Dosing & Uses
Dosage Forms & Strengths
doravirine/lamivudine/tenofovir DF
tablet
- 100mg/300mg/300mg
HIV Infection
Indicated as a complete regimen for treatment of HIV-1 infection in patients
- Without prior antiretroviral therapy (ART) treatment history, OR
- To replace current ART regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable ART regimen with no history of treatment failure and no known substitutions associated with resistance to the individual drug components
1 tablet (100 mg doravirine, 300 mg lamivudine, 300 mg tenofovir DF) PO qDay with or without food
Dosage Modifications
Renal impairment
- Estimated CrCl <50 mL/min: Not recommended (unable to adjust fixed-dose combination)
Hepatic impairment
- Mild or moderate (Child-Pugh A or B): No dosage adjustment required
- Severe (Child-Pugh C): Not studied
Coadministration with rifabutin
- Take 100 mg of doravirine (Pifeltro) ~12 hr after Delstrigo dose for duration of rifabutin coadministration
Dosing Considerations
Monitoring
- Obtain baseline test for hepatitis B virus (HBV) infection (see Black Box Warnings)
- Patients with chronic kidney disease: Obtain baseline serum phosphorus and periodically assess during treatment
-
Obtain the following tests at baseline and periodically assess during treatment for all patients
- Serum creatinine
- Estimated CrCl
- Urine glucose
- Urine protein
Dosage Forms & Strengths
doravirine/lamivudine/tenofovir DF
tablet
- 100mg/300mg/300mg
HIV Infection
Indicated as a complete regimen for treatment of HIV-1 infection in patients weighing ≥12 years ≥35 kg
- Without prior antiretroviral therapy (ART) treatment history, OR
- To replace current ART regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable ART regimen with no history of treatment failure and no known substitutions associated with resistance to the individual drug components
1 tablet (100 mg doravirine, 300 mg lamivudine, 300 mg tenofovir DF) PO qDay with or without food
Dosage Modifications
Renal impairment
- Estimated CrCl <50 mL/min: Not recommended (unable to adjust fixed-dose combination)
Hepatic impairment
- Mild or moderate (Child-Pugh A or B): No dosage adjustment required
- Severe (Child-Pugh C): Not studied
Coadministration with rifabutin
- Take 100 mg of doravirine (Pifeltro) ~12 hr after Delstrigo dose for duration of rifabutin coadministration
Dosing Considerations
Monitoring
- Obtain baseline test for hepatitis B virus (HBV) infection (see Black Box Warnings)
- Patients with chronic kidney disease: Obtain baseline serum phosphorus and periodically assess during treatment
-
Obtain the following tests at baseline and periodically assess during treatment for all patients
- Serum creatinine
- Estimated CrCl
- Urine glucose
- Urine protein
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (36)
- amobarbital
amobarbital will decrease the level or effect of doravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Coadministration of doravirine with a strong CYP3A inducer may decrease doravirine plasma concentrations and/or effects. Potential for loss of virologic response and possible resistance to doravirine.
- apalutamide
apalutamide will decrease the level or effect of doravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Coadministration of doravirine with a strong CYP3A inducer may decrease doravirine plasma concentrations and/or effects. Potential for loss of virologic response and possible resistance to doravirine.
- armodafinil
armodafinil will decrease the level or effect of doravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Coadministration of doravirine with a CYP3A inducer may decrease doravirine plasma concentrations and/or effects. Potential for loss of virologic response and possible resistance to doravirine.
- bexarotene
bexarotene will decrease the level or effect of doravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Coadministration of doravirine with a CYP3A inducer may decrease doravirine plasma concentrations and/or effects. Potential for loss of virologic response and possible resistance to doravirine.
- bosentan
bosentan will decrease the level or effect of doravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Coadministration of doravirine with a strong CYP3A inducer may decrease doravirine plasma concentrations and/or effects. Potential for loss of virologic response and possible resistance to doravirine.
- brigatinib
brigatinib will decrease the level or effect of doravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Coadministration of doravirine with a CYP3A inducer may decrease doravirine plasma concentrations and/or effects. Potential for loss of virologic response and possible resistance to doravirine.
- butabarbital
butabarbital will decrease the level or effect of doravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Coadministration of doravirine with a strong CYP3A inducer may decrease doravirine plasma concentrations and/or effects. Potential for loss of virologic response and possible resistance to doravirine.
- butalbital
butalbital will decrease the level or effect of doravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Coadministration of doravirine with a strong CYP3A inducer may decrease doravirine plasma concentrations and/or effects. Potential for loss of virologic response and possible resistance to doravirine.
- carbamazepine
carbamazepine will decrease the level or effect of doravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Coadministration of doravirine with a strong CYP3A inducer may decrease doravirine plasma concentrations and/or effects. Potential for loss of virologic response and possible resistance to doravirine.
- clobazam
clobazam will decrease the level or effect of doravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Coadministration of doravirine with a CYP3A inducer may decrease doravirine plasma concentrations and/or effects. Potential for loss of virologic response and possible resistance to doravirine.
- dabrafenib
dabrafenib will decrease the level or effect of doravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Coadministration of doravirine with a strong CYP3A inducer may decrease doravirine plasma concentrations and/or effects. Potential for loss of virologic response and possible resistance to doravirine.
- efavirenz
efavirenz will decrease the level or effect of doravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Coadministration of doravirine with a strong CYP3A inducer may decrease doravirine plasma concentrations and/or effects. Potential for loss of virologic response and possible resistance to doravirine.
- elvitegravir/cobicistat/emtricitabine/tenofovir DF
tenofovir DF, elvitegravir/cobicistat/emtricitabine/tenofovir DF. Other (see comment). Contraindicated. Comment: Elvitegravir/cobicistat/emtricitabine/tenofovir is a complete regimen for HIV and should not be administered with other antiretrovirals.
lamivudine, elvitegravir/cobicistat/emtricitabine/tenofovir DF. Other (see comment). Contraindicated. Comment: Elvitegravir/cobicistat/emtricitabine/tenofovir is a complete regimen for HIV and should not be administered with other antiretrovirals. - emtricitabine
emtricitabine and lamivudine both increase risk of immune reconstitution syndrome. Contraindicated. Coadministration of emtricitabine containing products and lamivudine containing products should be avoided. Combination will result in therapeutic duplication.
emtricitabine, lamivudine. Other (see comment). Contraindicated. Comment: Coadministration of emtricitabine containing products and lamivudine containing products should be avoided. Combination will result in therapeutic duplication. - encorafenib
encorafenib will decrease the level or effect of doravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Coadministration of doravirine with a CYP3A inducer may decrease doravirine plasma concentrations and/or effects. Potential for loss of virologic response and possible resistance to doravirine.
- enzalutamide
enzalutamide will decrease the level or effect of doravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Coadministration of doravirine with a strong CYP3A inducer may decrease doravirine plasma concentrations and/or effects. Potential for loss of virologic response and possible resistance to doravirine.
- eslicarbazepine acetate
eslicarbazepine acetate will decrease the level or effect of doravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Coadministration of doravirine with a CYP3A inducer may decrease doravirine plasma concentrations and/or effects. Potential for loss of virologic response and possible resistance to doravirine.
- etravirine
etravirine will decrease the level or effect of doravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Coadministration of doravirine with a strong CYP3A inducer may decrease doravirine plasma concentrations and/or effects. Potential for loss of virologic response and possible resistance to doravirine.
- fosphenytoin
fosphenytoin will decrease the level or effect of doravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Coadministration of doravirine with a strong CYP3A inducer may decrease doravirine plasma concentrations and/or effects. Potential for loss of virologic response and possible resistance to doravirine.
