Dolutegravir

ARV U.S. Brand Name

Tivicay

ARV Abbreviation(s)

DTG

U.S. FDA Label

Dolutegravir Labeling (Package Insert)

ARV Class

Integrase inhibitors

First U.S. Approval

August 12, 2013

U.S. Manufacturer

ViiV Healthcare

Formulations

Strength	Formulation	Image	Description	Boosted
10 mg	Film-Coated Tablets	X	White run tablet with "10" imprinted	No
25 mg	Film-Coated Tablets	X	round white tablet with "25" imprinted	No
50 mg	Film-Coated Tablets	X	Round light orange tablet with "50" imprinted	No

Generic Available?

FDCs

Abacavir / Dolutegravir / Lamivudine

Dolutegravir / Lamivudine

Dolutegravir / Rilpivirine

Assistance Programs

ViiV Connect

Displaying 1 - 52 of 52

	Interaction Color Code	Clinical Bottom Line	Clinical Effects	Drug 1 effect	Drug 2 dose	Drug 2 effect	Management
Rilpivirine (IM) DTG	Green: Administer standard doses	Administer standard doses
Darunavir DTG 907	Green: Administer standard doses	Administer standard doses		No significant change	30 mg once daily	Cmax decrease 11%, AUC decrease 22%, Cmin decrease 38%
Atazanavir DTG 811	Green: Administer standard doses	Administer standard doses		Not reported	30 mg daily	Dolutegravir AUC increased 91%, Cmax increased 50%, Cmin increased 180%
Atazanavir DTG 810	Green: Administer standard doses	Administer standard doses		Not reported	30 mg daily	Dolutegravir AUC increased 62%, Cmax increased 34%, Cmin increased 121%
Tenofovir disoproxil fumarate DTG 742	Green: Administer standard doses	Administer standard doses		No significant change	50 mg once daily	No significant change
Tenofovir alafenamide DTG 706	Green: Administer standard doses	Administer standard doses		Cmax increased 24%, AUC increased 19%	50 mg once daily	Cmax increased 15%, AUC increased 2%, Cmin increased 5%
Rilpivirine DTG 649	Green: Administer standard doses	Administer standard doses		Rilpivirine Cmin increased 21%	50 mg daily	Dolutegravir Cmin increased 22%
Nevirapine DTG 598	Green: Administer standard doses	Administer standard doses		Nevirapine Cmin increased 22%	50 mg daily	Dolutegravir AUC decreased 19%; Cmin decreased 34%
Etravirine DTG 541	Red: Avoid combination	Do not coadminister: Potential for reduced levels of dolutegravir	Potentially reduced dolutegravir effectiveness		50 mg daily	Dolutegravir AUC decreased 71%; Cmin decreased 88%	Do not coadminister etravirine with dolutegravir unless atazanavir / ritonavir, darunavir / ritonavir, or lopinavir / ritonavir are also part of the regimen. If one of these boosted PIs is present and known or clinically suspected INSTI resistance, increase dolutegravir dosage to 50 mg BID.
Etravirine DTG 537	Red: Avoid combination	Administer standard doses			50 mg daily	Dolutegravir AUC increased 11%; Cmin increased 28%	Do not coadminister etravirine with dolutegravir unless atazanavir / ritonavir, darunavir / ritonavir, or lopinavir / ritonavir are also part of the regimen. When using this combo and there is known or clinically suspected INSTI resistance, increase dolutegravir dosage to 50 mg BID.
Etravirine DTG 536	Red: Avoid combination	Administer standard doses	Potentially reduced dolutegravir effectiveness		50 mg daily	Dolutegravir AUC decreased 25%; Cmin decreased 37%	Do not coadminister etravirine with dolutegravir unless atazanavir / ritonavir, darunavir / ritonavir, or lopinavir / ritonavir are also part of the regimen. When using this combo and there is known or clinically suspected INSTI resistance, increase dolutegravir dosage to 50 mg BID.
Efavirenz DTG 362	Yellow: Adjust dosing	Adjust dosing to avoid reduced levels of dolutegravir	Potentially reduced dolutegravir effectiveness		50 mg daily	Dolutegravir AUC decreased 57%; Cmin decreased 75%	If no INSTI resistance, increase dolutegravir dosage to 50 mg BID. If known or clinically suspected INSTI resistance, use alternative combination
