EMEA/H/C/004534
EPAR summary of the public
Kigabeq (Aminohexenoate)
Kigabeq overview and its licensing reasons in the EU
What is Kigabeq and what is it used for?
Kigabeq is a treatment for children from 1 month to 7 years oldepilepsymedicine. It is used in the following ways: alone treatmentInfantile spasm(West Syndrome), a rare epilepsy that originates from very small age, usually in the first few months of life; treats partial epilepsy with other drugs (the seizure affects part of the brain), including when Seizures spread to other parts of the brain and become more common. Kigabeq is only used for partial epilepsy, when patients have tried all other appropriate treatments or are unable to use them due to side effects.
Kigabeq contains the active substance aminohexenoic acid, which is a "mixed drug". This means that it is similar to a "reference drug" containing the same active substance, but Kigabeq can be obtained in different forms and strengths. The reference drug for Kigabeq is Sabril (500 mg granules).
How is Kigabeq used?
Kigabeq can only be obtained by prescription, and treatment must be initiated and supervised by a doctor who specializes in treating epilepsy or neurological diseases. The drug can be used as a 100 or 500 mg soluble tablet with a fractional line so they can be halved. The tablets are dissolved in water to prepare a solution for the patient to drink. In patients who are not drinkable, they can enter the stomach through the tube.
The dosage will depend on the condition being treated and the weight of the patient, and will be adjusted based on the patient's response to the treatment. For more information on using Kigabeq, please refer to the package insert or contact your doctor or pharmacist.
How does Kigabeq work?
The active substance in Kigabeq, aminohexenoic acid, blocks the action of an enzyme called GABA transaminase, which breaks down a substance called GABA (gamma aminobutyric acid) in the brain. GABA reduces the electrical activity of the brain. Blocking the enzyme that destroys it increases the amount of GABA present in the brain, thereby increasing its effect. This helps to suppress abnormal electrical activity leading to infantile spasms and partial epilepsy, thereby controlling the symptoms of these conditions.
What are the benefits of Kigabeq already shown in the study?
The company provides information from published literature on the benefits and risks of aminohexenoic acid in approved uses.
As for each drug, the company provides research on the quality of Kigabeq. It also conducted a study showing that Kigabeq is bioequivalent to the reference drug Sabril. When two drugs produce the same level of active substance in the body, they are bioequivalent and therefore are expected to have the same effect.
What are the risks of Kigabeq?
The most common side effects of aminohexenoic acid (which may affect more than 10 people) are visual field defects (effect on vision), fatigue, drowsiness and joint pain. Because the effects on vision can lead to blindness, aminohexenoic acid can only be used after careful evaluation of possible alternatives, and the patient's vision must be tested periodically during treatment. Vigabatrin should not be used in patients with existing visual field defects.
Other common side effects include mental illnesses such as agitation, excitement, aggression, stress, depression and paranoid reactions, as well as reduced consciousness and confusion. It rarely affects the retina (photosensitive layer at the back of the eye), encephalopathy (brain damage) or suicide attempts.
For a complete list of Kigabeq side effects and limitations, please refer to the package insert.
Why is Kigabeq authorized in the EU?
The European Medicines Agency decided that Kigabeq has the same quality and bioequivalence as Sabril, according to EU requirements. Therefore, the IAEA believes that for Sabril, Kigabeq's interests outweigh its risks and can be authorized for use in the EU.
What measures are being taken to ensure the safe and effective use of Kigabeq?
The recommendations and precautions that medical professionals and patients should follow to use Kigabeq safely and effectively are included in the product feature summary and package insert.
As for all drugs, data on the use of Kigabeq is continuously monitored. The side effects reported by Kigabeq have been carefully evaluated and any necessary measures taken to protect the patient.
Additional information about Kigabeq
Kigabeq received an effective listing license throughout the European Union on September 20, 2018.
For more information on Kigabeq, please visit the agency's website at ema.europa.eu/Find medicine / Human medicine / European public assessment reports.
This overview was last updated on 09-2018.
简体中文 