emtricitabine/tenofovir DF (Rx)

Brand and Other Names:Truvada
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

emtricitabine/tenofovir disoproxil fumarate

tablet

  • 200mg/300mg

HIV Infection

Indicated in combination with other antiretroviral (ART) agents in adults and adolescents weighing at least 35 kg

One 200 mg/300 mg tablet PO qDay

HIV-1 Pre-exposure Prophylaxis

Indicated in combination with safer sex practices to reduce risk of sexually acquired HIV-1 in at-risk adults and adolescents weighing ≥35 kg

One 200 mg/300 mg tablet PO qDay

See Dosing Considerations

PrEP indications (CDC guidelines)

  • Men who have sex with men (MSM) at substantial lrisk of HIV acquisition
  • Adult heterosexually active men and women at substantial risk of HIV acquisition
  • Adult injection drug users (IDU) at substantial risk of HIV acquisition
  • Heterosexually-active women and men whose partners are known to have HIV infection (ie, HIV-discordant couples) to protect the uninfected partner during conception and pregnancy so that an informed decision can be made in awareness of what is known and unknown about benefits and risks of PrEP for mother and fetus

Factors that help identify individuals at high risk for HIV

  • Has partner(s) known to be HIV-1 infected or engages in sexual activity within a high prevalence area or social network and 1 or more of the following
  • Factors
    • Inconsistent or no condom use
    • Diagnosis or sexually transmitted infections
    • Exchange of sex for commodities (eg, money, food, shelter, drugs)
    • Illicit drug use or alcohol dependence
    • Incarceration
    • Partner(s) of unknown HIV-1 status with any of the risk factors listed above

Treatment of Hepatitis B / HIV-1 Coinfection (Off-label)

One 200 mg/300 mg tablet PO qDay in combination with other antiretroviral agents

Dosage Modifications

Renal impairment

  • HIV infection
    • CrCl ≥50 mL/min: Dose adjustment not necessary
    • CrCl 30-49 mL/min: One 200 mg/300 mg tablet PO q48hr
    • CrCl <30 mL/min and ESRD requiring dialysis: Not recommended
  • PrEP
    • CrCl ≥60 mL/min: Dose adjustment not necessary
    • CrCl <60 mL/min: Do not use for pre-exposure prophylaxis
    • If a decrease in estimated CrCl observed in an uninfected individual while taking emtricitabine/tenofovir DF for HIV-1 PrEP, evaluate potential causes and reassess potential risks and benefits of continued use

Hepatic impairment

  • No substantial alterations in tenofovir pharmacokinetics observed in clinical trials in subjects with hepatic impairment compared with unimpaired subjects
  • Pharmacokinetics of emtricitabine have not been studied with hepatic impairment; however, emtricitabine is not significantly metabolized by liver enzymes, so the impact of liver impairment should be limited

Dosing Considerations

All patients should be tested for the presence of chronic hepatitis B virus (HBV) before or when initiating

Before initiating and during use, on a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose and urine protein in all patients; in patients with chronic kidney disease, also assess serum phosphorus

HIV infection

  • Not recommended for use as a component of a triple nucleoside regimen
  • Should not be coadministered with combination products that are complete regimens or already contain emtricitabine or tenofovir (eg, Atripla, Complera, Emtriva, Genvoya, Odefsey, Stribild, Viread)
  • Do not coadminister with lamivudine-containing products (eg, Epivir, Combivir, Dutrebis, Epzicom, Triumeq, Trizivir) because of similarities between emtricitabine and lamivudine
  • In treatment experienced patients, use should be guided by laboratory testing and treatment history

PrEP

  • Individuals must have a negative HIV-1 test immediately prior to initiating emtricitabine/tenofovir AF for HIV-1
  • If clinical symptoms consistent with acute viral infection are present and recent (<1 month) exposures are suspected, delay starting PrEP for at least 1 month and reconfirm HIV-1 status or use a test cleared by the FDA as an aid in the diagnosis of HIV-1 infection, including acute or primary HIV-1 infection
  • Continuing screening at least once q3months while taking emtricitabine/tenofovir AF

