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Tenofovir disoproxil fumarate and emtricitabine: Drug information

Tenofovir disoproxil fumarate and emtricitabine: Drug information
(For additional information see "Tenofovir disoproxil fumarate and emtricitabine: Patient drug information" and see "Tenofovir disoproxil fumarate and emtricitabine: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
ALERT: US Boxed Warning
Posttreatment acute exacerbation of hepatitis B:

Severe, acute exacerbations of hepatitis B virus (HBV) have been reported in HBV-infected individuals who have discontinued emtricitabine/tenofovir disoproxil fumarate. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in individuals who are infected with HBV and discontinue emtricitabine/tenofovir disoproxil fumarate. If appropriate, initiation of antihepatitis B therapy may be warranted.

Risk of drug resistance with use for preexposure prophylaxis:

Emtricitabine/tenofovir disoproxil fumarate used for HIV-1 preexposure prophylaxis must only be prescribed to individuals confirmed to be HIV-negative immediately prior to initiating and at least every 3 months during use. Drug-resistant HIV-1 variants have been identified with use of emtricitabine/tenofovir disoproxil fumarate for HIV-1 preexposure prophylaxis following undetected acute HIV-1 infection. Do not initiate emtricitabine/tenofovir disoproxil fumarate for HIV-1 preexposure prophylaxis if signs or symptoms of acute HIV-1 infection are present unless negative infection status is confirmed.

Brand Names: US
  • Truvada
Brand Names: Canada
  • AG-Emtricitabine/Tenofovir;
  • APO-Emtricitabine-Tenofovir;
  • AURO-Emtricitabine-Tenofovir;
  • JAMP Emtricitabine/Tenofovir;
  • MINT-Emtricitabine/Tenofovir;
  • MYLAN-Emtricitabine/Tenofov DF;
  • PMS-Emtricitabine-Tenofovir;
  • TEVA-Emtricitabine/Tenofovir;
  • Truvada
Pharmacologic Category
  • Antiretroviral, Reverse Transcriptase Inhibitor, Nucleoside (Anti-HIV);
  • Antiretroviral, Reverse Transcriptase Inhibitor, Nucleotide (Anti-HIV)
Dosing: Adult
HIV-1 infection, preexposure prophylaxis

HIV-1 infection, preexposure prophylaxis:

Persons who inject drugs (off-label use): Oral: One tablet (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) once daily (Ref).

HIV-uninfected individuals at high-risk for sexual acquisition:

Daily dosing schedule: Oral: One tablet (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) once daily in combination with safe sex practices (Ref). In men who have sex with men, some experts recommend initiating with a double dose (2 tablets [emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg per tablet]) on day 1, followed by 1 tablet once daily to reduce time to anticipated maximal protection (Ref).

On demand (2-1-1) dosing schedule (for use in men who have sex with men only) (off label): Oral: Two tablets (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg per tablet) taken 2 to 24 hours (as close to 24 hours as possible) prior to sexual activity, 1 tablet 24 hours later, and 1 tablet 24 hours after that. In patients who initiate on demand therapy more than once within a week, only 1 tablet should be used for a loading dose (Ref).

HIV-1 infection, postexposure prophylaxis

HIV-1 infection, postexposure prophylaxis (off-label use):

Nonoccupational exposure: Oral: One tablet (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) once daily for 28 days in combination with other antiretroviral agents. Initiate therapy within 72 hours of exposure (Ref).

Occupational exposure: Oral: One tablet (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) once daily for 4 weeks with concomitant raltegravir. Initiate therapy as soon as possible after occupational exposure (and within 72 hours) (Ref).

HIV-1 infection, treatment

HIV-1 infection, treatment: Oral: One tablet (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) once daily in combination with other antiretroviral agents.

HIV-1/hepatitis B co-infection, treatment

HIV-1/hepatitis B co-infection, treatment (off-label use): Oral: One tablet (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) once daily in combination with other antiretroviral agents (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason A. Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.