- ivosidenib
ivosidenib will decrease the level or effect of doravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Coadministration of doravirine with a strong CYP3A inducer may decrease doravirine plasma concentrations and/or effects. Potential for loss of virologic response and possible resistance to doravirine.
- lumacaftor/ivacaftor
lumacaftor/ivacaftor will decrease the level or effect of doravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Coadministration of doravirine with a strong CYP3A inducer may decrease doravirine plasma concentrations and/or effects. Potential for loss of virologic response and possible resistance to doravirine.
- mitotane
mitotane will decrease the level or effect of doravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Coadministration of doravirine with a strong CYP3A inducer may decrease doravirine plasma concentrations and/or effects. Potential for loss of virologic response and possible resistance to doravirine.
- nafcillin
nafcillin will decrease the level or effect of doravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Coadministration of doravirine with a strong CYP3A inducer may decrease doravirine plasma concentrations and/or effects. Potential for loss of virologic response and possible resistance to doravirine.
- nevirapine
nevirapine will decrease the level or effect of doravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Coadministration of doravirine with a strong CYP3A inducer may decrease doravirine plasma concentrations and/or effects. Potential for loss of virologic response and possible resistance to doravirine.
- oxcarbazepine
oxcarbazepine will decrease the level or effect of doravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Coadministration of doravirine with a strong CYP3A inducer may decrease doravirine plasma concentrations and/or effects. Potential for loss of virologic response and possible resistance to doravirine.
- pentobarbital
pentobarbital will decrease the level or effect of doravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Coadministration of doravirine with a strong CYP3A inducer may decrease doravirine plasma concentrations and/or effects. Potential for loss of virologic response and possible resistance to doravirine.
- phenobarbital
phenobarbital will decrease the level or effect of doravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Coadministration of doravirine with a strong CYP3A inducer may decrease doravirine plasma concentrations and/or effects. Potential for loss of virologic response and possible resistance to doravirine.
- phenytoin
phenytoin will decrease the level or effect of doravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Coadministration of doravirine with a strong CYP3A inducer may decrease doravirine plasma concentrations and/or effects. Potential for loss of virologic response and possible resistance to doravirine.
- primidone
primidone will decrease the level or effect of doravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Coadministration of doravirine with a strong CYP3A inducer may decrease doravirine plasma concentrations and/or effects. Potential for loss of virologic response and possible resistance to doravirine.
- rifabutin
rifabutin will decrease the level or effect of doravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. If doravirine is coadministered with rifabutin, increase doravirine dose to 100 mg BID (~12 hr apart) for the duration of rifabutin coadministration.
- rifampin
rifampin will decrease the level or effect of doravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Coadministration of doravirine with a strong CYP3A inducer may decrease doravirine plasma concentrations and/or effects. Potential for loss of virologic response and possible resistance to doravirine.
- rifapentine
rifapentine will decrease the level or effect of doravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Coadministration of doravirine with a strong CYP3A inducer may decrease doravirine plasma concentrations and/or effects. Potential for loss of virologic response and possible resistance to doravirine.
- secobarbital
secobarbital will decrease the level or effect of doravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Coadministration of doravirine with a strong CYP3A inducer may decrease doravirine plasma concentrations and/or effects. Potential for loss of virologic response and possible resistance to doravirine.
- St John's Wort
St John's Wort will decrease the level or effect of doravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Coadministration of doravirine with a strong CYP3A inducer may decrease doravirine plasma concentrations and/or effects. Potential for loss of virologic response and possible resistance to doravirine.
- streptozocin
streptozocin and tenofovir DF both increase nephrotoxicity and/or ototoxicity. Contraindicated. Streptozocin should not be used in combination with or concomitantly with other potential nephrotoxins.
- telotristat ethyl
telotristat ethyl will decrease the level or effect of doravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Coadministration of doravirine with a CYP3A inducer may decrease doravirine plasma concentrations and/or effects. Potential for loss of virologic response and possible resistance to doravirine.
Serious - Use Alternative (21)
- adefovir
adefovir, tenofovir DF. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Enhanced nephrotoxicity. Avoid coadministration.
adefovir increases levels of tenofovir DF by Other (see comment). Avoid or Use Alternate Drug. Comment: Coadministration of tenofovir with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of tenofovir. Avoid coadministration. - bacitracin
tenofovir DF and bacitracin both increase nephrotoxicity and/or ototoxicity. Avoid or Use Alternate Drug. Avoid concurrent use of bacitracin with other nephrotoxic drugs
- betibeglogene autotemcel
doravirine, betibeglogene autotemcel. Other (see comment). Avoid or Use Alternate Drug. Comment: Do not take antiretroviral medications for at least 1 month before mobilization or expected duration for elimination of the medications, and until all cycles of apheresis are completed. Antiretroviral medications may interfere with manufacturing of apheresed cells.
tenofovir DF, betibeglogene autotemcel. Other (see comment). Avoid or Use Alternate Drug. Comment: Do not take antiretroviral medications for at least 1 month before mobilization or expected duration for elimination of the medications, and until all cycles of apheresis are completed. Antiretroviral medications may interfere with manufacturing of apheresed cells.
lamivudine, betibeglogene autotemcel. Other (see comment). Avoid or Use Alternate Drug. Comment: Do not take antiretroviral medications for at least 1 month before mobilization or expected duration for elimination of the medications, and until all cycles of apheresis are completed. Antiretroviral medications may interfere with manufacturing of apheresed cells. - cabotegravir
tenofovir DF, cabotegravir. Other (see comment). Avoid or Use Alternate Drug. Comment: Cabotegravir plus rilpivirine is a complete regimen. Coadministration with other antiretroviral medications for treating HIV-1 infection is not recommended.
lamivudine, cabotegravir. Other (see comment). Avoid or Use Alternate Drug. Comment: Cabotegravir plus rilpivirine is a complete regimen. Coadministration with other antiretroviral medications for treating HIV-1 infection is not recommended.
doravirine, cabotegravir. Other (see comment). Avoid or Use Alternate Drug. Comment: Cabotegravir plus rilpivirine is a complete regimen. Coadministration with other antiretroviral medications for treating HIV-1 infection is not recommended. - cyclosporine
cyclosporine and tenofovir DF both increase nephrotoxicity and/or ototoxicity. Avoid or Use Alternate Drug.
- elivaldogene autotemcel
elivaldogene autotemcel, doravirine. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Patients should not take antiretroviral medications for at least 1 month before initiating medications for stem cell mobilization, for the duration of the medications? elimination, and until all cycles of apheresis are completed.
- elivaldogene autotemcel
elivaldogene autotemcel, lamivudine. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Patients should not take antiretroviral medications for at least 1 month before initiating medications for stem cell mobilization, for the duration of the medications? elimination, and until all cycles of apheresis are completed.
- dabigatran
tenofovir DF will decrease the level or effect of dabigatran by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Avoid coadministration. P-gp inducers reduce systemic exposure of dabigatran
- edoxaban
tenofovir DF will decrease the level or effect of edoxaban by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Avoid coadministration of edoxaban with potent P-gp inducers
- elivaldogene autotemcel
elivaldogene autotemcel, tenofovir DF. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Patients should not take antiretroviral medications for at least 1 month before initiating medications for stem cell mobilization, for the duration of the medications? elimination, and until all cycles of apheresis are completed.
- fexinidazole
fexinidazole will increase the level or effect of doravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Fexinidazole inhibits CYP3A4. Coadministration may increase risk for adverse effects of CYP3A4 substrates.
