Référentiel des médicaments
Leniolisib
Leniolisib is a medicine in the class miscellaneous.
- Classe médicamenteuse: Miscellaneous
Dernière mise à jour Sources: EMA SmPC
Réservé aux professionnels de santé — à titre de référence uniquement. Cette page est un bref résumé, pas un avis médical, et ne remplace ni la notice officielle ni le jugement clinique. Vérifiez toujours avant de prescrire ou de délivrer.
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L'essentiel
- Classe médicamenteuse
- Miscellaneous
- Code ATC
- L03AX22
- Formes courantes
- comprimé
- Interactions connues
- 97 (Majeure: 17 · Modérée: 61 · Mineure: 19)
- Noms commerciaux
- 2
- Pays et marchés
- 2
Mécanisme d'action
Selectively inhibits PI3K delta by blocking its active binding site. This reduces PIP3 production and the hyperactive Akt/mTOR signalling seen in APDS, so B and T cell populations normalise.
Posologie adulte habituelle (résumé de la notice)
APDS (adults and adolescents 12 years and older weighing 45 kg or more): 70 mg orally twice daily, approximately 12 hours apart; continue while benefit is observed or until unacceptable toxicity
Grossesse et allaitement
- Grossesse
- Unsafe No human data; animal studies showed reproductive toxicity and leniolisib can cause foetal harm. Not recommended in pregnancy or in women of childbearing potential not using highly effective contraception.
- Allaitement
- Unsafe Excretion in human milk unknown; animal data show excretion in milk and risk to infants cannot be excluded. Breast-feeding should be discontinued during treatment.
Effets indésirables signalés
- Headache
- Vomiting
- Weight increased
- Alopecia
- Neutrophil count decreased
- Dyspepsia
Contre-indications
- Hypersensitivity to the active substance or any excipient.
Précautions particulières
- Serious immune-related adverse events (severe infections, SCARs, pneumonitis, colitis, hepatotoxicity) occurred with other PI3K delta inhibitors in cancer patients; not associated with Joenja in APDS.
- Avoid strong CYP3A4 inhibitors, which increase leniolisib exposure.
- Avoid strong and moderate CYP3A4 inducers, which may reduce efficacy.
Informez votre pharmacien ou votre médecin en cas de grossesse ou d'allaitement, de maladie rénale ou hépatique, d'allergies, ainsi que de tout autre médicament ou complément que vous prenez.
Principales interactions (97)
- Amobarbital + Leniolisib Major
- Apalutamide + Leniolisib Major
- Carbamazepine + Leniolisib Major
- Clarithromycin + Leniolisib Major
- Cyclosporin + Leniolisib Major
- Efavirenz + Leniolisib Major
- Enzalutamide + Leniolisib Major
- Itraconazole + Leniolisib Major
- Ketoconazole + Leniolisib Major
- Leniolisib + Modafinil Major
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- Dosing by age, kidney and liver function, and further dose lines
- Renal and hepatic dose adjustments
- Paediatric dosing
- Dosing in older adults
- How to give it
- Pharmacokinetics
- Patient counselling points
- Food interactions
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Questions fréquentes
What is Leniolisib used for?
Leniolisib is a medicine in the class miscellaneous.
What side effects have been reported with Leniolisib?
Headache, Vomiting, Weight increased, Alopecia, Neutrophil count decreased, Dyspepsia.
Can Leniolisib be taken in pregnancy or while breastfeeding?
Pregnancy: Unsafe. No human data; animal studies showed reproductive toxicity and leniolisib can cause foetal harm. Not recommended in pregnancy or in women of childbearing potential not using highly effective contraception. Breastfeeding: Unsafe. Excretion in human milk unknown; animal data show excretion in milk and risk to infants cannot be excluded. Breast-feeding should be discontinued during treatment.
What does Leniolisib interact with?
MediHelp lists 97 known interactions for Leniolisib. Major: 17 · Moderate: 61 · Minor: 19. The most serious include Amobarbital, Apalutamide, Carbamazepine.
Monographies complètes, posologies et vérificateur d'interactions dans l'application MediHelp
Ouvrez le référentiel complet, vérifiez les interactions entre plusieurs médicaments et utilisez les outils de posologie dans l'application MediHelp.
