Kigabeq · 4.8 Undesirable effects · 1

HOS-217717 · has-adverse-reaction-information · PDF-Seite 9

Summary of the safety profile The most commonly reported adverse reactions related to vigabatrin are visual field defects (ranging from mild to severe and occurring usually after months to years of vigabatrin therapy), psychiatric disorders such as agitation, excitation, aggression, nervousness, depression, paranoid reaction, nervous system disorders such as marked sedation, stupor and confusion. Rarely seen events include suicide attempts, encephalopathy and retinal disorders. Some patients may experience an increase in seizure frequency, including status epilepticus with vigabatrin. Patients with myoclonic seizures may be particularly susceptible to this effect. New onset myoclonus and exacerbation of existing myoclonus may occur in rare cases. Tabulated list of adverse reactions The adverse reactions listed below have been reported during pre- or post-approval use of vigabatrin worldwide. They are not specific to the paediatric population. 1The adverse reactions are listed below by SOC (System organ class) and by frequency, most frequent reactions first, with the following guidelines: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100), rare (≥ 1/10 000 to < 1/1 000), very rare (< 1/10 000), not known (cannot be estimated from the available data). System Very Common Uncommon Rare Very rare Not known organ class common Blood and Anaemia lymphatic system disorders Psychiatric Agitation, Hypomania, Suicide Hallucination disorders aggression, mania, attempt nervousness, psychotic depression, disorder paranoid reaction, insomnia  Nervous Somnolenc Speech Coordination Encephal Optic neuritis Brain MRI system e disorder, abnormal opathy abnormalities, disorders headache, (ataxia) intramyelinic dizziness, oedema paraesthesia, (particularly in disturbance in infants) (see attention and

Auszug; vollständigen Abschnitt im Original lesen.

HOS-217713 · has-contraindication-information · PDF-Seite 5

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

HOS-217712 · has-indication-information · PDF-Seite 2

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.

HOS-217715 · has-interaction-information · PDF-Seite 8

Interaction studies have only been performed in adults. As vigabatrin is neither metabolised, nor protein bound and is not an inducer of hepatic cytochrome P450 metabolising-enzymes, interactions with other medicinal products are unlikely. However, during controlled clinical studies, a gradual reduction of 16-33 % in the plasma concentration of phenytoin has been observed. The exact nature of this interaction is presently not understood, however, in the majority of cases it is unlikely to be of therapeutic significance. The plasma concentrations of carbamazepine, phenobarbital, and sodium valproate have also been monitored during controlled clinical trials and no clinically significant interactions have been detected.

HOS-217716 · has-pregnancy-information · PDF-Seite 8

Pregnancy This medicinal product is not intended for use in women of child-bearing potential. Breastfeeding This medicinal product is not intended for use in women who are breastfeeding. Fertility Fertility studies in rats have shown no effect on male and female fertility (see section 5.3).

HOS-217714 · has-warning-information · PDF-Seite 5

Visual field defects (VFD) have been reported in patients receiving vigabatrin with a high prevalence (about 1/3 of patients). Frequencies found in an open clinical study are presented in section 4.8. The onset is usually after months to years of vigabatrin therapy. The degree of visual field constriction may be severe and this may have practical consequences for the patient. Vigabatrin can cause permanent vision loss. Most of the patients with perimetry-confirmed defects have been asymptomatic. Hence, this undesirable effect can only be reliably detected by systematic perimetry which is usually possible only in patients with a developmental age of more than 9 years. For younger patients electroretinography should be used (see visual field defects). Available data suggests that visual field defects are irreversible even after discontinuation of vigabatrin. A deterioration of VFD after the treatment is discontinued cannot be excluded. Therefore, vigabatrin should only be used after careful benefit/ risk assessment compared with alternatives. Vigabatrin is not recommended for use in patients with any pre-existing clinically significant visual field defect. Patients should undergo systematic screening examination when starting vigabatrin and at regular intervals for detection of visual field defects. Visual field testing should continue at 6-month intervals for the whole duration of treatment. The assessment must be continued 6 to 12 months after the discontinuation of therapy (see visual field defects). Visual field defects (VFD) Based on available data, the usual pattern is a concentric constriction of the visual field of both eyes, which is generally more marked nasally than temporally. In the central visual field (within 30 degree of eccentricity), frequently an annular nasal defect is seen. However, the VFDs reported in patients receiving vigabatrin have ranged from mild to severe. Severe cases are potentially disabling and may be characterized by tunnel vision. Blindness was also reported in severe cases. Most patients with perimetry-confirmed defects had not previously spontaneously noticed any symptoms, even in cases where a severe defect was observed in perimetry. Available evidence suggests that the VFD is irreversible even after discontinuation of vigabatrin. A deterioration of VFD after the treatment is discontinued cannot be excluded. Pooled data from prevalence surveys suggest that as many as 1/3 of patients receiving vigabatrin therapy h

Auszug; vollständigen Abschnitt im Original lesen.