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What the FDA labels say about taking them together

Darunavir and sirolimus

Darunavir's FDA label of August 29, 2025 names sirolimus in its drug interactions section; the sirolimus labels PlainMeds reads (4) do not name darunavir. The darunavir label: “Therapeutic concentration monitoring of the immunosuppressive agent is recommended when co-administered with PREZISTA/ritonavir.”

Check it at the source: the darunavir FDA label on DailyMed (effective August 29, 2025, Janssen Products LP); the sirolimus FDA label on DailyMed (effective January 28, 2026, Glenmark Pharmaceuticals Inc., USA).

What does the darunavir label say about sirolimus?

Darunavir label, drug interactions

Concomitant Drug Class Drug Name Examples: Immunosuppressants: e.g. cyclosporine, tacrolimus, sirolimus; Effect on Concentration of Darunavir Or Concomitant Drug: ↑ immunosuppressants; Clinical Comment: Therapeutic concentration monitoring of the immunosuppressive agent is recommended when co-administered with PREZISTA/ritonavir.

Source: FDA drug label (PREZISTA), Janssen Products LP, effective August 29, 2025 (SPL set 814301f9-c990-46a5-b481-2879a521a16f), via openFDA; the full label on DailyMed

What does the sirolimus label say about darunavir?

Sirolimus's label (effective January 28, 2026) and its 3 other brand-application labels do not name darunavir in these sections. A label lists what its studies and reports found; it is not a complete list.

Source: FDA drug label (sirolimus), Glenmark Pharmaceuticals Inc., USA, effective January 28, 2026 (SPL set 57fb4d90-3ccb-4a69-af1e-53be83f7a504), 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

13Darunavir generic labelers
17Sirolimus generic labelers
DarunavirSirolimus
Labeled forHIVOrgan transplant rejection
Boxed warningNoYes
Pharmacy cost (NADAC)$1.16 per tablet 600 mg tablet$0.723 per tablet 1 mg tablet
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?