Darunavir and cobicistat and Emtricitabine, rilpivirine, and tenofovir interaction

Darunavir and cobicistat and Emtricitabine, rilpivirine, and tenofovir: both prescribing labels flag this combination with the strongest language, such as a contraindication, a boxed warning, or an instruction to avoid it.

Major

Do not combine without a prescriber's guidance. The label language below is the strongest FDA uses.

What the FDA labels say

From the Emtricitabine, rilpivirine, and tenofovir (COMPLERA) label · effective 2025-07-16

Major

COMPLERA is a complete regimen for the treatment of HIV-1 infection; therefore, coadministration with other antiretroviral medications for treatment of HIV-1 infection is not recommended.

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Major

Not Recommended with Other Antiretroviral Medications Because COMPLERA is a complete regimen, coadministration with other antiretroviral medications for the treatment of HIV-1 infection is not recommended.

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Moderate

Drugs Inducing or Inhibiting CYP3A Enzymes Rilpivirine is primarily metabolized by cytochrome P450 (CYP) 3A, and drugs that induce or inhibit CYP3A may thus affect the clearance of RPV [see Contraindications (4) , Warnings and Precautions (5.7) , and Clinical Pharmacology (12.3) ] .

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Moderate

Coadministration of RPV and drugs that inhibit CYP3A may result in increased plasma concentrations of RPV.

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Minor

Lactic Acidosis/Severe Hepatomegaly with Steatosis Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs, including TDF and FTC, components of COMPLERA, alone or in combination with other antiretrovirals.

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From the Darunavir and cobicistat (PREZCOBIX) label · effective 2026-02-01

Major

Co-administration of PREZCOBIX or PREZCOBIX PED and tenofovir DF is not recommended in patients who have an estimated creatinine clearance below 70 mL/min [see Dosage and Administration (2.4) ] .

Warnings and precautionsnames Emtricitabine, rilpivirine, and tenofovirView label on DailyMed
Major

Co-administration of PREZCOBIX or PREZCOBIX PED and tenofovir DF in combination with concomitant or recent use of a nephrotoxic agent is not recommended.

Warnings and precautionsnames Emtricitabine, rilpivirine, and tenofovirView label on DailyMed
Major

PREZCOBIX or PREZCOBIX PED is not recommended in combination with other antiretroviral drugs that require pharmacokinetic boosting.

Warnings and precautionsby drug classView label on DailyMed
Moderate

Document urine glucose and urine protein at baseline [see Dosage and Administration (2.4) ] and perform routine monitoring of estimated creatinine clearance, urine glucose, and urine protein during treatment when PREZCOBIX or PREZCOBIX PED is used with tenofovir DF.

Warnings and precautionsnames Emtricitabine, rilpivirine, and tenofovirView label on DailyMed
Moderate

Measure serum phosphorus in patients with or at risk for renal impairment when used with tenofovir DF.

Warnings and precautionsnames Emtricitabine, rilpivirine, and tenofovirView label on DailyMed

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Not medical advice. Interaction Checker quotes FDA label text and NIH fact sheets. Whether an interaction matters for you depends on doses, timing, kidney and liver function, and other conditions. Confirm with a pharmacist or prescriber.