Dosage Forms & Strengths

emtricitabine/tenofovir disoproxil fumarate

tablet

  • 100mg/150mg
  • 133mg/200mg
  • 167mg/250mg
  • 200mg/300mg

HIV Infection

Weight <17 kg: Safety and efficacy not established

Indicated in combination with other ART agents for children weighing at least 17 kg who can swallow the tablet whole

Weight ≥17 kg

  • 17 to <22 kg: One 100 mg/150 mg tablet PO qDay
  • 22 to <28 kg: One 133 mg/200 mg tablet PO qDay
  • 28 to <35 kg: One 167 mg/250 mg tablet PO qDay
  • ≥35 kg: One 200 mg/300 mg tablet PO qDay

HIV-1 Pre-exposure Prophylaxis

Indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in at-risk adults and adolescents weighing at least 35 kg

<35 kg: Safety and efficacy not established

≥35 kg: One 200 mg/300 mg tablet PO qDay

PrEP indications (CDC guidelines)

  • Men who have sex with men (MSM) at substantial risk of HIV acquisition
  • Adult heterosexually active men and women at substantial risk of HIV acquisition
  • Adult injection drug users (IDU) at substantial risk of HIV acquisition
  • Heterosexually-active women and men whose partners are known to have HIV infection (ie, HIV-discordant couples) to protect the uninfected partner during conception and pregnancy so that an informed decision can be made in awareness of what is known and unknown about benefits and risks of PrEP for mother and fetus

Factors that help identify individuals at high risk for HIV

  • Has partner(s) known to be HIV-1 infected or engages in sexual activity within a high prevalence area or social network and 1 or more of the following
  • Factors
    • Inconsistent or no condom use
    • Diagnosis or sexually transmitted infections
    • Exchange of sex for commodities (eg, money, food, shelter, drugs)
    • Illicit drug use or alcohol dependence
    • Incarceration
    • Partner(s) of unknown HIV-1 status with any of the risk factors listed above

Dosage Modifications

Renal impairment

  • No data are available to make dosage recommendations in pediatric patients infected with HIV-1 infection who have renal impairment
  • PrEP
    • CrCl ≥60 mL/min or greater: Dose adjustment not necessary
    • CrCl <60 mL/min: Do not use for pre-exposure prophylaxis
    • If a decrease in estimated CrCl observed in an uninfected individual while taking emtricitabine/tenofovir DF for HIV-1 PrEP, evaluate potential causes and reassess potential risks and benefits of continued use

Hepatic impairment

  • No substantial alterations in tenofovir pharmacokinetics observed in clinical trials in subjects with hepatic impairment compared with unimpaired subjects
  • Pharmacokinetics of emtricitabine have not been studied with hepatic impairment; however, emtricitabine is not significantly metabolized by liver enzymes, so the impact of liver impairment should be limited

Dosing Considerations

All patients should be tested for the presence of chronic hepatitis B virus (HBV) before or when initiating

Before initiating and during use, on a clinically appropriate schedule, assess serum creatinine, estimated creatinine clearance, urine glucose and urine protein in all patients; in patients with chronic kidney disease, also assess serum phosphorus

HIV infection

  • Not recommended for use as a component of a triple nucleoside regimen
  • Should not be coadministered with combination products that are complete regimens or already contain emtricitabine or tenofovir (eg, Atripla, Complera, Emtriva, Genvoya, Odefsey, Stribild, Viread)
  • Do not coadminister with lamivudine-containing products (eg, Epivir, Combivir, Dutrebis, Epzicom, Triumeq, Trizivir) because of similarities between emtricitabine and lamivudine
  • In treatment experienced patients, use should be guided by laboratory testing and treatment history

PrEP

  • Individuals must have a negative HIV-1 test immediately prior to initiating emtricitabine/tenofovir AF for HIV-1 PrEP
  • If clinical symptoms consistent with acute viral infection are present and recent (<1 month) exposures are suspected, delay starting PrEP for at least 1 month and reconfirm HIV-1 status or use a test cleared by the FDA as an aid in the diagnosis of HIV-1 infection, including acute or primary HIV-1 infection
  • Continuing screening at least once q3months while taking emtricitabine/tenofovir AF
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Interactions

Interaction Checker

and emtricitabine/tenofovir DF

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            Contraindicated (3)

            • 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.

              emtricitabine, 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

              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.

