Recommended Topic Related To:

Keppra Injection

"The U.S. Food and Drug Administration today approved a device to help reduce the frequency of seizures in epilepsy patients who have not responded well to medications.

The RNS Stimulator consists of a small neurostimulator implanted within "...

Keppra Injection

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

Clinical Studies 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 (levetiracetam) 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.

The prescriber should be aware that the adverse reaction incidence figures in the following tables, obtained when KEPPRA was added to concurrent AED therapy, cannot be used to predict the frequency of adverse experiences in the course of usual medical practice where patient characteristics and other factors may differ from those prevailing during clinical studies. Similarly, the cited frequencies cannot be directly compared with figures obtained from other clinical investigations involving different treatments, uses, or investigators. An inspection of these frequencies, however, does provide the prescriber with one basis to estimate the relative contribution of drug and non-drug factors to the adverse reaction incidences in the population studied.

Partial Onset Seizures

In well-controlled clinical studies using KEPPRA tablets in adults with partial onset seizures, the most frequently reported adverse reactions in patients receiving KEPPRA in combination with other AEDs, not seen at an equivalent frequency among placebo-treated patients, were somnolence, asthenia, infection and dizziness.

Of the most frequently reported adverse reactions in placebo-controlled studies using KEPPRA tablets in adults experiencing partial onset seizures, asthenia, somnolence and dizziness appeared to occur predominantly during the first 4 weeks of treatment with KEPPRA.

Table 3 lists treatment-emergent 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. Adverse reactions were usually mild to moderate in intensity.

Table 3: Incidence (%) Of Treatment-Emergent Adverse Reactions In Placebo-Controlled, Add-On Studies In Adults Experiencing Partial Onset Seizures By Body System (Adverse Reactions Occurred In At Least 1% Of KEPPRA-Treated Patients And Occurred More Frequently Than Placebo-Treated Patients)

Body System/
  Adverse Reaction
KEPPRA
(N=769)
%
Placebo
(N=439)
%
Body as a Whole
  Asthenia 15 9
  Headache 14 13
  Infection 13 8
  Pain 7 6
Digestive System
  Anorexia 3 2
Nervous System
  Somnolence 15 8
  Dizziness 9 4
  Depression 4 2
  Nervousness 4 2
  Ataxia 3 1
  Vertigo 3 1
  Amnesia 2 1
  Anxiety 2 1
  Hostility 2 1
  Paresthesia 2 1
  Emotional Lability 2 0
Respiratory System
  Pharyngitis 6 4
  Rhinitis 4 3
  Cough Increased 2 1
  Sinusitis 2 1
Special Senses
  Diplopia 2 1

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 well-controlled clinical study using KEPPRA tablets in patients with myoclonic seizures, the most frequently reported adverse reactions in patients using KEPPRA in combination with other AEDs, not seen at an equivalent frequency among placebo-treated patients, were somnolence, neck pain, and pharyngitis.

Table 4 lists treatment-emergent 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. Adverse reactions were usually mild to moderate in intensity.

Table 4: Incidence (%) Of Treatment-Emergent Adverse Reactions In A Placebo-Controlled, Add-On Study In Patients With Myoclonic Seizures By Body System (Adverse Reactions Occurred In At Least 5% Of KEPPRA-Treated Patients And Occurred More Frequently Than Placebo-Treated Patients)

Body System/
  Adverse Reaction
KEPPRA
(N=60)
%
Placebo
(N=60)
%
Ear and labyrinth disorders
  Vertigo 5 3
Infections and infestations
  Pharyngitis 7 0
  Influenza 5 2
Musculoskeletal and connective tissue disorders
  Neck pain 8 2
Nervous system disorders
  Somnolence 12 2
Psychiatric disorders
  Depression 5 2

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 PGTC seizures is expected to be essentially the same as for patients with partial seizures.

In the well-controlled clinical study that included patients 4 years of age and older with primary generalized tonic- clonic (PGTC) seizures, the most frequently reported adverse reaction associated with the use of KEPPRA in combination with other AEDs, not seen at an equivalent frequency among placebo-treated patients, was nasopharyngitis.

Table 5 lists treatment-emergent 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. Adverse reactions were usually mild to moderate in intensity.