HIV-1 infection, treatment:

Note: The tenofovir disoproxil fumarate component of this product is associated with proximal tubular injury, Fanconi syndrome, and progression of chronic kidney disease (CKD). Avoid use in patients with preexisting CKD (eGFR <60 mL/minute/1.73 m2), especially if the patient has any proximal tubular impairment (Ref). If use cannot be avoided, the following dose adjustments are recommended:

Manufacturer's labeling:

CrCl ≥50 mL/minute: No dosage adjustment necessary.

CrCl 30 to 49 mL/minute: Increase interval to every 48 hours.

CrCl <30 mL/minute: Not recommended.

Hemodialysis, intermittent (thrice weekly): Not recommended.

CRRT: Use of fixed dose combination is not recommended (Ref).

HIV-1 preexposure prophylaxis (Ref):

CrCl ≥60 mL/minute: No dosage adjustment necessary.

CrCl <60 mL/minute: Not recommended.

HIV-1 postexposure prophylaxis (Ref):

eGFR ≥60 mL/minute/1.73 m2: No dosage adjustment necessary.

eGFR <60 mL/minute/1.73 m2: Not recommended.

Acute kidney injury during treatment: Infectious Diseases Society of America guidelines recommend discontinuing tenofovir (and substituting with alternative antiretroviral therapy) in HIV-infected patients who develop a decline in GFR (a >25% decrease in GFR from baseline and to a level of <60 mL/minute/1.73 m2) during use, particularly in presence of proximal tubular dysfunction (eg, euglycemic glycosuria, increased urinary phosphorus excretion and hypophosphatemia, proteinuria [new onset or worsening]) (Ref).

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Tenofovir disoproxil fumarate and emtricitabine: Pediatric drug information")

Note: Multiple tablet strengths exist and contain different amounts of emtricitabine and tenofovir. International Considerations: Tenofovir doses are expressed as tenofovir disoproxil fumarate, consistent with US labeling; in some other countries, dosing may be expressed as tenofovir disoproxil base. Tenofovir disoproxil fumarate 300 mg is equivalent to tenofovir disoproxil base 245 mg.

HIV-1 infection, treatment

HIV-1 infection, treatment: Use in combination with another antiretroviral agent. Gene mutation and antiretroviral resistance patterns should be evaluated (refer to https://www.iasusa.org for more information) when necessary.

Children and Adolescents weighing ≥17 kg:

17 to <22 kg: Oral: One tablet (emtricitabine 100 mg/tenofovir disoproxil fumarate 150 mg) once daily.

22 to <28 kg: Oral: One tablet (emtricitabine 133 mg/tenofovir disoproxil fumarate 200 mg) once daily.

28 to <35 kg: Oral: One tablet (emtricitabine 167 mg/tenofovir disoproxil fumarate 250 mg) once daily.

≥35 kg: Oral: One tablet (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) once daily.

HIV infection, postexposure prophylaxis, nonoccupational

HIV infection, postexposure prophylaxis, nonoccupational (nPEP) (Ref): Limited data available:

Adolescents: Oral: One tablet (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) once daily for 28 days in combination with other antiretroviral agents. Initiate therapy within 72 hours of exposure.

HIV-1 infection, preexposure prophylaxis in uninfected high-risk individuals

HIV-1 infection, preexposure prophylaxis (PrEP) in uninfected high-risk individuals: Note: Patients should be confirmed HIV-negative immediately prior to initiation of therapy and screened again at least once every 3 months and upon diagnosis of any other sexually transmitted infections (Ref).

Adolescents weighing ≥35 kg: Oral: One tablet (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) once daily.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Pediatric

HIV-1 infection, treatment: Children and Adolescents weighing ≥17 kg: Oral:

CrCl ≥50 mL/minute: No dosage adjustment necessary.

CrCl <50 mL/minute: There are no pediatric-specific recommendations; based on experience in adult patients, dosage adjustment suggested; use in hemodialysis is not recommended.

Preexposure prophylaxis: Adolescents weighing ≥35 kg:

CrCl ≥60 mL/minute: No dosage adjustment necessary.

CrCl <60 mL/minute: Use is not recommended.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling; however, no dosing adjustments are necessary for tenofovir in hepatic impairment. No specific data is available on emtricitabine in hepatic impairment, but given its limited hepatic metabolism, the impact of liver impairment should be minimal; need for dose adjustment is unlikely.

