Approved Drug Label (PDF)
4
Contraindications
(Additions and/or revisions are underlined)
TRILEPTAL is
contraindicated in patients
with a known hypersensitivity to oxcarbazepine or to any of its components,
or to eslicarbazepine acetate.
5
Warnings and Precautions
5.1 Hyponatremia
(Additions and/or revisions are underlined)
…Cases of
symptomatic hyponatremia and syndrome of inappropriate antidiuretic hormone
secretion (SIADH) have been reported during postmarketing use…
5.11 Risk of Seizure Aggravation
(Newly added subsection)
Exacerbation of or
new onset primary generalized seizures has been reported with TRILEPTAL. The
risk of aggravation of primary generalized seizures is seen especially in
children but may also occur in adults. In case of seizure aggravation,
TRILEPTAL should be discontinued.
5.3 Cross Hypersensitivity Reaction to Carbamazepine
(Additions and/or revisions are underlined; subsection
title revised)
Approximately
25% to 30% of patients who
have had hypersensitivity reactions to carbamazepine will experience
hypersensitivity reactions with TRILEPTAL…
5.6 Withdrawal of AEDs
(Additions and/or revisions are underlined)
As with most
antiepileptic drugs, TRILEPTAL should generally be withdrawn gradually because
of the risk of increased seizure frequency and status epilepticus.
But if withdrawal is needed because of a serious adverse event, rapid
discontinuation can be considered.
5.7 Cognitive/Neuropsychiatric Adverse Reactions
(Additions and/or revisions are underlined; subsection
title revised)
Use of TRILEPTAL
has been associated with central nervous system-related adverse reactions…
Patients should
be monitored for these signs and symptoms and advised not to drive or operate
machinery until they have gained sufficient experience on TRILEPTAL to gauge
whether it adversely affects their ability to drive or operate machinery.
5.8 Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multi-Organ Hypersensitivity
(Additions and/or revisions are underlined)
…Some of these
events have been fatal or life-threatening. DRESS typically, although not
exclusively, presents with fever, rash, lymphadenopathy and/or facial
swelling, in association with other organ system involvement, such as
hepatitis, nephritis, hematologic abnormalities, myocarditis, or myositis
sometimes resembling an acute viral infection…
6
Adverse Reactions
(Additions and/or revisions are underlined)
The following
serious adverse reactions are described below and elsewhere in the labeling:
Hyponatremia
Anaphylactic
Reactions and Angioedema
Cross
Hypersensitivity Reaction to Carbamazepine
Serious
Dermatological Reactions
Suicidal
Behavior and Ideation
Cognitive/Neuropsychiatric
Adverse Reactions
Drug
Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multi-Organ Hypersensitivity
Hematologic
Events
6.1 Clinical Trials Experience
(Additions and/or revisions are underlined)
Most Common
Adverse Reactions in All Clinical Studies
The most common (greater than or equal to 10%
more than placebo for adjunctive or low dose for monotherapy) adverse
reactions with TRILEPTAL: dizziness, somnolence, diplopia, fatigue, nausea,
vomiting, ataxia, abnormal vision, headache, nystagmus tremor, and
abnormal gait.
Controlled
Clinical Studies of Adjunctive Therapy/Monotherapy in Adults Previously Treated
with Other AEDs
Table 3 lists adverse
reactions that occurred in at least 2% of adult patients with epilepsy
treated with TRILEPTAL or placebo as adjunctive treatment and were numerically
more common in the patients treated with any dose of TRILEPTAL.
Table 4 lists adverse
reactions in patients converted from other AEDs to either high-dose TRILEPTAL
(2400 mg/day) or low-dose (300 mg/day) TRILEPTAL.
Table 3 Adverse Reactions
in a Controlled Clinical Study of Adjunctive Therapy with TRILEPTAL
in Adults (Table title has been revised)
Table 4 Adverse Reactions
in Controlled Clinical Studies of Monotherapy with TRILEPTAL in Adults Previously Treated with
Other AEDs (Table title
has been revised)
Controlled
Clinical Study of Monotherapy in Adults Not Previously Treated with Other AEDs
Table 5 lists adverse
reactions in a controlled clinical study of monotherapy in adults not
previously treated with other AEDs that occurred in at least 2% of adult
patients with epilepsy treated with TRILEPTAL or placebo and were numerically more
common in the patients treated with TRILEPTAL.
Table 5 Adverse Reactions
in a Controlled Clinical Study of Monotherapy with TRILEPTAL in Adults Not Previously
Treated with Other AEDs (Table
title has been revised)
Controlled
Clinical Studies of Adjunctive Therapy/Monotherapy in Pediatric Patients
Previously Treated with Other
AEDs
Table 6 lists adverse
reactions that occurred in at least 2% of pediatric patients with epilepsy
treated with TRILEPTAL or placebo as adjunctive treatment and were numerically
more common in the patients treated with TRILEPTAL.
Table 6 Adverse Reactions in Controlled Clinical Studies of Adjunctive Therapy/Monotherapy with TRILEPTAL in
Pediatric Patients Previously Treated with Other AEDs (Table title has been revised)
6.2 Postmarketing Experience
(Additions and/or revisions are underlined)
The following
adverse reactions have been identified during postapproval use of TRILEPTAL.
Because these reactions are reported voluntarily from a population of uncertain
size, it is not always possible to reliably estimate their frequency or establish
a causal relationship to drug exposure.
