Version November 2024
Severe acute exacerbations of hepatitis B (HBV) have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued emtricitabine. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who are coinfected with HIV-1 and HBV and discontinue emtricitabine. If appropriate, initiation of anti-HBV therapy may be warranted.
Hepatitis B/HIV coinfection, treatment (off-label use): Oral: Capsule: 200 mg once daily, in combination with tenofovir and other appropriate antiretrovirals (Ref).
HIV-1 infection, treatment: Oral:
Capsule: 200 mg once daily in combination with other antiretrovirals.
Solution: 240 mg once daily in combination with other antiretrovirals.
HIV-1 nonoccupational postexposure prophylaxis (nPEP) (off-label use): Oral: Capsule: 200 mg once daily; initiate therapy within 72 hours of exposure and continue for 28 days in combination with other antiretrovirals (3-drug regimen) Note: The fixed-dose emtricitabine and tenofovir disoproxil fumarate combination product is recommended for these components of the 3-drug regimen (Ref).
HIV-1 occupational postexposure prophylaxis (oPEP) (off-label use): Oral: Capsule: 200 mg once daily in combination with tenofovir disoproxil fumarate and raltegravir; initiate therapy as soon as possible after occupational exposure (and within 72 hours) and continue for 4 weeks; Note: The fixed-dose emtricitabine and tenofovir disoproxil fumarate combination product is recommended for these components of the regimen (Ref).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
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.
Altered kidney function:
Note: Emtricitabine is primary eliminated by the kidney; dose adjustments are generally recommended to prevent accumulation in patients with kidney dysfunction, particularly when CrCl is <30 mL/minute. Concomitant use of other medications that affect tubular creatinine secretion (eg, dolutegravir, cobicistat) may overestimate the severity of kidney impairment and should be considered prior to adjusting the dose of emtricitabine (Ref).
Emtricitabine Dosage Adjustments for Altered Kidney Function: Oral:
|
CrCl (mL/minute) |
Manufacturer's labeling |
Alternative recommendationa | |
|---|---|---|---|
|
Capsule |
Solution |
Capsule | |
|
a Manufacturer's labeling contains the traditional dose adjustments aimed to provide equal exposures to those with normal kidney function. However, since emtricitabine is usually well tolerated, and the capsule dose adjustments involve prolonging the dosing interval (which can make adherence more difficult), the risks and benefits of the alternative recommendation (ie, no [or limited] dose adjustment) should be weighed on an individualized basis, with close monitoring for GI adverse effects (eg, nausea), as well as symptoms that could suggest more rare side effects (eg, lactic acidemia, pancreatitis, rhabdomyolysis) (Wood 2021). b Considerations may include but are not limited to: Use of emtricitabine as an individual component of an antiretroviral regimen versus as part of an emtricitabine-containing combination product (refer to combination product monographs for dosing recommendations); patient's ability to adhere to the regimen; availability/accessibility of formulations (capsules, oral solution); prior tolerability issues with emtricitabine; anticipated duration of use (Wood 2021; expert opinion). c Dialyzable (30%) (manufacturer's labeling). d When scheduled dose falls on a hemodialysis day, administer after hemodialysis. e Several combination products require “no dosage adjustment” in hemodialysis patients according to manufacturer's labeling (see specific combination monographs for more details). | |||
|
≥50 mL/minute |
No dose adjustment necessary. |
No dosage adjustment necessary. |
No dosage adjustment necessary. |
|
30 to <50 mL/minute |
200 mg every 48 hours |
120 mg every 24 hours |
No dosage adjustment necessary (Post 2017; Pozniak 2016; Valade 2014; expert opinion). |
|
15 to <30 mL/minute |
200 mg every 72 hours |
80 mg every 24 hours |
Due to increased emtricitabine exposure, the manufacturer's recommended dose adjustments are generally preferred. However, in some situationsb use of unadjusted doses (ie, 200 mg once daily for capsules) may be considered, along with frequent monitoring for adverse effects (Wood 2021; expert opinion). |
|
<15 mL/minute (not on dialysis) |
200 mg every 96 hours |
60 mg every 24 hours | |
|
Hemodialysis, intermittent (thrice weekly) |
200 mg every 96 hoursc,d |
60 mg every 24 hoursc,d |
Although emtricitabine exposure will be increased (Eron 2018), in some situationsb,e use of unadjusted doses (ie, 200 mg once daily for capsules) may be considered, along with frequent monitoring for adverse effects (Eron 2018; HHS [adult] 2023; Sidman 2023).c,d |
|
Peritoneal dialysis |
There are no dosage adjustments provided in the manufacturer's labeling; may consider utilizing dose adjustments provided for hemodialysis patients (expert opinion). |
There are no dosage adjustments provided in the manufacturer's labeling; may consider utilizing dose adjustments provided for hemodialysis patients (expert opinion). |
Due to increased emtricitabine exposure, the manufacturer's recommended dose adjustments for patients on hemodialysis are generally preferred for patients on peritoneal dialysis. However, although data is limited to one case report (Partosh 2023), in some situationsb use of unadjusted doses (ie, 200 mg once daily for capsules) may be considered, along with frequent monitoring for adverse effects (expert opinion). |
CRRT:
Note: Drug clearance is dependent on the effluent flow rate, filter type, and method of renal replacement. Recommendations are based on high-flux dialyzers and effluent flow rates of 20 to 25 mL/kg/hour (or ~1,500 to 3,000 mL/hour) and minimal residual kidney function unless otherwise noted. Appropriate dosing requires consideration of adequate drug concentrations. Close monitoring of response and adverse reactions due to drug accumulation is important.
