Dolutegravir/Rilpivirine

DEA Class; Rx

Common Brand Names; Juluca

Fixed dose combination product containing an integrase strand transfer inhibitor (INSTI) and integrase strand transfer inhibitor (INSTI)
Indicated as a complete regimen for the treatment of HIV-1 in adults who are virologically suppressed and on a stable antiretroviral regimen for at least 6 months
Monitor for severe skin reactions and hepatotoxicity

Dolutegravir/rilpivirine

Documented hypersensitivity to dolutegravir or rilpivirine

Concomitant use with other drugs

• Also see Cautions and Dosage Modifications
• Dofetilide, carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin, rifapentine, dexamethasone, St. John’s wort, esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole

Dolutegravir

• Lipase, Grade 2 (5%)
• Hyperglycemia, Grade 2 (4%)
• ALT, Grade 2 (2%)
• Total bilirubin, Grade 2 (2%)
• Creatine kinase, Grade 3 or 4 (1%)
• Lipase, Grade 3 or 4 (2%)

Rilpivirine

• Lipase, Grade 2 (5%)
• Hyperglycemia, Grade 3 or 4 (5%)
• Total bilirubin, Grade 2 (4%)
• Creatine kinase, Grade 3 or 4 (2%)
• Lipase, Grade 3 or 4 (2%)

ALT, Grade 3 or 4

AST, Grade 3 or 4

Creatine kinase, Grade 2

Hyperglycemia, Grade 3 or 4

Dolutegravir has been shown to cross the placenta; data from a birth outcome surveillance study has identified an increased risk of neural tube defects when dolutegravir, a component of the drug combination, is administered at time of conception compared with non-dolutegravir-containing antiretroviral regimens

The Centers for Disease Control and Prevention do not recommend HIV-1-infected mothers in the United States breastfeed their infants to avoid risking postnatal transmission of HIV-1 infection

Dolutegravir and lamivudine are present in human milk; there is no information on effects of the drug components on the breastfed infant or effects on milk production