Indications for TIVICAY:
In combination with other antiretroviral agents for treatment of HIV-1 infection in adults (treatment-naïve or -experienced) and in pediatric patients (treatment-naïve or -experienced but integrase strand transfer inhibitor [INSTI]-naïve) aged ≥4weeks and weighing ≥3kg. In combination with rilpivirine as a complete regimen for 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 + rilpivirine: 50mg once daily. Treatment-naïve or treatment-experienced INSTI-naïve when concomitant with certain UDP-UGT1A or CYP3A inducers: 50mg twice daily. INSTI-experienced with certain INSTI-associated resistance substitutions or clinically suspected INSTI resistance: 50mg twice daily.
See full labeling. <4weeks, <3kg, or INSTI-experienced with documented or clinically suspected resistance to other INSTIs (eg, raltegravir, elvitegravir): not established. ≥4weeks: (14–<20kg): 40mg once daily; (≥20kg): 50mg once daily. If concomitant with certain UGT1A or CYP3A inducers, increase weight-based dose to twice daily.
Tabs and tabs for oral susp are not interchangeable on a mg per mg basis. 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. INSTI-experienced patients (with certain INSTI-associated resistance substitutions or clinically suspected INSTI resistance) with severe renal impairment: may result in loss of efficacy and development of resistance. Dialysis. Elderly. Embryo-fetal toxicity: increased risk of neural tube defects (assess risks/benefits; consider alternative treatment at time of conception through 1st trimester or if pregnancy is confirmed). Pregnancy: exclude status prior to initiation. 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 (eg, dofetilide, dalfampridine, metformin). 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.
Insomnia, fatigue, headache; hypersensitivity reactions, hepatotoxicity, immune reconstitution syndrome.
Register pregnant patients exposed to dolutegravir by calling (800) 258-4263.
Generic Drug Availability:
Tabs—30; PD—60 (w. dosing cup + oral dosing syringe)