APTIOM- eslicarbazepine acetate tablet APTIOM- eslicarbazepine acetate kit

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

ESLICARBAZEPINE ACETATE (UNII: BEA68ZVB2K) (ESLICARBAZEPINE - UNII:S5VXA428R4)

Sẵn có từ:

Sumitomo Pharma America, Inc.

INN (Tên quốc tế):

ESLICARBAZEPINE ACETATE

Thành phần:

ESLICARBAZEPINE ACETATE 200 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

APTIOM is indicated for the treatment of partial-onset seizures in patients 4 years of age and older. APTIOM is contraindicated in patients with a hypersensitivity to eslicarbazepine acetate or oxcarbazepine [see Warnings and Precautions (5.2, 5.3, and 5.4)]. Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to AEDs, such as APTIOM, during pregnancy. Encourage women who are taking APTIOM 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 Limited available data with APTIOM use in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. In oral studies conducted in pregnant mice, rats, and rabbits, eslicarbazepine acetate demonstrated developmental toxicity, including increased incidence of malformations (mice), embryolethality (rats), and fetal growth retardation (all species), at clinically relevant doses (see Data). Advise a pregnant woman of the potential risk to a fetus. 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. Data Animal Data When eslicarbazepine acetate was orally administered (150, 350, 650 mg/kg/day) to pregnant mice throughout organogenesis, increased incidences of fetal malformations was observed at all doses and fetal growth retardation was observed at the mid and high doses. A no-effect dose for adverse developmental effects was not identified. At the lowest dose tested, plasma eslicarbazepine exposure (Cmax , AUC) is less than that in humans at the maximum recommended human dose (MRHD, 1600 mg/day). Oral administration of eslicarbazepine acetate (40, 160, 320 mg/kg/day) to pregnant rabbits throughout organogenesis resulted in fetal growth retardation and increased incidences of skeletal variations at the mid and high doses. The no-effect dose (40 mg/kg/day) is less than the MRHD on a mg/m2 basis. Oral administration to pregnant rats (65, 125, 250 mg/kg/day) throughout organogenesis resulted in embryolethality at all doses, increased incidences of skeletal variations at the mid and high doses, and fetal growth retardation at the high dose. The lowest dose tested (65 mg/kg/day) is less than the MRHD on a mg/m2 basis. When eslicarbazepine acetate was orally administered to female mice during pregnancy and lactation (150, 350, 650 mg/kg/day), the gestation period was prolonged at the highest dose tested. In offspring, a persistent reduction in offspring body weight and delayed physical development and sexual maturation were observed at the mid and high doses. The lowest dose tested (150 mg/kg/day) is less than the MRHD on a mg/m2 basis. When eslicarbazepine acetate was orally administered (65, 125, 250 mg/kg/day) to rats during pregnancy and lactation, reduced offspring body weight was seen at the mid and high doses. Delayed sexual maturation and a neurological deficit (decreased motor coordination) were observed at the highest dose tested. The no-effect dose for adverse developmental effects (65 mg/kg/day) is less than the MRHD on a mg/m2 basis. The rat data are of uncertain relevance to humans because of differences in metabolic profile between species. Eslicarbazepine is present in human milk. The effects of APTIOM on the breastfed infant or on milk production are unknown. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for APTIOM and any potential adverse effects on the breastfed infant from APTIOM or from the underlying maternal condition. Contraception Use of APTIOM with hormonal contraceptives containing ethinylestradiol or levonorgestrel is associated with lower plasma levels of these hormones. Advise women of reproductive potential taking APTIOM who are using a contraceptive containing ethinylestradiol or levonorgestrel to use additional or alternative non-hormonal birth control [see Drug Interactions (7.4)] . Infertility Eslicarbazepine acetate was evaluated in rats and mice for potential adverse impact on fertility of the parental and first generation [see Nonclinical Toxicology (13.1)] . In a fertility study in male and female mice, adverse developmental outcomes were observed in embryos. In a fertility study in male and female rats, impairment of female fertility by eslicarbazepine