For treatment-naïve and virologically suppressed adults with HIV-1. See Full Indication.

DOSING AND DRUG

INTERACTIONS OF DOVATO

DOSING AND DRUG INTERACTIONS OF DOVATO

Dosing Of DOVATO

A Complete Regimen Offering Convenient Dosing for Your Adult Patients

ONCE A DAY

TAKEN ANY TIME OF DAY

WITH OR WITHOUT FOOD

Potential Drug Interactions With DOVATO

Established and Other Potentially Significant Drug to Drug Interactions

AVOID

Contraindicated

Dofetilide

Avoid Coadministration
Agent	Recommendations
Oxcarbazepine Phenobarbital Phenytoin St John's wort (Hypericum perforatum)	Avoid coadministration with DOVATO because there are insufficient data to make dosing recommendations
Sorbitol	When possible, avoid use of sorbitol-containing medicines with DOVATO

Because DOVATO is a complete regimen, coadministration with other ARVs for the treatment of HIV-1 infection is not recommended

ARVs=antiretrovirals.

CONSIDERATIONS

Dosing Adjustments and Considerations
Agent	Recommendations
Certain UGT1A/CYP3A inducers: carbamazepine or rifampin	An additional dolutegravir 50-mg dose should be taken, separated by 12 hours from DOVATO
Metformin	Refer to the prescribing information for metformin for assessing the benefit and risk of concomitant use of DOVATO and metformin
Medications containing polyvalent cations (eg, Mg or Al): cation-containing antacids or laxatives, sucralfate, or buffered medications	Administer DOVATO 2 hours before or 6 hours after taking medications containing polyvalent cations
Oral calcium or iron supplements, including multivitamins containing calcium or iron	When taken with food, DOVATO and supplements or multivitamins containing calcium or iron can be taken at the same time. Under fasting conditions, DOVATO should be taken 2 hours before or 6 hours after taking supplements containing calcium or iron
Dalfampridine	Elevated levels of dalfampridine increase the risk of seizures. The potential benefits of taking dalfampridine concurrently with DOVATO should be considered against the risk of seizures in these patients

Please see Section 7 of the full Prescribing Information for additional drug interaction information

Al=aluminum; Mg=magnesium.

NO ADJUSTMENTS

Dolutegravir and Lamivudine, Components of DOVATO, Have No Clinically Relevant Effects on the Pharmacokinetics of the Following Agents

Based on available pharmacokinetics drug interaction studies
Prednisone Midazolam Rifabutin Oral contraceptives containing norgestimate* and ethinyl estradiol Proton pump inhibitors (omeprazole)
Based on pharmacokinetics, metabolic pathways, and/or available drug interaction studies
Hepatitis C drugs, including^1,2:
Sofosbuvir Ledipasvir/sofosbuvir³ Simeprevir⁴ Elbasvir/grazoprevir⁵ Daclatasvir plus sofosbuvir Ombitasvir/paritaprevir/r plus dasabuvir⁶ Sofosbuvir/velpatasvir Sofosbuvir/velpatasvir/voxilaprevir⁷ Glecaprevir/pibrentasvir⁸	Ombitasvir/paritaprevir/r plus dasabuvir⁶ Sofosbuvir/velpatasvir Sofosbuvir/velpatasvir/voxilaprevir⁷ Glecaprevir/pibrentasvir⁸

Norelgestromin is the active metabolite of norgestimate and no drug interaction is expected with norgestimate.⁹

References:

