Myoclonic Epilepsy Treatments
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Generic Name
Levetiracetam
Brand Names
Elepsia, Keppra, Roweepra, Spritam
FDA approval date: April 24, 2000
Form: Injection, Tablet, Solution
What is Elepsia (Levetiracetam)?
ELEPSIA XR is indicated as adjunctive therapy for the treatment of partial-onset seizures in patients 12 years of age and older. ELEPSIA XR is indicated as adjunctive therapy for the treatment of partial-onset seizures in patients 12 years of age and older
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A Phase II Randomized Open-Label Trial of Levetiracetam for Prevention of Seizures in Patients With Brain Metastases in Primary Motor Cortex
Summary: This is a randomized trial for patients with brain metastases in the primary motor cortex who have not had seizures to receive either the prophylactic anti-seizure medication levetiracetam (also known by its trade name Keppra) or proceed with standard of care management, which does not currently include prophylactic levetiracetam. Patients who enroll to this trial will be randomized to receive pro...
Clinical Trial Evaluating the Efficacy and Safety of AGB101 for Treatment of Parkinson's Disease Related Psychosis
Summary: This clinical trial will test whether AGB101 (low-dose levetiracetam, 220 mg, extended release tablet) can improve symptoms of psychosis in Parkinson's disease. Participants will be asked to complete up to 5 in-person study visits over approximately 20 weeks. Participants will receive both AGB101 and a placebo to take once a day for 6 weeks, with a 4-week washout in between. Participation will als...
Seizure Treatment IN Glioma (STING): Comparing a Treatment Strategy With Levetiracetam Versus Treatment With Valproic Acid in Glioma Patients With a First Seizure
Summary: Currently, treatment with a specific anti-epileptic drug mainly depends on the physicians' preference, as there are no studies supporting the use of one specific anticonvulsant in glioma patients. The overall aim of this randomized controlled trial is to directly compare the effectiveness of treatment with levetiracetam or valproic acid in glioma patients with a first seizure.
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Brand Information
ELEPSIA XR 1000 MG (levetiracetam)
1INDICATIONS AND USAGE
ELEPSIA XR is indicated as adjunctive therapy for the treatment of partial-onset seizures in patients 12 years of age and older.
2DOSAGE FORMS AND STRENGTHS
Extended-release tablets:
- 1000 mg: oval biconvex, coated, blue and white to off-white, bilayer tablet with drilled portal on blue layer; imprinted with "574" with black ink on one side and plain on the other side.
- 1500 mg: oval biconvex, coated, blue and white to off-white, bilayer tablet with drilled portal on blue layer; imprinted with "575" with black ink on one side and plain on the other side.
3CONTRAINDICATIONS
ELEPSIA XR is contraindicated in patients with a hypersensitivity to levetiracetam. Reactions have included anaphylaxis and angioedema
4ADVERSE REACTIONS
The following serious adverse reactions are discussed in more detail in other sections of labeling:
- Behavioral Abnormalities and Psychotic Symptoms
- Suicidal Behavior and Ideation
- Somnolence and Fatigue
- Anaphylaxis and Angioedema
- Serious Dermatological Reactions
- Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity
- Coordination Difficulties
- Hematologic Abnormalities
4.1Clinical 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.
4.2Postmarketing Experience
The following adverse reactions have been identified during postapproval use of immediate-release levetiracetam tablets. 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 listing is alphabetized: abnormal liver function test, acute kidney injury, anaphylaxis, angioedema, agranulocytosis, choreoathetosis, drug reaction with eosinophilia and systemic symptoms (DRESS), dyskinesia, erythema multiforme, hepatic failure, hepatitis, hyponatremia, muscular weakness, pancreatitis, pancytopenia (with bone marrow suppression identified in some of these cases), panic attack, thrombocytopenia, weight loss, and worsening of seizures. Alopecia has been reported with immediate-release levetiracetam tablet use; recovery was observed in majority of cases where immediate-release levetiracetam tablets were discontinued.
5DESCRIPTION
ELEPSIA XR contains levetiracetam, an antiepileptic drug, as extended-release tablets for oral administration.
The chemical name of levetiracetam, a single enantiomer, is (-)-(S)-α-ethyl-2-oxo-1-pyrrolidine acetamide, its molecular formula is C
Levetiracetam, USP is a white to off-white crystalline powder with a faint odor and a bitter taste. It is very soluble in water (104 g/100 mL). It is freely soluble in chloroform (65.3 g/100 mL) and in methanol (53.6 g/100 mL), soluble in ethanol (16.5 g/100 mL), sparingly soluble in acetonitrile (5.7 g/100 mL), and practically insoluble in n-hexane.
