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Keppra Injection

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Keppra Injection

Keppra Injection Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Keppra (levetiracetam) Injection is an antiseizure (antiepileptic) drug (AED) for adult patients (16 years and older) in the treatment of partial onset seizures when oral administration is temporarily not feasible. The drug is used with other medications in adults with epilepsy. Side effects of Keppra include drowsiness and dizziness.

The recommended initial dosage of Keppra is 1,000 mg/day, given as twice-daily dosing (500 mg twice daily). Additional dosing increments may be given (1,000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3,000 mg. Do not to drive, use machinery or do any activity that requires alertness while taking Keppra. Keppra may interact with other antiepileptic drugs. Tell your doctor all medications you use. Keppra should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Talk to your doctor about taking Keppra if you are breastfeeding.

Our Keppra (levetiracetam) Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Keppra Injection FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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

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.

The adverse reactions that result from KEPPRA injection use include all of those reported for KEPPRA tablets and oral solution. Equivalent doses of intravenous (IV) levetiracetam and oral levetiracetam result in equivalent Cmax, Cmin, and total systemic exposure to levetiracetam when the IV levetiracetam is administered as a 15-minute infusion.

Partial Onset Seizures

Adults

In controlled clinical studies using KEPPRA tablets in adults with partial onset seizures, the most common adverse reactions in adult patients receiving KEPPRA in combination with other AEDs, for events with rates greater than placebo, were somnolence, asthenia, infection, and dizziness. Of the most common adverse reactions in adults experiencing partial onset seizures, asthenia, somnolence, and dizziness occurred predominantly during the first 4 weeks of treatment with KEPPRA.

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

Table 4: Adverse Reactions* in Adults Experiencing Partial Onset Seizures

  KEPPRA
(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
* Adverse reactions occurred in at least 1% of KEPPRA-treated patients and occurred more frequently than placebo-treated patients

In controlled adult clinical studies using KEPPRA tablets, 15% of patients receiving KEPPRA and 12% receiving placebo either discontinued or had a dose reduction as a result of an adverse reaction. Table 5 lists the most common ( > 1%) adverse reactions that resulted in discontinuation or dose reduction and that occurred more frequently in KEPPRA-treated patients than in placebo-treated patients.

Table 5: Adverse Reactions That Most Commonly Resulted in Discontinuation or Dose Reduction in Adults Experiencing Partial Onset Seizures

Adverse Reaction KEPPRA
(N=769) %
Placebo
(N=439) %
Somnolence 4 2
Dizziness 1 0

Pediatric Patients 4 Years to < 16 Years

The adverse reaction data presented below was obtained from a pooled analysis of two controlled pediatric clinical studies using an oral formulation in pediatric patients 4 to 16 years of age with partial onset seizures. The most common adverse reactions in pediatric patients receiving KEPPRA in combination with other AEDs, for events with rates greater than placebo, were fatigue, aggression, nasal congestion, decreased appetite, and irritability.

Table 6 lists adverse reactions from the pooled pediatric controlled studies (4 to 16 years of age) that occurred in at least 2% of pediatric KEPPRA-treated patients and were numerically more common than in pediatric patients treated with placebo. In these studies, either KEPPRA or placebo was added to concurrent AED therapy.

Table 6: Adverse Reactions* in Pediatric Patients Ages 4 to 16 Years Experiencing Partial Onset Seizures

  KEPPRA
(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 2
Lethargy 6 5
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
* Adverse reactions occurred in at least 2% of pediatric KEPPRA-treated patients and occurred more frequently than placebo-treated patients

In the controlled pooled pediatric clinical studies in patients 4-16 years of age, 7% of patients receiving KEPPRA and 9% receiving placebo discontinued as a result of an adverse reaction.

Pediatric Patients 1 Month to < 4 Years

In the 7-day controlled pediatric clinical study using an oral formulation of KEPPRA in children 1 month to less than 4 years of age with partial onset seizures, the most common adverse reactions in patients receiving KEPPRA in combination with other AEDs, for events with rates greater than placebo, were somnolence and irritability. Because of the shorter exposure period, incidences of adverse reactions are expected to be lower than in other pediatric studies in older patients. Therefore, other controlled pediatric data, presented above, should also be considered to apply to this age group.

Table 7 lists adverse reactions that occurred in at least 5% of pediatric epilepsy patients (ages 1 month to < 4 years) treated with KEPPRA participating in the placebo-controlled study and were numerically more common than in patients treated with placebo. In this study, either KEPPRA or placebo was added to concurrent AED therapy.

Table 7: Adverse Reactions* in Pediatric Patients Ages 1 Month to < 4 Years Experiencing Partial Onset Seizures

  KEPPRA
(N=60)%
Placebo
(N=56)%
Somnolence 13 2
Irritability 12 0
* Adverse reactions occurred in at least 5% of KEPPRA-treated patients and occurred more frequently than placebo-treated patients

In the 7-day controlled pediatric clinical study in patients 1 month to < 4 years of age, 3% of patients receiving KEPPRA and 2% receiving placebo either discontinued or had a dose reduction as a result of an adverse reaction. There was no adverse reaction that resulted in discontinuation for more than one patient.

