LEVETIRACETAM (Page 7 of 9)

14.2 Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy

Effectiveness of Myoclonic Seizures in Patients ≥12 Years of Age with Juvenile Myoclonic Epilepsy (JME)

The effectiveness of Levetiracetam tablets as adjunctive therapy (added to other antiepileptic drugs) in patients 12 years of age and older with juvenile myoclonic epilepsy (JME) experiencing myoclonic seizures was established in one multicenter, randomized, double-blind, placebo-controlled study (study 6), conducted at 37 sites in 14 countries. Of the 120 patients enrolled, 113 had a diagnosis of confirmed or suspected JME. Eligible patients on a stable dose of 1 antiepileptic drug (AED) experiencing one or more myoclonic seizures per day for at least 8 days during the prospective 8-week baseline period were randomized to either Levetiracetam tablets or placebo (Levetiracetam tablets N=60, placebo N=60). Patients were titrated over 4 weeks to a target dose of 3000 mg/day and treated at a stable dose of 3000 mg/day over 12 weeks (evaluation period). Study drug was given in 2 divided doses.

The primary measure of effectiveness was the proportion of patients with at least 50% reduction in the number of days per week with one or more myoclonic seizures during the treatment period (titration + evaluation periods) as compared to baseline. Table 14 displays the results for the 113 patients with JME in this study.

Table 14: Responder Rate (≥50% Reduction from Baseline) in Myoclonic Seizure Days per Week for Patients with JME in Study 6
* statistically significant versus placebo
Placebo(N=59) Levetiracetam tablets (N=54)
Percentage of responders 23.7% 60.4%*

14.3 Primary Generalized Tonic-Clonic Seizures

Effectiveness in Primary Generalized Tonic-Clonic Seizures in Patients ≥6 Years of Age

The effectiveness of Levetiracetam tablets as adjunctive therapy (added to other antiepileptic drugs) 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, placebo-controlled 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 tablets 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 effectiveness was the percent reduction from baseline in weekly PGTC seizure frequency for Levetiracetam tablets and placebo treatment groups over the treatment period (titration + evaluation periods). The population included 164 patients (Levetiracetam tablets 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 tablets-treated patients compared to the placebo-treated patients.

Table 15: Median Percent Reduction from Baseline in PGTC Seizure Frequency per Week in Study 7
*statistically significant versus placebo
Placebo(N=84)Levetiracetam tablets (N=78)
Percent reduction inPGTC seizure frequency 44.6%77.6%*

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

figure6
(click image for full-size original)

*statistically significant versus placebo

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied


Levetiracetam tablets USP 250 mg are yellow colored, oval capsule shaped, biconvex, film-coated tablets with ‘L and 1’ engraved on either side of break line on one side and plain on other side. They are supplied in white HDPE bottles containing 120 tablets (NDC 27241-007-12), 500 tablets (NDC 27241-007-50) and 1000 tablets (NDC 27241-007-90).

Levetiracetam tablets USP 500 mg are orange colored, oval capsule shaped, biconvex, film-coated tablets with ‘L and 2’ engraved on either side of break line on one side and plain on other side. They are supplied in white HDPE bottles containing 120 tablets (NDC 27241-008-12), 500 tablets (NDC 27241-008-50) and 1000 tablets (NDC 27241-008-90).

Levetiracetam tablets USP 750 mg are blue colored, oval capsule shaped, biconvex, film-coated tablets with ‘L and 3’ engraved on either side of break line on one side and plain on other side. They are supplied in white HDPE bottles containing 120 tablets (NDC 27241-009-12), 500 tablets (NDC 27241-009-50) and 1000 tablets (NDC 27241-009-90).

Levetiracetam tablets USP 1000 mg are white to off-white colored, oval capsule shaped, biconvex, film-coated tablets with ‘L and 4’ engraved on either side of break line on one side and plain on other side. They are supplied in white HDPE bottles containing 60 tablets (NDC 27241- 010-06), 100 tablets (NDC 27241-010-10) and 1000 tablets (NDC 27241-010-90).

PHARMACIST: Please dispense with attached Medication Guide.

16.2 Storage

Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Psychiatric Reactions and Changes in Behavior
Advise patients that Levetiracetam tablets 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)].

Suicidal Behavior and Ideation
Counsel patients, their caregivers, and/or families that antiepileptic drugs (AEDs), including Levetiracetam tablets, may increase the risk of suicidal thoughts and behavior and advise patients to be alert for the emergence or worsening of symptoms of depression; unusual changes in mood or behavior; or suicidal thoughts, behavior, or thoughts about self-harm. Advise patients, their caregivers, and/or families to immediately report behaviors of concern to a healthcare provider [see Warnings and Precautions (5.2)].

Effects on Driving or Operating Machinery
Inform patients that Levetiracetam tablets may cause dizziness and somnolence. Inform patients not to drive or operate machinery until they have gained sufficient experience on Levetiracetam tablets to gauge whether it adversely affects their ability to drive or operate machinery [see Warnings and Precautions (5.3)].

Anaphylaxis and Angioedema
Advise patients to discontinue Levetiracetam tablets and seek medical care if they develop signs and symptoms of anaphylaxis or angioedema [see Warnings and Precautions (5.4)].

Dermatological Adverse Reactions
Advise patients that serious dermatological adverse reactions have occurred in patients treated with Levetiracetam tablets and instruct them to call their physician immediately if a rash develops [see Warnings and Precautions (5.5)].

Pregnancy
Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during Levetiracetam tablets therapy. Encourage patients to enroll in the North American Antiepileptic Drug (NAAED) pregnancy registry if they become pregnant. This registry is collecting information about the safety of antiepileptic drugs during pregnancy. To enroll, patients can call the toll free number 1-888-233- 2334. [see Use In Specific Populations (8.1) ].
Marketed by:

Ajanta Pharma USA Inc.
Bridgewater, NJ 08807.


Manufactured by:

Ajanta Pharma Limited
B-4/5/6, MIDC Area, Paithan 431 148, India. Revised: 11/2017

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