Elepsia XR (Page 3 of 8)

6 Adverse Reactions to Elepsia XR

The following serious adverse reactions are discussed in more detail in other sections of labeling:

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Levetiracetam Extended-Release TabletsIn the controlled clinical study in patients with partial-onset seizures, the most common adverse reactions in patients receiving levetiracetam extended-release tablets in combination with other AEDs, for events with rates greater than placebo, were irritability and somnolence.

Table 3 lists adverse reactions that occurred in at least 5% of epilepsy patients receiving levetiracetam extended-release tablets in the placebo-controlled study and were numerically more common than in patients treated with placebo. In this study, either levetiracetam extended-release tablets or placebo was added to concurrent AED therapy.

Table 3: Adverse Reactions in the Placebo-Controlled, Add-On Study in Patients Experiencing Partial- Onset Seizures

Adverse Reactions

Levetiracetam Extended-Release Tablets (N=77) %

Placebo (N=79) %

Influenza

8

4

Somnolence

8

3

Irritability

7

0

Nasopharyngitis

7

5

Dizziness

5

3

Nausea

5

3

Discontinuation or Dose Reduction in the Levetiracetam Extended-Release Tablets Controlled Clinical Study
In the controlled clinical study, 5% of patients receiving levetiracetam extended-release tablets and 3% receiving placebo discontinued as a result of an adverse reaction. The adverse reactions that resulted in discontinuation and that occurred more frequently in levetiracetam extended-release tablet-treated patients than in placebo-treated patients were asthenia, epilepsy, mouth ulceration, rash, and respiratory failure. Each of these adverse reactions led to discontinuation in a levetiracetam extended-release tablet-treated patient and no placebo-treated patients.

Immediate-Release Levetiracetam Tablets
Table 4 lists the adverse reactions in the controlled studies of immediate-release levetiracetam tablets in adult patients experiencing partial-onset seizures. Although the pattern of adverse reactions in the levetiracetam extended-release tablets study seems somewhat different from that seen in partial-onset seizure controlled studies for immediate-release levetiracetam tablets, this is possibly due to the much smaller number of patients in this study compared to the immediate-release tablet studies. The adverse reactions for levetiracetam extended-release tablets are expected to be similar to those seen with immediate-release levetiracetam tablets.

Adults In controlled clinical studies of immediate-release levetiracetam tablets as adjunctive therapy to other AEDs in adults with partial-onset seizures, the most common adverse reactions, for events with rates greater than placebo, were somnolence, asthenia, infection, and dizziness.

Table 4 lists adverse reactions that occurred in at least 1% of adult epilepsy patients receiving immediate-release levetiracetam tablets in placebo-controlled studies and were numerically more common than in patients treated with placebo. In these studies, either immediate-release levetiracetam tablets or placebo was added to concurrent AED therapy.

Table 4: Adverse Reactions in Pooled Placebo-Controlled, Add-On Studies in Adults Experiencing Partial-Onset Seizures

Adverse Reaction

Immediate-Release Levetiracetam Tablets (N=769) %

Placebo (N=439) %

Asthenia

15

9

Somnolence

15

8

Headache

14

13

Infection

13

8

Dizziness

9

4

Pain

7

6

Pharyngitis

6

4

Depression

4

2

Nervousness

4

2

Rhinitis

4

3

Anorexia

3

2

Ataxia

3

1

Vertigo

3

1

Amnesia

2

1

Anxiety

2

1

Cough Increased

2

1

Diplopia

2

1

Emotional Lability

2

0

Hostility

2

1

Paresthesia

2

1

Sinusitis

2

1

Pediatric Patients 4 Years to <16 Years In a pooled analysis of two controlled pediatric clinical studies in children 4 to 16 years of age with partial-onset seizures, the adverse reactions most frequently reported with the use of immediate-release levetiracetam tablets in combination with other AEDs, and with greater frequency than in patients on placebo, were fatigue, aggression, nasal congestion, decreased appetite, and irritability.

Table 5 lists adverse reactions that occurred in at least 2% of pediatric patients treated with immediate -release levetiracetam tablets and were more common than in pediatric patients on placebo. In these studies, either immediate-release levetiracetam tablets or placebo was added to concurrent AED therapy. Adverse reactions were usually mild to moderate in intensity.

Table 5: Adverse Reactions in Pooled Placebo-Controlled, Add-On Studies in Pediatric Patients Ages 4 to 16 Years Experiencing Partial-Onset Seizures

Adverse Reaction

Immediate-Release Levetiracetam Tablets (N=165) %

Placebo (N=131) %

Headache

19

15

Nasopharyngitis

15

12

Vomiting

15

12

Somnolence

13

9

Fatigue

11

5

Aggression

10

5

Abdominal Pain Upper

9

8

Cough

9

5

Nasal Congestion

9

2

Decreased Appetite

8

2

Abnormal Behavior

7

4

Dizziness

7

5

Irritability

7

1

Pharyngolaryngeal Pain

7

4

Diarrhea

6

5

Lethargy

6

2

Insomnia

5

3

Agitation

4

1

Anorexia

4

3

Head Injury

4

0

Constipation

3

1

Contusion

3

1

Depression

3

1

Fall

3

2

Influenza

3

1

Mood Altered

3

1

Affect Lability

2

1

Anxiety

2

1

Arthralgia

2

0

Confusional State

2

0

Conjunctivitis

2

0

Ear Pain

2

1

Gastroenteritis

2

0

Joint Sprain

2

1

Mood Swings

2

1

Neck Pain

2

1

Rhinitis

2

0

Sedation

2

1

In controlled pediatric clinical studies in patients 4 to 16 years of age, 7% of patients treated with immediate-release levetiracetam tablets and 9% of patients on placebo discontinued as a result of an adverse event.

In addition, the following adverse reactions were seen in other controlled studies of immediate-release levetiracetam tablets: balance disorder, disturbance in attention, eczema, hyperkinesia, memory impairment, myalgia, personality disorders, pruritus, and blurred vision.

Comparison of Gender, Age and Race
There are insufficient data for levetiracetam extended-release tablets to support a statement regarding the distribution of adverse reactions by gender, age, and race.

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