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What the FDA labels say about taking them together

Leflunomide and mitoxantrone

Leflunomide's FDA label of June 4, 2025 names mitoxantrone in its drug interactions section; the mitoxantrone label PlainMeds reads does not name leflunomide. The leflunomide label: “For other substrates of BCRP (e.g., mitoxantrone) and drugs in the OATP family, especially HMG-Co reductase inhibitors, consider reducing the dose of these drugs and monitor patients closely for signs and symptoms of …”

Check it at the source: the leflunomide FDA label on DailyMed (effective June 4, 2025, sanofi-aventis U.S. LLC); the mitoxantrone FDA label on DailyMed (effective April 24, 2025, Meitheal Pharmaceuticals Inc.).

What does the leflunomide label say about mitoxantrone?

Leflunomide label, drug interactions

For other substrates of BCRP (e.g., mitoxantrone) and drugs in the OATP family (e.g., methotrexate, rifampin), especially HMG-Co reductase inhibitors (e.g., atorvastatin, nateglinide, pravastatin, repaglinide, and simvastatin), consider reducing the dose of these drugs and monitor patients closely for signs and symptoms of increased exposures to the drugs while patients are taking ARAVA [see Clinical Pharmacology (12.3) ].

Source: FDA drug label (Arava), sanofi-aventis U.S. LLC, effective June 4, 2025 (SPL set 320f63f2-fac3-4aee-aff8-85724e00ef52), via openFDA; the full label on DailyMed

What does the mitoxantrone label say about leflunomide?

Mitoxantrone's label (effective April 24, 2025) does not name leflunomide in these sections. A label lists what its studies and reports found; it is not a complete list.

Source: FDA drug label (mitoXANTRONE), Meitheal Pharmaceuticals Inc., effective April 24, 2025 (SPL set 1634528a-30c5-4309-acc8-4c0293ae14ae), 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

16Leflunomide generic labelers
3Mitoxantrone generic labelers
LeflunomideMitoxantrone
Labeled forRheumatoid arthritisLeukemia, lymphoma and myeloma
Boxed warningYesYes
Pharmacy cost (NADAC)$0.324 per tablet 10 mg tabletn/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?