Each extended-release tablet contains 1000 mg or 1500 mg of levetiracetam. Inactive ingredients: amino methacrylate copolymer, colloidal silicon dioxide, crospovidone, dibutyl sebacate, ethyl cellulose, FD&C Blue #1 aluminum lake, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 20, polysorbate 80, polyvinyl alcohol, povidone, silicified microcrystalline cellulose, sodium lauryl sulfate, talc, and triethyl citrate. The imprinting ink contains ammonium hydroxide, iron oxide black, N-butyl alcohol, propylene glycol, and shellac glaze.
ELEPSIA XR is a bilayer coated tablet. The medication is present in core of tablet and release controlling polymers are present in core and coating of tablet. The biologically inert components of core tablet and/or coating may occasionally remain intact during GI transit and may be eliminated in feces as inert fragments of coating and/or soft, hydrated mass.
6CLINICAL STUDIES
The efficacy of ELEPSIA XR is based upon bioavailability studies comparing levetiracetam extended-release tablets to ELEPSIA XR extended-release tablets
The effectiveness of levetiracetam extended-release tablets as adjunctive therapy in partial-onset seizures in adults was established in one multicenter, randomized, double-blind, placebo-controlled clinical study in patients who had refractory partial-onset seizures with or without secondary generalization. This was supported by the demonstration of efficacy of immediate-release levetiracetam tablets (see below) in partial seizures in three multicenter, randomized, double-blind, placebo-controlled clinical studies in adults, as well as a demonstration of comparable bioavailability between the extended-release and immediate-release formulations
6.1Levetiracetam Extended-Release Tablets in Adults
The effectiveness of levetiracetam extended-release tablets as adjunctive therapy (added to other antiepileptic drugs) was established in one multicenter, randomized, double-blind, placebo-controlled clinical study across 7 countries in patients who had refractory partial-onset seizures with or without secondary generalization (Study 1).
6.2Immediate-Release Levetiracetam Tablets in Adults
The effectiveness of immediate-release levetiracetam as adjunctive therapy (added to other antiepileptic drugs) in adults was established in three multicenter, randomized, double-blind, placebo-controlled clinical studies in patients who had refractory partial-onset seizures with or without secondary generalization (Studies 2, 3, and 4). The tablet formulation was used in all three studies. In these studies, 904 patients were randomized to placebo, levetiracetam 1000 mg, levetiracetam 2000 mg, or levetiracetam 3000 mg/day. Patients enrolled in Study 2 or Study 3 had refractory partial-onset seizures for at least two years, and had taken two or more AEDs. Patients enrolled in Study 4 had refractory partial-onset seizures for at least 1 year and had taken one AED. At the time of the study, patients were taking a stable dose regimen of at least one AED, and could take a maximum of two AEDs. During the baseline period, patients had to have experienced at least two partial-onset seizures during each 4-week period.
6.3Immediate-Release Levetiracetam in Pediatric Patients 4 Years to 16 Years
The use of levetiracetam extended-release tablets in pediatric patients 12 years of age and older is supported by Study 5, which was conducted using immediate-release levetiracetam. ELEPSIA XR is not indicated in pediatric patients below 12 years of age.
7PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved Patient Labeling (Medication Guide).
8MEDICATION GUIDE
ELEPSIA™ XR (e lep' see a ex are)
Read this Medication Guide before you start taking ELEPSIA XR and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.
What is the most important information I should know about ELEPSIA XR?
Like other antiepileptic drugs, ELEPSIA XR may cause suicidal thoughts or actions in a very small number of people, about 1 in 500 people taking it.
Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:
- thoughts about suicide or dying
- attempts to commit suicide
- new or worse depression
- new or worse anxiety
- feeling agitated or restless
- panic attacks
- trouble sleeping (insomnia)
- new or worse irritability
- acting aggressive, being angry, or violent
- acting on dangerous impulses
- an extreme increase in activity and talking (mania)
- other unusual changes in behavior or mood
Do not stop ELEPSIA XR without first talking to a healthcare provider.
- Stopping ELEPSIA XR suddenly can cause serious problems. Stopping a seizure medicine suddenly can cause seizures that will not stop (status epilepticus).
- Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes.
How can I watch for early symptoms of suicidal thoughts and actions?
- Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
- Keep all follow-up visits with your healthcare provider as scheduled.
Call your healthcare provider between visits as needed, especially if you are worried about symptoms.
What is ELEPSIA XR?
ELEPSIA XR is a prescription medicine taken by mouth that is used with other medicines to treat partial onset seizures in people 12 years of age and older.
It is not known if ELEPSIA XR is safe or effective in people under 12 years of age.
Who should not take ELEPSIA XR?
Do not take ELEPSIA XR if you are allergic to levetiracetam.
What should I tell my healthcare provider before starting ELEPSIA XR?
Before taking ELEPSIA XR, tell your healthcare provider about all of your medical conditions, including if you:
- have or have had depression, mood problems or suicidal thoughts or behavior.
- have kidney problems.
