Interaksi Darunavir dan kobisistat dan Emtrisitabin, rilpivirin, dan tenofovir
Darunavir dan kobisistat dan Emtrisitabin, rilpivirin, dan tenofovir: kedua label peresepan menandai kombinasi ini dengan bahasa yang paling tegas, seperti kontraindikasi, peringatan kotak hitam, atau instruksi untuk menghindarinya.
Jangan dikombinasikan tanpa arahan dokter yang meresepkan. Bahasa label di bawah ini adalah yang paling tegas yang digunakan FDA.
Apa kata label FDA
Dari label Emtrisitabin, rilpivirin, dan tenofovir (COMPLERA) · berlaku sejak 2025-07-16
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.
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.
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) ] .
Coadministration of RPV and drugs that inhibit CYP3A may result in increased plasma concentrations of RPV.
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.
Dari label Darunavir dan kobisistat (PREZCOBIX) · berlaku sejak 2026-02-01
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) ] .
Co-administration of PREZCOBIX or PREZCOBIX PED and tenofovir DF in combination with concomitant or recent use of a nephrotoxic agent is not recommended.
PREZCOBIX or PREZCOBIX PED is not recommended in combination with other antiretroviral drugs that require pharmacokinetic boosting.
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.
Measure serum phosphorus in patients with or at risk for renal impairment when used with tenofovir DF.
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