Prezcobix Dosage/Direction for Use

Recommended Dosage: PREZCOBIX is a fixed-dose combination product containing 800 mg of darunavir and 150 mg of cobicistat. In treatment-naïve and treatment-experienced adults with no darunavir resistance-associated substitutions, the recommended dosage of PREZCOBIX is one tablet taken once daily orally with food. Administer PREZCOBIX in conjunction with other antiretroviral agents.
Testing Prior to Initiation of PREZCOBIX: HIV Genotypic Testing: HIV genotypic testing is recommended for antiretroviral treatment-experienced patients. However, when HIV genotypic testing is not feasible, PREZCOBIX can be used in protease inhibitor-naïve patients, but it is not recommended in protease inhibitor-experienced patients.
Creatinine Clearance: Prior to starting PREZCOBIX, assess estimated creatinine clearance because cobicistat decreases estimated creatinine clearance due to inhibition of tubular secretion of creatinine without affecting actual renal glomerular function [see Effects on Serum Creatinine under Precautions]. When co-administering PREZCOBIX with tenofovir disoproxil fumarate (tenofovir DF) assess estimated creatinine clearance, urine glucose, and urine protein at baseline [see New Onset or Worsening Renal Impairment When Used With Tenofovir Disoproxil Fumarate under Precautions].
Not Recommended in Severe Renal Impairment: PREZCOBIX co-administered with tenofovir DF is not recommended in patients who have an estimated creatinine clearance below 70 mL per minute [see New Onset or Worsening Renal Impairment When Used With Tenofovir Disoproxil Fumarate under Precautions and Clinical Trials Experience under Adverse Reactions].
Not Recommended in Severe Hepatic Impairment: PREZCOBIX is not recommended for use in patients with severe hepatic impairment [see Hepatic Impairment under Precautions and Pharmacology: Pharmacokinetics under Actions].
Not Recommended During Pregnancy: PREZCOBIX is not recommended during pregnancy because of substantially lower exposures of darunavir and cobicistat during the second and third trimesters [see Pregnancy under Use in Pregnancy & Lactation and Pharmacology: Pharmacokinetics under Actions].
PREZCOBIX should not be initiated in pregnant individuals. An alternative regimen is recommended for those who become pregnant during therapy with PREZCOBIX.