- lasmiditan
lasmiditan increases levels of tenofovir DF by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug.
lasmiditan increases levels of tenofovir DF by Other (see comment). Avoid or Use Alternate Drug. Comment: Lasmiditan inhibits BCRP in vitro. Avoid coadministration of lasmiditan with BCRP substrates. - leniolisib
leniolisib will increase the level or effect of tenofovir DF by Other (see comment). Avoid or Use Alternate Drug. Leniolisib, a BCRP inhibitor, may increase systemic exposure of BCRP substrates
- letermovir
tenofovir DF will decrease the level or effect of letermovir by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Coadministration of letermovir with P-gp inducers is not recommended.
- nintedanib
tenofovir DF decreases levels of nintedanib by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. Avoid coadministration, particularly for P-gp inducers that are also CYP3A4 inducers; nintedanib is a substrate of P-gp and to a less extent CYP3A4.
- sorbitol
sorbitol will decrease the level or effect of lamivudine by Other (see comment). Avoid or Use Alternate Drug. Sorbitol-containing solution decreased systemic exposure of lamivudine oral solution in a pediatric study (ARROW trial). Results showed lower rates of virologic suppression, lower plasma lamivudine exposure, and development of viral resistance more frequently than children receiving lamivudine tablets.
- sotorasib
sotorasib will decrease the level or effect of tenofovir DF by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. If use is unavoidable, refer to the prescribing information of the P-gp substrate for dosage modifications.
- tafenoquine
tafenoquine will increase the level or effect of lamivudine by Other (see comment). Avoid or Use Alternate Drug. Tafenoquine inhibits organic cation transporter-2 (OCT2) and multidrug and toxin extrusion (MATE) transporters in vitro. Avoid coadministration with OCT2 or MATE substrates. If coadministration cannot be avoided, monitor for substrate-related toxicities and consider dosage reduction if needed based on product labeling of the coadministered drug.
- tepotinib
tepotinib will increase the level or effect of tenofovir DF by P-glycoprotein (MDR1) efflux transporter. Avoid or Use Alternate Drug. If concomitant use unavoidable, reduce the P-gp substrate dosage if recommended in its approved product labeling.
- trilaciclib
trilaciclib will decrease the level or effect of lamivudine by Other (see comment). Avoid or Use Alternate Drug. Avoid coadministration of trilaciclib (OCT2, MATE1, and MATE-2K inhibitor) with substrates where minimal increased concentration in kidney or blood may lead to serious or life-threatening toxicities.
- tucatinib
tucatinib will increase the level or effect of doravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid concomitant use of tucatinib with CYP3A substrates, where minimal concentration changes may lead to serious or life-threatening toxicities. If unavoidable, reduce CYP3A substrate dose according to product labeling.
Monitor Closely (155)
- abacavir
abacavir and lamivudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
abacavir and tenofovir DF both increase risk of immune reconstitution syndrome. Use Caution/Monitor. - acalabrutinib
acalabrutinib increases levels of tenofovir DF by Other (see comment). Use Caution/Monitor. Comment: Acalabrutinib may increase exposure to coadministered BCRP substrates by inhibition of intestinal BCRP.
- atazanavir
atazanavir will increase the level or effect of doravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration of doravirine and CYP3A4 inhibitors may increase plasma concentrations and toxicities of doravirine.
atazanavir and lamivudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor. - acyclovir
acyclovir and tenofovir DF both increase nephrotoxicity and/or ototoxicity. Use Caution/Monitor.
acyclovir increases levels of tenofovir DF by Other (see comment). Use Caution/Monitor. Comment: Coadministration of tenofovir with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of tenofovir. - belzutifan
belzutifan will decrease the level or effect of doravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. If unable to avoid coadministration of belzutifan with sensitive CYP3A4 substrates, consider increasing the sensitive CYP3A4 substrate dose in accordance with its prescribing information.
- aldesleukin
aldesleukin, tenofovir DF. Either increases toxicity of the other by nephrotoxicity and/or ototoxicity. Use Caution/Monitor.
aldesleukin increases levels of tenofovir DF by decreasing renal clearance. Use Caution/Monitor. - amikacin
amikacin and tenofovir DF both increase nephrotoxicity and/or ototoxicity. Use Caution/Monitor.
amikacin increases levels of tenofovir DF by decreasing elimination. Use Caution/Monitor. - amiloride
tenofovir DF increases levels of amiloride by decreasing renal clearance. Use Caution/Monitor. Potential for increased toxicity. .
- amphotericin B cholesteryl sulfate
amphotericin B cholesteryl sulfate and tenofovir DF both increase nephrotoxicity and/or ototoxicity. Use Caution/Monitor. Combination may also increase tenofovir levels.
- amphotericin B deoxycholate
amphotericin B deoxycholate and tenofovir DF both increase nephrotoxicity and/or ototoxicity. Use Caution/Monitor. Combination may also increase tenofovir levels.
- amphotericin B liposomal
amphotericin B liposomal and tenofovir DF both increase nephrotoxicity and/or ototoxicity. Use Caution/Monitor. Combination may also increase tenofovir levels.
- amphotericin B phospholipid complex
amphotericin B phospholipid complex and tenofovir DF both increase nephrotoxicity and/or ototoxicity. Use Caution/Monitor. Combination may also increase tenofovir levels.
- apalutamide
apalutamide will decrease the level or effect of tenofovir DF by increasing elimination. Use Caution/Monitor. Apalutamide weakly induces BCRP and may decrease systemic exposure of drugs that are BCRP substrates.
- atazanavir
atazanavir and tenofovir DF both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
tenofovir DF decreases levels of atazanavir by unknown mechanism. Use Caution/Monitor. May result in loss of atazanavir antiviral activity; ritonavir boosting may help to compensate. - berotralstat
berotralstat will increase the level or effect of tenofovir DF by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Monitor or titrate P-gp substrate dose if coadministered.
- bleomycin
bleomycin increases levels of tenofovir DF by decreasing renal clearance. Use Caution/Monitor. Potential for increased toxicity. .
- cabozantinib
lamivudine will increase the level or effect of cabozantinib by Other (see comment). Use Caution/Monitor. MRP2 inhibitors increase cabozantinib toxicity
- capreomycin
capreomycin and tenofovir DF both increase nephrotoxicity and/or ototoxicity. Use Caution/Monitor.
- carboplatin
carboplatin and tenofovir DF both increase nephrotoxicity and/or ototoxicity. Use Caution/Monitor. Combination may also increase tenofovir levels.
- celecoxib
tenofovir DF, celecoxib. Either increases levels of the other by decreasing renal clearance. Modify Therapy/Monitor Closely. Toxicity may result from coadministration of tenofovir DF with other drugs that are also primarily excreted by glomerular filtration and/or active tubular secretion including high-dose or multiple-dose NSAIDs; alternatives to NSAIDs should be considered.
- cenobamate
cenobamate will decrease the level or effect of doravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Increase dose of CYP3A4 substrate, as needed, when coadministered with cenobamate.
- ceritinib
ceritinib will increase the level or effect of doravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- chloramphenicol
chloramphenicol will increase the level or effect of doravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration of doravirine and CYP3A4 inhibitors may increase plasma concentrations and toxicities of doravirine.
- cidofovir
cidofovir and tenofovir DF both increase nephrotoxicity and/or ototoxicity. Use Caution/Monitor.
cidofovir increases levels of tenofovir DF by Other (see comment). Use Caution/Monitor. Comment: Coadministration of tenofovir with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of tenofovir. - cimetidine
cimetidine, tenofovir DF. Either increases levels of the other by decreasing renal clearance. Use Caution/Monitor.
