Leniolisib phosphate: prescribing and clinical use
Focused clinical detail for use alongside current product information, local policy and patient-specific assessment.
Leniolisib phosphate: clinical details
Prescribing considerations
- Confirm APDS and eligibility through an appropriate specialist service.
- Verify pregnancy status where relevant and counsel about fetal risk and effective contraception.
- Review medicines, supplements, herbal products, grapefruit intake and planned vaccinations.
- Use is not recommended in moderate or severe hepatic impairment because pharmacokinetics have not been studied.
- Clinical studies did not include people aged 65 years or older.
Contraindications and cautions
- Hypersensitivity to leniolisib or any excipient.
- The lactose-containing product must not be used with galactose intolerance, total lactase deficiency or glucose-galactose malabsorption.
Monitoring
- Check pregnancy status before initiation where relevant.
- Remain alert to neutrophil reductions; no routine blood-count schedule is specified.
- Report suspected adverse reactions through the Yellow Card Scheme.
Clinical pharmacology
Leniolisib is a selective oral PI3K-delta inhibitor. It reduces PIP3 formation and downstream Akt–mTOR activity in dysregulated B- and T-cell populations. It is extensively metabolised in the liver, predominantly through CYP3A4, and food has no clinically meaningful effect on exposure.
Formulation and product differences
- The selected product is a lactose-containing film-coated tablet that must be swallowed whole.
- No alternative formulation is represented by the selected UK product document.
Leniolisib phosphate preparations and strengths
Tablet
Route: Oral
Strengths: 70 mg
Leniolisib phosphate interactions
All prescribed, non-prescribed and herbal products should be reviewed before treatment.
Strong or moderate CYP3A4 inhibitors, including clarithromycin, azole antifungals, ritonavir, diltiazem and verapamil
These can increase leniolisib exposure, so combined use should be avoided.
Grapefruit or grapefruit juice
May increase leniolisib exposure; avoid during treatment.
Strong or moderate CYP3A4 inducers, including rifampicin, carbamazepine, phenytoin and St John’s wort
These can lower leniolisib exposure and potentially reduce effectiveness, so combined use should be avoided.
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.