There are no data available in patients on CRRT (has not been studied); however, no dosage adjustment is likely necessary since some emtricitabine removal by CRRT is expected based on its physicochemical characteristics and it is generally well tolerated; monitor frequently for adverse effects (Ref).
PIRRT (eg, sustained, low-efficiency diafiltration):
Note: Drug clearance is dependent on the effluent flow rate, filter type, and method of renal replacement. Appropriate dosing requires consideration of adequate drug concentrations. Close monitoring of response and adverse reactions due to drug accumulation is important.
There are no data available in patients on PIRRT (has not been studied); however, no dosage adjustment is likely necessary since some emtricitabine removal by PIRRT is expected based on its physicochemical characteristics and it is generally well-tolerated; monitor frequently for adverse effects (Ref).
There are no dosage adjustments provided in the manufacturer’s labeling; however, not hepatically metabolized, so impact of hepatic impairment would be minimal.
Refer to adult dosing.
(For additional information see "Emtricitabine: Pediatric drug information")
Note: Due to bioavailability differences, oral dosage forms are not bioequivalent; oral solution and capsules should not be interchanged on a mg:mg basis. Gene mutation and antiretroviral (ARV) resistance patterns should be evaluated (refer to https://www.iasusa.org/ for more information) when necessary.
HIV-1 infection, treatment: Note: Use in combination with other ARV agents. Oral:
Infants 1 to <3 months: Oral solution: 3 mg/kg/dose once daily.
Infants ≥3 months, Children, and Adolescents ≤17 years:
Oral solution: 6 mg/kg/dose once daily; maximum daily dose: 240 mg/day.
Capsules: Patient weight >33 kg and able to swallow capsule whole: 200 mg once daily.
Adolescents ≥18 years:
Capsules: 200 mg once daily.
Oral solution: 240 mg once daily.
HIV-1 nonoccupational postexposure prophylaxis (nPEP) (Ref): Note: Initiate therapy within 72 hours of exposure and continue for 28 days in combination with other ARV agents. Oral:
Infants 1 to <3 months: Oral solution: 3 mg/kg/dose once daily.
Infants ≥3 months and Children:
Oral solution: 6 mg/kg/dose once daily; maximum daily dose: 240 mg/day.
Capsules: Patient weight >33 kg and able to swallow capsule whole: 200 mg once daily.
Adolescents: The combination product is recommended (see emtricitabine and tenofovir disoproxil fumarate monograph).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Monitor clinical response and renal function closely. Dialysis: 30% of the dose is removed by hemodialysis (over 3 hours).
Infants, Children, and Adolescents <18 years: There are no specific dosage adjustments provided in the manufacturer's labeling; however, may consider a reduction in the dose and/or an increase in the dosing interval similar to dosage adjustments for adults.
Adolescents ≥18 years:
CrCl ≥50 mL/minute: No dosage adjustment necessary.
CrCl 30 to 49 mL/minute: Capsule: 200 mg every 48 hours; oral solution: 120 mg every 24 hours.
CrCl 15 to 29 mL/minute: Capsule: 200 mg every 72 hours; oral solution: 80 mg every 24 hours.
CrCl <15 mL/minute: Capsule: 200 mg every 96 hours; oral solution: 60 mg every 24 hours.
Hemodialysis: Capsule: 200 mg every 24 hours; solution: 240 mg every 24 hours; administer after hemodialysis on dialysis days (Ref).
No dosage adjustments are required (Ref).
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported with combination therapy in adults.