            • 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.

            Serious - Use Alternative (11)

            • 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

            • cabotegravir

              emtricitabine, 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.

              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.

            • cyclosporine

              cyclosporine and tenofovir DF both increase nephrotoxicity and/or ototoxicity. Avoid or Use Alternate Drug.

            • 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

            • 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.

            • 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.

            • 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.

            • 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.

            Monitor Closely (129)

            • abacavir

              abacavir and tenofovir DF both increase risk of immune reconstitution syndrome. Use Caution/Monitor.

              abacavir and emtricitabine 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.

            • acyclovir

              acyclovir increases levels of emtricitabine by Other (see comment). Use Caution/Monitor. Comment: Coadministration of emtricitabine with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of emtricitabine.

            • 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.

            • adefovir

              adefovir increases levels of emtricitabine by Other (see comment). Use Caution/Monitor. Comment: Coadministration of emtricitabine with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of emtricitabine.

            • 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.

              atazanavir and emtricitabine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.

            • 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.

            • celecoxib

              emtricitabine, celecoxib. Either increases levels of the other by decreasing renal clearance. Modify Therapy/Monitor Closely. Toxicity may result from coadministration of emtricitabine 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.

            • bleomycin

              bleomycin increases levels of tenofovir DF by decreasing renal clearance. Use Caution/Monitor. Potential for increased 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.

            • cidofovir

              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.

              cidofovir and tenofovir DF both increase nephrotoxicity and/or ototoxicity. Use Caution/Monitor.

              cidofovir increases levels of emtricitabine by Other (see comment). Use Caution/Monitor. Comment: Coadministration of emtricitabine with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of emtricitabine.

            • cimetidine

              cimetidine, tenofovir DF. Either increases levels of the other by decreasing renal clearance. Use Caution/Monitor.

            • diclofenac

              emtricitabine, diclofenac. Either increases levels of the other by decreasing renal clearance. Modify Therapy/Monitor Closely. Toxicity may result from coadministration of emtricitabine 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.

            • 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.

            • colistin

              colistin and tenofovir DF both increase nephrotoxicity and/or ototoxicity. Use Caution/Monitor.

            • 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).

            • 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

              emtricitabine, diflunisal. Either increases levels of the other by decreasing renal clearance. Modify Therapy/Monitor Closely. Toxicity may result from coadministration of emtricitabine 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.

              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. .

            • efavirenz

              efavirenz and emtricitabine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.

            • 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 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.

            • emtricitabine

              emtricitabine and tenofovir DF both increase risk of immune reconstitution syndrome. Use Caution/Monitor.

            • enfuvirtide

              emtricitabine and enfuvirtide both increase risk of immune reconstitution syndrome. Use Caution/Monitor.

              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.

            • etodolac

              emtricitabine, etodolac. Either increases levels of the other by decreasing renal clearance. Modify Therapy/Monitor Closely. Toxicity may result from coadministration of emtricitabine 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.

            • 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

              emtricitabine, fenoprofen. Either increases levels of the other by decreasing renal clearance. Modify Therapy/Monitor Closely. Toxicity may result from coadministration of emtricitabine 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.

              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

              emtricitabine, flurbiprofen. Either increases levels of the other by decreasing renal clearance. Modify Therapy/Monitor Closely. Toxicity may result from coadministration of emtricitabine 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.

            • 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 emtricitabine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.

              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.

            • ganciclovir

              ganciclovir, emtricitabine. Either increases toxicity of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Use alternatives if available. Increased risk of hematologic toxicity.

              ganciclovir increases levels of emtricitabine by Other (see comment). Use Caution/Monitor. Comment: Coadministration of emtricitabine with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of emtricitabine.

            • 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

              emtricitabine, ibuprofen. Either increases levels of the other by decreasing renal clearance. Modify Therapy/Monitor Closely. Toxicity may result from coadministration of emtricitabine 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.

              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.

              emtricitabine, ibuprofen IV. Either increases levels of the other by decreasing renal clearance. Modify Therapy/Monitor Closely. Toxicity may result from coadministration of emtricitabine 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.

