lations (8.1, 8.3)].
Lactic Acidosis/Hepatomegaly with SteatosisInform patients that some HIV medicines, including DOVATO, can cause a rare, but seriouscondition called lactic acidosis with liver enlargement (hepatomegaly) [see Warnings andPrecautions (5.5)].
Drug Interactions
DOVATO may interact with many drugs; therefore, advise patients to report to their healthcareprovider the use of any other prescription or nonprescription medication or herbal products,including St. John’s wort [see Contraindications (4), Warnings and Precautions (5.6), DrugInteractions (7)].
Immune Reconstitution Syndrome
Advise patients to inform their healthcare provider immediately of any signs and symptoms ofinfection as inflammation from previous infection may occur soon after combinationantiretroviral therapy, including DOVATO, is started [see Warnings and Precautions (5.7)].
Pregnancy Registry
Inform patients that there is an antiretroviral pregnancy registry to monitor fetal outcomes inthose exposed to DOVATO during pregnancy [see Use in Specific Populations (8.1)].
Lactation
Instruct mothers with HIV-1 infection not to breastfeed because HIV-1 can be passed to the babyin the breast milk [see Use in Specific Populations (8.2)].
Missed Dose
Instruct patients that if they miss a dose of DOVATO, to take it as soon as they remember.Advise patients not to double their next dose or take more than the prescribed dose [see Dosageand Administration (2)].
DOVATO, EPIVIR, TIVICAY, and TRIUMEQ are trademarks owned by or licensed to the ViiVHealthcare group of companies.
The other brand listed is a trademark owned by or licensed to its respective owner and is notowned by or licensed to the ViiV Healthcare group of companies. The maker of this brand is notaffiliated with and does not endorse the ViiV Healthcare group of companies or its products.
Manufactured for:
ViiV Healthcare
Research Triangle Park, NC 27709
by:
GlaxoSmithKline
Research Triangle Park, NC 27709
©2019 ViiV Healthcare group of companies or its licensor.
DVT:1PI
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