Levetiracetam Sun

What is Levetiracetam Sun?

Levetiracetam Sun is a medicine that contains the active substance levetiracetam. It is available as a concentrate for the preparation of a solution for infusion (drip into a vein, 100 mg / ml).

Levetiracetam Sun is a "generic medicine". This means that Levetiracetam Sun is similar to a "reference medicine" already authorized in the European Union (EU) called Keppra. For more information on generic medicines, see the questions and answers by clicking here.

What is Levetiracetam Sun used for?

Levetiracetam Sun is indicated as monotherapy in the treatment of partial onset seizures with or without secondary generalization, in patients from 16 years of age with newly diagnosed epilepsy. This type of epilepsy is evidenced by excessive electrical activity in one part of the brain, with symptoms such as sudden spasmodic movements of a part of the body, problems with hearing, smell or sight, numbness or sudden sense of fear. Secondary generalization occurs when hyperactivity expands subsequently to the whole brain.

Levetiracetam Sun may also be indicated as an adjunctive therapy to other anti-epileptic medicines in the treatment of:

partial onset crisis with or without secondary generalization in patients from four years of age;
myoclonic seizures (short, jerky contractions of a muscle or group of muscles) in patients from 12 years of age with juvenile myoclonic epilepsy;
primary generalized tonic-clonic seizures (more severe crises, in which there is loss of consciousness) in patients from 12 years of age with idiopathic generalized epilepsy (the type of epilepsy believed to be of genetic origin).

Levetiracetam Sun is indicated for patients in whom oral administration is temporarily not possible.

The medicine can only be obtained with a prescription.

How is Levetiracetam Sun used?

In monotherapy, the recommended starting dose of Levetiracetam Sun is 250 mg twice a day, which should be increased to a dose of 500 mg twice a day after two weeks. The dose can be further increased every two weeks based on the clinical response, up to a maximum dose of 1 500 mg twice a day.

When Levetiracetam Sun is added to another anti-epileptic therapy, the starting dose is 500 mg twice a day in patients over 12 years of age, weighing 50 kg or more. The daily dose can be increased up to a maximum of 1 500 mg twice a day. In patients between four and 17 years of age who weigh less than 50 kg, the starting dose is 10 mg per kilogram of body weight twice a day and can be increased up to 30 mg / kg twice a day.

Lower doses are used in subjects with renal function problems (such as elderly patients).

Infusion using Levetiracetam Sun must be temporary.

How does Levetiracetam Sun work?

The active substance in Levetiracetam Sun, levetiracetam, is an anti-epileptic medicine. Epilepsy is caused by excessive electrical activity in the brain. The exact mode of action of levetiracetam is not yet fully known; however, the medicine seems to interfere with a protein, called protein 2A of the synaptic vesicle, present in the space between the nerves, which intervenes in the release of chemical transmitters from nerve cells. This allows Levetiracetam Sun to stabilize electrical activity in the brain and prevent seizures.

How has Levetiracetam Sun been studied?

The company presented data on levetiracetam taken from the scientific literature. No further studies were needed as Levetiracetam Sun is a generic medicine given by infusion and contains the same active substance as the reference medicine, Keppra.

What are the benefits and risks of Levetiracetam Sun?

Because Levetiracetam Sun is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are considered to be the same as those of the reference medicine.

Why has Levetiracetam Sun been approved?

The CHMP concluded that, in accordance with EU requirements, Levetiracetam Sun has been shown to have comparable quality and to be bioequivalent to Keppra. Therefore, the CHMP considered that, as in the case of Keppra, the benefits outweigh the identified risks and recommended the granting of a marketing authorization for Levetiracetam Sun.