Adverse Reactions (Significant): Considerations
Bone effects

Tenofovir disoproxil fumarate (TDF) is associated with a larger decreased bone mineral density (BMD) in HIV-1 infected patients of all ages than in those not taking TDF (Ref). The rate of bone loss slows after 1 to 2 years following initiation (Ref). TDF may be associated with in increased risk of bone fracture (Ref). When used as preexposure prophylaxis (PrEP), there is a smaller reduction in BMD (Ref). Mean BMD returns to baseline levels within 12 to 18 months after TDF-based PrEP discontinuation in both hip and spine (Ref). TDF is also associated with bone loss (both absolute BMD and reduced Z-score) in children and adolescents (Ref). Patients with HIV aged ≥12 years treated with TDF are more likely to experience a >4% decline in lumber spine BMD than those treated with placebo (Ref). Those with sexual maturity ratings (SMR [formerly Tanner staging]) 1 to 2 may be at greater risk (Ref). Bone loss partially recovers after discontinuation in children and adolescents (Ref).

Mechanism: Time-related; not clearly established. Tenofovir inhibition of calcium-sensing receptors in the parathyroid (Ref) may increase PTH levels (Ref). It has been proposed that PTH levels accelerate bone remodeling which, combined with persistent HIV-associated demineralization in persons with HIV, results in increased osteoid volume (Ref).

Onset: Varied; markers of bone resorption are apparent within 12 weeks after beginning TDF (Ref). Reductions in BMD are observed during the first 1 to 2 years following initiation (Ref).

Risk factors (for bone loss and/or fracture):

• Treatment duration (Ref)

• Females (especially postmenopausal) (Ref)

• Transgender (Ref)

• White race (Ref)

• Prior fracture (and patients at risk for recurrent falls) (Ref)

• Prolonged systemic corticosteroid use (Ref)

• Medroxyprogesterone use (Ref)

• Smoking (Ref)

• Early stages of puberty (Ref)

• Older age (Ref)

• Vitamin D insufficiency/deficiency (Ref)

• Low BMI (Ref)

• Lack of weight-bearing exercise (Ref)

• Cardiovascular disease (Ref)

• Longer duration and greater severity of HIV disease (Ref)

• CD4+ cell count <350 cells/mm3 (Ref)

• Pharmacologic boosters (cobicistat or ritonavir) (Ref)

• IV Drug use (Ref)

• Lipodystrophy (Ref)

• Recent non-AIDS cancer (Ref)

Kidney injury

The tenofovir disoproxil fumarate (TDF) component is associated with multiple renal syndromes. Toxic acute tubular necroses manifest as acute kidney injury, chronic interstitial nephritis as chronic kidney disease, and renal tubulopathies as Fanconi syndrome and rarely nephrogenic diabetes insipidus (Ref).

Acute kidney injury (AKI): TDF is associated with AKI, with the majority of cases meeting the risk definition according to the RIFLE classification or AKIN Stage I (Ref). Kidney function improves over months after TDF discontinuation but does not reverse completely in all cases (Ref). It is reported to recur on rechallenge (Ref).

Chronic kidney disease (CKD): TDF reduces estimated glomerular filtration rate (eGFR) by ~4 mL/minute compared with non–TDF-containing regimens (Ref) and this may progress to CKD (Ref). A smaller reduction in eGFR occurs when used for preexposure prophylaxis (PrEP) compared with placebo (eg, 1.59 mL/minute in PARTNERS) (Ref). When used for PrEP, eGFR returns to baseline 4 to 8 weeks after discontinuation (Ref) but may not return to baseline in some cases (Ref).

Fanconi syndrome (FS): TDF is associated with partial or, more rarely, complete FS (proximal renal tubular acidosis with a normal anion gap metabolic acidosis, hypophosphatemia and osteomalacia with renal phosphate wasting, hypokalemia, hypouricemia, glycosuria with normal blood glucose, and aminoaciduria) (Ref). FS has resulted in fatal cases (Ref). In most patients, proximal tubulopathy resolves within 2 months of TDF discontinuation, but CrCl takes longer to recover and may not return to baseline (Ref). Osteomalacia resolved within 14 weeks of discontinuing TDF in one case report (Ref). FS may present as bone pain as a manifestation of osteomalacia (Ref). FS occurs less frequently when used for PrEP (Ref).

