Indications for TIVICAY:
In combination with other antiretroviral agents for the treatment of HIV-1 infection in patients ≥30kg. In combination with rilpivirine as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 copies per mL) on a stable antiretroviral regimen for ≥6 months with no history of treatment failure or known substitutions associated with resistance to either antiretroviral agent.
Treatment-naïve or treatment-experienced INSTI-naïve or virologically suppressed adults switching to dolutegravir plus rilpivirine: 50mg once daily. Treatment-naïve or treatment-experienced INSTI-naïve when concomitant with certain UGT1A or CYP3A inducers: 50mg twice daily. INSTI-experienced with certain INSTI-associated resistance substitutions or clinically suspected INSTI resistance: 50mg twice daily.
<30kg or INSTI-experienced with documented or clinically suspected resistance to other INSTIs (raltegravir, elvitegravir): not established. Treatment-naïve or treatment-experienced INSTI-naïve: (30–<40kg): 35mg once daily; (≥40kg): 50mg once daily. If concomitant with certain UGT1A or CYP3A inducers, increase weight-based dose to twice daily.
Discontinue if hypersensitivity reactions develop. Increased risk for worsening/development of elevated transaminases in patients with underlying hepatitis B or C; monitor for hepatotoxicity. Severe hepatic impairment: not recommended. Immune reconstitution syndrome. INSTI-experienced patients (with certain INSTI-associated resistance substitutions or clinically suspected INSTI resistance) with severe renal impairment: decrease in dolutegravir concentrations may result in loss of efficacy and development of resistance. Dialysis. Elderly. Embryo-fetal toxicity: increased risk of neural tube defects (avoid use at time of conception through 1st trimester). Pregnancy: exclude status prior to initiation; if confirmed in 1st trimester, consider switching to alternative HIV regimen. Advise females of reproductive potential to use effective contraception. Nursing mothers: not recommended.
HIV-1 integrase strand transfer inhibitor (INSTI).
Avoid concomitant nevirapine, oxcarbazepine, phenytoin, phenobarbital, St. John’s wort. Avoid etravirine unless coadministered with atazanavir/ritonavir, darunavir/ritonavir, or lopinavir/ritonavir. Concomitant efavirenz, fosamprenavir/ritonavir, tipranavir/ritonavir, rifampin, or carbamazepine: adjust dose (see Adults, Children). May be affected by drugs that induce or inhibit UGT1A1, UGT1A3, UGT1A9, BCRP, and P-gp enzymes or transporters. May potentiate drugs eliminated via OCT2 or MATE1. Concomitant cation-containing antacids, laxatives, sucralfate, buffered drugs, or oral iron/calcium supplements (also can give together with a meal): give dolutegravir 2hrs before or 6hrs after. Limit concomitant metformin dose to 1000mg/day; adjust metformin dose when stopping dolutegravir; monitor closely.
Insomnia, fatigue, headache; hypersensitivity reactions.
Register pregnant patients exposed to dolutegravir by calling (800) 258-4263.