Keppra - levetiracetam

What is Keppra?

Keppra is a medicine that contains the active substance levetiracetam. It is available as oblique-shaped tablets (blue: 250 mg; yellow: 500 mg; orange: 750 mg; white: 1 000 mg), oral solution (100 mg / ml) and concentrate for solution for infusion (drip injection). drop into a vein, 100 mg / ml).

What is Keppra used for?

Keppra can be used on its own in patients from 16 years of age with newly diagnosed epilepsy, in the treatment of partial seizures with or without secondary generalization. It is a type of epilepsy in which there is "excessive electrical activity in one part of the brain, which causes symptoms such as sudden spasmodic movements of a part of the body, problems with hearing, smell or vision, numbness or a sudden sense of fear. Secondary generalization occurs when hyperactivity subsequently expands to the entire brain. Keppra can also be used as an adjuvant in patients who are already taking other antiepileptic drugs to treat:

1. partial seizures with or without generalization in patients from one month of age;
2. in the treatment of myoclonic seizures (short jerky contractions of a muscle or group of muscles) in patients from 12 years of age with juvenile myoclonic epilepsy;
3. in the treatment of primary generalized tonic-clonic seizures (major seizures, including loss of consciousness) in patients from 12 years of age with idiopathic generalized epilepsy (the type of epilepsy believed to have a genetic cause).

The medicine can only be obtained with a prescription.

How is Keppra used?

Keppra monotherapy should be given at a starting dose of 250 mg twice daily, which should be increased to 500 mg twice daily after two weeks. The dose may be further increased at 2-week intervals based on the patient's response up to a maximum dose of 1,500 mg twice daily.
When Keppra is added to another antiepileptic therapy, the starting dose in patients over 12 years of age who weigh more than 50 kg is 500 mg twice daily. The daily dose can be increased up to 1,500 mg twice daily. per day. In patients 6 months to 17 years of age who weigh less than 50 kg the starting dose is 10 mg / kg twice a day, which may be increased
up to 30 mg / kg twice a day. The oral solution is indicated at the beginning of treatment in children weighing less than 20 kg.
In infants aged one to six months, the starting dose is 7mg / kg twice a day, using the oral solution, which can be increased up to 21mg / kg twice a day.
Lower doses are used in patients who have kidney problems (such as older patients).
Keppra tablets can be taken with or without food and swallowed with liquid. The oral solution can be diluted in a glass of water before taking. Keppra can be administered by infusion, at the same doses and frequency, when oral or tablet administration is temporarily not possible.

How does Keppra work?

The active substance in Keppra, levetiracetam, is an antiepileptic drug. Epilepsy is caused by excessive electrical activity in the brain. The exact modes of action of levetiracetam are not yet fully understood. However, it appears to interfere with a protein known as synaptic vesicle protein 2A, which is found in the space between nerves and is involved in the release of chemical transmitters from nerve cells. This allows Keppra to stabilize electrical activity in the brain and prevent seizures.

How has Keppra been studied?

Keppra used on its own has been used in 579 patients aged 16 years and over who were given Keppra or carbamazepine (another anti-epileptic medicine) for up to two years. The study recorded the number of patients who did not report seizures for six months once the effective dose was reached.
Keppra has also been studied as an adjuvant:

1. in the treatment of partial seizures, it has been studied in three main studies involving a total of 904 patients. In these studies, Keppra 1 000 mg, 2 000 mg or 3 000 mg per day was compared with placebo (a dummy treatment) for 12-14 weeks. All patients were taking at least one other antiepileptic drug. Keppra was also compared with placebo in 198 children between the ages of 4 and 17 and in 116 children between the ages of one month and four years. In all of these studies, the main measure of effectiveness was the change in the number of seizures;
2. in myoclonic seizures was studied in 122 patients, who were given Keppra or a placebo as an add-on to their usual antiepileptic drug. The study ran for 30 weeks and looked at the number of seizures before and during the study to check the possible reduction of such episodes;
3. in the treatment of primary generalized tonic-clonic seizures Keppra was compared with placebo in 164 patients aged 4 to 65 years. The study looked at the change in seizure rate between the start of the study and the 20-week period when patients were given the full dose.

What benefit has Keppra shown during the studies?

On its own, in the treatment of partial seizures, Keppra was as effective as carbamazepine in preventing seizures. In both groups, 73% of patients reported no seizures for six months once the adequate dose was reached.
Keppra was more effective than placebo as an add-on therapy:

1. in the case of partial seizures, the placebo treatment resulted in a reduction in the weekly seizure rate of 6% to 7%, while the reduction in the group treated with Keppra at a dose of 1 000 mg per day was between 18% and 33%, depending on the study. With Keppra at a dose of 2,000 mg, the reduction was 27% and with Keppra at a dose of 3,000 mg, 37% or 40%. In children, Keppra was also more effective than placebo;
2. in the case of myoclonic seizures, 58% of the patients receiving Keppra had a reduction of at least half in the number of myoclonic seizures per week compared to 23% of the patients treated with placebo;
3. in the case of tonic-clonic seizures, the mean reduction in the seizure rate was 28% in patients taking placebo, compared with 57% in those taking Keppra. However, the number of children under 12 years of age was too small to support the efficacy of using Keppra for this type of seizure in patients in this age group.

What are the risks associated with Keppra?

The most common side effects (seen in more than 1 in 10 patients) with Keppra are sleepiness and asthenia (weakness) or fatigue. For the full list of side effects reported with Keppra, see the Package Leaflet.
Keppra must not be used in individuals who are potentially hypersensitive (allergic) to levetiracetam or other pyrrolidone derivatives (medicines with a similar structure) or to any of the other substances.

Why has Keppra been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that the benefits of Keppra as monotherapy are greater than its risks in treating partial seizures with or without secondary generalization in newly diagnosed patients over 16 years of age, as well as as a therapy. adjunctive treatment of partial seizures in patients from 1 month of age with epilepsy, of myoclonic seizures in patients from 12 years of age with juvenile myoclonic epilepsy and primary generalized tonic-clonic seizures in patients from 12 years of age of age with idiopathic generalized epilepsy. The committee recommended that Keppra be given a marketing authorization.

Other information about Keppra:

On 29 September 2000, the European Commission issued a "Marketing Authorization" for Keppra, valid throughout the European Union. The "Marketing Authorization" was renewed on 29 September 2005.
The holder of the marketing authorization is UCB Pharma SA.
For the full version of Keppra's EPAR click here.

Last update of this summary: 08-2009

The information on Keppra - levetiracetam published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.