Mechanism: Dose- and time-related; inhibition of DNA polymerase gamma results in mitochondrial DNA (mtDNA) depletion, mitochondrial dysfunction, and cell toxicity (Ref). Proximal tubule epithelial cells are particularly susceptible (Ref).

Onset:

AKI: Varied; mean of 6 months (range, 3 to 16.5 months) (Ref).

CKD: Varied; an eGFR decline is seen within 1 month of initiation (Ref). Significant (stage 3 or greater) CKD has occurred at a median of 45 weeks (interquartile range, 11 to 137 weeks) (Ref).

FS: Varied; diagnosis ranged from 3.9 months to 11 years in a representative case series (Ref).

Risk factors:

AKI:

• Lower baseline SCr (Ref)

• Higher baseline eGFR (Ref)

• Concurrent protease inhibitor (Ref)

• Concurrent sulfamethoxazole/trimethoprim (Ref)

• Concurrent non-steroidal anti-inflammatory drugs (NSAIDs), particularly diclofenac (Ref)

• Lower baseline CD4 cell count (Ref)

• Higher baseline viral load (Ref)

CKD:

• Cumulative TDF exposure (Ref)

• Higher preexisting risk of CKD (Ref)

• Preexisting kidney disease (Ref)

• Lower eGFR at initiation (Ref)

• Prior AKI (Ref)

• Concurrent atazanavir/lopinavir or ritonavir (Ref)

• Concurrent NSAIDs, particularly diclofenac (Ref)

• Hypertension (Ref)

• Older age (Ref)

• Hepatitis C coinfection (Ref)

• Lower CD4 (Ref)

• Higher viral load (Ref)

FS:

• Longer TDF treatment duration (Ref)

• Reduced CrCl before TDF initiation (Ref)

• Concurrent cobicistat or ritonavir (Ref)

• Previous or concurrent lopinavir/ritonavir (Ref)

• Coronary artery disease (Ref)

• Diabetes (Ref)

• Low body weight (Ref)

• Older age (Ref)

• Hepatitis C coinfection (Ref)

• Hypertension (Ref)

• White race (Ref)

• Longer HIV duration (Ref)

• Lower nadir CD4 counts (Ref)

• Prior AIDS diagnosis (Ref)

• ABCC2 & ABCC10 polymorphism (Ref)

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adult monotherapy studies for HIV-1 pre-exposure prophylaxis. Also see individual agents.

>10%: Neuromuscular & skeletal: Decreased bone mineral density (13%) (table 1)

Emtricitabine and Tenofovir Disoproxil Fumarate: Adverse Reaction: Decreased Bone Mineral Density

Drug (Emtricitabine and Tenofovir Disoproxil Fumarate)

Placebo

Comments

13%

6%

≥5% bone mineral density loss at the spine during treatment

1% to 10%:

Endocrine & metabolic: Abnormal phosphorus levels (<2.0 mg/dL: 10%), weight loss (3%)

Gastrointestinal: Abdominal pain (4%)

Hematologic & oncologic: Decreased neutrophils (5%)

Nervous system: Headache (7%)

Neuromuscular & skeletal: Bone fracture (2%) (table 2)

Emtricitabine and Tenofovir Disoproxil Fumarate: Adverse Reaction: Bone Fracture

Drug (Emtricitabine and Tenofovir Disoproxil Fumarate)

Placebo

2%

1%

<1%: Genitourinary: Glycosuria, proteinuria

Frequency not defined: Hepatic: Exacerbation of hepatitis B (following discontinuation)

Postmarketing:

Immunologic: Immune reconstitution syndrome

Renal: Fanconi syndrome (Rao 2021)

Contraindications

As preexposure prophylaxis in patients with unknown or HIV-1 positive status

Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to emtricitabine, tenofovir, or any component of the formulation

Warnings/Precautions

Concerns related to adverse effects:

• Immune reconstitution syndrome: Patients may develop immune reconstitution syndrome resulting in the occurrence of an inflammatory response to an indolent or residual opportunistic infection during initial HIV treatment or activation of autoimmune disorders (eg, Graves disease, polymyositis, Guillain-Barré syndrome, autoimmune hepatitis) later in therapy; further evaluation and treatment may be required.

