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What the FDA labels say about taking them together

Axitinib and pembrolizumab

Axitinib's FDA label of March 12, 2026 names pembrolizumab in its warnings and precautions section, and pembrolizumab's label names axitinib too. The pembrolizumab label: “KEYTRUDA with Axitinib KEYTRUDA in combination with axitinib can cause hepatic toxicity with higher than expected frequencies of Grades 3 and 4 ALT and AST elevations compared to KEYTRUDA alone.”

Check it at the source: the axitinib FDA label on DailyMed (effective March 12, 2026, U.S. Pharmaceuticals); the pembrolizumab FDA label on DailyMed (effective July 10, 2026, Merck Sharp & Dohme LLC).

What does the axitinib label say about pembrolizumab?

Axitinib label, warnings and precautions

When used in combination with avelumab or pembrolizumab, higher frequencies of Grade 3 and 4 ALT and AST elevation may occur.

Source: FDA drug label (INLYTA), NDA202324 (Pf Prism Cv), as published by U.S. Pharmaceuticals, effective March 12, 2026 (SPL set 8a903e31-936e-4ed7-8a59-59f32374f338), via openFDA; the full label on DailyMed

What does the pembrolizumab label say about axitinib?

Pembrolizumab label, warnings and precautions

KEYTRUDA with Axitinib KEYTRUDA in combination with axitinib can cause hepatic toxicity with higher than expected frequencies of Grades 3 and 4 ALT and AST elevations compared to KEYTRUDA alone.

Source: FDA drug label (KEYTRUDA), Merck Sharp & Dohme LLC, effective July 10, 2026 (SPL set 9333c79b-d487-4538-a9f0-71b91a02b287), 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

0Axitinib generic labelers
0Pembrolizumab generic labelers
AxitinibPembrolizumab
Labeled forn/aLung cancer, Colorectal cancer, Leukemia, lymphoma and myeloma, Breast cancer
Boxed warningNoNo
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?