Embryo Fetal Toxicity:

Alternative treatments to DOVATO should be considered at the time of conception through the first trimester of pregnancy due to the risk of neural tube defects

Perform pregnancy testing before use of DOVATO and counsel that consistent use of effective contraception is recommended while using DOVATO in individuals of childbearing potential

Adverse Reactions or Loss of Virologic Response Due to Drug Interactions with concomitant use of DOVATO and other drugs may occur (see Contraindications and Drug interactions).

Adverse reactions

The most common adverse reactions (incidence ≥2%, all grades) with DOVATO were headache (3%), nausea (2%), diarrhea (2%), insomnia (2%), fatigue (2%), and anxiety (2%).

Use in specific populations

Pregnancy: There are insufficient human data on the use of DOVATO during pregnancy to definitively assess a drug-associated risk for birth defects and miscarriage. An Antiretroviral Pregnancy Registry has been established. If planning a pregnancy or if pregnancy is confirmed while taking DOVATO during the first trimester, assess the risks and benefits of continuing DOVATO versus switching to another antiretroviral regimen. For individuals actively trying to become pregnant, initiation of DOVATO is not recommended unless there is no suitable alternative

Lactation: Breastfeeding is not recommended due to the potential for HIV-1 transmission, developing viral resistance in HIV-positive infants, and adverse reactions in a breastfed infant

Females and Males of Reproductive Potential: Perform pregnancy testing before initiation of DOVATO. Advise individuals of childbearing potential to consistently use effective contraception while taking DOVATO

Renal Impairment: DOVATO is not recommended for patients with creatinine clearance <50 mL/min

Hepatic Impairment: DOVATO is not recommended in patients with severe hepatic impairment (Child-Pugh Score C)

Please see full Prescribing Information, including Boxed Warning, for DOVATO.