• Primary immune deficiency

Joenja Generic Name & Formulations

General Description

Leniolisib 70mg; tabs.

Pharmacological Class

Kinase inhibitor.

How Supplied


Generic Availability


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


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


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


Plasma protein bound: 94.5%.


Hepatic (CYP3A4). 


Fecal (67%), renal (25.5%). Half-life: ~10 hours.

Joenja 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