Source: European Medicines Agency (EU) Revision Year: 2020 Publisher: ORPHELIA Pharma SAS, 85 boulevard Saint-Michel, 75005, PARIS, France
Kigabeq is indicated in infants and children from 1 month to less than 7 years of age for:
Vigabatrin treatment may only be initiated by a specialist in epileptology, neurology or paediatric neurology. Follow-up should be arranged under supervision of a specialist in epileptology, neurology or paediatric neurology.
Monotherapy for infantile spasms (West’s Syndrome) The recommended starting dose is 50 mg/kg/day. Subsequent dosing can be titrated by 25 mg/kg/day increments every 3 days up to the maximum recommended dose of 150 mg/kg/day.
Table 1. Number of soluble tablets according to body weight, starting dose and dose increment in infantile spasms:
| Body weight (kg) | Starting dose of 50 mg/kg/day | Proposed doses for first titration step (75 mg/kg/day) (Day 3) | Proposed doses for second titration step (100 mg/kg/day) (Day 6) |
|---|---|---|---|
| 3 | 0.5 × 100 mg tablet morning | 1.0 × 100 mg tablet morning | 1.5 × 100 mg tablet morning |
| 1 × 100 mg tablet evening | 1.5 × 100 mg tablet evening | 1.5 × 100 mg tablet evening | |
| 4 | 1 × 100 mg tablet morning | 1.5 × 100 mg tablet morning | 2 × 100 mg tablet morning |
| 1 × 100 mg tablet evening | 1.5 × 100 mg tablet evening | 2 × 100 mg tablet evening | |
| 5 | 1 × 100 mg tablet morning | 1.5 × 100 mg tablet morning | 2.5 × 100 mg tablet morning |
| 1.5 × 100 mg tablet evening | 2 × 100 mg tablet evening | 2.5 × 100 mg tablet evening | |
| 6 | 1.5 × 100 mg tablet morning | 2 × 100 mg tablet morning | 3 × 100 mg tablet morning |
| 1.5 × 100 mg tablet evening | 2.5 × 100 mg tablet evening | 3 × 100 mg tablet evening | |
| 7 | 1.5 × 100 mg tablet morning | 2.5 × 100 mg tablet morning | 3.5 × 100 mg tablet morning |
| 2 × 100 mg tablet evening | 2.5 × 100 mg tablet evening | 3.5 × 100 mg tablet evening | |
| 8 | 2 × 100 mg tablet morning | 3 × 100 mg tablet morning | 4 × 100 mg tablet morning |
| 2 × 100 mg tablet evening | 3 × 100 mg tablet evening | 4 × 100 mg tablet evening | |
| 9 | 2 × 100 mg tablet morning | 3.5 × 100 mg tablet morning | 4.5 × 100 mg tablet morning |
| 2.5 × 100 mg tablet evening | 3.5 × 100 mg tablet evening | 4.5 × 100 mg tablet evening | |
| 10 | 0.5 × 500 mg tablet morning | 0.5 × 500 mg tablet morning | 1 × 500 mg tablet morning |
| 0.5 × 500 mg tablet evening | 1 × 500 mg tablet evening | 1 × 500 mg tablet evening | |
| 11 | 2.5 × 100 mg tablet morning | 4 × 100 mg tablet morning | 1 × 500 mg tablet morning |
| 3 × 100 mg tablet evening | 4 × 100 mg tablet evening | 1 × 500 mg και 1 × 100 mg tablet evening | |
| 12 | 3 × 100 mg tablet morning | 4.5 × 100 mg tablet morning | 1 × 500 mg και 1 × 100 mg tablet morning |
| 3 × 100 mg tablet evening | 4.5 × 100 mg tablet evening | 1 × 500 mg και 1 × 100 mg tablet evening | |
| 13 | 3 × 100 mg tablet morning | 4.5 × 100 mg tablet morning | 1 × 500 mg και 1 × 100 mg tablet morning |
| 3.5 × 100 mg tablet evening | 1 × 500 mg tablet evening | 1 × 500 mg και 2 × 100 mg tablet evening | |
| 14 | 3.5 × 100 mg tablet morning | 1 × 500 mg tablet morning | 1 × 500 mg και 2 × 100 mg tablet morning |
| 3.5 × 100 mg tablet evening | 1 × 500 mg tablet evening | 1 × 500 mg και 2 × 100 mg tablet evening | |
| 15 | 0.5 × 500 mg tablet morning | 1 × 500 mg tablet morning | 1.5 × 500 mg tablet morning |
| 1 × 500 mg tablet evening | 1 × 500 mg και 1 × 100 mg tablet evening | 1.5 × 500 mg tablet evening | |
| 16 | 4 × 100 mg tablet morning | 1 × 500 mg και 1 × 100 mg tablet morning | 1 × 500 mg και 3 × 100 mg tablet morning |
| 4 × 100 mg tablet evening | 1 × 500 mg και 1 × 100 mg tablet evening | 1 × 500 mg και 3 × 100 mg tablet evening |
The recommended starting dose is 40 mg/kg/day.
