Generic Name and Formulations:
Dolutegravir 50mg; tablets.

Company:
ViiV Healthcare
Indications for TIVICAY:
In combination with other antiretroviral agents for the treatment of HIV-1 infection.

Adult Dose for TIVICAY:
≥12 years and ≥40kg: treatment-naïve or treatment-experienced INSTI-naïve: 50mg once daily. Treatment-naïve or treatment-experienced INSTI-naïve with concomitant potent UGT1A/CYP3A inducers (eg, efavirenz, fosamprenavir/ritonavir, tipranavir/ritonavir, or rifampin): 50mg twice daily. INSTI-experienced with certain INSTI-associated resistance substitutions or clinically suspected INSTI resistance: 50mg twice daily.

Children's Dose for TIVICAY:
<12 years or <40kg, or INSTI-experienced with documented or clinically suspected resistance to other INSTIs (raltegravir, elvitegravir): not established.

Pharmacological Class:
HIV-1 integrase strand transfer inhibitor (INSTI).

Contraindications:
Concomitant dofetilide.

Warnings/Precautions:
Discontinue if hypersensitivity reactions develop. Increased risk for worsening/development of elevated transaminases in patients with hepatitis B or C; monitor LFTs prior to starting and during therapy. Severe hepatic impairment: not recommended. 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. Pregnancy (Cat. B). Nursing mothers: not recommended.

Interactions:
May be affected by drugs that induce or inhibit UGT1A1, UGT1A3, UGT1A9, BCRP, and P-gp enzymes or transporters. Avoid concomitant nevirapine, oxcarbazepine, phenytoin, phenobarbital, carbamazepine, St. John’s wort. Avoid etravirine unless coadministered with atazanavir/ritonavir, darunavir/ritonavir, or lopinavir/ritonavir. Concomitant efavirenz, fosamprenavir/ritonavir, tipranavir/ritonavir, or rifampin: adjust dose to 50mg twice daily. Concomitant cation-containing antacids, laxatives, sucralfate, oral iron/calcium supplements, and buffered drugs: give dolutegravir 2 hours before or 6 hours after. Concomitant metformin; monitor closely and adjust metformin dose if necessary.

Adverse Reactions:
Insomnia, headache; immune reconstitution syndrome, lab abnormalities.

How Supplied:
Tabs—30