Joenja Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Tabs—60
Manufacturer
Generic Availability
NO
Mechanism of Action
Leniolisib inhibits PI3K-delta by blocking the active binding site of PI3K-delta. In cell-based assays, leniolisib reduced pAKT pathway activity and inhibited proliferation and activation of B and T cell subsets. Gain-of-function variants in the gene encoding the p110-delta catalytic subunit or loss of function variants in the gene encoding the p85-alpha regulatory subunit each cause hyperactivity of PI3K-delta. Leniolisib inhibits the signalling pathways that lead to increased production of PIP3, hyperactivity of the downstream mTOR/AKT pathway, and to the dysregulation of B and T cells.
Joenja Indications
Indications
Treatment of activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS).
Joenja Dosage and Administration
Adults and Children
<12yrs: not established. ≥12yrs: (<45kg): not recommended; (≥45kg): 70mg twice daily (~12hrs apart).
Joenja Contraindications
Not Applicable
Joenja Boxed Warnings
Not Applicable
Joenja Warnings/Precautions
Warnings/Precautions
Moderate to severe hepatic impairment: not recommended. Embryo-fetal toxicity. Advise females of reproductive potential to use highly effective contraception during and for 1 week after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 week after the last dose).
Joenja Pharmacokinetics
Distribution
Plasma protein bound: 94.5%.
Elimination
Fecal (67%), renal (25.5%). Half-life: ~10 hours.
Joenja Interactions
Interactions
May reduce efficacy of live, attenuated vaccines. Potentiated by strong CYP3A4 inhibitors (eg, itraconazole); avoid concomitant use. Antagonized by moderate and strong CYP3A4 inducers; avoid concomitant use. Avoid concomitant drugs metabolized by CYP1A2 (with a narrow therapeutic index), and substrates of BCRP, OATP1B1, OATP1B3.
Joenja Adverse Reactions
Adverse Reactions
Headache, sinusitis, atopic dermatitis.
Joenja Clinical Trials
See Literature
Joenja Note
Not Applicable
Joenja Patient Counseling
See Literature