>10%:
Dermatologic: Skin rash (7% to 30%; includes allergic skin rash, exfoliative rash, maculopapular rash, pruritus, pustular rash, urticaria, vesiculobullous rash)
Endocrine & metabolic: Hypercholesterolemia (grades 3/4: 22%)
Gastrointestinal: Abdominal pain (8% to 14%), diarrhea (9% to 23%), nausea (9% to 18%)
Nervous system: Abnormal dreams (2% to 11%), asthenia (12% to 16%), dizziness (4% to 25%), headache (6% to 22%), insomnia (5% to 16%)
Neuromuscular & skeletal: Increased creatine phosphokinase in blood specimen (grades 3/4: 9% to 12%)
Respiratory: Increased cough (14%), rhinitis (12% to 18%)
1% to 10%:
Endocrine & metabolic: Decreased serum glucose (grades 3/4: ≤3%), hyperglycemia (grades 3/4: ≤3%), increased serum triglycerides (grades 3/4: 4% to 10%)
Gastrointestinal: Dyspepsia (4% to 8%), increased serum amylase (grades 3/4: ≤8%), increased serum lipase (grades 3/4: ≤1%), vomiting (2% to 9%)
Genitourinary: Hematuria (grades 3/4: 3%)
Hematologic & oncologic: Decreased neutrophils (grades 3/4: 3% to 5%)
Hepatic: Increased serum alanine aminotransferase (grades 3/4: 2% to 5%), increased serum alkaline phosphatase (grades 3/4: 1%), increased serum aspartate aminotransferase (grades 3/4: 3% to 6%), increased serum bilirubin (grades 3/4: ≤1%)
Nervous system: Depression (6% to 9%), fatigue (9%), neuropathy (≤4%), paresthesia (5% to 6%), peripheral neuritis (≤4%)
Neuromuscular & skeletal: Arthralgia (3% to 5%), myalgia (4% to 6%)
Respiratory: Nasopharyngitis (5%), sinusitis (8%), upper respiratory tract infection (8%)
<1%: Genitourinary: Glycosuria (grades 3/4)
Frequency not defined: Dermatologic: Skin discoloration
Postmarketing:
Dermatologic: Hyperpigmentation (palms or soles) (Shirasaka 2011)
Endocrine & metabolic: Lactic acidosis
Gastrointestinal: Gastroenteritis (eosinophilic) (Lozier 2018)
Hematologic & oncologic: Immune thrombocytopenia (Howard 2019), pure red cell aplasia (Manickchund 2019)
Hepatic: Exacerbation of hepatitis B (with discontinuation of therapy) (Mondou 2005), hepatomegaly with steatosis (severe)
Immunologic: Immune reconstitution syndrome (IRIS: including IRIS-related hepatitis B flare and tinea-IRIS) (Arshad 2023, Mapesi 2016)
Nervous system: Trigeminal neuralgia (Van Slyke 2018)
Hypersensitivity to emtricitabine or any component of the formulation
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) 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 analogs, 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:
• Renal impairment: Use with caution in patients with renal impairment; dosage adjustment may be necessary.
Dosage form specific issues:
• Propylene glycol: Some dosage forms may contain propylene glycol; large amounts are potentially toxic and have been associated with hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Zar 2007).
Other warnings/precautions:
• Appropriate use: Emtricitabine combined with lamivudine is not recommended as a dual-nucleoside reverse transcriptase inhibitor combination due to similar resistance patterns and negligible additive antiviral activity (HHS [adult] 2023).
Hyperpigmentation may occur at a higher frequency in pediatric patients compared to adults (children: 32%; adults: 2% to 6%).
Some dosage forms may contain propylene glycol; in neonates large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults including hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Shehab 2009).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Capsule, Oral:
Emtriva: 200 mg [contains fd&c blue #2 (indigotine,indigo carmine)]
Generic: 200 mg
Solution, Oral:
Emtriva: 10 mg/mL (170 mL) [contains edetate (edta) disodium, fd&c yellow #6 (sunset yellow), methylparaben, propylene glycol, propylparaben; cotton candy flavor]
May be product dependent
Capsules (Emtricitabine Oral)
200 mg (per each): $19.31
Capsules (Emtriva Oral)
200 mg (per each): $21.46
Solution (Emtriva Oral)
10 mg/mL (per mL): $0.89
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.
Administer with or without food.
Oral: May be administered without regard to food
HIV-1 infection, treatment: Treatment of HIV-1 infection in combination with other antiretroviral agents.
HIV-1/hepatitis B coinfection, treatment; HIV-1 nonoccupational postexposure prophylaxis; HIV-1 occupational postexposure prophylaxis
None known.
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 drug interactions program by clicking on the “Launch drug interactions program” link above.
