SYMTUZA

Absorption, Distribution, Metabolism, and

ExcretionThe bioavailability of the components of SYMTUZA was not affected when administered orally as a split tablet compared to administration as a tablet swallowed whole. Pharmacokinetic (PK) properties and PK parameters of the components of SYMTUZA are provided in Table 5 and Table 6, respectively.

Table 5Pharmacokinetic Properties of the Components of SYMTUZA Darunavir Cobicistat Emtricitabine TAF PBMCs = peripheral blood mononuclear cells; CES-1...

14.1 Clinical Trial Results in Subjects with HIV-1 Infection with no Prior Antiretroviral Treatment History The efficacy of SYMTUZA in HIV-1 subjects with no prior antiretroviral treatment history was evaluated in the Phase 3 trial TMC114FD2HTX3001 [NCT02431247, (AMBER)] in which subjects were randomized in a 1:1 ratio to receive either SYMTUZA (N=362) or a combination of PREZCOBIX and FTC/TDF (N=363) once daily. The median age was 34.0 years (range 18–71), 88.3% were male, 83% White, 11% Black, and 2% Asian. The mean baseline plasma HIV-1 RNA was 4.5 log 10 copies/mL (range 1.3–6.7), and 18% ...

The following adverse reactions are discussed in other sections of the labeling: Severe acute exacerbations of hepatitis B [see Warnings and Precautions (5.1) ] Hepatotoxicity [see Warnings and Precautions (5.2) ] Severe skin reactions [see Warnings and Precautions (5.3) ] Immune reconstitution syndrome [see Warnings and Precautions (5.5) ] New onset or worsening renal impairment [see Warnings and Precautions (5.6) ] Lactic acidosis/severe hepatomegaly with steatosis [see Warnings and Precaution...

Darunavir and cobicistat are both inhibitors of the cytochrome P450 3A (CYP3A) isoform. SYMTUZA should not be co-administered with medicinal products that are highly dependent on CYP3A for clearance and for which increased plasma concentrations are associated with serious and/or life-threatening events (narrow therapeutic index). Darunavir and cobicistat are both substrates of the cytochrome P450 ...

Drug-induced hepatitis (e.g., acute hepatitis, cytolytic hepatitis) including some fatalities can occur with SYMTUZA. Monitor liver function before and during therapy, especially in patients with underlying chronic hepatitis, cirrhosis, or in patients who have pre-treatment elevations of transaminases. ( 5.2 ) Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash with eosinophilia and systemic symptoms, and acute generalized exanthematous pustulosis may...

7. DRUG INTERACTIONS Co-administration of SYMTUZA with other drugs can alter the concentration of other drugs and other drugs may alter the concentrations of SYMTUZA components. Consult the full prescribing information prior to and during treatment for potential drug interactions. ( 4 , 5.4 , 7 , 12.3 ) 7.1 Not Recommended With Other Antiretroviral Medications SYMTUZA is a complete regimen for HIV...