Dolutegravir CBZ 124	Red: Avoid combination	Do not coadminister: Reduced levels of dolutegravir	Potential decrease in antiretroviral efficacy	Cmax decreased 33%, AUC decreased 49%, Cmin decreased 73%	300 mg BID	Not studied	Use alternative agents. If this combination must be used in an INSTI-na•ve adult patient, adminster dolutegravir 50 mg twice daily. Do not use in cases of clinically suspected InSTI resistance. Monitor antiviral efficacy
Dolutegravir ETR 123	Red: Avoid combination	Do not coadminister: Reduced levels of dolutegravir	Potential decrease in antiretroviral efficacy	Cmax decreased 52%, AUC decreased 71%, Cmin decreased 88%	200 mg once daily	Not studied	Contraindicated. Use in combination with ATV / r or DRV / r
Dolutegravir Aluminum and magnesium hydroxide antacid 122	Red: Avoid combination	Do not coadminister: Reduced levels of dolutegravir	Potential decrease in antiretroviral efficacy	Cmax decreased 72%, AUC decreased 74%, Cmin decreased 74%	Maalox given simultaneously as dolutegravir	Not studied	Administer dolutegravir 2 hours before or 6 hours after antacids.
Dolutegravir NVP 121	Red: Avoid combination	Do not coadminister: Potential for reduced levels of dolutegravir	Potential decrease in antiretroviral efficacy	Not studied		Not studied	Contraindicated. Use alternative agents.
Dolutegravir St. John's Wort (Hypericum perforatum) 120	Red: Avoid combination	Do not coadminister: Potential for reduced levels of dolutegravir	Potential decrease in antiretroviral efficacy	Not studied (may decreased dolutegravir levels)		Not studied	Contraindicated. Use alternative agents.
Dolutegravir RPT 119	Red: Avoid combination	Do not coadminister: Potential for reduced levels of dolutegravir	Potential decrease in antiretroviral efficacy	Not studied (may decreased dolutegravir levels)		Not studied	Contraindicated. Use alternative agents.
Dolutegravir Phenytoin 118	Red: Avoid combination	Do not coadminister: Potential for reduced levels of dolutegravir	Potential decrease in antiretroviral efficacy	Not studied (may decreased dolutegravir levels)		Not studied	Avoid combination or use alternative agents
Dolutegravir Phenobarbital 117	Red: Avoid combination	Do not coadminister: Potential for reduced levels of dolutegravir	Potential decrease in antiretroviral efficacy	Not studied (may decreased dolutegravir levels)		Not studied	Avoid combination or use alternative agents
Dolutegravir Oxcarbazepine 116	Red: Avoid combination	Do not coadminister: Potential for reduced levels of dolutegravir	Potential decrease in antiretroviral efficacy	Not studied (may decreased dolutegravir levels)		Not studied	Avoid combination or use alternative agents
Dolutegravir Dofetilide 115	Red: Avoid combination	Do not coadminister: Potential for increased levels of dofetilide	Potential for increased dofetilide toxicity	Not studied		Not studied	Contraindicated. Use alternative agents.
Dolutegravir Dalfampridine 114	Red: Avoid combination	Do not coadminister: Potential for increased levels of dalfampridine	Potential for increased dalfampridine toxicity	Not studied		Not studied	Contraindicated. Use alternative agents.
Dolutegravir INH 113	Red: Avoid combination	Do not coadminister: Increased levels of izoniazid and reduced levels of dolutegravir	Potential for increased adverse effects of isoniazid (flu-like symptoms, nausea, vomiting, and fever)	AUC decreased 46%, Cmin decreased 74%	15 mg / kg + rifapentine 900 mg once weekly	INH AUC increased 67-92% in 2 / 4 subjects. Rifapentine no significant change.	Use alternative agents
Dolutegravir SOF/VEL 112	Green: Administer standard doses	Administer standard doses		Not studied	400 / 100 mg daily	Sofosbuvir Cmax decreased 12%, AUC decreased 8%. No significant change in sofosbuvir metabolite GS-331007. Velpatasvir Cmax decreased 6%, AUC decreased 9%, Cmin decreased 12%.
Dolutegravir DRV/r 111	Green: Administer standard doses	Administer standard doses		Cmax decreased 11%, AUC decreased 22%, Cmin decreased 38%	600 / 100 mg once daily	Not studied
Dolutegravir Prednisone 110	Green: Administer standard doses	Administer standard doses		Cmax increased 6%, AUC increased 11%, Cmin increased 17%	60 mg daily with taper	Not studied
