Leniolisib phosphate at a glance
Medicine class
Selective PI3K-delta inhibitor
Licensed use
APDS in adults and adolescents aged 12 years and older
Taking the tablets
Swallow whole, with or without food; do not split, crush or chew
Additional monitoring
Suspected adverse reactions should be reported through the Yellow Card Scheme
What is Leniolisib phosphate used for?
It is licensed to treat:
Activated phosphoinositide 3-kinase delta syndrome (APDS) in adults and adolescents aged 12 years and older.
How does Leniolisib phosphate work?
APDS causes excessive PI3K-delta signalling, disrupting B- and T-lymphocyte development and activity. Leniolisib selectively blocks PI3K-delta and reduces downstream Akt–mTOR signalling, helping rebalance immune-cell activity.
Leniolisib phosphate preparations and strengths
Tablet
Route: Oral
Strengths: 70 mg
How to take Leniolisib phosphate
Follow the specialist team's instructions. The film-coated tablets may be taken with or without food and must be swallowed whole.
Do not split, crush or chew the tablets.
Do not stop treatment without discussing it with the prescribing team.
Leniolisib phosphate side effects
Common or expected effects
- Headache
- Sinusitis
- Eczema or atopic dermatitis
- Faster heartbeat
- Diarrhoea
- Fatigue or fever
- Back or neck pain
- Hair loss
Get urgent medical advice
- Symptoms of a severe allergic reaction, such as facial or throat swelling, breathing difficulty or collapse
- A significant or persistent infection that may be associated with reduced neutrophils
Leniolisib phosphate in pregnancy
Human pregnancy data are unavailable, and animal studies indicate potential fetal harm. Leniolisib is not recommended during pregnancy. Pregnancy status should be checked before treatment, and highly effective contraception is advised during treatment and for 1 week afterwards. Contact the specialist team immediately if pregnancy is suspected.
Leniolisib phosphate while breastfeeding
Breastfeeding is not advised during treatment or for 1 week afterwards because transfer into human milk is unknown and serious effects in a breastfed child are possible. Discuss feeding plans with the specialist team.
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.
Common questions about Leniolisib phosphate
Answers are fully visible for fast scanning and source review.
What is leniolisib phosphate used for?
It is licensed to treat activated phosphoinositide 3-kinase delta syndrome, an inherited disorder of immune regulation.
Does leniolisib phosphate cure APDS?
It targets abnormal PI3K-delta signalling but does not remove the underlying genetic variant. Specialist follow-up remains necessary.
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.