Skip to main content

What the FDA labels say about taking them together

Daratumumab and lenalidomide

Daratumumab's FDA label of September 8, 2026 names lenalidomide in its warnings and precautions section; the lenalidomide label PlainMeds reads does not name daratumumab. The daratumumab label: “The combination of DARZALEX with lenalidomide, pomalidomide, or thalidomide is contraindicated in pregnant women, because lenalidomide, pomalidomide, and thalidomide may cause birth defects and death of the unborn child.”

Check it at the source: the daratumumab FDA label on DailyMed (effective September 8, 2026, Janssen Biotech, Inc.); the lenalidomide FDA label on DailyMed (effective March 24, 2023, Celgene Corporation).

What does the daratumumab label say about lenalidomide?

Daratumumab label, warnings and precautions

The combination of DARZALEX with lenalidomide, pomalidomide, or thalidomide is contraindicated in pregnant women, because lenalidomide, pomalidomide, and thalidomide may cause birth defects and death of the unborn child.

Source: FDA drug label (Darzalex IV), Janssen Biotech, Inc., effective September 8, 2026 (SPL set a4d0efe9-5e54-467e-9eb4-56fa7d53b60b), via openFDA; the full label on DailyMed

What does the lenalidomide label say about daratumumab?

Lenalidomide's label (effective March 24, 2023) does not name daratumumab in these sections. A label lists what its studies and reports found; it is not a complete list.

Source: FDA drug label (Revlimid), NDA021880 (Bristol Myers Squibb), as published by Celgene Corporation, effective March 24, 2023 (SPL set 5fa97bf5-28a2-48f1-8955-f56012d296be), 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

0Daratumumab generic labelers
18Lenalidomide generic labelers
DaratumumabLenalidomide
Labeled forLeukemia, lymphoma and myelomaLeukemia, lymphoma and myeloma, Anemia
Boxed warningNoYes
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?