What is Keppra?
Keppra is a medicine that contains the active substance levetiracetam. It is available as oblique tablets (blue: 250 mg; yellow: 500 mg; orange: 750 mg; white: 1 000 mg), in an oral solution (100 mg / ml) and in concentrate for solution for infusion (drop injection drop in 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, hearing problems, smell or sight, numbness or sudden sense of fear. Secondary generalization occurs when hyperactivity expands subsequently to the entire brain. Keppra can also be used as an adjuvant in patients who are already taking other antiepileptic drugs to treat:
- partial seizures with or without generalization in patients from one month of age;
- 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;
- in the treatment of generalized primary tonic-clonic seizures (major seizures, including loss of consciousness) in patients from the age of 12 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?
In monotherapy Keppra should be given at an initial dose of 250 mg twice a day, which should be increased to 500 mg twice a day after two weeks. The dose can be further increased at 2-week intervals based on the patient's response up to a maximum dose of 1 500 mg twice a day.
When Keppra is added to another anti-epileptic therapy, the starting dose in patients over 12 years weighing more than 50 kg is 500 mg twice a day. The daily dose can be increased up to 1 500 mg twice a day. In patients aged 6 months to 17 years who weigh less than 50 kg the initial dose is 10 mg / kg twice a day, which can 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 between one and six months, the starting dose is 7 mg / kg twice a day, using the oral solution, which can be increased up to 21 mg / 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 given 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 anti-epileptic drug. Epilepsy is caused by excessive electrical activity in the brain. The exact mode of action of levetiracetam is still not entirely clear: however, it seems to interfere with a protein known as synaptic vesicle protein 2A, which is located in the space between the nerves and is implicated in the release of chemical transmitters from nerve cells. This allows Keppra to stabilize electrical activity in the brain and prevent seizures.
What studies have been carried out on Keppra?
Keppra used as monotherapy was used in 579 patients aged 16 or over who received Keppra or carbamazepine (another anti-epileptic medicine) for up to two years. The study reported 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:
- 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 a placebo (a dummy treatment) for 12-14 weeks. All patients were taking at least one more anti-epileptic drug. Keppra was also compared with placebo in 198 children aged 4 to 17 years and in 116 children aged between one month and four years. In all these studies, the main measure of effectiveness was the change in the number of crises;
- in myoclonic seizures it was studied in 122 patients, who were given Keppra or a placebo as adjunctive therapy to the usual antiepileptic drug. The study lasted for 30 weeks and examined the number of seizures before and during the study, to verify the possible reduction of these episodes;
- in the treatment of generalized primary tonic-clonic seizures Keppra was compared with placebo in 164 patients aged between 4 and 65 years. The study examined the change in the crisis 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?
In monotherapy, 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 after reaching the appropriate dose.
As adjunctive therapy Keppra was more effective than placebo:
- in the case of partial seizures placebo treatment showed a reduction in the weekly seizure rate of 6% to 7%, while the reduction in the Keppra group 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 of 37% or 40%. In children, Keppra also proved more effective than placebo;
- in the case of myoclonic seizures, 58% of the patients who received Keppra had a reduction of at least half of the number of myoclonic seizures per week compared to 23% of placebo-treated patients;
- in the case of tonic-clonic seizures the average reduction in the seizure rate was 28% in patients taking placebo, compared to 57% of those taking Keppra. However, the number of children under the age of 12 was too limited to support the effectiveness of the use of Keppra for this type of crisis in patients in this age group.
What are the risks associated with Keppra?
The most common side effects (seen in more than 1 patient in 10) with Keppra are drowsiness and asthenia (weakness) or fatigue. For the full list of all side effects reported with Keppra, see the Package Leaflet.
Keppra should not be used in people who may be hypersensitive (allergic) to levetiracetam or other pyrrolidone derivatives (medicines with a similar structure) or to any of the other substances.
Why was Keppra approved?
The Committee for Medicinal Products for Human Use (CHMP) has determined that the benefits of Keppra alone are greater than the risks in treating partial seizures with or without secondary generalization in newly diagnosed patients over the age of 16, as well as therapy additional in the treatment of partial seizures in patients from 1 month of age with epilepsy, 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 with idiopathic generalized epilepsy. The Committee recommended that Keppra be given marketing authorization.
More information on 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 marketing authorization holder is UCB Pharma SA.
The full EPAR for Keppra can be found here.
Last update of this summary: 08-2009