- are pregnant or planning to become pregnant. It is not known if ELEPSIA XR will harm your unborn baby. You and your healthcare provider will have to decide if you should take ELEPSIA XR while you are pregnant. If you become pregnant while taking ELEPSIA XR, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334 or go to http://www.aedpregnancyregistry.org. The purpose of this registry is to collect information about the safety of ELEPSIA XR and other antiepileptic medicines during pregnancy.
- are breastfeeding or plan to breastfeed. ELEPSIA XR can pass into your breast milk. It is not known if the ELEPSIA XR that passes into your breast milk can harm your baby. Talk to your healthcare provider about the best way to feed your baby while you receive ELEPSIA XR.
Tell your healthcare provider about all the medicines you take, including prescription and over -the-counter medicines, vitamins, and herbal supplements. Do not start a new medicine without first talking with your healthcare provider.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist each time you get a new medicine.
How should I take ELEPSIA XR?
Take ELEPSIA XR exactly as your healthcare provider tells you take it.
- Your healthcare provider will tell you how much ELEPSIA XR to take and when to take it. ELEPSIA XR is usually taken 1 time per day.
- Your healthcare provider may change your dose.
- Swallow the tablets whole.
- Each coated tablet has 2 layers, a blue layer and a white to off-white layer. If you
- The inactive part of ELEPSIA XR tablets may not dissolve after all the medicine has been released in your body. You may sometimes notice something in your bowel movement that looks like pieces of coating or swollen pieces of the original tablet. This is normal.
- If you take too much ELEPSIA XR, call your local Poison Control Center or go to the nearest emergency room right away.
What should I avoid while taking ELEPSIA XR?
Do not drive, operate machinery or do other dangerous activities until you know how ELEPSIA XR affects you. ELEPSIA XR may make you dizzy or sleepy.
What are the possible side effects of ELEPSIA XR?
See
Call your healthcare provider right away if you have any of these symptoms:
- mood and behavior changes such as aggression, agitation, anger, anxiety, apathy, mood swings, depression, hostility, and irritability. A few people may get psychotic symptoms such as hallucinations (seeing or hearing things that are really not there), delusions (false or strange thoughts or beliefs) and unusual behavior.
- extreme sleepiness, tiredness, and weakness
- problems with muscle coordination (problems walking and moving)
- allergic reactions such as swelling of the face, lips, eyes, tongue, and throat, trouble swallowing or breathing, and hives.
- a skin rash. Serious skin rashes can happen after you start taking ELEPSIA XR. There is no way to tell if a mild rash will become a serious reaction.
- a serious allergic reaction that may affect your skin or other parts of your body such as your liver, kidneys, heart, or blood cells. This allergic reaction can be life-threatening and can cause death, particularly if it is not treated as early as possible. Call your healthcare provider right away if you have:
Common side effects seen in people who take ELEPSIA XR:
- flu
- sleepiness
- irritability
- nasal congestion, sore throat, and runny nose (nasopharyngitis)
- dizziness
- nausea
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of ELEPSIA XR. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store ELEPSIA XR?
Store ELEPSIA XR at room temperature, between 68°F to 77°F (20°C to 25°C) away from light.
Keep ELEPSIA XR and all medicines out of the reach of children.
General information about the safe and effective use of ELEPSIA XR.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ELEPSIA XR for a condition for which it was not prescribed. Do not give ELEPSIA XR to other people, even if they have the same symptoms that you have. It may harm them.
You can ask your pharmacist or healthcare provider for information about ELEPSIA XR that is written for health professionals.
What are the ingredients of ELEPSIA XR?
Active ingredient: levetiracetam
Inactive ingredients: amino methyacrylate copolymer, colloidal silicon dioxide, crospovidone, dibutyl sebacate, ethyl cellulose, FD&C Blue #1 aluminum lake, hypromellose, magnesium stearate, polyethylene glycol, polysorbate 20, polysorbate 80, polyvinyl alcohol, povidone, silicified microcrystalline cellulose, sodium lauryl sulfate, talc, and triethyl citrate. The imprinting ink contains ammonium hydroxide, iron oxide black, N-butyl alcohol, propylene glycol, and shellac glaze.
Rx Only
Manufactured by
Manufactured for
Copyright 2020, Tripoint Therapeutics LLC
For more information, call Tripoint Therapeutics at (908) 928-4500.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Revised: 03/2024
9PRINCIPAL DISPLAY PANEL - 1000 mg Tablet Bottle Label
NDC 80705-100-30
ELEPSIA™ XR
1000 mg
Once Daily Dosing
PHARMACIST: Dispense with Medication
Rx only
Tripoint
30 tablets
10PRINCIPAL DISPLAY PANEL - 1500 mg Tablet Bottle Label
NDC 80705-101-30
ELEPSIA™ XR
1500 mg
Once Daily Dosing
PHARMACIST: Dispense with Medication
Rx only
Tripoint
30 tablets