Atidarsagene Autotemcel: Antiretroviral Agents may diminish the therapeutic effect of Atidarsagene Autotemcel. Risk X: Avoid combination
Betibeglogene Autotemcel: Antiretroviral Agents may diminish the therapeutic effect of Betibeglogene Autotemcel. Risk X: Avoid combination
Cladribine: Agents that Undergo Intracellular Phosphorylation may diminish the therapeutic effect of Cladribine. Risk X: Avoid combination
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
Lovotibeglogene Autotemcel: Antiretroviral Agents may diminish the therapeutic effect of Lovotibeglogene Autotemcel. Risk X: Avoid combination
Orlistat: May decrease the serum concentration of Antiretroviral Agents. Risk C: Monitor therapy
Food decreases peak plasma concentrations, but does not alter the extent of absorption or overall systemic exposure. Management: Administer without regard to meals.
Contraception is not required to initiate or continue antiretroviral therapy (ART).
The Health and Human Services (HHS) perinatal HIV guidelines consider emtricitabine a preferred nucleoside reverse transcriptase inhibitor for patients with HIV who are not yet pregnant but are trying to conceive.
Maximum viral suppression sustained below the limits of detection prior to conception is recommended for all persons with HIV who are planning a pregnancy. Optimization of the health of the person who will become pregnant is recommended. Selection of or changes to a specific antiretroviral regimen prior to pregnancy should be done as part of a shared decision-making process. In most cases, recommendations from the HHS perinatal HIV guidelines (based on data obtained from cisgender women) can be applied to transgender and gender diverse people assigned female sex at birth.
Emtricitabine is a recommended component 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. Pregnancy testing should be done at baseline, then as indicated. PrEP with emtricitabine may continue if pregnancy occurs.
Health care providers caring for couples planning a pregnancy when one or both partners are diagnosed with HIV may contact the National Perinatal HIV Hotline (1-888-448-8765) for clinical consultation (HHS [perinatal] 2023).
Emtricitabine has a high level of transfer across the human placenta.
No increased risk of overall teratogenic effects has been observed according to data collected by the antiretroviral pregnancy registry. Maternal antiretroviral therapy (ART) may be associated with adverse pregnancy outcomes including preterm birth, low birth weight, and small-for-gestational-age infants. Actual risks may be influenced by maternal factors, such as disease severity, gestational age at initiation of therapy, and specific ART regimen; therefore, close fetal monitoring is recommended. Because there is clear benefit to appropriate treatment, maternal ART should not be withheld due to concerns for adverse neonatal outcomes. Long-term follow-up is recommended for all infants exposed to antiretroviral medications; children not diagnosed with HIV but who were exposed to ART in utero or as a neonate and develop significant organ system abnormalities of unknown etiology (particularly of the CNS or heart) should be evaluated for potential metabolic dysfunction.
The Health and Human Services (HHS) perinatal HIV guidelines consider emtricitabine a preferred nucleoside reverse transcriptase inhibitor (NRTI) for pregnant patients with HIV who are antiretroviral-naive, who have had ART therapy in the past but are restarting, or who require a new ART regimen (due to poor tolerance or poor virologic response of current regimen). In addition, patients who become pregnant while taking emtricitabine may continue if viral suppression is effective and the regimen is well tolerated.
The HHS perinatal HIV guidelines consider emtricitabine with tenofovir disoproxil fumarate or tenofovir alafenamide to be a preferred NRTI backbone for initial therapy in antiretroviral-naive patients who are pregnant. The guidelines also consider emtricitabine plus tenofovir disoproxil fumarate or tenofovir alafenamide a recommended dual NRTI backbone in regimens for patients who are HIV/hepatitis B virus-coinfected and pregnant.
Emtricitabine is a recommended component for pre-exposure prophylaxis (PrEP) in uninfected patients at risk for HIV infection who are pregnant. Emtricitabine is also a preferred component of an initial 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 pharmacokinetics of emtricitabine are not significantly altered during pregnancy and dose adjustments are not needed.
ART is recommended for all pregnant people with HIV to maximize their health, maintain the viral load below the limit of detection, and reduce the risk of perinatal transmission. Selection of or changes to a specific antiretroviral regimen during pregnancy should be done as part of a shared decision-making process. Patients on fully suppressive regimens prior to pregnancy generally may continue the same regimen considering known pregnancy outcomes and pharmacokinetic data. Monitoring of patients who are pregnant is more frequent than in patients who are not pregnant. ART initiated during pregnancy can be modified after delivery. In most cases, recommendations from the HHS perinatal HIV guidelines (based on data obtained from cisgender women) can be applied to transgender and gender diverse people assigned female sex at birth.