- cisplatin
cisplatin and tenofovir DF both increase nephrotoxicity and/or ototoxicity. Use Caution/Monitor.
cisplatin increases levels of tenofovir DF by decreasing elimination. Use Caution/Monitor. - clarithromycin
clarithromycin will increase the level or effect of doravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration of doravirine and CYP3A4 inhibitors may increase plasma concentrations and toxicities of doravirine.
- cobicistat
cobicistat will increase the level or effect of doravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration of doravirine and CYP3A4 inhibitors may increase plasma concentrations and toxicities of doravirine.
- colistin
colistin and tenofovir DF both increase nephrotoxicity and/or ototoxicity. Use Caution/Monitor.
- conivaptan
conivaptan will increase the level or effect of doravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration of doravirine and CYP3A4 inhibitors may increase plasma concentrations and toxicities of doravirine.
- contrast media (iodinated)
contrast media (iodinated) and tenofovir DF both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely.
- darolutamide
darolutamide will increase the level or effect of tenofovir DF by Other (see comment). Modify Therapy/Monitor Closely. Darolutamide is a BCRP inhibitor. Avoid coadministration with BCRP inhibitors. If use is unavoidable, closely monitor for adverse reactions and consider dose reduction of BCRP substrate drug (refer BCRP substrate prescribing information).
- darunavir
darunavir will increase the level or effect of doravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration of doravirine and CYP3A4 inhibitors may increase plasma concentrations and toxicities of doravirine.
- dichlorphenamide
dichlorphenamide and tenofovir DF both decrease serum potassium. Use Caution/Monitor.
- diclofenac
tenofovir DF, diclofenac. Either increases levels of the other by decreasing renal clearance. Modify Therapy/Monitor Closely. Toxicity may result from coadministration of tenofovir DF with other drugs that are also primarily excreted by glomerular filtration and/or active tubular secretion including high-dose or multiple-dose NSAIDs; alternatives to NSAIDs should be considered.
- didanosine
tenofovir DF increases toxicity of didanosine by decreasing elimination. Use Caution/Monitor. May increase risk of pancreatitis; decrease didanosine dose to 250 mg/day if weight >60 kg and decrease to 200 mg/day if weight <60 kg .
- diflunisal
tenofovir DF, diflunisal. Either increases levels of the other by decreasing renal clearance. Modify Therapy/Monitor Closely. Toxicity may result from coadministration of tenofovir DF with other drugs that are also primarily excreted by glomerular filtration and/or active tubular secretion including high-dose or multiple-dose NSAIDs; alternatives to NSAIDs should be considered.
- digoxin
tenofovir DF increases levels of digoxin by decreasing renal clearance. Use Caution/Monitor. Potential for increased toxicity. .
- dofetilide
tenofovir DF increases levels of dofetilide by decreasing renal clearance. Use Caution/Monitor. Potential for increased toxicity. .
- duvelisib
tenofovir DF will decrease the level or effect of duvelisib by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.
- efavirenz
efavirenz and lamivudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
efavirenz and tenofovir DF both increase risk of immune reconstitution syndrome. Use Caution/Monitor. - elagolix
elagolix will increase the level or effect of tenofovir DF by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.
elagolix will decrease the level or effect of doravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Elagolix is a weak-to-moderate CYP3A4 inducer. Monitor CYP3A substrates if coadministered. Consider increasing CYP3A substrate dose if needed. - enfuvirtide
enfuvirtide and lamivudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- fedratinib
fedratinib will increase the level or effect of doravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Adjust dose of drugs that are CYP3A4 substrates as necessary.
- emtricitabine
emtricitabine and tenofovir DF both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- encorafenib
encorafenib will increase the level or effect of tenofovir DF by Other (see comment). Modify Therapy/Monitor Closely. Encorafenib (a BCRP inhibitor) may increase the concentration and toxicities of BCRP substrates. Closely monitor for signs and symptoms of increased exposure and consider adjusting the dose of these substrates.
- enfuvirtide
enfuvirtide and tenofovir DF both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- entecavir
tenofovir DF increases levels of entecavir by decreasing renal clearance. Use Caution/Monitor. Potential for increased toxicity. Both drugs are excreted by active tubular secretion.
- erdafitinib
lamivudine increases levels of erdafitinib by decreasing renal clearance. Modify Therapy/Monitor Closely. Consider alternatives that are not OCT2 substrates or consider reducing the dose of OCT2 substrates based on tolerability.
- etodolac
tenofovir DF, etodolac. Either increases levels of the other by decreasing renal clearance. Modify Therapy/Monitor Closely. Toxicity may result from coadministration of tenofovir DF with other drugs that are also primarily excreted by glomerular filtration and/or active tubular secretion including high-dose or multiple-dose NSAIDs; alternatives to NSAIDs should be considered.
- famciclovir
tenofovir DF increases levels of famciclovir by decreasing renal clearance. Use Caution/Monitor. Potential for increased toxicity. .
- fenofibrate
fenofibrate increases levels of tenofovir DF by decreasing renal clearance. Use Caution/Monitor. Increased risk of myopathy.
- fenofibrate micronized
fenofibrate micronized increases levels of tenofovir DF by decreasing renal clearance. Use Caution/Monitor. Increased risk of myopathy.
- fenofibric acid
fenofibric acid increases levels of tenofovir DF by decreasing renal clearance. Use Caution/Monitor. Increased risk of myopathy.
- fenoprofen
tenofovir DF, fenoprofen. Either increases levels of the other by decreasing renal clearance. Modify Therapy/Monitor Closely. Toxicity may result from coadministration of tenofovir DF with other drugs that are also primarily excreted by glomerular filtration and/or active tubular secretion including high-dose or multiple-dose NSAIDs; alternatives to NSAIDs should be considered.
- flucytosine
flucytosine, tenofovir DF. Either increases toxicity of the other by nephrotoxicity and/or ototoxicity. Use Caution/Monitor.
flucytosine increases levels of tenofovir DF by decreasing renal clearance. Use Caution/Monitor. - flurbiprofen
tenofovir DF, flurbiprofen. Either increases levels of the other by decreasing renal clearance. Modify Therapy/Monitor Closely. Toxicity may result from coadministration of tenofovir DF with other drugs that are also primarily excreted by glomerular filtration and/or active tubular secretion including high-dose or multiple-dose NSAIDs; alternatives to NSAIDs should be considered.
- fosamprenavir
fosamprenavir and lamivudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
fosamprenavir will increase the level or effect of doravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration of doravirine and CYP3A4 inhibitors may increase plasma concentrations and toxicities of doravirine.
fosamprenavir and tenofovir DF both increase risk of immune reconstitution syndrome. Use Caution/Monitor. - foscarnet
foscarnet and tenofovir DF both increase nephrotoxicity and/or ototoxicity. Use Caution/Monitor.
- grapefruit
grapefruit will increase the level or effect of doravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration of doravirine and CYP3A4 inhibitors may increase plasma concentrations and toxicities of doravirine.
- ganciclovir
ganciclovir, lamivudine. Either increases toxicity of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Increased risk of hematologic toxicity.
- fostamatinib
fostamatinib will increase the level or effect of tenofovir DF by decreasing metabolism. Use Caution/Monitor. Concomitant use of fostamatinib may increase concentrations of BCRP substrate drugs. Monitor for toxicities of BCRP substrate drug that may require dosage reduction when given concurrently with fostamatinib.
