JULUCA (dolutegravir sodium)

Absorption, Distribution, Metabolism, and

ExcretionThe pharmacokinetic (PK) properties of the components of JULUCA are provided in Table 5 . The multiple-dose pharmacokinetic parameters are provided in Table 6 . Table 5. Pharmacokinetic Properties of the Components of JULUCA UGT = uridine diphosphate glucuronosyltransferase; CYP = Cytochrome P450. a Geometric mean ratio (fed/fasted) in PK parameters and (90% confidence interval). High-calorie/high-fat meal = ~900 kcal, 56% fat. Moderate-fat mea...

14.1 Clinical Trials in Adult Subjects Switching to JULUCA The efficacy of JULUCA is supported by data from 2 open-label, controlled trials (SWORD-1 [NCT02429791] and SWORD-2 [NCT02422797]) in virologically suppressed patients switching from their current antiretroviral regimen to dolutegravir plus rilpivirine. SWORD-1 and SWORD-2 are identical 148-week, Phase 3, randomized, multicenter, parallel-group, non-inferiority trials. A total of 1,024 adult HIV-1–infected subjects who were on a stable suppressive antiretroviral regimen (containing 2 NRTIs plus either an INSTI, an NNRTI, or a PI) for a...

The following adverse reactions are described below and in other sections of the labeling:

• Skin and hypersensitivity reactions [see Warnings and Precautions ( 5.1 )].
• Hepatotoxicity [see Warnings and Precautions ( 5.2 )].
• Depressive disorders [see Warnings and Precautions ( 5.3 )]. The most common adverse reactions (all grades) observed in at least 2% of subjects were diarrhea, headache, and nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact ViiV Healthcare at 1-877-844-8872 or...

JULUCA is contraindicated in patients:

• with previous hypersensitivity reaction to dolutegravir or rilpivirine [see Warnings and Precautions ( 5.1 )] .
• receiving dofetilide due to the potential for increased dofetilide plasma concentrations and the risk for serious and/or life-threatening events [see Drug Interactions ( 7 )] .
• receiving other coadministered drugs in Table 1 that significantly...

• Severe skin and hypersensitivity reactions characterized by rash, constitutional findings, and sometimes organ dysfunction, including liver injury, have been reported with the individual components. Discontinue JULUCA immediately if signs or symptoms of severe skin or hypersensitivity reactions develop, as a delay in stopping treatment may result in a life-threatening reaction. ( 5.1 )
• Hepatotoxicity has been reported in patients receiving a dolutegravir- or rilpivirine-containing regimen. M...

7 DRUG INTERACTIONS

• Because JULUCA is a complete regimen, coadministration with other antiretroviral medications for the treatment of HIV-1 infection is not recommended. ( 7.1 )
• Refer to the full prescribing information for important drug interactions with JULUCA. ( 4 , 5.4 , 7 )
• Drugs that induce or inhibit cytochrome P450 (CYP)3A4 or uridine diphosphate glucuronosyltransferase (UGT)1A1 may...