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Kanuma
Eintrag öffnenKanuma · 4.1 Therapeutic indications · 1
Eintrag öffnenKanuma · 4.3 Contraindications · 1
Eintrag öffnenKanuma · 4.3 · Life-threatening hypersensitivity (anaphylactic reaction) to the active substance when attempts to rechallenge
Eintrag öffnenKanuma · 4.4 Special warnings and precautions for use · 1
Eintrag öffnenKanuma · 4.5 Interaction with other medicinal products and other forms of interaction · 1
Eintrag öffnenKanuma · 4.5 · Because it is a recombinant human protein, sebelipase alfa is an unlikely candidate for cytochrome P450 mediat
Eintrag öffnenKanuma · 4.5 · No interaction studies have been performed.
Eintrag öffnenKanuma · 4.6 Fertility, pregnancy and lactation · 1
Eintrag öffnenKanuma · 4.8 Undesirable effects · 1
Eintrag öffnenKanuma · 4.8 · 5 Of the 106 children and adults enrolled in clinical studies, 102 (96.2%) have received sebelipase alfa at a
Eintrag öffnenKanuma · 4.8 · 6 Nervous system disorders Dizziness Very common Cardiac disorders Tachycardia Common Hyperaemia Vascular diso
Eintrag öffnenKanuma · 4.8 · 7 Deficiency, ADA positivity was transient with generally low titers of ADAs reported. Persistence of ADA posi
Eintrag öffnenKanuma · 4.8 · Adverse reactions are listed by system organ class (SOC) and frequency. Frequencies are defined according to t
Eintrag öffnenKanuma · 4.8 · Among 125 patients with LAL Deficiency enrolled in the clinical studies, 19/125 (15.0%) patients tested positi
Eintrag öffnenKanuma · 4.8 · Description of selected adverse reactions
Eintrag öffnenKanuma · 4.8 · Hypersensitivity Five of 125 (4%) patients treated with sebelipase alfa, including 3 of 19 (16%) infants and 2
Eintrag öffnenKanuma · 4.8 · Immunogenicity There is potential for immunogenicity (see section 4.4). Patients have developed anti-drug anti
Eintrag öffnenKanuma · 4.8 · In clinical studies, 59 of 125 (47%) sebelipase alfa-treated patients, including 13 of 19 (68%) infants and 46
Eintrag öffnenKanuma · 4.8 · Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medi
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