Kigabeq
Authorised
This medicine is authorised for use in the European Union
vigabatrin
Medicine
Human
Authorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Kigabeq is a medicine for treating epilepsy in children between 1 month and 7 years of age. It is used in the following ways:
- on its own to treat infantile spasms (West syndrome), a rare epilepsy disorder that starts at a very young age, usually in the first few months of life;
- together with other medicines to treat partial epilepsy (seizures affecting one part of the brain), including when the seizures spread to other parts of the brain and become more generalised. Kigabeq is only used in partial epilepsy when patients have already tried all other appropriate treatments or cannot use them because of side effects.
Kigabeq contains the active substance vigabatrin and is a ‘hybrid medicine’. This means that it is similar to a ‘reference medicine’ containing the same active substance, but Kigabeq is available in a different form and strengths. The reference medicine for Kigabeq is Sabril (500 mg granules).
Kigabeq can only be obtained with a prescription and treatment must started and supervised by a doctor specialising in the treatment of epilepsy or nervous system disorders. The medicine is available as soluble tablets of 100 or 500 mg, with a score-line so they can be halved. The tablets are dissolved in water to make a solution for the patient to drink. In patients who cannot drink it can be given by a tube into the stomach.
The dose depends on the condition being treated and the patient’s body weight, and is adjusted according to the patient’s response to treatment. For more information about using Kigabeq, see the package leaflet or contact your doctor or pharmacist.
The active substance in Kigabeq, vigabatrin, blocks the action of an enzyme called GABA transaminase, which breaks down a substance in the brain called GABA (gamma aminobutyric acid). GABA reduces the electrical activity of the brain. Blocking the enzyme that breaks it down increases the amount of GABA present in the brain, and so increases its effect. This helps suppress the abnormal electrical activity that leads to infantile spasms and partial epilepsy, and so controls the symptoms of these conditions.
The company provided information from the published literature on the benefits and risks of vigabatrin in the approved uses.
As for every medicine, the company provided studies on the quality of Kigabeq. It also carried out a study that showed that Kigabeq is bioequivalent to the reference medicine, Sabril. Two medicines are bioequivalent when they produce the same levels of the active substance in the body and are therefore expected to have the same effect.
The most common side effects with vigabatrin (which may affect more than 1 in 10 people) are visual field defects (effects on vision), tiredness, sleepiness and joint pains. Because the effects on vision can lead to blindness, vigabatrin should only be used after careful assessment of possible alternatives, and patients’ vision must be regularly tested during treatment. Vigabatrin should not be used in patients who already have visual field defects.
Other common side effects include psychiatric disorders such as agitation, excitedness, aggression, nervousness, depression and paranoid reactions, as well as reduced consciousness and confusion. Rarely there may be effects on the retina (the light-sensing layer at the back of the eye), encephalopathy (brain damage) or attempts at suicide.
For the full list of side effects and restrictions with Kigabeq, see the package leaflet.
The European Medicines Agency decided that in accordance with EU requirements, Kigabeq has been shown to have comparable quality and to be bioequivalent to Sabril. Therefore, the Agency’s view was that, as for Sabril, Kigabeq’s benefits are greater than its risks and it can be authorised for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Kigabeq have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Kigabeq are continuously monitored. Side effects reported with Kigabeq are carefully evaluated and any necessary action taken to protect patients.
Kigabeq received a marketing authorisation valid throughout the EU on 20 September 2018.
Product information
Latest procedure affecting product information:N/0015
16/01/2025
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Kigabeq
- Active substance
- vigabatrin
- International non-proprietary name (INN) or common name
- vigabatrin
- Therapeutic area (MeSH)
- Spasms, Infantile
- Epilepsies, Partial
- Anatomical therapeutic chemical (ATC) code
- N03AG04
Pharmacotherapeutic group
AntiepilepticsTherapeutic indication
Kigabeq is indicated in infants and children from 1 month to less than 7 years of age for:
- Treatment in monotherapy of infantile spasms (West's syndrome).
- Treatment in combination with other antiepileptic medicinal products for patients with resistant partial epilepsy (focal onset seizures) with or without secondary generalisation, that is where all other appropriate medicinal product combinations have proved inadequate or have not been tolerated.
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