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leniolisib (Joenja)

Indications: - treatment of immune dysregulation in PI3K delta syndrome* (APDS), formerly known as PASLI disease, in adults & pediatric patients >= 12 years * activated phosphoinositide 3-kinase delta syndrome Dosage: - 70 mg BID Mechanism of action: - inhibits PI3K delta by blocking the active binding site of PI3K delta - inhibits signaling pathways leading to increased production of PIP3, hyperactivity of the downstream mTOR/AKT pathway, & dysregulation of B-cells & T cells - reduces spleen size

General

biological response modifier; immune factor; immunomodulator; biomodulator small inhibitory antineoplastic agent (ib drug)

References

  1. Rao VK et al A randomized, placebo-controlled phase 3 trial of the PI3Kdelta inhibitor leniolisib for activated PI3Kdelta syndrome Blood. 2023 Mar 2;141(9):971-983 PMID: 36399712 PMCID: PMC10163280 Free PMC article