• Lactic acidosis/hepatomegaly: Lactic acidosis and severe hepatomegaly with steatosis, sometimes fatal, have been reported with use of nucleoside analogues, alone or in combination with other antiretrovirals. Suspend treatment in any patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity (marked transaminase elevation may/may not accompany hepatomegaly and steatosis).

Disease-related concerns:

• Comprehensive prevention program: Preexposure prophylaxis (PrEP) should be accompanied by a comprehensive HIV-1 prevention program (eg, risk reduction counseling, access to condoms), with particular emphasis on medication adherence. In addition, regular monitoring (eg, HIV status of patient and partner(s), risk behavior, adherence, adverse effects, sexually transmitted infections that facilitate HIV-1 transmission) is highly recommended. Time from initiation of therapy to maximal protection against HIV-1 is unknown.

• Renal impairment: Use with caution in patients with renal impairment; see "Dosing in Altered Kidney Function" for additional information.

Concurrent drug therapy issues:

• Duplicate therapy: Do not use concurrently with emtricitabine, lamivudine, tenofovir disoproxil fumarate, tenofovir alafenamide, or any combination of these drugs.

Warnings: Additional Pediatric Considerations

Emtricitabine-associated hyperpigmentation may occur at a higher frequency in pediatric patients compared to adults (children: 32%; adults: 2% to 6%).

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral:

Truvada: Emtricitabine 100 mg and tenofovir disoproxil fumarate 150 mg, Emtricitabine 133 mg and tenofovir disoproxil fumarate 200 mg, Emtricitabine 167 mg and tenofovir disoproxil fumarate 250 mg, Emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg [contains fd&c blue #2 (indigo carm) aluminum lake]

Generic: Emtricitabine 100 mg and tenofovir disoproxil fumarate 150 mg, Emtricitabine 133 mg and tenofovir disoproxil fumarate 200 mg, Emtricitabine 167 mg and tenofovir disoproxil fumarate 250 mg, Emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg

Generic Equivalent Available: US

Yes

Pricing: US

Tablets (Emtricitabine-Tenofovir DF Oral)

100-150 mg (per each): $70.01

133-200 mg (per each): $70.01

167-250 mg (per each): $70.01

200-300 mg (per each): $2.34 - $70.01

Tablets (Truvada Oral)

100-150 mg (per each): $73.69

133-200 mg (per each): $73.69

167-250 mg (per each): $73.69

200-300 mg (per each): $73.69

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral:

Truvada: Emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg [contains fd&c blue #2 (indigo carm) aluminum lake]

Generic: Emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg

Administration: Adult

Oral: May be administered with or without food.

Administration: Pediatric

Oral: May be administered without regard to food

Medication Guide and/or Vaccine Information Statement (VIS)

An FDA-approved patient medication guide, which is available with the product information and at https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021752Orig1s063lbl.pdf#page=35, must be dispensed with this medication.

Use: Labeled Indications

HIV-1 infection, treatment: Treatment of HIV-1 infection in combination with other antiretroviral agents in adults and pediatric patients weighing ≥17 kg

HIV-1 infection, preexposure prophylaxis: Preexposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in at-risk adults and adolescents weighing ≥35 kg.

Use: Off-Label: Adult

HIV-1/hepatitis B co-infection, treatment; HIV-1 nonoccupational postexposure prophylaxis; HIV-1 occupational postexposure prophylaxis

Metabolism/Transport Effects

Refer to individual components.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Acyclovir-Valacyclovir: May increase the serum concentration of Tenofovir Products. Tenofovir Products may increase the serum concentration of Acyclovir-Valacyclovir. Risk C: Monitor therapy

Adefovir: May diminish the therapeutic effect of Tenofovir Products. Adefovir may increase the serum concentration of Tenofovir Products. Tenofovir Products may increase the serum concentration of Adefovir. Risk X: Avoid combination

