1. TIVICAY (TIV-eh-kay) (Dolutegravir)

2. Date of Approval: August 12, 2013 Approved by :U.S. Food and Drug Administration (FDA) Company: ViiV Healthcare Generic Name : Dolutegravir Brand Name: Tivicay Other Names: DTG Drug Class: Integrase Inhibitors Approved Use: Treatment of HIV Infection Chemical structure: Molecular Weight: 419.3821 3. DOSAGE AND ADMINISTRATION: TIVICAY tablets may be taken with or without food.For Adults :50 mg tablet once a d for people on HIV therapy for the first time . Twice-daily dosing in people who have viral resistance to Isentress and elvitegravir. Expected to have no food restriction Alternative combinations that do not include metabolic inducers should be considered where possible 4. Pediatric Patients : Age 12 years and older and weighing at least 40 kg 50 mg p/o -OD. Efavirenz, fosamprenavir/ritonavir, tipranavir/ritonavi r, or rifampin - 50 mg twice daily.Safety and efficacy of TIVICAY have not been established in pediatric patients younger than 12 years or weighing less than 40 kg, or in pediatric patients who are INSTI-experienced with documented or clinically suspected resistance to other INSTIs (raltegravir, elvitegravir). 5. DOSAGE FORMS AND STRENGTHS TIVICAY 50-mg tablets are yellow, round, filmcoated, biconvex tablets . Each tablet contains 50 mg of dolutegravir (as dolutegravir sodium) Pharmacokinetics Absorption Peak plasma time: 2-3 hr Peak plasma concentration: 3.67-4.15 mcg/l Distribution Protein bound: 98.9% Vd : 17.4 L; 4-232 ng/mL (CSF) 6. Metabolism : Metabolized by UGT1A1 with some contribution from CYP3A Elimination : Half-life: 14 hr Clearance: 1 L/hr Excretion: 53% feces (unchanged); 31% urine (as ether glucuronide, benzylic carbon, or N-dealkylation product);