Maintenance recommendations in relation to bodyweight are:
Bodyweight:
10 to 15 kg: 0.5 to 1 g/day
15 to 30 kg: 1 to 1.5 g/day
Table 2. Number of soluble tablets according to body weight and starting dose in resistant partial epilepsy:
| Body weight (kg) | Starting dose of 40 mg/kg/day |
|---|---|
| 3 | 0.5 × 100 mg tablet morning |
| 0.5 × 100 mg tablet evening | |
| 4 | 0.5 × 100 mg tablet morning |
| 1 × 100 mg tablet evening | |
| 5 | 1 × 100 mg tablet morning |
| 1 × 100 mg tablet evening | |
| 6 | 1 × 100 mg tablet morning |
| 1.5 × 100 mg tablet evening | |
| 7 | 1.5 × 100 mg tablet morning |
| 1.5 × 100 mg tablet evening | |
| 8 | 1.5 × 100 mg tablet morning |
| 2 × 100 mg tablet evening | |
| 10 | 2 × 100 mg tablet morning |
| 2 × 100 mg tablet evening | |
| 13 | 2.5 × 100 mg tablet morning |
| 2.5 × 100 mg tablet evening | |
| 15 | 3 × 100 mg tablet morning |
| 3 × 100 mg tablet evening | |
| 17 | 3.5 × 100 mg tablet morning |
| 3.5 × 100 mg tablet evening | |
| 19 | 3.5 × 100 mg tablet morning |
| 4 × 100 mg tablet evening | |
| 22 | 4.5 × 100 mg tablet morning |
| 4.5 × 100 mg tablet evening | |
| 25 | 1 × 500 mg tablet morning |
| 1 × 500 mg tablet evening | |
| 28 | 1 × 500 mg tablet morning |
| 1 × 500 mg και 1 × 100 mg tablet evening | |
| 30 | 1 × 500 mg και 1 × 100 mg tablet morning |
| 1 × 500 mg και 1 × 100 mg tablet evening |
Kigabeq is for oral or gastric administration twice daily and may be taken before or after meals.
The maximum recommended dose should not be exceeded.
If control of epilepsy is not clinically significantly improved after an adequate treatment course, vigabatrin treatment should be discontinued. Vigabatrin should be gradually withdrawn under close medical supervision.
Since vigabatrin is eliminated via the kidneys, caution should be exercised when administering the medicinal product to patients with creatinine clearance less than 60 ml/min. Adjustment of dose should be considered. Such patients may respond to a lower maintenance dose. Patients should be monitored for adverse reactions such as sedation or confusion (see sections 4.4 and 4.8).
There is no relevant use of Kigabeq in neonates (below 27 days of age) in the indication “infantile spasms” and in children and adolescents above 7 years of age in the indication “resistant partial epilepsy” (focal onset seizures).
Kigabeq is for oral or gastric use and may be taken before or after meals. Gastric administration should be used for children who cannot swallow, but can be fed by enteral route.
The method of administration will be determined by a physician specialised in epileptology, neurology or paediatric neurology. For instructions on dissolution and handling of the medicinal product before administration, see section 6.6.
Since no stability studies have been performed with other solvents than water, for preparing oral solution only water should be used. When the tablets are fully disintegrated, the whole content of solution should be administered straight away to the child directly from the drinking glass. If there is a risk of regurgitation or if the child is not old enough to drink from a glass, the whole content of solution should be withdrawn with a syringe for oral use, the end of the syringe should be put in the mouth of the child and gently pushed on the plunger.
Once the child has entirely drunk the medicine solution, the drinking glass should be rinsed with one or two teaspoons of water (approximately 5 or 10 ml) and dispensed to the child by the same way.
For patients who cannot swallow, administration of Kigabeq using a gastric tube is possible. Tablets are disintegrated in approximately 5 or 10 ml of water and the resulting solution is introduced into the tube using an adapted syringe. The gastric tube should be rinsed with 10 ml of water.
Vigabatrin overdose has been reported. When provided, doses were most commonly between 7.5 to 30 g; however, ingestions up to 90 g have been reported. Nearly half of the cases involved multiple drug ingestions. When reported, the most common symptoms included drowsiness or coma. Other less frequently reported symptoms included vertigo, headache, psychosis, respiratory depression or apnoea, bradycardia, hypotension, agitation, irritability, confusion, abnormal behaviour, and speech disorder.
There is no specific antidote. The usual supportive measures should be employed. Measures to remove unabsorbed medicinal product should be considered. Activated charcoal has been shown to not significantly adsorb vigabatrin in an in vitro study. The effectiveness of haemodialysis in the treatment of vigabatrin overdose is unknown. In isolated case reports in renal failure patients receiving therapeutic doses of vigabatrin, haemodialysis reduced vigabatrin plasma concentrations by 40% to 60%.
Shelf life: 4 years.
Use immediately following preparation of the oral solution.
After first opening: 100 days.
This medicinal product does not require any special storage conditions.
Kigabeq 100 mg soluble tablets:
HDPE bottle closed with a child resistant tamper evident PP screw cap.
Pack size: 100 soluble tablets.
Kigabeq 500 mg soluble tablets:
HDPE bottle closed with a child resistant tamper evident PP screw cap.
Pack size: 50 soluble tablets.
Fill a drinking glass with one or two teaspoons of water (approximately 5 or 10 ml), according to the age of the child. Add the prescribed number of Kigabeq tablets or tablet halves to the water. Wait until the tablet(s) fully disintegrate; tablets generally disintegrate in less than one minute but disintegration can be fastened by gently hand stirring the oral solution. The resulting solution is whitish and cloudy. This is normal and due to presence of water-insoluble excipients.
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