Aminoglycosides: May increase the serum concentration of Tenofovir Products. Tenofovir Products may increase the serum concentration of Aminoglycosides. Risk C: Monitor therapy

Aminosalicylic Acid: May decrease the serum concentration of Tenofovir Disoproxil Fumarate. Risk C: Monitor therapy

Asciminib: May increase the serum concentration of BCRP/ABCG2 Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor therapy

Atazanavir: Tenofovir Disoproxil Fumarate may decrease the serum concentration of Atazanavir. Atazanavir may increase the serum concentration of Tenofovir Disoproxil Fumarate. Management: Use boosted atazanavir in adults; give combo (atazanavir/ritonavir or atazanavir/cobicistat with tenofovir) as a single daily dose with food. Pediatric patients, pregnant patients, and use of H2-blockers require dose changes. See Lexi Interact monograph. Risk D: Consider therapy modification

Betibeglogene Autotemcel: Antiretroviral Agents may diminish the therapeutic effect of Betibeglogene Autotemcel. Risk X: Avoid combination

Cabozantinib: MRP2 Inhibitors may increase the serum concentration of Cabozantinib. Risk C: Monitor therapy

Cidofovir: May increase the serum concentration of Tenofovir Products. Tenofovir Products may increase the serum concentration of Cidofovir. Risk C: Monitor therapy

Cladribine: Agents that Undergo Intracellular Phosphorylation may diminish the therapeutic effect of Cladribine. Risk X: Avoid combination

Cobicistat: Tenofovir Disoproxil Fumarate may enhance the adverse/toxic effect of Cobicistat. More specifically, cobicistat may impair proper tenofovir disoproxil fumarate monitoring and dosing. Risk C: Monitor therapy

Darolutamide: May increase the serum concentration of BCRP/ABCG2 Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor therapy

Darunavir: Tenofovir Disoproxil Fumarate may increase the serum concentration of Darunavir. Darunavir may increase the serum concentration of Tenofovir Disoproxil Fumarate. Risk C: Monitor therapy

Didanosine: Tenofovir Disoproxil Fumarate may diminish the therapeutic effect of Didanosine. Tenofovir Disoproxil Fumarate may increase the serum concentration of Didanosine. Management: Avoid use of tenofovir disoproxil fumarate and didanosine when possible. If combined in adults with CrCL greater than 60 mL/min, decrease didanosine to 250 mg daily if 60 kg or more or to 200 mg if less than 60 kg. Avoid if CrCL is less than 60 mL/min. Risk D: Consider therapy modification

Elacestrant: May increase the serum concentration of BCRP/ABCG2 Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor therapy

Elivaldogene Autotemcel: Antiretroviral Agents may diminish the therapeutic effect of Elivaldogene Autotemcel. Management: Avoid use of antiretroviral medications for at least one month, or for the amount of time required for elimination of the retroviral medication, prior to stem cell mobilization and until the all apheresis cycles are finished Risk X: Avoid combination

Eltrombopag: May increase the serum concentration of BCRP/ABCG2 Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor therapy

Encorafenib: May increase the serum concentration of BCRP/ABCG2 Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor therapy

Futibatinib: May increase the serum concentration of BCRP/ABCG2 Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor therapy

Ganciclovir-Valganciclovir: Tenofovir Products may increase the serum concentration of Ganciclovir-Valganciclovir. Ganciclovir-Valganciclovir may increase the serum concentration of Tenofovir Products. Risk C: Monitor therapy

Gilteritinib: May increase the serum concentration of BCRP/ABCG2 Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor therapy

Ledipasvir: May increase the serum concentration of Tenofovir Disoproxil Fumarate. Management: Avoid this combination if TDF is used as part of the elvitegravir/cobicistat/emtricitabine/TDF product. Consider alternatives when TDF is used with a ritonavir or cobicistat boosted protease inhibitor. Monitor for increased TDF toxicities if combined. Risk D: Consider therapy modification

Leflunomide: May increase the serum concentration of BCRP/ABCG2 Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor therapy

Leniolisib: May increase the serum concentration of BCRP/ABCG2 Substrates (Clinically Relevant with Inhibitors). Risk X: Avoid combination

