Levetiracetam (Page 11 of 11)

14.3 Primary Generalized Tonic-Clonic Seizures

The effectiveness of levetiracetam as adjunctive therapy in patients 6 years of age and older with idiopathic generalized epilepsy experiencing primary generalized tonic-clonic (PGTC) seizures was established in one multicenter, randomized, double-blind, placebocontrolled study (study 7), conducted at 50 sites in 8 countries. Eligible patients on a stable dose of 1 or 2 antiepileptic drugs (AEDs) experiencing at least 3 PGTC seizures during the 8-week combined baseline period (at least one PGTC seizure during the 4 weeks prior to the prospective baseline period and at least one PGTC seizure during the 4-week prospective baseline period) were randomized to either levetiracetam or placebo. The 8-week combined baseline period is referred to as “baseline” in the remainder of this section. Patients were titrated over 4 weeks to a target dose of 3000 mg/day for adults or a pediatric target dose of 60 mg/kg/day and treated at a stable dose of 3000 mg/day (or 60 mg/kg/day for children) over 20 weeks (evaluation period). Study drug was given in 2 equally divided doses per day. The primary measure of efficacy was the percent reduction from baseline in weekly PGTC seizure frequency for levetiracetam and placebo treatment groups over the treatment period (titration + evaluation periods). The population included 164 patients (Levetiracetam N=80, placebo N=84) with idiopathic generalized epilepsy (predominately juvenile myoclonic epilepsy, juvenile absence epilepsy, childhood absence epilepsy, or epilepsy with Grand Mal seizures on awakening) experiencing primary generalized tonic-clonic seizures. Each of these syndromes of idiopathic generalized epilepsy was well represented in this patient population.

There was a statistically significant decrease from baseline in PGTC frequency in the levetiracetam-treated patients compared to the placebo-treated patients in Study 7 (see Table 15).

Table 15: Median Percent Reduction from Baseline in PGTC Seizure Frequency per Week in Study 7

Placebo (N=84)Levetiracetam (N=78)
Percentage reduction in PGTC seizure frequency44.6%77.6%*
*Statistically significant versus placebo

The percentage of patients (y-axis) who achieved ≥50% reduction in weekly seizure rates from baseline in PGTC seizure frequency over the entire randomized treatment period (titration + evaluation period) within the two treatment groups (x-axis) is presented in Figure 6.

Figure 6: Responder Rate (≥50% Reduction from Baseline) in PGTC Seizure Frequency per Week in Study 7

fig 6
(click image for full-size original)

16 HOW SUPPLIED

16.1 How Supplied

Levetiracetam 500 mg/5 mL injection is a clear, colorless, sterile solution. It is supplied in single-dose 5 mL vials, available in cartons of 10 vials (NDC 39822-4000-1).

16.2 Storage

Store at 20º -25º C (68 º – 77 º F); excursions permitted between 15º–30ºC (59º–86ºF) [see USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

Psychiatric Reactions and Changes in Behavior

Advise patients and their caregivers that levetiracetam may cause changes in behavior (e.g., aggression, agitation, anger, anxiety, apathy, depression, hostility, and irritability) and psychotic symptoms. [see Warnings and Precautions (5.1) ]

Effects on Driving or Operating Machinery

Inform patients that levetiracetam may cause dizziness and somnolence. Inform patients not to drive or operate machinery until they have gained sufficient experience on levetiracetam to gauge whether it adversely affects their ability to drive or operate machinery. [see Warnings and Precautions (5.2) ]

Anaphylaxis and Angioedema

Advise patients to discontinue levetiracetam and seek medical care if they develop signs and symptoms of anaphylaxis or angioedema [see Warnings and Precautions (5.3) ].

Dermatological Adverse Reactions

Advise patients that serious dermatological adverse reactions have occurred in patients treated with levetiracetam and instruct them to call their physician immediately if a rash develops. [see Warnings and Precautions (5.4)].

Withdrawal of Levetiracetam

Advise patients and caregivers not to discontinue use of levetiracetam without consulting with their healthcare provider. Levetiracetam Injection should normally be gradually withdrawn to reduce the potential of increased seizure frequency and status epilepticus [see Warnings and Precautions (5.7)].

Pregnancy

Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during levetiracetam therapy. Encourage patients to enroll in the North American Antiepileptic Drug (NAAED) pregnancy registry if they become pregnant. [see Use In Specific Populations (8.1)].

Manufactured for:
X-GEN Pharmaceuticals, Inc.
Big Flats, NY 14814

Manufactured in India
LEVE-PI-16

August 2020

PRINCIPAL DISPLAY PANEL

June 2020
(click image for full-size original)

Leve-vl-05

NDC 39822-4000-1

5 mL
levetiracetam Injection 500 mg/ 5mL (100 mg/mL)

Rx only

FOR INTRAVENOUS USE ONLY

MUST BE DILUTED PRIOR TO ADMINISTRATION

X-GEN Pharmaceuticals, Inc.

June 2020
(click image for full-size original)

LEVE-CM-07

NDC 39822-4000-1

5 mL
levetiracetam Injection 500 mg/ 5mL (100 mg/mL)

Rx only

FOR INTRAVENOUS USE ONLY

MUST BE DILUTED PRIOR TO ADMINISTRATION

X-GEN Pharmaceuticals, Inc.

LEVETIRACETAM levetiracetam injection, solution, concentrate
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:39822-4000
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVETIRACETAM (LEVETIRACETAM) LEVETIRACETAM 500 mg in 5 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:39822-4000-1 5 mL in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091485 08/05/2011
Labeler — XGen Pharmaceuticals DJB, Inc. (117380305)

Revised: 08/2020 XGen Pharmaceuticals DJB, Inc.

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