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PI3Kδ inhibitor Pregnancy: US §8.1/§5.1: can cause foetal harm based on animal findings (embryofoetal toxicity including malformations in rats and rabbits at 2-6 times the maximum recommended human dose on an AUC basis); no human data. Verify pregnancy status in females of reproductive potential before starting, advise pregnant women of the potential risk to a foetus, and advise females of reproductive potential to use highly effective contraception during treatment and for 1 week after the last dose.

Leniolisib

Brand names: Joenja

Leniolisib is an oral selective PI3K-delta inhibitor used to treat activated PI3K-delta syndrome (APDS), a rare inborn error of immunity. It is taken under specialist immunology supervision.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: 70 mg twice daily, approximately 12 hours apart
Route: Oral (tablets, with or without food)
Frequency: Twice daily, approximately 12 hours apart
NO UK SPC WAS AVAILABLE IN THE FETCHED BUNDLE — dose taken from the US prescribing information (Joenja, Pharming Healthcare Inc., label date 2025-06-05). US §2.2: 'The recommended dosage of JOENJA in adult and pediatric patients 12 years of age and older weighing 45 kg or greater is 70 mg administered orally twice daily approximately 12 hours apart, with or without food. There is no recommended dosage for patients weighing less than 45 kg.' Verify pregnancy status in females of reproductive potential prior to initiating treatment (§2.1). Missed dose: if a dose is missed by more than 6 hours, wait and take the next dose at the usual time. Vomiting: if vomiting occurs within 1 hour after taking the dose, take the dose again as soon as possible; if vomiting occurs more than 1 hour after dosing, wait and take the next dose at the usual time. PAEDIATRIC (non-per-kg, so not captured in paedDose): safety and effectiveness are established in paediatric patients 12 years of age and older weighing 45 kg or greater, who receive the same 70 mg twice-daily dose as adults; there is no recommended dosage for patients 12 years and older weighing less than 45 kg, and safety and effectiveness have not been established below 12 years of age (§8.4). ELDERLY: clinical studies did not include any patients 65 years of age and older, so it cannot be determined whether they respond differently (§8.5). Clinician to confirm the UK licensed posology and indication against the current SPC before publication.

Dose auto-extracted from US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • US labelling §4 states 'None.' (no UK SPC §4.3 available in the fetched bundle — clinician to verify)

Side effects

  • Headache (incidence >10%)
  • Sinusitis (incidence >10%)
  • Atopic dermatitis (incidence >10%)
  • Hypersensitivity reactions including anaphylaxis (reported post-marketing) — discontinue and institute appropriate therapy if they occur

Interactions

  • Strong CYP3A4 inhibitors: avoid concomitant use — leniolisib is a CYP3A4 substrate and exposure was increased 2-fold with itraconazole (US §7.1)
  • Strong and moderate CYP3A4 inducers: avoid concomitant use — may reduce leniolisib exposure and efficacy (US §7.1)
  • BCRP, OATP1B1 and OATP1B3 substrates: avoid concomitant use — leniolisib inhibits these transporters and increases substrate exposure, which may increase the risk of substrate-related adverse reactions (US §7.2)
  • Live, attenuated vaccines may be less effective if administered during treatment (US §5.2)

Clinical monograph

How it works

It selectively inhibits the p110-delta catalytic subunit of phosphoinositide 3-kinase delta, counteracting the overactive PI3K-delta signalling that causes APDS.

Prescribing in practice

  • Use is restricted to patients with a genetically confirmed diagnosis of activated PI3K-delta syndrome.
  • It is a CYP3A4 substrate, so avoid strong inducers and inhibitors of CYP3A4 where possible.
  • Routine immune and haematological assessment of this complex immunodeficiency continues alongside treatment.

Monitoring

Monitor full blood count and clinical features of the underlying immunodeficiency, including lymphadenopathy and infections.

Counselling the patient

  • Take the tablets as directed and do not stop without specialist advice.
  • Avoid grapefruit and tell the team about all other medicines.
  • Continue to report infections and attend immunology follow-up.

Evidence & guidelines

Leniolisib improved immunological and clinical measures in a randomised placebo-controlled trial in activated PI3K-delta syndrome.

Reference: SmPC; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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