            • indinavir

              indinavir and emtricitabine 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

              emtricitabine, indomethacin. Either increases levels of the other by decreasing renal clearance. Modify Therapy/Monitor Closely. Toxicity may result from coadministration of emtricitabine 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.

              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.

            • 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.

            • ketoprofen

              emtricitabine, ketoprofen. Either increases levels of the other by decreasing renal clearance. Modify Therapy/Monitor Closely. Toxicity may result from coadministration of emtricitabine 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.

            • 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

              emtricitabine, ketorolac. Either increases levels of the other by decreasing renal clearance. Modify Therapy/Monitor Closely. Toxicity may result from coadministration of emtricitabine 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.

              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.

            • meclofenamate

              emtricitabine, meclofenamate. Either increases levels of the other by decreasing renal clearance. Modify Therapy/Monitor Closely. Toxicity may result from coadministration of emtricitabine 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.

            • 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.

            • 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.

            • 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

              emtricitabine, mefenamic acid. Either increases levels of the other by decreasing renal clearance. Modify Therapy/Monitor Closely. Toxicity may result from coadministration of emtricitabine 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.

              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

              emtricitabine, meloxicam. Either increases levels of the other by decreasing renal clearance. Modify Therapy/Monitor Closely. Toxicity may result from coadministration of emtricitabine 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.

              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. .

            • nabumetone

              emtricitabine, nabumetone. Either increases levels of the other by decreasing renal clearance. Modify Therapy/Monitor Closely. Toxicity may result from coadministration of emtricitabine 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.

            • 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. .

            • 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

              emtricitabine, naproxen. Either increases levels of the other by decreasing renal clearance. Modify Therapy/Monitor Closely. Toxicity may result from coadministration of emtricitabine 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.

              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.

            • nelfinavir

              nelfinavir and emtricitabine 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.

            • nevirapine

              emtricitabine 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 emtricitabine 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.

            • oxaliplatin

              oxaliplatin and tenofovir DF both increase nephrotoxicity and/or ototoxicity. Use Caution/Monitor. Combination may also increase tenofovir levels.

            • oxaprozin

              emtricitabine, oxaprozin. Either increases levels of the other by decreasing renal clearance. Modify Therapy/Monitor Closely. Toxicity may result from coadministration of emtricitabine 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.

            • 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.

            • 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.

              emtricitabine, piroxicam. Either increases levels of the other by decreasing renal clearance. Modify Therapy/Monitor Closely. Toxicity may result from coadministration of emtricitabine 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. .

            • ribavirin

              ribavirin increases toxicity of emtricitabine by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Use alternatives if available. Increased risk of lactic acidosis.

            • 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.

            • ritonavir

              ritonavir and emtricitabine 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.

            • 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 emtricitabine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.

            • saquinavir

              saquinavir and tenofovir DF both increase risk of immune reconstitution syndrome. Use Caution/Monitor.

            • 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.

              emtricitabine 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.

            • sulindac

              emtricitabine, sulindac. Either increases levels of the other by decreasing renal clearance. Modify Therapy/Monitor Closely. Toxicity may result from coadministration of emtricitabine 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.

            • 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.

            • tenofovir DF

              emtricitabine and tenofovir DF both increase risk of immune reconstitution syndrome. Use Caution/Monitor.

            • tipranavir

              tipranavir and emtricitabine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.

              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.

            • tolmetin

              emtricitabine, tolmetin. Either increases levels of the other by decreasing renal clearance. Modify Therapy/Monitor Closely. Toxicity may result from coadministration of emtricitabine 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.

            • 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.

            • 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.

              valacyclovir increases levels of emtricitabine by Other (see comment). Use Caution/Monitor. Comment: Coadministration of emtricitabine with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of emtricitabine.

            • 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.

              valganciclovir, emtricitabine. Either increases toxicity of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Use alternatives if available. Increased risk of hematologic toxicity.

              valganciclovir increases levels of emtricitabine by Other (see comment). Use Caution/Monitor. Comment: Coadministration of emtricitabine with drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of emtricitabine.

            • vancomycin

              tenofovir DF and vancomycin both increase nephrotoxicity and/or ototoxicity. Use Caution/Monitor.

