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What the FDA labels say about taking them together

Busulfan and inotuzumab ozogamicin

Inotuzumab ozogamicin's FDA label of February 6, 2026 names busulfan in its warnings and precautions section; the busulfan labels PlainMeds reads (2) do not name inotuzumab ozogamicin. The inotuzumab ozogamicin label: “The risk of VOD was greater in patients who underwent HSCT after BESPONSA treatment; use of HSCT conditioning regimens containing 2 alkylating agents and last total bilirubin level greater than or equal to the ULN …”

Check it at the source: the busulfan FDA label on DailyMed (effective June 27, 2024, Eugia US LLC); the inotuzumab ozogamicin FDA label on DailyMed (effective February 6, 2026, Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.).

What does the busulfan label say about inotuzumab ozogamicin?

Busulfan's label (effective June 27, 2024) and its 1 other brand-application label do not name inotuzumab ozogamicin in these sections. A label lists what its studies and reports found; it is not a complete list.

Source: FDA drug label (Busulfan), Eugia US LLC, effective June 27, 2024 (SPL set 06883ac0-4b2a-4f26-89bf-512d37b9ba7f), via openFDA; the full label on DailyMed

What does the inotuzumab ozogamicin label say about busulfan?

Inotuzumab ozogamicin label, warnings and precautions

The risk of VOD was greater in patients who underwent HSCT after BESPONSA treatment; use of HSCT conditioning regimens containing 2 alkylating agents (e.g., busulfan in combination with other alkylating agents) and last total bilirubin level greater than or equal to the ULN before HSCT are significantly associated with an increased risk of VOD.

Source: FDA drug label (Besponsa), Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc., effective February 6, 2026 (SPL set cc7014b1-c775-411d-b374-8113248b4077), 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

7Busulfan generic labelers
0Inotuzumab ozogamicin generic labelers
BusulfanInotuzumab ozogamicin
Labeled forLeukemia, lymphoma and myelomaLeukemia, lymphoma and myeloma
Boxed warningYesYes
Pharmacy cost (NADAC)n/an/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)

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