Emtricitabine
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From MedlinePlus, U.S. National Library of Medicine
Boxed warning
WARNING: POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B Severe acute exacerbations of hepatitis B (HBV) have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued e mtricitabine. 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-hepatitis B therapy may be warranted [see Warnings and Precautions ( 5.1 )] . WARNING: POSTTREATMENT ACUTE EXACERBATION OF HEPATITIS B See full prescribing information for complete boxed warning.
Severe acute exacerbations of Hepatitis B (HBV) have been reported in patients coinfected with HIV-1 and HBV who have discontinued Emtricitabine. Hepatic function should be monitored closely in patients coinfected with HIV-1 and HBV who discontinue Emtricitabine. If appropriate, initiation of anti-hepatitis B therapy may be warranted. ( 5.1 )
Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Dosing in kidney impairment
Dosage Adjustment in Patients with Renal Impairment Table 1 provides dosage interval adjustment for patients with renal impairment. No dosage adjustment is necessary for patients with mild renal impairment (creatinine clearance 50–80 mL/min). The safety and effectiveness of dose adjustment recommendations in patients with moderate to severe renal impairment (creatinine clearance below 50 mL/min) have not been clinically evaluated.
Therefore, clinical response to treatment and renal function should be closely monitored in these patients [see Warnings and Precautions, Use in Specific Populations] . [See table below.] There are insufficient data available to make dosage recommendations in pediatric patients with renal impairment.
| a. Hemodialysis Patients: If dosing on day of dialysis, give dose after dialysis. | ||||
| Formulation | Creatinine Clearance (mL/min) | |||
| ≥50 mL/min | 30–49 mL/min | 15–29 mL/min | <15 mL/min or on hemodialysisa | |
| Capsule (200 mg) | 200 mg every 24 hours | 200 mg every 48 hours | 200 mg every 72 hours | 200 mg every 96 hours |
| Formulation | Creatinine Clearance (mL/min) | |||
|---|---|---|---|---|
| ≥50 mL/min | 30–49 mL/min | 15–29 mL/min | <15 mL/min or on hemodialysisa | |
| Capsule (200 mg) | 200 mg every 24 hours | 200 mg every 48 hours | 200 mg every 72 hours | 200 mg every 96 hours |
| a. Hemodialysis Patients: If dosing on day of dialysis, give dose after dialysis. | ||||
Drug interactions
Check emtricitabine against a medication listLabel text (1 paragraph)
The potential for drug interactions with emtricitabine has been studied in combination with AZT, indinavir, d4T, famciclovir, and tenofovir DF (TDF). There were no clinically significant drug interactions for any of these drugs. Drug interactions trials are described elsewhere in the labeling [see Clinical Pharmacology ( 12.3 )].
Contraindications
Emtricitabine is contraindicated in patients with previously demonstrated hypersensitivity to any of the components of the products. Emtricitabine is contraindicated in patients with previously demonstrated hypersensitivity to any of the components of the products. ( 4 )
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to emtricitabine during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263. Risk Summary Available data from the APR show no increase in the overall risk of major birth defects with first trimester exposure for emtricitabine (FTC) (2.3%) compared with the background rate for major birth defects of 2.7% in a U.S. reference population of the Metropolitan Atlanta Congenital Defects Program (MACDP) (see Data) .
The rate of miscarriage for individual drugs is not reported in the APR. In the U.S., general population, the estimated background risk of miscarriage in clinically recognized pregnancies is 15–20%. In animal reproduction studies, no adverse developmental effects were observed when FTC was administered at exposures ≥60 times that of the recommended daily dose of emtricitabine (see Data) .
Data Human Data Based on prospective reports to the APR of exposures to FTC-containing regimens during pregnancy resulting in live births (including over 2,700 exposed in the first trimester and over 1,200 exposed in the second/third trimester), there was no increase between FTC and overall birth defects compared with the background birth defect rate of 2.7% in a U.S. reference population of the MACDP. The prevalence of birth defects in live births was 2.4% (95% CI: 1.9% to 3.1%) with first trimester exposure to FTC-containing regimens and 2.3% (95% CI: 1.5% to 3.3%) with the second/third trimester exposure to FTC-containing regimens.
Prospective reports from the APR of overall major birth defects in pregnancies exposed to FTC are compared with a U.S. background major birth defect rate. Methodologic limitations of the APR include the use of MACDP as the external comparator group. Limitations of using an external comparator include differences in methodology and populations, as well as confounding due to the underlying disease. Additionally, published observational studies on FTC exposure in pregnancy have not shown an increased risk for major malformations.
Animal Data FTC was administered orally to pregnant mice (at 0, 250, 500, or 1,000 mg/kg/day), and rabbits (at 0, 100, 300, or 1,000 mg/kg/day) through organogenesis (on gestation days 6 through 15, and 7 through 19, respectively). No significant toxicological effects were observed in embryo-fetal toxicity studies performed with FTC in mice at exposures (AUC) approximately 60 times higher and in…
Lactation
8.2 Lactation Risk Summary The Centers for Disease Control and Prevention recommend that HIV-1 infected mothers not breastfeed their infants to avoid risking postnatal transmission of HIV-1 . Based on published data, FTC has been shown to be present in human breast milk. It is not known if FTC affects milk production or has effects on the breastfed child. Because of the potential for: (1) HIV transmission (in HIV-negative infants); (2) developing viral resistance (in HIV-positive infants); and (3) adverse reactions in a breastfed infant similar to those seen in adults, instruct mothers not to breastfeed if they are taking emtricitabine.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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