam extended-release tablets in these patients. It is expected that the safety of ELEPSIA XR in elderly patients 65 and over would be comparable to the safety observed in clinical studies of immediate-release levetiracetam tablets. There were 347 subjects in clinical studies of immediate-release levetiracetam that were 65 and over. No overall differences in safety were observed between these subjects and younger subjects. There were insufficient numbers of elderly subjects in controlled trials of epilepsy to adequately assess the effectiveness of immediate-release levetiracetam tablets in these patients. Levetiracetam is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function [see Clinical Pharmacology (12.3)]. Clearance of levetiracetam is decreased in patients with renal impairment and is correlated with creatinine clearance [see Clinical Pharmacology (12.3)] . Dose adjustment is recommended for patients with mild renal impairment [see Dosage and Administration (2.2)] . ELEPSIA XR is not recommended in patients with moderate or severe renal impairment. In patients with moderate or severe renal impairment, it is recommended that lower strength levetiracetam tablets be used instead of ELEPSIA XR. In patients with end stage renal disease on dialysis, it is recommended that immediate-release levetiracetam tablets be used instead of ELEPSIA XR.

Product samenvatting:

ELEPSIA XR tablets, 1000 mg are oval biconvex, coated, blue and white to off -white, bilayer tablet with drilled portal on the blue layer; imprinted with "574" with black ink on one side and plain on the other side. They are supplied as follows: ELEPSIA XR tablets, 1500 mg are oval biconvex, coated, blue and white to off -white, bilayer tablet with drilled portal on the blue layer; imprinted with "575" with black ink on one side and plain on the other side. They are supplied as follows: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Dispense in tight, light-resistant container.

Autorisatie-status:

New Drug Application

Bijsluiter

ELEPSIA XR 1000 MG- LEVETIRACETAM TABLET, EXTENDED RELEASE
ELEPSIA XR 1500 MG- LEVETIRACETAM TABLET, EXTENDED RELEASE
TRIPOINT THERAPEUTICS, LLC
----------
MEDICATION GUIDE
ELEPSIA™ XR (e lep' see a ex are)
(levetiracetam)
extended-release tablets, for oral use
Read this Medication Guide before you start taking ELEPSIA XR 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 ELEPSIA XR?
Like other antiepileptic drugs, ELEPSIA XR may cause suicidal thoughts
or actions in a very small
number of people, about 1 in 500 people taking it.
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
•
attempts 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
Do not stop ELEPSIA XR without first talking to a healthcare provider.
•
Stopping ELEPSIA XR suddenly can cause serious problems. Stopping a
seizure medicine
suddenly can cause seizures that will not stop (status epilepticus).
•
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.
What is ELEPSIA XR?
ELEP

Productkenmerken

ELEPSIA XR 1000 MG- LEVETIRACETAM TABLET, EXTENDED RELEASE
ELEPSIA XR 1500 MG- LEVETIRACETAM TABLET, EXTENDED RELEASE
TRIPOINT THERAPEUTICS, LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ELEPSIA XR SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ELEPSIA XR.
ELEPSIA™ XR (LEVETIRACETAM) EXTENDED-RELEASE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1999
INDICATIONS AND USAGE
ELEPSIA XR is indicated as adjunctive therapy for the treatment of
partial- onset seizures in patients 12
years of age and older (1)
DOSAGE AND ADMINISTRATION
Initiate treatment with a dose of 1000 mg once daily; increase by 1000
mg every 2 weeks to a
maximum recommended dose of 3000 mg once daily (2.1)
ELEPSIA XR should be taken whole; do not split or cut tablets (2.1)
Not recommended for use in patients with moderate or severe renal
impairment; the maximum
recommended dose in patients with mild renal impairment is 2000 mg
(2.2)
DOSAGE FORMS AND STRENGTHS
Extended-release tablets, 1000 mg, 1500 mg (3)
CONTRAINDICATIONS
Known hypersensitivity to levetiracetam; angioedema and anaphylaxis
have occurred (4)
WARNINGS AND PRECAUTIONS
Behavioral abnormalities including psychotic symptoms, suicidal
ideation, irritability, and aggressive
behavior have been observed; monitor patients for psychiatric signs
and symptoms (5.1)
Suicidal Behavior and Ideation: Monitor patients for new or worsening
depression, suicidal
thoughts/behavior, and/or unusual changes in mood or behavior (5.2)
Monitor for somnolence and fatigue and advise patients not to drive or
operate machinery until they
have gained sufficient experience on ELEPSIA XR (5.3)
Serious Dermatological Reactions: Discontinue ELEPSIA XR at the first
sign of rash unless clearly not
drug related (5.5)
Coordination Difficulties: Monitor for ataxia, abnormal gait, and
incoordination. Advise patients to not
drive or operate machinery until they have gained experience on
ELEPSIA XR (5.6)
Withdrawal Seizures: ELEPSIA XR must