AIDSinfo website. https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/AdultandAdolescentGL.pdf. Accessed July 16, 2020.
American Association for the Study of Liver Diseases and Infectious Diseases Society of America. HCV Guidance: Recommendations for Testing, Managing, and Treating Hepatitis C. https://www.hcvguidelines.org/unique-populations/hiv-hcv. Updated May 24, 2018. Accessed July 16, 2020.
Harvoni [package insert]. Foster City, CA: Gilead Sciences, Inc.; 2017.
Olysio [package insert]. Titusville, NJ: Janssen Therapeutics; 2017.
Zepatier [package insert]. Whitehouse Station, NJ: Merck & Co, Inc.; 2018.
Viekira Pak [package insert]. North Chicago, IL: AbbVie, Inc.; 2018.
Vosevi [package insert]. Foster City, CA: Gilead Sciences, Inc.; 2017.
Mavyret [package insert]. North Chicago, IL: AbbVie, Inc.; 2018.
Song IH, Borland J, Chen S, Wajima T, Peppercorn AF, Piscitelli SC. Dolutegravir has no effect on the pharmacokinetics of oral contraceptives with norgestimate and ethinyl estradiol. Ann Pharmacother. 2015;49(7):784–789.

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DLLWCNT200030

ARROW

IMPORTANT SAFETY INFORMATION

BOXED WARNING: PATIENTS CO-INFECTED WITH HEPATITIS B VIRUS (HBV) AND HIV-1: EMERGENCE OF LAMIVUDINE-RESISTANT HBV AND EXACERBATIONS OF HBV

All patients with HIV-1 should be tested for the presence of HBV prior to or when initiating DOVATO. Emergence of lamivudine-resistant HBV variants associated with lamivudine-containing antiretroviral regimens has been reported. If DOVATO is used in patients co-infected with HIV-1 and HBV, additional treatment should be considered for appropriate treatment of chronic HBV; otherwise, consider an alternative regimen.

Severe acute exacerbations of HBV have been reported in patients who are co-infected with HIV-1 and HBV and have discontinued lamivudine, a component of DOVATO. Closely monitor hepatic function in these patients and, if appropriate, initiate anti-HBV treatment.

Contraindications

Do not use DOVATO in patients with previous hypersensitivity reaction to dolutegravir or lamivudine

Do not use DOVATO in patients receiving dofetilide

Warnings and precautions

Hypersensitivity Reactions:

Hypersensitivity reactions have been reported with dolutegravir and were characterized by rash, constitutional findings, and sometimes organ dysfunction, including liver injury

Discontinue DOVATO immediately if signs or symptoms of severe skin or hypersensitivity reactions develop, as a delay in stopping treatment may result in a life-threatening reaction. Clinical status, including liver aminotransferases, should be monitored and appropriate therapy initiated

Hepatotoxicity:

Hepatic adverse events have been reported, including cases of hepatic toxicity (elevated serum liver biochemistries, hepatitis, and acute liver failure), in patients receiving a dolutegravir-containing regimen without pre-existing hepatic disease or other identifiable risk factors

Patients with underlying hepatitis B or C or marked elevations in transaminases prior to treatment may be at increased risk for worsening or development of transaminase elevations with use of DOVATO. In some cases, the elevations in transaminases were consistent with immune reconstitution syndrome or hepatitis B reactivation, particularly in the setting where anti-hepatitis therapy was withdrawn

Monitoring for hepatotoxicity is recommended

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

Lactic Acidosis and Severe Hepatomegaly with Steatosis:

Fatal cases have been reported with the use of nucleoside analogs, including lamivudine. Discontinue DOVATO if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations.

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).

Immune Reconstitution Syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported with the use of DOVATO.

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%).

Drug interactions

Consult full Prescribing Information for DOVATO for more information on potentially significant drug interactions

DOVATO is a complete regimen. Coadministration with other antiretroviral medications for the treatment of HIV-1 infection is not recommended

Drugs that induce or inhibit CYP3A or UGT1A1 may affect the plasma concentrations of dolutegravir

Administer DOVATO 2 hours before or 6 hours after taking polyvalent cation-containing antacids or laxatives, sucralfate, oral supplements containing iron or calcium, or buffered medications. Alternatively, DOVATO and supplements containing calcium or iron can be taken with food

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)

INDICATION

DOVATO is indicated as a complete regimen to treat HIV-1 infection in adults with no antiretroviral (ARV) treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable ARV regimen with no history of treatment failure and no known resistance to any component of DOVATO.

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

DLLWCNT200023

To report SUSPECTED ADVERSE REACTIONS, contact ViiV Healthcare at
1-877-844-8872 or FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch.

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