Table 5: Incidence (%) Of Treatment-Emergent Adverse Reactions In A Placebo-Controlled, Add-On Study In Patients 4 Years Of Age And Older With PGTC Seizures By MedDRA System Organ Class (Adverse Reactions Occurred In At Least 5% Of KEPPRA-Treated Patients And Occurred More Frequently Than Placebo-Treated Patients)

Body System/
  Adverse Reaction
KEPPRA
(N=79)
%
Placebo
(N=84)
%
Gastrointestinal disorders
  Diarrhea 8 7
General disorders and administration site conditions
  Fatigue 10 8
Infections and infestations
  Nasopharyngitis 14 5
Psychiatric disorders
  Irritability 6 2
  Mood swings 5 1

Discontinuation Or Dose Reduction In Well-Controlled Clinical Studies

Partial Onset Seizures In well-controlled adult clinical studies using KEPPRA tablets, 15.0% of patients receiving KEPPRA and 11.6% receiving placebo either discontinued or had a dose reduction as a result of an adverse event. Table 6 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 6: Adverse Reactions That Most Commonly Resulted In Discontinuation Or Dose Reduction That Occurred More Frequently in KEPPRA-Treated Patients In Placebo-Controlled Studies In Adult Patients Experiencing Partial Onset Seizures

Adverse Reaction KEPPRA
(N=769)
n (%)
Placebo
(N=439)
n (%)
Asthenia 10 (1.3%) 3 (0.7%)
Dizziness 11 (1.4%) 0
Somnolence 34 (4.4%) 7 (1.6%)

Myoclonic Seizures

In the placebo-controlled study using KEPPRA tablets, 8.3% of patients receiving KEPPRA and 1.7% receiving placebo either discontinued or had a dose reduction as a result of an adverse event. The adverse reactions that led to discontinuation or dose reduction in the well-controlled study and that occurred more frequently in KEPPRA-treated patients than in placebo-treated patients are presented in Table 7.

Table 7: Adverse Reactions That Resulted In Discontinuation Or Dose Reduction That Occurred More Frequently in KEPPRA-Treated Patients In The Placebo-Controlled Study In Patients With Juvenile Myoclonic Epilepsy

Adverse Reaction KEPPRA
(N=60)
n (%)
Placebo
(N=60)
n (%)
Anxiety 2 (3.3%) 1 (1.7%)
Depressed mood 1 (1.7%) 0
Depression 1 (1.7%) 0
Diplopia 1 (1.7%) 0
Hypersomnia 1 (1.7%) 0
Insomnia 1 (1.7%) 0
Irritability 1 (1.7%) 0
Nervousness 1 (1.7%) 0
Somnolence 1 (1.7%) 0

Primary Generalized Tonic-Clonic Seizures

In the placebo-controlled study, 5.1% of patients receiving KEPPRA and 8.3% receiving placebo either discontinued or had a dose reduction during the treatment period as a result of a treatment-emergent adverse reaction.

This study was too small to adequately characterize the adverse reactions leading to discontinuation. 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 6 - 7).

Comparison Of Gender, Age And Race

The overall adverse experience 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 events have been identified during postapproval use of KEPPRA. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a casual relationship to drug exposure.

In addition to the adverse reactions listed above [see ADVERSE REACTIONS], the following adverse events have been reported in patients receiving marketed KEPPRA worldwide. The listing is alphabetized: abnormal liver function test, hepatic failure, hepatitis, leukopenia, neutropenia, pancreatitis, pancytopenia (with bone marrow suppression identified in some of these cases), thrombocytopenia and weight loss. Alopecia has been reported with KEPPRA use; recovery was observed in majority of cases where KEPPRA was discontinued. There have been reports of suicidal behavior (including completed suicide) with marketed KEPPRA.

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

A A A

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Epilepsy

Find tips and treatments to control seizures.

Related Supplements
advertisement
advertisement
Use Pill Finder Find it Now See Interactions

Pill Identifier on RxList

  • quick, easy,
    pill identification

Find a Local Pharmacy

  • including 24 hour, pharmacies

Interaction Checker

  • Check potential drug interactions
Search the Medical Dictionary for Health Definitions & Medical Abbreviations