Data collection to monitor pregnancy and infant outcomes following exposure to ART is ongoing. Health care providers should enroll all patients exposed to antiretroviral medications during pregnancy in the Antiretroviral Pregnancy Registry (1-800-258-4263). Enrollment should be done as early in pregnancy as possible.
Health care providers caring for pregnant patients with HIV and their infants may contact the National Perinatal HIV Hotline (1-888-448-8765) for clinical consultation (HHS [perinatal] 2023).
Emtricitabine is present in breast milk.
Breast milk concentrations may be higher than those in the maternal serum. Emtricitabine can be detected in the serum of breastfed infants.
Emtricitabine is a recommended component of an initial regimen when early (acute/recent) HIV infection is detected in patients who are breastfeeding. Breastfeeding should be interrupted and not continued if infection is confirmed. Milk may be expressed and stored while waiting for confirmation.
Emtricitabine is a recommended component for pre-exposure prophylaxis (PrEP) in uninfected patients at risk for HIV infection who are breastfeeding.
Maintaining maximum viral suppression during pregnancy and postpartum decreases but does not eliminate the risk of HIV transmission via breast milk. In addition, multiclass-resistant virus has been detected in breastfeeding infants who acquire HIV despite maternal therapy. In the United States, where formula is usually accessible, affordable, safe, and sustainable, and the risk of infant mortality due to diarrhea and respiratory infections is low, the Health and Human Services perinatal HIV guidelines do not recommend breastfeeding for patients with HIV when safer infant feeding options are available. Persons with HIV who maintain an undetectable viral load while taking antiretroviral therapy (ART) should evaluate infant feeding options (formula, banked donor milk, or breastfeeding) as part of a shared decision-making process (if breastfeeding is being considered, see guidelines for measures to reduce the risk of HIV transmission). When the HIV status at delivery is not known, breastmilk may be expressed and stored until a negative test is available. If HIV infection is diagnosed after breastfeeding has been initiated, breastfeeding should be discontinued immediately. Breastfeeding is not recommended for persons with HIV who are not taking ART and/or who do not have sustained viral suppression.
Information is available for counseling and managing patients with HIV who are considering breastfeeding (1-888-448-8765). In most cases, recommendations from the HHS perinatal HIV guidelines (based on data obtained from cisgender women) can be applied to transgender and gender diverse people assigned female sex at birth (HHS [perinatal] 2023).
Viral load, CD4, liver function tests; serum creatinine; hepatitis B testing is recommended prior to or when initiating therapy.
Nucleoside reverse transcriptase inhibitor; emtricitabine is a cytidine analogue which is phosphorylated intracellularly to emtricitabine 5'-triphosphate which interferes with HIV viral RNA dependent DNA polymerase resulting in inhibition of viral replication.
Absorption: Rapid, extensive
Protein binding: <4%
Metabolism: Converted intracellularly to the active triphosphate form; undergoes minimal biotransformation via oxidation and glucuronide conjugation
Bioavailability: Capsule: 93%; solution: 75%; Note: Relative bioavailability of solution to capsule: 80%
Half-life elimination: Normal renal function:
Infants, Children, and Adolescents: Elimination half-life (emtricitabine):
Single dose: 11 hours
Multiple dose: 7.9 to 9.5 hours
Infants 0 to 3 months (n=20; median age: 26 days): 12.1 ± 3.1 hours
Infants 3 to 24 months (n=14): 8.9 ± 3.2 hours
Children 25 months to 6 years (n=19): 11.3 ± 6.4 hours
Children 7 to 12 years (n=17): 8.2 ± 3.2 hours
Adolescents 13 to 17 years (n=27): 8.9 ± 3.3 hours
Adults: Emtricitabine: 10 hours; Intracellular half-life (emtricitabine 5'-triphosphate): 39 hours
Time to peak, plasma: 1 to 2 hours
Excretion: Urine (86% primarily as unchanged drug, 13% as metabolites, 9% of dose as oxidative metabolite; 4% as glucuronide metabolite); feces (14%)
Clearance: Renal clearance is greater than creatinine clearance; thus, emtricitabine may be eliminated by both glomerular filtration and active tubular secretion
Altered kidney function: Cmax and AUC are increased in patients with CrCl <50 mL/minute. In patients on hemodialysis, emtricitabine exposure was increased 5.5 times compared to patients with normal kidney function, although no overt toxicity was reported (Eron 2018).
Pediatric: Exposure is similar to adults. In neonates, the AUC was similar to the AUC observed in children at least 3 months to 17 years of age.
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