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What the FDA labels say about taking them together

Itraconazole and leniolisib

Leniolisib's FDA label of June 5, 2025 names itraconazole in its drug interactions section; the itraconazole labels PlainMeds reads (2) do not name leniolisib. The leniolisib label: “Leniolisib exposure was increased 2-fold when co-administered with itraconazole, a strong CYP3A4 inhibitor.”

Check it at the source: the itraconazole FDA label on DailyMed (effective July 13, 2026, Janssen Pharmaceuticals, Inc.); the leniolisib FDA label on DailyMed (effective June 5, 2025, Pharming Healthcare Inc.).

What does the itraconazole label say about leniolisib?

Itraconazole's label (effective July 13, 2026) and its 1 other brand-application label do not name leniolisib in these sections. A label lists what its studies and reports found; it is not a complete list.

Source: FDA drug label (SPORANOX), Janssen Pharmaceuticals, Inc., effective July 13, 2026 (SPL set a4d555fa-787c-40fb-bb7d-b0d4f7318fd0), via openFDA; the full label on DailyMed

What does the leniolisib label say about itraconazole?

Leniolisib label, drug interactions

Leniolisib exposure was increased 2-fold when co-administered with itraconazole, a strong CYP3A4 inhibitor [see Clinical Pharmacology ( 12.3 )].

Source: FDA drug label (Joenja), Pharming Healthcare Inc., effective June 5, 2025 (SPL set eefbcef8-2130-4654-8f29-b58077e08212), via openFDA; the full label on DailyMed

These are the labels' own sentences. PlainMeds does not grade interactions; a pharmacist or prescriber can say what they mean for one person's medicines.

Both medicines on the record

11Itraconazole generic labelers
0Leniolisib generic labelers
ItraconazoleLeniolisib
Labeled forFungal infectionsn/a
Boxed warningYesNo
Pharmacy cost (NADAC)$0.910 per capsule 100 mg capsulen/a
Shortage nowA presentation being discontinuedNo current entry

Source: FDA NDC Directory, CMS NADAC of October 7, 2026 and the FDA Drug Shortage Database (FDA files October 8, 2026)

What next?