Riferimento farmaci
Leniolisib
Leniolisib is a medicine in the class miscellaneous.
- Classe del farmaco: Miscellaneous
Ultimo aggiornamento Fonti: EMA SmPC
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In breve
- Classe del farmaco
- Miscellaneous
- Codice ATC
- L03AX22
- Forme farmaceutiche comuni
- compressa
- Interazioni note
- 97 (Maggiore: 17 · Moderata: 61 · Minore: 19)
- Nomi commerciali
- 2
- Paesi e mercati
- 2
Come agisce
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.
Dose abituale nell'adulto (sintesi del foglio illustrativo)
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
Gravidanza e allattamento
- Gravidanza
- 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.
- Allattamento
- 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.
Effetti indesiderati segnalati
- Headache
- Vomiting
- Weight increased
- Alopecia
- Neutrophil count decreased
- Dyspepsia
Controindicazioni
- Hypersensitivity to the active substance or any excipient.
Chi deve prestare attenzione
- 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.
Informare il farmacista o il medico di gravidanza o allattamento, malattie renali o epatiche, allergie e di ogni altro farmaco o integratore assunto.
Interazioni principali (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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Domande frequenti
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.
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