- ganciclovir
ganciclovir increases levels of tenofovir DF by Other (see comment). Use Caution/Monitor. Comment: Coadministration of tenofovir with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of tenofovir.
- gentamicin
gentamicin and tenofovir DF both increase nephrotoxicity and/or ototoxicity. Use Caution/Monitor.
gentamicin increases levels of tenofovir DF by decreasing elimination. Use Caution/Monitor. - glecaprevir/pibrentasvir
glecaprevir/pibrentasvir will increase the level or effect of tenofovir DF by decreasing metabolism. Use Caution/Monitor. Glecaprevir/pibrentasvir may increase plasma concentration of BCRP substrates.
- ibuprofen
tenofovir DF, ibuprofen. Either increases levels of the other by decreasing renal clearance. Modify Therapy/Monitor Closely. Toxicity may result from coadministration of tenofovir DF with other drugs that are also primarily excreted by glomerular filtration and/or active tubular secretion including high-dose or multiple-dose NSAIDs; alternatives to NSAIDs should be considered.
- ibuprofen IV
tenofovir DF, ibuprofen IV. Either increases levels of the other by decreasing renal clearance. Modify Therapy/Monitor Closely. Toxicity may result from coadministration of tenofovir DF with other drugs that are also primarily excreted by glomerular filtration and/or active tubular secretion including high-dose or multiple-dose NSAIDs; alternatives to NSAIDs should be considered.
- idelalisib
idelalisib will increase the level or effect of doravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration of doravirine and CYP3A4 inhibitors may increase plasma concentrations and toxicities of doravirine.
- imatinib
imatinib will increase the level or effect of doravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration of doravirine and CYP3A4 inhibitors may increase plasma concentrations and toxicities of doravirine.
- indinavir
indinavir will increase the level or effect of doravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration of doravirine and CYP3A4 inhibitors may increase plasma concentrations and toxicities of doravirine.
indinavir and lamivudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
indinavir and tenofovir DF both increase risk of immune reconstitution syndrome. Use Caution/Monitor. - indomethacin
tenofovir DF, indomethacin. Either increases levels of the other by decreasing renal clearance. Modify Therapy/Monitor Closely. Toxicity may result from coadministration of tenofovir DF with other drugs that are also primarily excreted by glomerular filtration and/or active tubular secretion including high-dose or multiple-dose NSAIDs; alternatives to NSAIDs should be considered.
- isoniazid
isoniazid will increase the level or effect of doravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration of doravirine and CYP3A4 inhibitors may increase plasma concentrations and toxicities of doravirine.
- interferon alfa 2b
interferon alfa 2b, lamivudine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of liver decompensation.
- istradefylline
istradefylline will increase the level or effect of tenofovir DF by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Istradefylline 40 mg/day increased peak levels and AUC of P-gp substrates in clinical trials. Consider dose reduction of sensitive P-gp substrates.
istradefylline will increase the level or effect of doravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Istradefylline 40 mg/day increased peak levels and AUC of CYP3A4 substrates in clinical trials. This effect was not observed with istradefylline 20 mg/day. Consider dose reduction of sensitive CYP3A4 substrates. - itraconazole
itraconazole will increase the level or effect of doravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration of doravirine and CYP3A4 inhibitors may increase plasma concentrations and toxicities of doravirine.
- ketoprofen
tenofovir DF, ketoprofen. Either increases levels of the other by decreasing renal clearance. Modify Therapy/Monitor Closely. Toxicity may result from coadministration of tenofovir DF with other drugs that are also primarily excreted by glomerular filtration and/or active tubular secretion including high-dose or multiple-dose NSAIDs; alternatives to NSAIDs should be considered.
- ketorolac
tenofovir DF, ketorolac. Either increases levels of the other by decreasing renal clearance. Modify Therapy/Monitor Closely. Toxicity may result from coadministration of tenofovir DF with other drugs that are also primarily excreted by glomerular filtration and/or active tubular secretion including high-dose or multiple-dose NSAIDs; alternatives to NSAIDs should be considered.
- lamivudine
lamivudine and tenofovir DF both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- ledipasvir/sofosbuvir
ledipasvir/sofosbuvir will increase the level or effect of tenofovir DF by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor.
ledipasvir/sofosbuvir will increase the level or effect of tenofovir DF by unspecified interaction mechanism. Use Caution/Monitor. - lenacapavir
lenacapavir will increase the level or effect of doravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Lencapavir (a moderate CYP3A4 inhibitor) may increase CYP3A4 substrates initiated within 9 months after last SC dose of lenacapavir, which may increase potential risk of adverse reactions of CYP3A4 substrates.
- lonafarnib
lonafarnib will increase the level or effect of tenofovir DF by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. Lonafarnib is a weak P-gp inhibitor. Monitor for adverse reactions if coadministered with P-gp substrates where minimal concentration changes may lead to serious or life-threatening toxicities. Reduce P-gp substrate dose if needed.
- lopinavir
lopinavir will increase the level or effect of doravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration of doravirine and CYP3A4 inhibitors may increase plasma concentrations and toxicities of doravirine.
- lorlatinib
lorlatinib will decrease the level or effect of doravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.
- meclofenamate
tenofovir DF, meclofenamate. Either increases levels of the other by decreasing renal clearance. Modify Therapy/Monitor Closely. Toxicity may result from coadministration of tenofovir DF with other drugs that are also primarily excreted by glomerular filtration and/or active tubular secretion including high-dose or multiple-dose NSAIDs; alternatives to NSAIDs should be considered.
- mefenamic acid
tenofovir DF, mefenamic acid. Either increases levels of the other by decreasing renal clearance. Modify Therapy/Monitor Closely. Toxicity may result from coadministration of tenofovir DF with other drugs that are also primarily excreted by glomerular filtration and/or active tubular secretion including high-dose or multiple-dose NSAIDs; alternatives to NSAIDs should be considered.
- meloxicam
tenofovir DF, meloxicam. Either increases levels of the other by decreasing renal clearance. Modify Therapy/Monitor Closely. Toxicity may result from coadministration of tenofovir DF with other drugs that are also primarily excreted by glomerular filtration and/or active tubular secretion including high-dose or multiple-dose NSAIDs; alternatives to NSAIDs should be considered.
- memantine
tenofovir DF increases levels of memantine by decreasing renal clearance. Use Caution/Monitor. Potential for increased toxicity. .
- metformin
tenofovir DF increases levels of metformin by decreasing renal clearance. Use Caution/Monitor. Increased risk of lactic acidosis.
- midodrine
tenofovir DF increases levels of midodrine by decreasing renal clearance. Use Caution/Monitor. Potential for increased toxicity. .
- mifepristone
mifepristone will increase the level or effect of doravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration of doravirine and CYP3A4 inhibitors may increase plasma concentrations and toxicities of doravirine.
- mitomycin
mitomycin, tenofovir DF. Either increases toxicity of the other by nephrotoxicity and/or ototoxicity. Use Caution/Monitor.
mitomycin increases levels of tenofovir DF by decreasing renal clearance. Use Caution/Monitor. - morphine
tenofovir DF increases levels of morphine by decreasing renal clearance. Use Caution/Monitor. Potential for increased toxicity. .
- nabumetone
tenofovir DF, nabumetone. Either increases levels of the other by decreasing renal clearance. Modify Therapy/Monitor Closely. Toxicity may result from coadministration of tenofovir DF with other drugs that are also primarily excreted by glomerular filtration and/or active tubular secretion including high-dose or multiple-dose NSAIDs; alternatives to NSAIDs should be considered.
