Juluca (dolutegravir + rilpivirine)
12 May 2018. Related: ARVs, Fixed dose combinations, Integrase inhibitors, NNRTIs.
Juluca is a fixed dose combination (FDC) of dolutegravir (50 mg) and rilpivirine (25 mg).
It is only approved (in the US) as a switch therapy in HIV positive people who have been on stable ART with undetectable viral load for more than six months. Other conditions include not having a history of HIV drug resistance.
- Standard adult dose is once pill, once daily.
- Juluca needs to be taken with food (to boost the rilpivirine).
- A drug interaction with the TB medicine rifabutin requires taking an additional daily 25 mg rilpivirine tablet.
- Other drug interactions mean that Juluca should not be taken with the following drugs: dofetilide, carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin, rifapentine, proton pump inhibitors (including: esomeprazole, lansoprazole, omeprazole, pantoprazole sodium, rabeprazole), St. John’s wort, or more than 1 dose of the steroid medicine dexamethasone or dexamethasone sodium phosphate,
- No dose adjustment is needed with mild or moderate kidney damage (defined as CrCl greater than 30mL/min). Increased monitoring is recommended is more severe kidney damage (CrCl less than 30mL/min).
- No dose adjustment is needed with mild or moderate liver damage.
- For more information, see separate information on dolutegravir and rilpivirine.
- Juluca was approved in the US in November 2017.
- Juluca was approved in the EU in May 2018.
The European patient information and detailed Product Information for dolutegravir/rilpivirine (Juluca) are available at this link on European Medicines Agency (EMA) website.
The Patient Information is a simplified summary: what the drug is, why it is used, results from studies and cautions including side effects.
The Product Information is a detailed technical summary that you can access as a PDF file by clicking the ‘Product Information’ tab. It describes more precisely how the drug works and how it is processed by your body. This includes, for example, reported food interaction studies in terms of calories or fat content. It includes more details of the study results and a full list of side effects and drug interactions.