and 217 cells/mm3
for the group receiving TIVICAY plus TRUVADA.
16 HOW SUPPLIED/STORAGE AND HANDLING
Each DOVATO tablet contains 50 mg of dolutegravir as dolutegravir sodium and 300 mglamivudine and is an oval, biconvex, white, film-coated tablet, debossed with “SV 137” on oneface.
Bottle of 30 tablets with child-resistant closure NDC 49702-246-13.
Store below 30C (86F).
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Emergence of Lamivudine-Resistant HBV in Hepatitis B Co-infectionAdvise all patients with HIV-1 to be tested for the presence of HBV prior to or when initiating
DOVATO. Advise patients co-infected with HIV-1 and HBV that emergence of HBV variantsassociated with resistance to lamivudine has been reported in HIV-1–infected subjects who havereceived lamivudine-containing antiretroviral regimens. Advise patients co-infected with HIV-1and HBV who are being treated with DOVATO to discuss with their healthcare provider ifadditional treatment should be considered for appropriate treatment of chronic HBV [seeWarnings and Precautions (5.1)].
Severe Acute Exacerbations of Hepatitis in Patients with HBV Co-infectionAdvise all patients with HIV-1 to be tested for the presence of HBV prior to or when initiatingDOVATO. Advise patients co-infected with HIV-1 and HBV that worsening of liver disease hasoccurred in some cases when treatment with lamivudine was discontinued. Advise patients todiscuss any changes in regimen with their healthcare provider [see Warnings and Precautions(5.1)].
Hypersensitivity Reactions
Advise patients to immediately contact their healthcare provider if they develop a rash. Instructpatients to immediately stop taking DOVATO and seek medical attention if they develop a rashassociated with any of the following symptoms, as it may be a sign of a more serious reactionsuch as severe hypersensitivity: fever; generally ill feeling; extreme tiredness; muscle or jointaches; blisters or peeling of the skin; oral blisters or lesions; eye inflammation; facial swelling;swelling of the eyes, lips, tongue, or mouth; breathing difficulty; and/or signs and symptoms ofliver problems (e.g., yellowing of the skin or whites of the eyes; dark or tea-colored urine; palecoloredstools or bowel movements; nausea; vomiting; loss of appetite; or pain, aching, orsensitivity on the right side below the ribs). Advise patients that if hypersensitivity occurs, theywill be closely monitored, laboratory tests will be ordered, and appropriate therapy will beinitiated [see Warnings and Precautions (5.2)].
Hepatotoxicity
Inform patients that hepatotoxicity has been reported with dolutegravir, a component ofDOVATO [see Warnings and Precautions (5.3), Adverse Reactions (6.1)]. Inform patients thatmonitoring for hepatotoxicity during therapy with DOVATO is recommended.
Embryo-Fetal Toxicity
Advise individuals of childbearing potential to avoid use of DOVATO at the time of conceptionthrough the first trimester of pregnancy. Advise individuals of childbearing potential to contacttheir healthcare provider if they plan to become pregnant, become pregnant, or if pregnancy issuspected during treatment with DOVATO [see Warnings and Precaution (5.4)].
Advise individuals of childbearing potential taking DOVATO to consistently use effectivecontraception [see Use in Specific Popu |
