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).
How is Kigabeq used?
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.
How does Kigabeq
work?
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.
What benefits of Kigabeq
have been shown in studies?
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.
What are the risks
associated with Kigabeq?
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.
Why is Kigabeq
authorised in the EU?
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.
What measures are
being taken to ensure the safe and effective use of Kigabeq?
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.
Other information
about Kigabeq
Kigabeq received
a marketing authorisation valid throughout the EU on 20
September 2018.