            • zidovudine

              emtricitabine and zidovudine both increase risk of immune reconstitution syndrome. Use Caution/Monitor.

            Minor (2)

            • black cohosh

              black cohosh, tenofovir DF. Either increases toxicity of the other by pharmacodynamic synergism. Minor/Significance Unknown. Increased risk of hepatoxicity.

            • 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.

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            Adverse Effects

            >10%

            Note: includes adverse effects of any severity rating

            Diarrhea

            Nausea

            Fatigue

            Headache

            Dizziness

            Depression

            Insomnia

            Abnormal dreams

            Rash

            1-10%

            Note: includes adverse effects grade 2-4

            Diarrhea (9%)

            Nausea (9%)

            Fatigue (9%)

            Depression (9%)

            Sinusitis (8%)

            URI infections (8%)

            Dizziness (8%)

            Rash event (7%)

            Headache (6%)

            Nasopharyngitis (5%)

            Insomnia (5%)

            Vomiting (2%)

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            Warnings

            Black Box Warnings

            Posttreatment acute exacerbation of hepatitis B

            • Severe acute exacerbations of hepatitis B virus (HBV) reported in HBV-infected patients who have discontinued emtricitabine/tenofovir DF
            • Monitor hepatic function with both clinical and laboratory follow-up for at least several months after discontinuing
            • If appropriate, initiation of antihepatitis B therapy may be warranted

            Pre-exposure prophylaxis (PrEP)

            • Use for PrEP must only be prescribed to individuals confirmed to be HIV-negative immediately prior to initiating and periodically (at least every 3 months) during use
            • Drug-resistant HIV-1 variants have been identified with use of emtricitabine/tenofovir for a PrEP indication following undetected acute HIV-1 infection
            • Do not initiate emtricitabine/tenofovir for PrEP if signs or symptoms of acute HIV-1 infection are present unless negative infection status is confirmed

            Contraindications

            Hypersensitivity

            Do not use as PrEP in HIV-infected individuals or individuals with unknown HIV status

            Use as monotherapy in HIV-infected patients

            Cautions

            Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, reported with nucleoside analogues, including emtricitabine and tenofovir; suspend dosing in those who develop clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity

            Do not coadminister with other drugs containing emtricitabine or tenofovir

            Severe exacerbation of hepatitis B may occur upon discontinuation (see Black Box Warning)

            Immune reconstitution syndrome reported with combination ART; during the initial treatment phase, patients whose immune systems respond may develop an inflammatory response to indolent or residual opportunistic infections (eg, Mycobacterium avium infection, cytomegalovirus, Pneumocystis jirovecii pneumonia [PCP], or tuberculosis); autoimmune disorders (eg, Grave disease, polymyositis, and Guillain-Barré syndrome) have also been reported

            PrEP

            • Use for HIV-1 PrEP only as part of a comprehensive prevention strategy that includes other prevention measures, such as safer sex practices, because emtricitabine/tenofovir AF is not always effective in preventing acquisition of HIV-1
            • Care should be taken to minimize risk of initiating or continuing therapy before confirming individual is HIV-1 negative
            • Counsel individuals on use of other prevention measures (e.g., consistent and correct condom use, knowledge of partner(s)’ HIV-1 status, including viral suppression status, regular testing for STIs that can facilitate HIV-1 transmission)
            • Inform uninfected individuals about and support their efforts in reducing sexual risk behavior
            • While on therapy for HIV-1 PrEP, HIV-1 testing should be repeated at least every 3 months, and upon diagnosis of any other STIs
            • If an HIV-1 test indicates possible HIV-1 infection, or if symptoms consistent with acute HIV-1 infection develop following a potential exposure event, convert the HIV-1 PrEP regimen to HIV treatment regimen until negative infection status confirmed using a test approved or cleared by FDA as an aid in diagnosis of acute or primary HIV-1 infection
            • Counsel HIV-1 uninfected individuals to strictly adhere to the once daily dosing schedule
            • Some individuals, such as adolescents, may benefit from more frequent visits and counseling to support adherence

