Tegrad Patient Counseling Information

Advise the patient to read the patient labeling (Patient Information).
Drug Interactions: Dolutegravir tablet is contraindicated with dofetilide because interactions between these drugs can result in potentially life-threatening adverse events [see Contraindications].
Hypersensitivity Reactions: Advise patients to immediately contact their healthcare provider if they develop rash. Instruct patients to immediately stop taking dolutegravir tablets and other suspect agents, and seek medical attention if they develop a rash associated with any of the following symptoms, as it may be a sign of a more serious reaction such as severe hypersensitivity: fever; generally ill feeling; extreme tiredness; muscle or joint aches; 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 of liver problems (e.g., yellowing of the skin or whites of the eyes, dark or tea-colored urine, pale-colored stools or bowel movements, nausea, vomiting, loss of appetite, or pain, aching, or sensitivity on the right side below the ribs) [see Precautions].
Effects on Serum Liver Biochemistries in Patients with Hepatitis B or C Co-infection: Advise patients that it is recommended to have laboratory testing before and during therapy as patients with underlying hepatitis B or C may be at increased risk for worsening or development of transaminase elevations with use of dolutegravir tablets [see Precautions].
Fat Redistribution: Inform patients that redistribution or accumulation of body fat may occur in patients receiving antiretroviral therapy and that the cause and long-term health effects of these conditions are not known at this time [see Precautions].
Immune Reconstitution Syndrome: Advise patients to inform their healthcare provider immediately of any signs or symptoms of infection as inflammation from previous infection may occur soon after combination antiretroviral therapy, including when dolutegravir tablet is started [see Precautions].
Pregnancy Registry: Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to dolutegravir tablets during pregnancy [see Use in Pregnancy and Lactation]. Lactation: Instruct women with HIV-1 infection not to breastfeed because HIV-1 can be passed to the baby in the breast milk [see Use in Pregnancy and Lactation].
Missed Dosage: Instruct patients that if they miss a dose of dolutegravir tablets, to take it as soon as they remember. Advise patients not to double their next dose or take more than the prescribed dose [see Dosage & Administration].
Storage Condition: Store below 30°C and protect from moisture.