Myoclonic Seizures

Although the pattern of adverse reactions in this study seems somewhat different from that seen in patients with partial seizures, this is likely due to the much smaller number of patients in this study compared to partial seizure studies. The adverse reaction pattern for patients with JME is expected to be essentially the same as for patients with partial seizures.

In the controlled clinical study using KEPPRA tablets in patients with myoclonic seizures, the most common adverse reactions in patients receiving KEPPRA in combination with other AEDs, for events with rates greater than placebo, were somnolence, neck pain, and pharyngitis.

Table 8 lists adverse reactions that occurred in at least 5% of juvenile myoclonic epilepsy patients experiencing myoclonic seizures treated with KEPPRA tablets and were numerically more common than in patients treated with placebo. In this study, either KEPPRA or placebo was added to concurrent AED therapy.

Table 8: Adverse Reactions* in Patients 12 Years Of Age and Older With Myoclonic Seizures

  KEPPRA
(N=60) %
Placebo
(N=60) %
Somnolence 12 2
Neck pain 8 2
Pharyngitis 7 0
Depression 5 2
Influenza 5 2
Vertigo 5 3
* Adverse reactions occurred in at least 5% of KEPPRA-treated patients and occurred more frequently than placebo-treated patients

In the placebo-controlled study using KEPPRA tablets in patients with JME, 8% of patients receiving KEPPRA and 2% receiving placebo either discontinued or had a dose reduction as a result of an adverse reaction. The adverse reactions that led to discontinuation or dose reduction and that occurred more frequently in KEPPRA-treated patients than in placebo-treated patients are presented in Table 9.

Table 9: Adverse Reactions That Resulted In Discontinuation or Dose Reduction in Patients With Juvenile Myoclonic Epilepsy

Adverse Reaction KEPPRA (N=60) % Placebo (N=60) %
Anxiety 3 2
Depressed mood 2 0
Depression 2 0
Diplopia 2 0
Hypersomnia 2 0
Insomnia 2 0
Irritability 2 0
Nervousness 2 0
Somnolence 2 0

Primary Generalized Tonic-Clonic Seizures

Although the pattern of adverse reactions in this study seems somewhat different from that seen in patients with partial seizures, this is likely due to the much smaller number of patients in this study compared to partial seizure studies. The adverse reaction pattern for patients with primary generalized tonic-clonic (PGTC) seizures is expected to be essentially the same as for patients with partial seizures.

In the controlled clinical study that included patients 4 years of age and older with PGTC seizures, the most common adverse reaction in patients receiving KEPPRA oral formulation in combination with other AEDs, for events with rates greater than placebo was nasopharyngitis.

Table 10 lists adverse reactions that occurred in at least 5% of idiopathic generalized epilepsy patients experiencing PGTC seizures treated with KEPPRA and were numerically more common than in patients treated with placebo. In this study, either KEPPRA or placebo was added to concurrent AED therapy.

Table 10: Adverse Reactions* in Patients 4 Years of Age and Older With PGTC Seizures

  KEPPRA
(N=79) %
Placebo
(N=84) %
Nasopharyngitis 14 5
Fatigue 10 8
Diarrhea 8 7
Irritability 6 2
Mood swings 5 1
* Adverse reactions occurred in at least 5% of KEPPRA-treated patients and occurred more frequently than placebo-treated patients

In the placebo-controlled study, 5% of patients receiving KEPPRA and 8% receiving placebo either discontinued or had a dose reduction during the treatment period as a result of an adverse reaction.

This study was too small to adequately characterize the adverse reactions that could be expected to result in discontinuation of treatment in this population. It is expected that the adverse reactions that would lead to discontinuation in this population would be similar to those resulting in discontinuation in other epilepsy trials (see tables 5 and 9).

In addition, the following adverse reactions were seen in other controlled adult studies of KEPPRA: balance disorder, disturbance in attention, eczema, memory impairment, myalgia, and vision blurred.

Comparison of Gender, Age and Race

The overall adverse reaction profile of KEPPRA was similar between females and males. There are insufficient data to support a statement regarding the distribution of adverse experience reports by age and race.

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of KEPPRA. 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.

The following adverse events have been reported in patients receiving KEPPRA worldwide. The listing is alphabetized: abnormal liver function test, choreoathetosis, dyskinesia, erythema multiforme, hepatic failure, hepatitis, hyponatremia, leukopenia, muscular weakness, neutropenia, pancreatitis, pancytopenia (with bone marrow suppression identified in some of these cases), panic attack, thrombocytopenia, and weight loss. Alopecia has been reported with KEPPRA use; recovery was observed in majority of cases where KEPPRA was discontinued.

Read the entire FDA prescribing information for Keppra Injection (Levetiracetam) »

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