Body as a Whole: multi-organ hypersensitivity disorders characterized by features such
as rash, fever, lymphadenopathy, abnormal liver function tests, eosinophilia
and arthralgia
Cardiovascular System: atrioventricular block
Immune System Disorders: anaphylaxis
Metabolism and Nutrition Disorders: hypothyroidism and syndrome of
inappropriate antidiuretic hormone secretion (SIADH)
Injury, Poisoning, and Procedural Complications: fall
Nervous System Disorders: dysarthria
7
Drug Interactions
7.1 Antiepileptic Drugs
Table 7 Summary of AED Interactions with TRILEPTAL (Table has been revised; please refer to
label)
8
Use in Specific Populations
8.1 Pregnancy
(Additions and/or
revisions are underlined)
Clinical
Considerations
TRILEPTAL levels
may decrease during pregnancy.
Pregnancy Category
C
Fetal Risk
Summary
… Data
on a limited number of pregnancies from pregnancy registries suggest congenital
malformations associated with TRILEPTAL monotherapy use (e.g., craniofacial
defects such as oral clefts
and cardiac malformations such as ventricular septal defects)…
Data
Animal
Increased
incidences of fetal structural abnormalities and other manifestations of developmental
toxicity (embryolethality, growth retardation) were observed in the offspring
of animals treated with either oxcarbazepine or its active 10-hydroxy
metabolite (MHD) during pregnancy at doses similar to the maximum recommended
human dose (MRHD).
8.4 Pediatric Use
(Additions and/or revisions are underlined)
The safety and
effectiveness for use as adjunctive therapy for partial seizures in pediatric
patients below the age of 2 have not been established…
The safety and
effectiveness for use as monotherapy for partial seizures in pediatric patients
below the age of 4 have not been established.
8.5 Geriatric Use
(Additions and/or revisions are underlined)
…Close
monitoring of sodium levels is required in elderly patients at risk for
hyponatremia.
8.6 Renal Impairment
(Additions and/or revisions are underlined)
Dose adjustment
is recommended for renally
impaired patients (CLcr<30 mL/min).
17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)
17 PATIENT COUNSELING INFORMATION
(Additions and/or revisions are underlined)
Advise the patient to read the FDA-approved
patient labeling (Medication Guide).
Administration
Information
Counsel patients
that TRILEPTAL may be taken with or without food.
For TRILEPTAL
oral suspension, advise patients to shake the bottle well and prepare the dose
immediately afterwards using the oral dosing syringe supplied. Inform patients
that TRILEPTAL oral suspension can be mixed in a small glass of water just prior
to administration or, alternatively, may be swallowed directly from the
syringe. Instruct patients to discard any unused TRILEPTAL oral suspension
after 7 weeks of first opening the bottle.
Hyponatremia
…Instruct
patients to report symptoms of low sodium like nausea, tiredness, lack of energy,
confusion, and more frequent or more severe seizures.
Anaphylactic Reactions
and Angioedema
Anaphylactic reactions and angioedema may occur during treatment
with TRILEPTAL…
Cross
Hypersensitivity Reaction to Carbamazepine
Inform patients who have exhibited hypersensitivity reactions
to carbamazepine that approximately 25% to 30% of these patients may experience
hypersensitivity reactions with TRILEPTAL…
Serious
Dermatological Reactions
Advise patients that serious skin reactions have been reported
in association with TRILEPTAL…
Suicidal
Behavior and Ideation
Patients, their
caregivers, and families should be counseled that AEDs, including TRILEPTAL, may
increase the risk of suicidal thoughts and behavior…
Driving and Operating
Machinery
Advise patients
that TRILEPTAL may cause adverse reactions such as dizziness, somnolence, ataxia,
visual disturbances, and depressed level of consciousness. Accordingly,
advise patients not to drive or operate machinery until they have gained sufficient
experience on TRILEPTAL to gauge whether it adversely affects their ability to
drive or operate machinery.
Multi-Organ
Hypersensitivity
Instruct patients
that a fever associated with other organ system involvement (e.g., rash,
lymphadenopathy, hepatic dysfunction) may be drug-related and should be
reported to their healthcare provider immediately.
Hematologic Events
Advise patients
that there have been rare reports of blood disorders reported in patients
treated with TRILEPTAL…
Drug
Interactions
Caution female
patients of reproductive potential that the concurrent use of TRILEPTAL
with hormonal contraceptives may render this method of contraception less
effective…
Pregnancy
Registry
Encourage patients to
enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry if
they become pregnant…
MEDICATION GUIDE
(Additions and/or revisions are underlined)
What is the most important information I
should know about TRILEPTAL?
TRILEPTAL can cause serious side effects,
including:
1. TRILEPTAL may cause the level of sodium in
your blood to be low…
…Your healthcare
provider may do blood tests to check your sodium levels during your treatment
with TRILEPTAL.
What is TRILEPTAL?
It is not known
if TRILEPTAL is safe and effective for use alone to treat partial seizures in
children less than 4 years of age or for use with other medicines to
treat partial seizures in children less than 2 years of age.
Do not take TRILEPTAL if you are allergic to TRILEPTAL or any of the other
ingredients in TRILEPTAL, or to eslicarbazepine acetate. See the end of
this Medication Guide for a complete list of ingredients in TRILEPTAL.
Before taking TRILEPTAL, tell your
healthcare provider about all your medical conditions, including if you:
How should I take TRILEPTAL?
What are the possible side effects of
TRILEPTAL?
TRILEPTAL may cause other serious side
effects including:
How should I store TRILEPTAL?
What are the ingredients in TRILEPTAL?
Inactive ingredients:
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