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What the FDA labels say about taking them together

Fludarabine and midostaurin

Midostaurin's FDA label of June 8, 2026 names fludarabine in its warnings and precautions section; the fludarabine label PlainMeds reads does not name midostaurin. The midostaurin label: “… of midostaurin in combination with chemotherapy, including anthracyclines, fludarabine, and cytarabine; these two patients were coadministered an azole antifungal, which may increase midostaurin concentrations and …”

Check it at the source: the fludarabine FDA label on DailyMed (effective October 14, 2024, Fresenius Kabi USA, LLC); the midostaurin FDA label on DailyMed (effective June 8, 2026, Novartis Pharmaceuticals Corporation).

What does the fludarabine label say about midostaurin?

Fludarabine's label (effective October 14, 2024) does not name midostaurin in these sections. A label lists what its studies and reports found; it is not a complete list.

Source: FDA drug label (Fludarabine), Fresenius Kabi USA, LLC, effective October 14, 2024 (SPL set cf5255cc-91fd-4132-973b-764dba142eae), via openFDA; the full label on DailyMed

What does the midostaurin label say about fludarabine?

Midostaurin label, warnings and precautions

Neutropenia and Thrombocytopenia in Pediatric Patients Treated With Combination Chemotherapy Prolonged Grade 4 neutropenia and thrombocytopenia occurred in two pediatric patients with AML who received an unapproved formulation of midostaurin in combination with chemotherapy, including anthracyclines, fludarabine, and cytarabine; these two patients were coadministered an azole antifungal (a strong CYP3A4 inhibitor), which may increase midostaurin concentrations and subsequently, the risk of toxicity [see Drug Interactions (7.1), Use in Specific Populations (8.4)].

Source: FDA drug label (RYDAPT), Novartis Pharmaceuticals Corporation, effective June 8, 2026 (SPL set 11fa3fc9-6776-49a6-b1c1-653f627c3e58), 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

6Fludarabine generic labelers
0Midostaurin generic labelers
FludarabineMidostaurin
Labeled forLeukemia, lymphoma and myelomaLeukemia, lymphoma and myeloma
Boxed warningYesNo
Pharmacy cost (NADAC)n/an/a
Shortage nowNo current entryNo 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?