Dolutegravir ATV 109	Green: Administer standard doses	Administer standard doses		Cmax increased 50%, AUC increased 91%, Cmin increased 180%	400 mg once daily	Not studied
Dolutegravir Omeprazole 108	Green: Administer standard doses	Administer standard doses		No significant change	40 mg once daily	Not studied
Dolutegravir ATV/r 107	Green: Administer standard doses	Administer standard doses		Cmax increased 34%, AUC increased 62%, Cmin increased 121%	300 / 100 mg once daily	Not studied
Dolutegravir ETR + DRV/r 106	Green: Administer standard doses	Administer standard doses		Cmax decreased 12%, AUC decreased 25%, Cmin decreased 37%	200 mg + 600 / 100 mg BID	Not studied
Dolutegravir EBR/GZR 105	Green: Administer standard doses	Administer standard doses		Cmax increased 22%, AUC increased 16%, Cmin increased 14%	elbasvir 50 mg + grazoprevir 200 mg once daily	No significant change in elbasvir. Grazoprevir Cmax decreased 36%, AUC decreased 19%, Cmin decreased 14%
Dolutegravir Daclatasvir 104	Green: Administer standard doses	Administer standard doses		Cmax increased 29%, AUC increased 33%, Cmin increased 45%	60 mg once daily	No significant change
Dolutegravir Midazolam 103	Green: Administer standard doses	Administer standard doses		Not studied	3 mg	No significant change
Dolutegravir Methadone 102	Green: Administer standard doses	Administer standard doses		Not studied	16-150 mg	No significant change
Dolutegravir Norelgestromin 101	Green: Administer standard doses	Administer standard doses		No significant change	0.25 mg	No significant change
Dolutegravir EE/NGM 100	Green: Administer standard doses	Administer standard doses		No significant change	0.035 mg ethinyl estradiol + norelgestromin 0.25 mg	No significant change
Dolutegravir TDF 99	Green: Administer standard doses	Administer standard doses		Cmax decreased 3%, AUC increased 1%, Cmin decreased 8%	300 mg once daily	Cmax increased 9%, AUC increased 12%, Cmin increased 19%
Dolutegravir RPV 98	Green: Administer standard doses	Administer standard doses		Cmax increased 13%, AUC increased 12%, Cmin increased 22%	25 mg once daily	Cmax increased 10%, AUC increased 6%, Cmin increased 21%
Dolutegravir RFB 97	Green: Administer standard doses	Administer standard doses		Cmax increased 16%, AUC decreased 5%, Cmin decreased 30%	300 mg once daily	Not studied
Dolutegravir Iron 96	Yellow: Adjust dosing	Adjust dosing to avoid reduced levels of dolutegravir	Potential decrease in antiretroviral efficacy if given with iron.	Cmax decreased 57%, AUC decreased 54%, Cmin decreased 56% when administered simultaneously with ferrous fumarate, fasting conditions. No significant change in dolutegravir Cmax or AUC if given simultaneously with ferrous fumarate, with food or if given 2 hours after ferrous fumarate.	324 mg	Not studied	Administer dolutegravir 2 hours before or 6 hours after taking medications containing polyvalent cations. Alternatively, administer dolutegravir simulatenously with iron supplements and with food.
Dolutegravir Multivitamin 95	Yellow: Adjust dosing	Adjust dosing to avoid reduced levels of dolutegravir	Potential decrease in antiretroviral efficacy	Cmax decreased 35%, AUC decreased 33%, Cmin decreased 32%	One-A-Day given simultaneously with dolutegravir	Not studied	Administer dolutegravir 2 hours before or 6 hours after taking medications containing polyvalent cations.
Dolutegravir Sucralfate 94	Yellow: Adjust dosing	Adjust dosing to avoid reduced levels of dolutegravir	Potential decrease in antiretroviral efficacy	Not studied (may decreased dolutegravir levels)		Not studied	Administer dolutegravir 2 hours before or 6 hours after sucralfate
Dolutegravir Calcium carbonate 93	Yellow: Adjust dosing	Adjust dosing to avoid reduced levels of dolutegravir	Potential decrease in antiretroviral efficacy if taken without food	Cmax decreased 37%, AUC decreased 39%, Cmin decreased 39% if taken together, fasting conditions. No significant change in dolutegravir AUC if taken 2 hours before calcium carbonate or if taken simultaneously with food.	1200 mg	Not studied	Administer dolutegravir 2 hours before or 6 hours after calcium-containing supplements. Alternatively, administer dolutegravir simulatenously with calcium supplements and with food.
