ELEPSIA XR 1000 MG

ELEPSIA XR 1000 MG- levetiracetam tablet, extended release
ELEPSIA XR 1500 MG- levetiracetam tablet, extended release
TRIPOINT THERAPEUTICS, LLC

1 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.

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosing

ELEPSIA XR is administered orally once daily.

Initiate treatment with a dose of 1000 mg once daily. The once daily dosage may be adjusted in increments of 1000 mg every 2 weeks, to a maximum recommended daily dose of 3000 mg/day.

ELEPSIA XR should be taken whole; do not split or cut tablets.

2.2 Dosage Adjustment in Adult Patients with Renal Impairment

ELEPSIA XR is not recommended for use in patients with moderate or severe renal impairment. Recommended doses and adjustment for patients with mild renal impairment are shown in Table 1. In order to calculate the dose recommended for patients with renal impairment, creatinine clearance adjusted for body surface area must be calculated. To do this, an estimate of the patient’s creatinine clearance (CLcr ) in mL/min must first be calculated using the following formula:

CLcr = [140-age (years)] × weight (kg) (× 0.85 for female patients)
72 × serum creatinine (mg/dL)

Then CLcr is adjusted for body surface area (BSA) as follows:

CLcr (mL/min/1.73m2) = CLcr (mL/min) × 1.73
BSA subject (m2)
Table 1: Dosing Adjustment Regimen for Adult Patients with Impaired Renal Function
Group Creatinine Clearance (mL/min/1.73m2) Dosage (mg) Frequency
Normal greater than 80 1000 to 3000 Every 24 hours
Mild 50 to 80 1000 to 2000 Every 24 hours

2.3 Discontinuation of ELEPSIA XR

When discontinuing ELEPSIA XR, reduce the dosage gradually and avoid abrupt discontinuation because of the risk of increased seizure frequency and status epilepticus [see Warnings and Precautions (5.7)].

3 DOSAGE FORMS AND STRENGTHS

Extended-release tablets:

  • 1000 mg: oval biconvex, coated, blue and white to off-white, bilayer tablet with drilled portal on blue layer; imprinted with “574” with black ink on one side and plain on the other side.
  • 1500 mg: oval biconvex, coated, blue and white to off-white, bilayer tablet with drilled portal on blue layer; imprinted with “575” with black ink on one side and plain on the other side.

4 CONTRAINDICATIONS

ELEPSIA XR is contraindicated in patients with a hypersensitivity to levetiracetam. Reactions have included anaphylaxis and angioedema [see Warnings and Precautions (5.4)].

5 WARNINGS AND PRECAUTIONS

5.1 Behavioral Abnormalities and Psychotic Symptoms

ELEPSIA XR may cause behavioral abnormalities and psychotic symptoms. Patients treated with ELEPSIA XR should be monitored for psychiatric signs and symptoms.

Behavioral Abnormalities

Levetiracetam Extended-Release Tablets

A total of 7% of levetiracetam extended-release tablets-treated patients experienced non-psychotic behavioral disorders (reported as irritability and aggression), compared to 0% of placebo-treated patients. Irritability was reported in 7% of levetiracetam extended-release tablet-treated patients. Aggression was reported in 1% of levetiracetam extended-release tablet-treated patients.

No patient discontinued treatment or had a dose reduction as a result of these adverse reactions.

The number of patients exposed to levetiracetam extended-release tablets was considerably smaller than the number of patients exposed to immediate-release levetiracetam tablets in controlled trials. Therefore, certain adverse reactions observed in the immediate-release levetiracetam controlled trials will likely to occur in patients receiving ELEPSIA XR.

Immediate-Release Levetiracetam Tablets

A total of 13% of adult patients and 38% of pediatric patients (4 to 16 years of age) treated with immediate-release levetiracetam tablets experienced non-psychotic behavioral symptoms (reported as aggression, agitation, anger, anxiety, apathy, depersonalization, depression, emotional lability, hostility, hyperkinesias, irritability, nervousness, neurosis, and personality disorder), compared to 6% and 19% of adult and pediatric patients on placebo. A randomized, double-blind, placebo-controlled study was performed to assess the neurocognitive and behavioral effects of immediate-release levetiracetam tablets as adjunctive therapy in pediatric patients (4 to 16 years of age). An exploratory analysis suggested a worsening in aggressive behavior in patients treated with immediate-release levetiracetam tablets in that study [see Use in Specific Populations (8.4)].

A total of 1.7% of adult patients treated with immediate-release levetiracetam tablets discontinued treatment due to behavioral adverse reactions, compared to 0.2% of placebo-treated patients. The treatment dose was reduced in 0.8% of adult patients treated with immediate-release levetiracetam tablets, compared to 0.5% of placebo-treated patients. Overall, 11% of pediatric patients treated with immediate-release levetiracetam tablets experienced behavioral symptoms associated with discontinuation or dose reduction, compared to 6.2% of placebo-treated pediatric patients.

One percent of adult patients and 2% of pediatric patients (4 to 16 years of age) treated with immediate-release levetiracetam tablets experienced psychotic symptoms, compared to 0.2% and 2%, respectively, in adult and pediatric placebo-treated patients. In the controlled study that assessed the neurocognitive and behavioral effects of immediate- release levetiracetam tablets in pediatric patients 4 to 16 years of age, 1.6% levetiracetam -treated patients experienced paranoia, compared to no placebo-treated patients. There were 3.1% patients treated with immediate-release levetiracetam tablets who experienced confusional state, compared to no placebo-treated patients [see Use in Specific Populations (8.4) ].

Psychotic Symptoms

Immediate-Release Levetiracetam Tablets

One percent of immediate-release levetiracetam tablets-treated adult patients experienced psychotic symptoms, compared to 0.2% of placebo-treated patients.

Two (0.3%) immediate-release levetiracetam tablets-treated adult patients were hospitalized and their treatment was discontinued due to psychosis. Both events, reported as psychosis, developed within the first week of treatment and resolved within 1 to 2 weeks following treatment discontinuation. There was no difference between drug and placebo- treated patients in the incidence of pediatric patients who discontinued treatment due to psychotic and non-psychotic adverse reactions.

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