Lopinavir: May enhance the nephrotoxic effect of Tenofovir Disoproxil Fumarate. Lopinavir may increase the serum concentration of Tenofovir Disoproxil Fumarate. Risk C: Monitor therapy

Lovotibeglogene Autotemcel: Antiretroviral Agents may diminish the therapeutic effect of Lovotibeglogene Autotemcel. Risk X: Avoid combination

Lumacaftor and Ivacaftor: May increase the serum concentration of P-glycoprotein/ABCB1 Substrates (High risk with Inhibitors or Inducers). Lumacaftor and Ivacaftor may decrease the serum concentration of P-glycoprotein/ABCB1 Substrates (High risk with Inhibitors or Inducers). Risk C: Monitor therapy

Nonsteroidal Anti-Inflammatory Agents: May enhance the nephrotoxic effect of Tenofovir Products. Management: Seek alternatives to these combinations whenever possible. Avoid use of tenofovir with multiple NSAIDs or any NSAID given at a high dose due to a potential risk of acute renal failure. Diclofenac appears to confer the most risk. Risk D: Consider therapy modification

Nonsteroidal Anti-Inflammatory Agents (Topical): May enhance the nephrotoxic effect of Tenofovir Products. Risk C: Monitor therapy

Orlistat: May decrease the serum concentration of Antiretroviral Agents. Risk C: Monitor therapy

Osimertinib: May increase the serum concentration of BCRP/ABCG2 Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor therapy

Oteseconazole: May increase the serum concentration of BCRP/ABCG2 Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor therapy

Pacritinib: May increase the serum concentration of BCRP/ABCG2 Substrates (Clinically Relevant with Inhibitors). Risk X: Avoid combination

P-glycoprotein/ABCB1 Inhibitors: May increase the serum concentration of Tenofovir Disoproxil Fumarate. Risk C: Monitor therapy

Pretomanid: May increase the serum concentration of BCRP/ABCG2 Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor therapy

Regorafenib: May increase the serum concentration of BCRP/ABCG2 Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor therapy

Rolapitant: May increase the serum concentration of BCRP/ABCG2 Substrates (Clinically Relevant with Inhibitors). Management: Monitor patients receiving rolapitant for increased exposure to and/or effects of BCRP/ABCG2 substrates. Use the lowest effective rosuvastatin dose when used in combination with rolapitant. Risk C: Monitor therapy

Sparsentan: May increase the serum concentration of BCRP/ABCG2 Substrates (Clinically Relevant with Inhibitors). Risk X: Avoid combination

Tacrolimus (Systemic): Tenofovir Products may enhance the nephrotoxic effect of Tacrolimus (Systemic). Risk C: Monitor therapy

Tafamidis: May increase the serum concentration of BCRP/ABCG2 Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor therapy

Taurursodiol: May increase the serum concentration of BCRP/ABCG2 Substrates (Clinically Relevant with Inhibitors). Risk X: Avoid combination

Tedizolid: May increase the serum concentration of BCRP/ABCG2 Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor therapy

Teriflunomide: May increase the serum concentration of BCRP/ABCG2 Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor therapy

Tipranavir: Tenofovir Disoproxil Fumarate may decrease the serum concentration of Tipranavir. Tipranavir may decrease the serum concentration of Tenofovir Disoproxil Fumarate. Risk C: Monitor therapy

Voxilaprevir: Tenofovir Disoproxil Fumarate may increase the serum concentration of Voxilaprevir. Voxilaprevir may increase the serum concentration of Tenofovir Disoproxil Fumarate. Risk C: Monitor therapy

Food Interactions

See individual agents.

Reproductive Considerations

The Health and Human Services (HHS) perinatal HIV guidelines consider this a preferred combination for patients with HIV who are not yet pregnant but are trying to conceive.

This combination is recommended for pre-exposure prophylaxis (PrEP) in patients at risk for HIV infection who are planning a pregnancy. The partner without HIV should begin therapy 20 days prior to attempting conception. Up to 20 days of therapy are required to achieve protective drug concentrations in cervicovaginal tissue, therefore continued use of condoms to prevent HIV exposure is recommended during this time. PrEP should continue for 28 days after attempting conception or condomless sex exposure. Episodic or on demand dosing is not effective for prevention of HIV via vaginal exposure. Pregnancy testing should be done at baseline, then as indicated (HHS [perinatal] 2023).

