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Ogsiveo
Eintrag öffnenOgsiveo · 4.1 Therapeutic indications · 1
Eintrag öffnenOgsiveo · 4.3 Contraindications · 1
Eintrag öffnenOgsiveo · 4.3 · - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. - Pregnancy (see
Eintrag öffnenOgsiveo · 4.4 Special warnings and precautions for use · 1
Eintrag öffnenOgsiveo · 4.5 Interaction with other medicinal products and other forms of interaction · 1
Eintrag öffnenOgsiveo · 4.5 · 6 Patients should avoid consuming grapefruit and grapefruit juice when taking Ogsiveo since they include inhib
Eintrag öffnenOgsiveo · 4.5 · Agents that may decrease nirogacestat serum concentrations
Eintrag öffnenOgsiveo · 4.5 · Agents that may increase nirogacestat serum concentrations
Eintrag öffnenOgsiveo · 4.5 · Alternative concomitant medicinal products with no or minimal CYP3A4 inhibition should be considered. If thera
Eintrag öffnenOgsiveo · 4.5 · CYP substrates A drug‑drug interaction study in healthy volunteers investigating the effects of multiple doses
Eintrag öffnenOgsiveo · 4.5 · Concomitant use with strong inhibitors of CYP3A4 (e.g., clarithromycin, oral ketoconazole, itraconazole) and m
Eintrag öffnenOgsiveo · 4.5 · Drug transporter systems A single-dose drug‑drug interaction study demonstrated that nirogacestat did not affe
Eintrag öffnenOgsiveo · 4.5 · Effect of acid‑reducing agents Nirogacestat has pH‑dependent solubility, with substantially reduced solubility
Eintrag öffnenOgsiveo · 4.5 · Effect of moderate and strong CYP3A4 inhibitors In a clinical study, co‑administration of itraconazole (a stro
Eintrag öffnenOgsiveo · 4.5 · Effect of strong and moderate CYP3A4 inducers The effects of CYP3A4 inducers on nirogacestat exposure have not
Eintrag öffnenOgsiveo · 4.5 · Effects of nirogacestat on the pharmacokinetics of other medicinal products
Eintrag öffnenOgsiveo · 4.5 · In vitro studies showed that nirogacestat may induce CYP2C8, CYP2C9, CYP2C19, and CYP2B6 and thus there is a r
Eintrag öffnenOgsiveo · 4.5 · Interaction studies have only been performed in adults.
Eintrag öffnenOgsiveo · 4.5 · Nirogacestat is primarily metabolized by CYP3A4 and is a substrate of P‑glycoprotein (P-gp).
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