Dolutegravir Calcium carbonate 92	Yellow: Adjust dosing	Adjust dosing to avoid reduced levels of dolutegravir	Potential decrease in antiretroviral efficacy if taken without food	Cmax decreased 37%, AUC decreased 39%, Cmin decreased 39% if taken together, fasting conditions. No significant change in dolutegravir AUC if taken 2 hours before calcium carbonate or if taken simultaneously with food.	1200 mg	Not studied	Administer dolutegravir 2 hours before or 6 hours after calcium-containing supplements. Alternatively, administer dolutegravir simulatenously with calcium supplements and with food.
Dolutegravir Calcium carbonate 91	Yellow: Adjust dosing	Adjust dosing to avoid reduced levels of dolutegravir	Potential decrease in antiretroviral efficacy if taken without food	Cmax decreased 37%, AUC decreased 39%, Cmin decreased 39% if taken together, fasting conditions. No significant change in dolutegravir AUC if taken 2 hours before calcium carbonate or if taken simultaneously with food.	1200 mg	Not studied	Administer dolutegravir 2 hours before or 6 hours after calcium-containing supplements. Alternatively, administer dolutegravir simulatenously with calcium supplements and with food.
Dolutegravir Aluminum and magnesium hydroxide antacid 90	Yellow: Adjust dosing	Adjust dosing to avoid reduced levels of dolutegravir	Potential decrease in antiretroviral efficacy	Cmax decreased 18%, AUC decreased 26%, Cmin decreased 30%	Maalox given 2 hours after dolutegravir	Not studied	Administer dolutegravir 2 hours before or 6 hours after antacids.
Dolutegravir EFV 89	Yellow: Adjust dosing	Adjust dosing to avoid reduced levels of dolutegravir	Potential decrease in antiretroviral efficacy	Cmax decreased 39%, AUC decreased 57%, Cmin decreased 75%	600 mg once daily	Not studied	Adjust dose of dolutegravir to 50 mg twice daily for treatment-naive and treatment experienced, INSTI naive adult patients, in pediatrics, increased the weight-based dose to twice daily, Use alternate combinations in INSTI experienced or INSTI resistance patients
Dolutegravir RIF 88	Yellow: Adjust dosing	Adjust dosing to avoid reduced levels of dolutegravir	Potential decrease in antiretroviral efficacy	Cmax increased 18%, AUC increased 33%, Cmin increased 22% (when compared to dolutegravir 50 mg once daily)	600 mg daily	Not studied	Adjust dose of dolutegravir to 50 mg twice daily for treatment-na•ve and treatment experienced, INSTI na•ve adult patients, in pediatrics, increased the weight-based dose to twice daily, Use alternate combinations in INSTI experienced or INSTI resistance patients
Dolutegravir RIF 87	Yellow: Adjust dosing	Adjust dosing to avoid reduced levels of dolutegravir	Potential decrease in antiretroviral efficacy	Cmax decreased 43%, AUC decreased 54%, Cmin decreased 72% (when compared to dolutegravir 50 mg BID without rifampin)	600 mg daily	Not studied	Adjust dose of dolutegravir to 50 mg twice daily for treatment-na•ve and treatment experienced, INSTI na•ve adult patients, in pediatrics, increased the weight-based dose to twice daily, Use alternate combinations in INSTI experienced or INSTI resistance patients
Dolutegravir Metformin 86	Yellow: Adjust dosing	Adjust dosing to avoid increased levels of metformin	Potential increased adverse effects from metformin (e.g. GI side effects).	Not studied	500 mg BID	Cmax increased 66%, AUC increased 79%, Cmin increased 9% when given with dolutegravir once daily. If given with dolutegravir 50 mg BID, then metformin Cmax increased 111%, AUC increased 145%, and Cmin increased 14%	Limit metformin dose to 1,000 mg per day. When starting / stopping DTG in patient on metformin, dose adjustment of metformin may be necessary to maintain optimal glycemic control and / or minimize GI symptoms.
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