acetate was shown. Safety and effectiveness of APTIOM have been established in the age groups 4 to 17 years. Use of APTIOM in these age groups is supported by evidence from adequate and well-controlled studies of APTIOM in adults with partial-onset seizures, pharmacokinetic data from adult and pediatric patients, and safety data from clinical studies in 393 pediatric patients 4 to 17 years of age [see Adverse Reactions (6.1) and Clinical Pharmacology (12.3)] . Safety and effectiveness in pediatric patients below the age of 4 years have not been established. Animal Data In a juvenile animal study in which eslicarbazepine acetate (40, 80, 160 mg/kg/day) was orally administered to young dogs for 10 months starting on postnatal day 21, adverse effects on bone growth (decreased bone mineral content and density) were seen in females at all doses at the end of the dosing period, but not at the end of a 2-month recovery period. Convulsions were seen at the highest dose tested. A no-effect dose for adverse effects in juvenile dogs was not identified. The lowest dose tested is less than the maximum recommended pediatric dose (1200 mg/day) on a body surface area (mg/m2 ) basis. A separate juvenile animal study was conducted to assess possible adverse effects on the immune system. Eslicarbazepine acetate (10, 40, 80 mg/kg/day) was orally administered to young dogs for 17 weeks starting on postnatal day 21. No effects on the immune system were observed. There were insufficient numbers of patients ≥65 years old enrolled in the controlled adjunctive epilepsy trials (N=15) to determine the efficacy of APTIOM in this patient population. The pharmacokinetics of APTIOM were evaluated in elderly healthy subjects (N=12) (Figure 1). Although the pharmacokinetics of eslicarbazepine are not affected by age independently, dose selection should take in consideration the greater frequency of renal impairment and other concomitant medical conditions and drug therapies in the elderly patient. Dose adjustment is necessary if CrCl is <50 mL/min [see Clinical Pharmacology (12.3)]. Clearance of eslicarbazepine is decreased in patients with impaired renal function and is correlated with creatinine clearance. Dosage adjustment is necessary in patients with CrCl<50 mL/min (Figure 1) [see Dosage and Administration (2.4) and Clinical Pharmacology (12.3)]. Dose adjustments are not required in patients with mild to moderate hepatic impairment (Figure 1). Use of APTIOM in patients with severe hepatic impairment has not been evaluated, and use in these patients is not recommended [see Clinical Pharmacology (12.3)]. APTIOM is not a controlled substance. Prescription drug abuse is the intentional non-therapeutic use of a drug, even once, for its rewarding psychological or physiological effects. Drug addiction, which develops after repeated drug abuse, is characterized by a strong desire to take a drug despite harmful consequences, difficulty in controlling its use, giving a higher priority to drug use than to obligations, increased tolerance, and sometimes physical withdrawal. Drug abuse and drug addiction are separate and distinct from physical dependence (for example, abuse may not be accompanied by physical dependence) [see Drug Abuse and Dependence (9.3)]. In a human abuse study in recreational sedative abusers APTIOM showed no evidence of abuse. In Phase 1, 1.5% of the healthy volunteers taking APTIOM reported euphoria compared to 0.4% taking placebo. Physical dependence is characterized by withdrawal symptoms after abrupt discontinuation or a significant dose reduction of a drug. There was some evidence of physical dependence or a withdrawal syndrome with APTIOM in a physical dependence study conducted in healthy volunteers who were maintained at a daily dose of 800 mg APTIOM for 4 weeks prior to discontinuation. The primary endpoint was the maximum change from steady-state baseline in the total score of the Physician's Withdrawal Checklist (PWC-34) during the 21-day discontinuation period. APTIOM and placebo were shown to be equivalent on the primary endpoint. Two out of 8 secondary endpoints (visual analog scales for anxiety and nausea) showed some increase in these symptoms for subjects who were maintained on APTIOM and discontinued, versus subjects who were maintained on placebo. In general, AEDs should not be abruptly discontinued in patients with epilepsy because of the risk of increased seizure frequency and status epilepticus.