            Hepatitis B exacerbations

            • All individuals should be tested for the presence of chronic hepatitis B virus (HBV) before or when initiating therapy
            • Individuals infected with HBV who discontinue drug should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment
            • If appropriate, anti-hepatitis B therapy may be warranted, especially in individuals with advanced liver disease or cirrhosis, since posttreatment exacerbation of hepatitis may lead to hepatic decompensation and liver failure; HBV-uninfected individuals should be offered vaccination

            Renal toxicity

            • Increased risk of new onset or worsening renal impairment
            • Obtain estimated CrCl in all patients before initiating
            • Routinely monitor calculated creatinine clearance and serum phosphorus
            • Avoid use if CrCl <30 mL/min (<60 mL/min for PrEP), hemodialysis, or concurrent or recent use of nephrotoxic drugs
            • Tenofovir DF may cause renal toxicity (acute renal failure and/or Fanconi syndrome); avoid administering therapy with concurrent or recent use of nephrotoxic drugs, including NSAIDs; consider alternative to NSAIDs in patients taking tenofovir DF and at risk of renal impairment

            Bone effects of tenofovir

            • Bone mineral density may decrease; consider assessment of bone mineral density in patients with a history of pathologic fracture or other risk factors for osteoporosis or bone loss
            • Osteomalacia associated with proximal renal tubulopathy, manifested as bone pain or pain in extremities and which may contribute to fractures, have been reported
            • Consider hypophosphatemia and osteomalacia secondary to proximal renal tubulopathy in patients at risk of renal dysfunction who present with persistent or worsening bone or muscle symptoms while receiving TDF-containing products

            Drug interaction overview

            • Drug affecting renal function
              • Emtricitabine and tenofovir are primarily excreted by the kidneys by a combination of glomerular filtration and active tubular secretion
              • No drug-drug interactions due to competition for renal excretion have been observed; however, coadministration with drugs that are eliminated by active tubular secretion may increase concentrations of emtricitabine, tenofovir, and/or the coadministered drug
            • P-gp and BCRP inhibitors
              • Tenofovir DF is a substrate of P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP) transporters
              • Increased tenofovir absorption may occur if coadministered with inhibitors of these transporters
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            Pregnancy & Lactation

            Pregnancy

            Data on the use during pregnancy from observational studies have shown no increased risk of major birth defects

            Available data from the Antiretroviral Regnancy Registry (APR) show no increase in the overall risk of major birth defects with first trimester exposure for emtricitabine (2.3%) or tenofovir DF (2.1%) compared with the background rate for major birth defects of 2.7%

            Healthcare providers are encouraged to register pregnant women by calling the APR at 1-800-258-4263

            Pregnant women with HIV infection should continue antiretroviral drugs according to current guidelines during pregnancy to decrease maternal-fetal viral transmission (https://aidsinfo.nih.gov)

            Lactation

            Emtricitabine and tenofovir have been shown to be present in human breast milk

            HIV-1 infected women

            • The CDC recommend that HIV-1 infected mothers not breastfeed their infants to avoid risking postnatal transmission of HIV-1
            • Because of the potential for HIV transmission (in HIV-negative infants); developing viral resistance (in HIV-positive infants); and adverse reactions in a breastfed infant similar to those seen in adults
            • Instruct mothers not to breastfeed

            Women taking PrEP

            • In HIV-uninfected women, consider the developmental and health benefits of breastfeeding and the mother’s clinical need of drug therapy for HIV-1 PrEP along with any potential adverse effects on the breastfed child from drug therapy and the risk of HIV-1 acquisition due to nonadherence and subsequent mother to child transmission
            • Women should not breastfeed if acute HIV-1 infection is suspected because of the risk of HIV-1 transmission to the infant

            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.

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            Pharmacology

            Mechanism of Action

            Emtricitabine: Nucleoside reverse transcriptase inhibitor (NRTI); following phosphorylation, interferes with HIV viral DNA polymerase and inhibits viral replication; cytosine analogue

            Tenofovir: Nucleoside reverse transcriptase inhibitor (NRTI); following hydrolysis and phosphorylation, inhibits HIV-1 reverse transcriptase by competing with AMP as substrate

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            Administration

            Oral Administration

            May take with or without food

            Swallow tablet whole; do not chew, crush, break, or dissolve

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            Images

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            Patient Handout

            A Patient Handout is not currently available for this monograph.
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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.