Refer to individual monographs for additional information.

Pregnancy Considerations

The Health and Human Services (HHS) perinatal HIV guidelines consider emtricitabine with tenofovir disoproxil fumarate to be a preferred nucleoside reverse transcriptase inhibitor backbone for initial therapy in antiretroviral-naive pregnant patients. In addition, this combination is preferred for use in pregnant patients with HIV who have had antiretroviral therapy (ART) in the past but are restarting, or who require a new ART regimen (due to poor tolerance or poor virologic response of current regimen). Patients who become pregnant while taking this combination may continue if viral suppression is effective and the regimen is well tolerated.

This combination is recommended for pre-exposure prophylaxis (PrEP) in uninfected patients at risk for HIV infection who are pregnant; if started prior to conception, it may be continued during pregnancy. Emtricitabine and tenofovir disoproxil fumarate are recommended as part of a preferred regimen when early (acute/recent) HIV infection is detected during pregnancy; genotyping may be required if the person had prior use of long acting cabotegravir for PrEP.

The HHS perinatal guidelines also recommend emtricitabine plus tenofovir disoproxil fumarate as a component of regimens for HIV/hepatitis B virus–coinfected patients who are pregnant (HHS [perinatal] 2023).

Refer to individual monographs for additional information.

Breastfeeding Considerations

Emtricitabine and tenofovir are present in breast milk.

Emtricitabine and tenofovir disoproxil are recommended for pre-exposure prophylaxis (PrEP) in uninfected patients at risk for HIV infection who are breastfeeding (HHS [perinatal] 2023).

Refer to individual monographs for additional information.

Dietary Considerations

Consider calcium and vitamin D supplementation in patients with history of bone fracture or osteopenia.

Monitoring Parameters

CBC with differential, reticulocyte count, creatine kinase, CD4 count, HIV RNA plasma levels, serum phosphorus (individuals with chronic kidney disease) or at risk of kidney dysfunction with persistent or worsening bone or muscle symptoms); serum creatinine, urine glucose and urine protein (prior to initiation and as clinically indicated during therapy), hepatic function tests, bone density (patients with a history of bone fracture or have risk factors for bone loss or kidney dysfunction with persistent or worsening bone or muscle symptoms); testing for hepatitis B virus (HBV) is recommended prior to the initiation of antiretroviral therapy; weight (children).

Patients with HIV and HBV coinfection should be monitored for several months following tenofovir discontinuation.

HIV-1 preexposure prophylaxis (PrEP) (CDC 2021): Documented negative HIV test (≤1 week before initiating or reinitiating PrEP, at least every 3 months while taking PrEP, and following discontinuation of PrEP). Screen for acute viral infections and potential exposure events (eg, condomless sex/condom breaking during sex with a partner of unknown HIV-1 status or unknown viremic status, or a recent STI) within 1 month of starting PrEP; if infections or events exist, reconfirm HIV-1 negative status. Assess symptoms of side effects and acute HIV infection (every 3 months); renal function (prior to initiation, then every 6 to 12 months); testing for HBV (prior to initiation).

HIV occupational postexposure prophylaxis (PEP) (Kuhar 2013): Documented HIV test (at baseline and 6 weeks, 12 weeks, and 6 months after exposure); if confirmation that a fourth generation HIV p2 antigen-HIV antibody test is being used, monitor at baseline, 6 weeks and 4 months after exposure. CBC, renal and hepatic function assessments at baseline and 2 weeks after exposure (minimum recommendations, others dictated by clinical assessment).

Mechanism of Action

Nucleoside and nucleotide reverse transcriptase inhibitor combination; emtricitabine is a cytidine analogue while tenofovir is an analog of adenosine 5'-monophosphate. Each drug interferes with HIV viral RNA dependent DNA polymerase resulting in inhibition of viral replication.

Pharmacokinetics (Adult Data Unless Noted)

Refer to individual monographs.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (EC) Ecuador: Calprega;
  • (MX) Mexico: Luviren pro
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