- naproxen
tenofovir DF, naproxen. Either increases levels of the other by decreasing renal clearance. Modify Therapy/Monitor Closely. Toxicity may result from coadministration of tenofovir DF with other drugs that are also primarily excreted by glomerular filtration and/or active tubular secretion including high-dose or multiple-dose NSAIDs; alternatives to NSAIDs should be considered.
- nefazodone
nefazodone will increase the level or effect of doravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration of doravirine and CYP3A4 inhibitors may increase plasma concentrations and toxicities of doravirine.
- nelfinavir
nelfinavir will increase the level or effect of doravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration of doravirine and CYP3A4 inhibitors may increase plasma concentrations and toxicities of doravirine.
nelfinavir and lamivudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
nelfinavir and tenofovir DF both increase risk of immune reconstitution syndrome. Use Caution/Monitor. - neomycin PO
neomycin PO and tenofovir DF both increase nephrotoxicity and/or ototoxicity. Use Caution/Monitor.
neomycin PO increases levels of tenofovir DF by decreasing elimination. Use Caution/Monitor. - posaconazole
posaconazole will increase the level or effect of doravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration of doravirine and CYP3A4 inhibitors may increase plasma concentrations and toxicities of doravirine.
- nevirapine
lamivudine and nevirapine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- nevirapine
nevirapine and tenofovir DF both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- orlistat
orlistat will decrease the level or effect of tenofovir DF by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Loss of virological control reported in HIV-infected patients taking orlistat concomitantly. Exact mechanism is unclear, but may include a drug-drug interaction that inhibits systemic absorption of the antiretroviral drug. Monitor HIV RNA levels frequently and if increased HIV viral load confirmed, discontinue orlistat.
orlistat will decrease the level or effect of lamivudine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Loss of virological control reported in HIV-infected patients taking orlistat concomitantly. Exact mechanism is unclear, but may include a drug-drug interaction that inhibits systemic absorption of the antiretroviral drug. Monitor HIV RNA levels frequently and if increased HIV viral load confirmed, discontinue orlistat. - oteseconazole
oteseconazole will increase the level or effect of tenofovir DF by Other (see comment). Modify Therapy/Monitor Closely. Otesezonale, a BCRP inhibitor, may increase the effects and risk of toxicities of BCRP substrates. Use lowest starting dose of BCRP substrate, or consider reducing BCRP substrate dose.
- peginterferon alfa 2a
peginterferon alfa 2a, lamivudine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of liver decompensation.
- oxaliplatin
oxaliplatin and tenofovir DF both increase nephrotoxicity and/or ototoxicity. Use Caution/Monitor. Combination may also increase tenofovir levels.
- oxaprozin
tenofovir DF, oxaprozin. Either increases levels of the other by decreasing renal clearance. Modify Therapy/Monitor Closely. Toxicity may result from coadministration of tenofovir DF with other drugs that are also primarily excreted by glomerular filtration and/or active tubular secretion including high-dose or multiple-dose NSAIDs; alternatives to NSAIDs should be considered.
- pamidronate
pamidronate increases levels of tenofovir DF by decreasing renal clearance. Use Caution/Monitor. Combination may increase risk of nephrotoxicity.
- peginterferon alfa 2b
peginterferon alfa 2b, lamivudine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Increased risk of liver decompensation.
- pemetrexed
pemetrexed, tenofovir DF. Either increases levels of the other by decreasing renal clearance. Use Caution/Monitor.
pemetrexed, tenofovir DF. Either increases toxicity of the other by nephrotoxicity and/or ototoxicity. Use Caution/Monitor. - penicillamine
penicillamine, tenofovir DF. Either increases toxicity of the other by nephrotoxicity and/or ototoxicity. Use Caution/Monitor.
penicillamine increases levels of tenofovir DF by decreasing renal clearance. Use Caution/Monitor. - pentamidine
pentamidine and tenofovir DF both increase nephrotoxicity and/or ototoxicity. Use Caution/Monitor. Combination may also increase tenofovir levels.
- peramivir
tenofovir DF increases levels of peramivir by decreasing renal clearance. Use Caution/Monitor. Caution when peramivir coadministered with nephrotoxic drugs.
- piroxicam
tenofovir DF, piroxicam. Either increases levels of the other by decreasing renal clearance. Modify Therapy/Monitor Closely. Toxicity may result from coadministration of tenofovir DF with other drugs that are also primarily excreted by glomerular filtration and/or active tubular secretion including high-dose or multiple-dose NSAIDs; alternatives to NSAIDs should be considered.
- pramipexole
tenofovir DF increases levels of pramipexole by decreasing renal clearance. Use Caution/Monitor. Potential for increased toxicity. .
- probenecid
probenecid increases levels of tenofovir DF by decreasing renal clearance. Use Caution/Monitor. Potential for increased toxicity. .
- procainamide
tenofovir DF increases levels of procainamide by decreasing renal clearance. Use Caution/Monitor. Potential for increased toxicity. .
- quinidine
tenofovir DF, quinidine. Either increases levels of the other by decreasing renal clearance. Use Caution/Monitor.
- regorafenib
regorafenib will increase the level or effect of tenofovir DF by Other (see comment). Modify Therapy/Monitor Closely. Regorafenib likely inhibits BCRP (ABCG2) transport. Coadministration with a BCRP substrate may increase systemic exposure to the substrate and related toxicity.
- ribavirin
ribavirin increases toxicity of lamivudine by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Use alternatives if available. Increased risk of lactic acidosis.
- ritonavir
ritonavir will increase the level or effect of doravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration of doravirine and CYP3A4 inhibitors may increase plasma concentrations and toxicities of doravirine.
ritonavir and lamivudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
ritonavir and tenofovir DF both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
ritonavir increases levels of tenofovir DF by decreasing elimination. Use Caution/Monitor. - rucaparib
rucaparib will increase the level or effect of doravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Adjust dosage of CYP3A4 substrates, if clinically indicated.
- safinamide
safinamide will increase the level or effect of tenofovir DF by Other (see comment). Use Caution/Monitor. Safinamide and its major metabolite may inhibit intestinal BCRP. Monitor BCRP substrates for increased pharmacologic or adverse effects.
- saquinavir
saquinavir and lamivudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
saquinavir will increase the level or effect of doravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration of doravirine and CYP3A4 inhibitors may increase plasma concentrations and toxicities of doravirine. - saquinavir
saquinavir and tenofovir DF both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- stiripentol
stiripentol will increase the level or effect of doravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration of doravirine and CYP3A4 inhibitors may increase plasma concentrations and toxicities of doravirine.
- sarecycline
sarecycline will increase the level or effect of tenofovir DF by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Monitor for toxicities of P-gp substrates that may require dosage reduction when coadministered with P-gp inhibitors.
- sirolimus
sirolimus, tenofovir DF. Either increases toxicity of the other by nephrotoxicity and/or ototoxicity. Use Caution/Monitor.
sirolimus increases levels of tenofovir DF by decreasing renal clearance. Use Caution/Monitor. - sitagliptin
tenofovir DF, sitagliptin. Either increases levels of the other by decreasing renal clearance. Use Caution/Monitor.
- sofosbuvir
sofosbuvir will increase the level or effect of tenofovir DF by unspecified interaction mechanism. Use Caution/Monitor.
