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What the FDA labels say about taking them together

Capecitabine and lapatinib ditosylate

Lapatinib ditosylate's FDA label of November 30, 2023 names capecitabine in its warnings and precautions section; the capecitabine label PlainMeds reads does not name lapatinib ditosylate. The lapatinib ditosylate label: “… clinical exposure based on AUC following 1,250 mg dose of lapatinib plus capecitabine.”

Check it at the source: the capecitabine FDA label on DailyMed (effective February 5, 2026, H2-Pharma, LLC); the lapatinib ditosylate FDA label on DailyMed (effective November 30, 2023, Teva Pharmaceuticals, Inc.).

What does the capecitabine label say about lapatinib ditosylate?

Capecitabine's label (effective February 5, 2026) does not name lapatinib ditosylate in these sections. A label lists what its studies and reports found; it is not a complete list.

Source: FDA drug label (XELODA), NDA020896 (Cheplapharm), as published by H2-Pharma, LLC, effective February 5, 2026 (SPL set e702d84d-7162-4751-bf37-d724cc7e45a5), via openFDA; the full label on DailyMed

What does the lapatinib ditosylate label say about capecitabine?

Lapatinib ditosylate label, warnings and precautions

In animal reproductive studies, administration of lapatinib to pregnant rats during the period of organogenesis and through lactation led to death of offspring within the first 4 days after birth at maternal exposures that were ≥ 3.3 times the human clinical exposure based on AUC following 1,250 mg dose of lapatinib plus capecitabine.

Source: FDA drug label (Lapatinib), Teva Pharmaceuticals, Inc., effective November 30, 2023 (SPL set b09abf73-1eef-4e12-b400-c030d546d223), 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

18Capecitabine generic labelers
3Lapatinib ditosylate generic labelers
CapecitabineLapatinib ditosylate
Labeled forColorectal cancer, Breast cancerBreast cancer
Boxed warningYesYes
Pharmacy cost (NADAC)$0.456 per tablet 500 mg tabletn/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?