Tóm tắt sản phẩm:

APTIOM tablets are white, oblong and with functional scoring on one side (200 mg, 600 mg, and 800 mg) or white, circular bi-convex and plain on one side (400 mg) and identified with strength-specific one-sided engraving on the other side, “ESL 200” (200 mg), “ESL 400” (400 mg), “ESL 600” (600 mg), or “ESL 800” (800 mg). Tablets are supplied in the following strengths and package configurations (Table 6): Store APTIOM tablets at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Tình trạng ủy quyền:

New Drug Application

Tờ rơi thông tin

APTIOM- ESLICARBAZEPINE ACETATE
Sumitomo Pharma America, Inc.
----------
This Medication Guide has been approved by the U.S. Food and Drug
Administration.
Revised 9/2017
MEDICATION GUIDE
APTIOM (ap tee' om)
(eslicarbazepine acetate)
tablets
What is the most important information I should know about APTIOM?
•
Do not stop taking APTIOM without first talking to your healthcare
provider.
•
Stopping APTIOM suddenly can cause serious problems. Stopping a
seizure medicine
suddenly in a patient who has epilepsy may cause seizures that will
not stop (status
epilepticus).
1. Like other antiepileptic drugs, APTIOM 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
•
new or worse depression
•
feeling agitated or restless
•
trouble sleeping (insomnia)
•
acting aggressive, being angry, or violent
•
an extreme increase in activity and talking
(mania)
•
attempt to commit suicide
•
new or worse anxiety
•
panic attacks
•
new or worse irritability
•
acting on dangerous impulses
•
other unusual changes in behavior or mood
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.
Suicidal thoughts or actions may be caused by things other than
medicines. If you have suicidal
thoughts or actions, your healthcare provider may check for other
causes.
2. APTIOM may cause allergic reactions or serious problems which may
affect organs and other parts of
your body like the liver or blood cells. You may or may not have a
rash with these types of reactions.
Call your healthcare provider right away if you have any of the
following:
•
s

Đặc tính sản phẩm

APTIOM- ESLICARBAZEPINE ACETATE TABLET
APTIOM- ESLICARBAZEPINE ACETATE
SUMITOMO PHARMA AMERICA, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
APTIOM SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR APTIOM.
APTIOM (ESLICARBAZEPINE ACETATE) TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2013
INDICATIONS AND USAGE
APTIOM is indicated for the treatment of partial-onset seizures in
patients 4 years of age and older. (1)
DOSAGE AND ADMINISTRATION
Adult Patients: The recommended initial dosage of APTIOM is 400 mg
once daily. For some patients,
treatment may be initiated at 800 mg once daily if the need for
seizure reduction outweighs an
increased risk of adverse reactions. Increase the dose in weekly
increments of 400 mg to 600 mg once
daily, based on clinical response and tolerability, to a recommended
maintenance dosage of 800 mg to
1600 mg once daily. (2.2)
Pediatric Patients: The recommended dosage of APTIOM is based on body
weight and is administered
orally once daily. Increase the dose in weekly intervals based on
clinical response and tolerability, to the
recommended maintenance dosage. (2.2)
Patients with Moderate or Severe Renal Impairment: Reduce dosage by
50%. (2.4)
DOSAGE FORMS AND STRENGTHS
Tablets: 200 mg, 400 mg, 600 mg, 800 mg (3)
CONTRAINDICATIONS
Hypersensitivity to eslicarbazepine acetate or oxcarbazepine. (4)
WARNINGS AND PRECAUTIONS
Suicidal Behavior and Ideation: Monitor for suicidal thoughts or
behavior. (5.1)
Serious Dermatologic Reactions, Drug Reaction with Eosinophilia and
Systemic Symptoms (DRESS),
Anaphylactic Reactions and Angioedema: Monitor and discontinue if
another cause cannot be
established. (5.2, 5.3, 5.4)
Hyponatremia: Monitor sodium levels in patients at risk or patients
experiencing hyponatremia
symptoms. (5.5)
Neurological Adverse Reactions: Monitor for dizziness, disturbance in
gait and coordination,
somnolence, fatigue, cognitive dysfunction, and visual changes. Use
caution when driving or opera