pharmacopeia
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Boxed 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 )

Mechanism of action

Sourced from openFDA

Emtricitabine is an antiretroviral drug [see Microbiology ( 12.4 )].

Nucleoside Reverse Transcriptase

Indications

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  • Emtricitabine is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. Emtricitabine, a nucleoside analog HIV-1 reverse transcriptase inhibitor, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.ICD-10: B20

Contraindications

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  • 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.contraindicated

Dosage & administration

Sourced from openFDA

Testing: Prior to or when initiating emtricitabine test for hepatitis B virus infection. ( 2.1 ) Emtricitabine may be taken without regard to food. ( 2.2 ) Adult Patients (18 years of age and older) ( 2.3 ): Emtricitabine capsules: One 200 mg capsule administered once daily orally. Pediatric Patients (3 months through 17 years of age) ( 2.5 ): Emtricitabine capsules: For children weighing more than 33 kg who can swallow an intact capsule, one 200 mg capsule administered once daily orally. Dose interval adjustment in adult patients with renal impairment ( 2.6 ): 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 hemodialysis a Capsule (200 mg) 200 mg every 24 hours 200 mg every 48 hours 200 mg every 72 hours 200 mg every 96 hours 2.1 Testing Prior to Initiation of Treatment with Emtricitabine Prior to or when initiating emtricitabine, test patients for hepatitis B virus infection [see Warnings and Precautions ( 5.1 )]. 2.2 Recommended Dosage Emtricitabine is taken by mouth once daily and may be taken without regard to food [see Clinical Pharmacology ( 12.3 ) ]. 2.3 Recommended Dosage in Adult Patients (18 years of age and older) Emtricitabine capsules: One 200 mg capsule administered once daily orally. 2.5 Recommended Dosage in Pediatric Patients (3 months through 17 years of age) Emtricitabine capsules: For pediatric patients weighing more than 33 kg who can swallow an intact capsule, one 200 mg capsule administered once daily orally.

Warnings & precautions

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Immune reconstitution syndrome: May necessitate further evaluation and treatment. ( 5.2 ) Lactic acidosis/severe hepatomegaly with steatosis: Discontinue treatment in patients who develop symptoms or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity. ( 5.3 ) 5.1 Severe Acute Exacerbation of Hepatitis B in Patients Coinfected with HIV-1 and HBV All patients should be tested for the presence of chronic Hepatitis B virus (HBV) before or when initiating emtricitabine [see Dosage and Administration ( 2.1 )]. Severe acute exacerbations of hepatitis B (e.g., liver decompensation and liver failure) have been reported in patients who are coinfected with HIV-1 and HBV and have discontinued emtricitabine. Patients who are coinfected with HIV-1 and HBV who discontinue emtricitabine should be closely monitored with both clinical and laboratory follow-up for at least several months after stopping treatment. If appropriate, initiation of anti-hepatitis B therapy may be warranted, especially in patients with advanced liver disease or cirrhosis, since posttreatment exacerbation of hepatitis may lead to hepatic decompensation and liver failure. 5.2 Immune Reconstitution Syndrome Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy, including emtricitabine.

Adverse reactions

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The following adverse reactions are discussed in other sections of the labeling: Severe Acute Exacerbation of Hepatitis B in Patients Coinfected with HIV-1 and HBV [see Warnings and Precautions ( 5.1 )] . Immune Reconstitution Syndrome [see Warnings and Precautions ( 5.2 )] Lactic Acidosis/Severe Hepatomegaly with Steatosis [see Warnings and Precautions ( 5.3 )] . Most common adverse reactions (incidence ≥10%) are headache, diarrhea, nausea, fatigue, dizziness, depression, insomnia, abnormal dreams, rash, abdominal pain, asthenia, increased cough, and rhinitis. Skin hyperpigmentation was very common (≥10%) in pediatric patients. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Cipla Ltd. at 1-866-604-3268 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions from Clinical Trials Experience in Adults More than 2,000 adult subjects with HIV-1 infection have been treated with emtricitabine alone or in combination with other antiretroviral agents for periods of 10 days to 200 weeks in clinical trials.

Use in specific populations

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Lactation: Breastfeeding is not recommended. ( 8.2 ) Pediatrics: Dose adjustment based on age and weight. ( 2.5 , 12.3 ) 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) .

Pharmacokinetics

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Metabolism
Adults The pharmacokinetic properties of FTC were evaluated in healthy subjects and HIV- 1-infected subjects. Emtricitabine pharmacokinetics are similar between these populations.

Overdosage

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If overdose occurs, the patient should be monitored for evidence of toxicity, and standard supportive treatment applied as necessary. Hemodialysis treatment removes approximately 30% of the FTC dose over a 3-hour dialysis period starting within 1.5 hours of FTC dosing (blood flow rate of 400 mL/min and a dialysate flow rate of 600 mL/min). It is not known whether FTC can be removed by peritoneal dialysis.

Approval history

Sourced from openFDA
  • Jul 2, 2003NDANDA021500Gilead
  • Aug 2, 2004NDANDA021752Gilead
  • Sep 28, 2005NDANDA021896Gilead
  • Aug 10, 2011NDANDA202123Gilead Sciences Inc
  • Aug 27, 2012NDANDA203100Gilead Sciences Inc
  • Nov 5, 2015NDANDA207561Gilead Sciences Inc
  • Mar 1, 2016NDANDA208351Gilead Sciences Inc
  • Apr 4, 2016NDANDA208215Gilead Sciences Inc

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
77,543 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Bone Density Decreased20,69427%
  2. 2Chronic Kidney Disease12,76416%
  3. 3Renal Failure10,99414%
  4. 4Osteonecrosis10,91114%
  5. 5Bone Loss10,88814%
  6. 6Tooth Loss10,20513%
  7. 7Multiple Fractures9,83713%
  8. 8Renal Injury9,11712%
  9. 9Osteoporosis9,03712%
  10. 10Pain8,91912%
  11. 11Emotional Distress8,38511%
  12. 12Anxiety8,19511%
  13. 13Skeletal Injury8,08410%
  14. 14Anhedonia7,3629.5%
  15. 15Osteopenia5,2206.7%

Literature

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Recent PubMed references pinned to Emtricitabine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 769 ClinicalTrials.gov registrations naming Emtricitabine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Emtricitabine work?
Emtricitabine is an antiretroviral drug [see Microbiology ( 12.4 )].
What is Emtricitabine used for?
According to FDA labeling, Emtricitabine carries indications including: Emtricitabine is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. Emtricitabine, a nucleoside analog HIV-1 reverse transcriptase inhibitor, is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Emtricitabine?
Emtricitabine is classified as Nucleoside and nucleotide reverse transcriptase inhibitors, Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor, Nucleoside Reverse Transcriptase Inhibitors, Decreased Reverse Transcription to DNA.
What are the brand names for Emtricitabine?
Emtricitabine is marketed under brand names including Atripla, Biktarvy, Complera, Descovy, Emtriva, Genvoya, Odefsey, Stribild.
What are the contraindications for Emtricitabine?
Emtricitabine labeling lists contraindications including: 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.. Always consult the full prescribing information and a clinician.
Note. Data for emtricitabine is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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