- sofosbuvir/velpatasvir
sofosbuvir/velpatasvir will increase the level or effect of tenofovir DF by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Monitor for tenofovir-associated adverse reactions in patients receiving EPCLUSA concomitantly with a regimen containing tenofovir DF
- stavudine
stavudine and tenofovir DF both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
lamivudine and stavudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor. - stiripentol
stiripentol will increase the level or effect of tenofovir DF by P-glycoprotein (MDR1) efflux transporter. Modify Therapy/Monitor Closely. Consider reducing the dose of P-glycoprotein (P-gp) substrates, if adverse reactions are experienced when administered concomitantly with stiripentol.
stiripentol will increase the level or effect of tenofovir DF by Other (see comment). Use Caution/Monitor. Stiripentol is a BCRP transport inhibitor. Consider dosage reduction for BCRP substrates if adverse effects are experienced when coadministered. - tazemetostat
tazemetostat will decrease the level or effect of doravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely.
- tenofovir DF
lamivudine and tenofovir DF both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
- streptomycin
streptomycin and tenofovir DF both increase nephrotoxicity and/or ototoxicity. Use Caution/Monitor.
streptomycin increases levels of tenofovir DF by decreasing elimination. Use Caution/Monitor. - sulindac
tenofovir DF, sulindac. Either increases levels of the other by decreasing renal clearance. Modify Therapy/Monitor Closely. Toxicity may result from coadministration of tenofovir DF with other drugs that are also primarily excreted by glomerular filtration and/or active tubular secretion including high-dose or multiple-dose NSAIDs; alternatives to NSAIDs should be considered.
- tacrolimus
tacrolimus and tenofovir DF both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely.
- tafamidis
tafamidis will increase the level or effect of tenofovir DF by Other (see comment). Use Caution/Monitor. Tafamidis inhibits breast cancer resistant protein (BCRP) in vitro and may increase exposure of BCRP substrates following tafamidis or tafamidis meglumine administration. Dosage adjustment of these BCRP substrates may be necessary.
- tafamidis meglumine
tafamidis meglumine will increase the level or effect of tenofovir DF by Other (see comment). Use Caution/Monitor. Tafamidis inhibits breast cancer resistant protein (BCRP) in vitro and may increase exposure of BCRP substrates following tafamidis or tafamidis meglumine administration. Dosage adjustment of these BCRP substrates may be necessary.
- telavancin
telavancin, tenofovir DF. Either increases toxicity of the other by nephrotoxicity and/or ototoxicity. Use Caution/Monitor.
telavancin increases levels of tenofovir DF by decreasing renal clearance. Use Caution/Monitor. - tipranavir
tipranavir and lamivudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
tipranavir will increase the level or effect of doravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration of doravirine and CYP3A4 inhibitors may increase plasma concentrations and toxicities of doravirine.
tipranavir and tenofovir DF both increase risk of immune reconstitution syndrome. Use Caution/Monitor. - tobramycin
tenofovir DF and tobramycin both increase nephrotoxicity and/or ototoxicity. Use Caution/Monitor.
tobramycin increases levels of tenofovir DF by decreasing elimination. Use Caution/Monitor. - ublituximab
ublituximab decreases effects of doravirine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely.
- trimethoprim
trimethoprim increases effects of lamivudine by basic (cationic) drug competition for renal tubular clearance. Use Caution/Monitor. Potential for increased toxicity.
- tolmetin
tenofovir DF, tolmetin. Either increases levels of the other by decreasing renal clearance. Modify Therapy/Monitor Closely. Toxicity may result from coadministration of tenofovir DF with other drugs that are also primarily excreted by glomerular filtration and/or active tubular secretion including high-dose or multiple-dose NSAIDs; alternatives to NSAIDs should be considered.
- trospium chloride
tenofovir DF, trospium chloride. Either increases levels of the other by decreasing renal clearance. Use Caution/Monitor.
- tucatinib
tucatinib will increase the level or effect of tenofovir DF by P-glycoprotein (MDR1) efflux transporter. Use Caution/Monitor. Consider reducing the dosage of P-gp substrates, where minimal concentration changes may lead to serious or life-threatening toxicities.
- ublituximab
ublituximab decreases effects of tenofovir DF by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely.
ublituximab decreases effects of lamivudine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. - valacyclovir
valacyclovir increases levels of tenofovir DF by Other (see comment). Use Caution/Monitor. Comment: Coadministration of tenofovir with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of tenofovir.
- valganciclovir
valganciclovir, lamivudine. Either increases toxicity of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Use alternatives if available. Increased risk of hematologic toxicity.
- valganciclovir
valganciclovir increases levels of tenofovir DF by Other (see comment). Use Caution/Monitor. Comment: Coadministration of tenofovir with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of tenofovir.
- vancomycin
tenofovir DF and vancomycin both increase nephrotoxicity and/or ototoxicity. Use Caution/Monitor.
- verapamil
tenofovir DF increases levels of verapamil by decreasing renal clearance. Use Caution/Monitor. Potential for increased toxicity. .
- voclosporin
voclosporin, tenofovir DF. Either increases toxicity of the other by nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Coadministration with drugs associated with nephrotoxicity may increase the risk for acute and/or chronic nephrotoxicity.
- voriconazole
voriconazole will increase the level or effect of doravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Coadministration of doravirine and CYP3A4 inhibitors may increase plasma concentrations and toxicities of doravirine.
- zidovudine
lamivudine and zidovudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
tenofovir DF and zidovudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.
Minor (11)
- acetazolamide
acetazolamide will increase the level or effect of doravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- anastrozole
anastrozole will increase the level or effect of doravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- black cohosh
black cohosh, tenofovir DF. Either increases toxicity of the other by pharmacodynamic synergism. Minor/Significance Unknown. Increased risk of hepatoxicity.
- cyclophosphamide
cyclophosphamide will increase the level or effect of doravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- isavuconazonium sulfate
isavuconazonium sulfate will increase the level or effect of lamivudine by Other (see comment). Minor/Significance Unknown. Isavuconazonium sulfate, an OCT2 inhibitor, may increase the effects or levels of OCT2 substrates.
- ketoconazole
ketoconazole will increase the level or effect of doravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown. Coadministration of doravirine and CYP3A4 inhibitors may increase plasma concentrations and toxicities of doravirine.
- larotrectinib
larotrectinib will increase the level or effect of doravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- levoketoconazole
levoketoconazole will increase the level or effect of doravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown. Coadministration of doravirine and CYP3A4 inhibitors may increase plasma concentrations and toxicities of doravirine.
- paromomycin
paromomycin and tenofovir DF both increase nephrotoxicity and/or ototoxicity. Minor/Significance Unknown.
paromomycin increases levels of tenofovir DF by decreasing elimination. Minor/Significance Unknown. - ribociclib
ribociclib will increase the level or effect of doravirine by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Minor/Significance Unknown.
- sulfamethoxazole
sulfamethoxazole increases levels of lamivudine by decreasing renal clearance. Minor/Significance Unknown.
Adverse Effects
>10%
Sleep disorders and disturbances (12%)
1-10%
Dizziness (9%)
Nausea (7%)
Headache (6%)
Fatigue (6%)
Diarrhea (5%)
Abdominal pain (5%)
Total bilirubin 1.1 to <1.6x ULN (5%)
Altered sensorium (4%)
AST 2.5 to <5x ULN (4%)
Lipase 1.5 to <3x ULN (4%)
Creatinine >1.3 to 1.8x ULN (3%)
ALT 2.5 to <5x ULN (3%)
Lipase ≥3x ULN (3%)
Creatine kinase ≥10x ULN (3%)
Rash (2%)
Total bilirubin 1.6 to <2.6x ULN (2%)
Creatinine >1.8x ULN (2%)
Creatine kinase 6 to <10x ULN (2%)
Abnormal dreams (1%)
Insomnia (1%)
ALT ≥5x ULN (1%)
<1%
AST ≥5x ULN
Alkaline phosphatase 2.5 to <5x ULN
LDL cholesterol, fasted ≥190 mg/dL
Triglycerides, fasted >500 mg/dL
Postmarketing Reports
Lamivudine
- Body as a whole: Redistribution/accumulation of body fat
- Endocrine and metabolic: Hyperglycemia
- General: Weakness
- Hemic and lymphatic: Anemia (eg, pure red cell aplasia and severe anemias progressing on therapy)
- Hepatic and pancreatic: Lactic acidosis and hepatic steatosis, posttreatment exacerbations of hepatitis B
- Hypersensitivity: Anaphylaxis, urticaria
- Musculoskeletal: Muscle weakness, CPK elevation, rhabdomyolysis
- Skin: Alopecia, pruritus
Tenofovir DF
- Immune system disorders: Allergic reaction, including angioedema
- Metabolism and nutrition disorders: Lactic acidosis, hypokalemia, hypophosphatemia
- Respiratory, thoracic, and mediastinal disorders: Dyspnea
- Gastrointestinal disorders: Pancreatitis, increased amylase, abdominal pain
- Hepatobiliary disorders: Hepatic steatosis, hepatitis, increased liver enzymes (most commonly AST, ALT gamma GT)
- Skin and SC tissue disorders: Rash
- Musculoskeletal and connective tissue disorders: Rhabdomyolysis, osteomalacia (manifested as bone pain and which may contribute to fractures), muscular weakness, myopathy
- Renal and urinary disorders: Acute renal failure, renal failure, acute tubular necrosis, Fanconi syndrome, proximal renal tubulopathy, interstitial nephritis (including acute cases), nephrogenic diabetes insipidus, renal insufficiency, increased creatinine, proteinuria, polyuria
- General disorders and administration site conditions: Asthenia
Warnings
Black Box Warnings
Test all patients for HBV before initiating ARTs
Severe acute hepatitis B exacerbations reported in patients coinfected with HIV-1 and HBV who have discontinued lamivudine or tenofovir DF
Monitor both clinical and laboratory values for several months after discontinuing Delstrigo in patients who are coinfected with HIV-1 and HBV
If appropriate, initiate antihepatitis B therapy
Contraindications
Hypersensitivity to lamivudine
Strong CYP3A inducers
- Doravirine is contraindicated with strong CYP3A inducers, which may decrease effectiveness
-
Strong CYP3A inducer examples
- Anticonvulsants (eg, carbamazepine, oxcarbazepine, phenobarbital, phenytoin)
- Antimycobacterials (eg, rifampin, rifapentine)
- Enzalutamide
- Mitotane
- St. John’s wort (Hypericum perforatum)
Cautions
Severe acute exacerbations of hepatitis B (eg, liver decompensated, liver failure) reported in patients coinfected with HIV-1 and HBV and who have discontinued products containing lamivudine and/or tenofovir DF
Renal impairment, including cases of acute renal failure and Fanconi syndrome (renal tubular injury with severe hypophosphatemia), reported with tenofovir DF; avoid with concurrent or recent use of nephrotoxic agents (eg, high-dose or multiple NSAIDs)
Discontinue if CrCl declines below 50 mL/min
Tenofovir DF associated with decreased bone mineral density (BMD) and increased biochemical markers of bone metabolism; consider assessing BMD in patients at risk
Immune reconstitution syndrome reported with combination ART
Autoimmune disorders (eg, Grave disease, polymyositis, Guillain-Barré syndrome, autoimmune hepatitis) reported to occur in the setting of immune reconstitution; however, time to onset varies and can occur many months after initiation of treatment
Drug interaction overview
- Coadministration of doravirine with strong CYP3A inducers may decrease systemic exposure and lead to loss of therapeutic effect and possible HIV resistance
- Since Delstrigo is a complete regimen for HIV-1 infection, coadministration with other antiretroviral medications for HIV-1 infection not recommended; information regarding potential drug-drug interactions with other antiretroviral medications is not provided
Pregnancy
Pregnancy
Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263; pregnancy exposure registry monitors pregnancy outcomes in individuals exposed during pregnancy
Data are not available to establish drug-associated risks to pregnancy outcomes
Doravirine has not been evaluated in pregnancy; however, lamivudine and tenofovir DF use during pregnancy has been evaluated in a limited number of individuals reported to the APR; available data from the APR show no difference in the overall risk of major birth defects for lamivudine and TDF compared with the background rate for major birth defects of 2.7% in the US reference population
Lactation
The Centers for Disease Control and Prevention do not recommend HIV-infected women breastfeed their infants, owing to potential risk for postnatal transmission of HIV
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Doravirine: Non-nucleoside reverse transcriptase inhibitor (NNRTI); inhibits HIV-1 replication by noncompetitive inhibition of HIV-1 reverse transcriptase
Lamivudine: Nucleoside reverse transcriptase inhibitor (NRTI); following phosphorylation to active metabolite, inhibits HIV reverse transcriptase via DNA chain termination after incorporation
Tenofovir DF: NRTI; following hydrolysis and subsequent phosphorylation, inhibits HIV-1 reverse transcriptase by competing with the natural substrate deoxyadenosine 5′-triphosphate (ATP) and, after incorporation into DNA, by DNA chain termination
Absorption
Bioavailability
- Doravirine: 64%
- Lamivudine: 86%
- Tenofovir AF: 25%
Peak plasma time
- Doravirine: 2 hr
- Tenofovir AF: 1 hr
Peak plasma concentration
- Doravirine: 0.962 mcg/mL
- Lamivudine: 2.04 mcg/mL
- Tenofovir AF: 0.3 mcg/mL
AUC
- Doravirine: 16.1 mcg·h/mL
- Lamivudine: 8.87 mcg·h/mL
- Tenofovir AF: 2.29 mcg·h/mL
Distribution
Protein bound
- Doravirine: 76%
- Lamivudine: <36%
- Tenofovir AF: <0.7%
Vd
- Doravirine: 60.5 L
- Lamivudine: 1.3 L/kg
- Tenofovir AF: 1.3 L/kg
Metabolism
Doravirine: CYP3A (primary)
Lamivudine: CYP3A (minor)
Tenofovir AF: No CYP metabolism
Elimination
Half-life
- Doravirine: 15 hr
- Lamivudine: 5-7 hr
- Tenofovir AF: 17 hr
Renal clearance
- Doravirine: 9.3 mL/min
- Lamivudine: 199.7 mL/min
- Tenofovir AF: 243.5 mL/min
Total clearance
- Doravirine: 106 mL/min
- Lamivudine: 398.5 mL/min
- Tenofovir AF: 1043.7 mL/min
Excretion
Major elimination route
- Doravirine: Metabolism
- Lamivudine and tenofovir AF: Glomerular filtration and active tubular secretion
Urine (unchanged)
- Doravirine: 6%
- Lamivudine: 71%
- Tenofovir AF: 70-80%
Biliary/fecal (unchanged)
- Doravirine: Minor
- Lamivudine and tenofovir AF: Not applicable
Administration
Oral Administration
Complete regimen for HIV in adults without prior ART treatment history; do not prescribe with other ARTs
Instruct patient to take at a regularly scheduled time of the day
May take with or without food
Missed dose
- If patient forgets dose, instruct them to take the missed dose right away, unless it is almost time for the next dose
- If time nearer to next dose, advise not to take 2 doses at once and to take the next dose at the regularly scheduled time
Storage
Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F)
Store in original bottle
Keep bottle tightly closed to protect from moisture; do not remove desiccants
Images
Formulary
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