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Drug overview for EMTRICITABINE (emtricitabine):
Generic name: EMTRICITABINE (em-tri-SITE-ah-bean)
Drug class: Antiviral-HIV(Antiretroviral) Nucleoside/-tide RT Inhibitors
Therapeutic class: Anti-Infective Agents
Emtricitabine, an antiretroviral agent, is a human immunodeficiency virus (HIV) nucleoside reverse transcriptase inhibitor (NRTI).
No enhanced Uses information available for this drug.
Generic name: EMTRICITABINE (em-tri-SITE-ah-bean)
Drug class: Antiviral-HIV(Antiretroviral) Nucleoside/-tide RT Inhibitors
Therapeutic class: Anti-Infective Agents
Emtricitabine, an antiretroviral agent, is a human immunodeficiency virus (HIV) nucleoside reverse transcriptase inhibitor (NRTI).
No enhanced Uses information available for this drug.
DRUG IMAGES
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The following indications for EMTRICITABINE (emtricitabine) have been approved by the FDA:
Indications:
HIV infection
Professional Synonyms:
Human immunodeficiency virus disease
Human immunodeficiency virus infection
Indications:
HIV infection
Professional Synonyms:
Human immunodeficiency virus disease
Human immunodeficiency virus infection
The following dosing information is available for EMTRICITABINE (emtricitabine):
Emtricitabine capsules and oral solution are not bioequivalent. Bioavailability of the oral solution is 80% relative to that of the capsule.
Reduce dosage in patients with renal impairment; emtricitabine is principally eliminated by the kidney.
Reduce dosage in patients with renal impairment; emtricitabine is principally eliminated by the kidney.
Emtricitabine is administered orally once daily without regard to meals. Single-entity emtricitabine is commercially available as 200-mg capsules or an oral solution containing 10 mg/mL. Emtricitabine is also commercially available in the following fixed-combination tablets for oral use: emtricitabine/tenofovir DF (Truvada(R)), efavirenz/emtricitabine/tenofovir DF (Atripla(R)), emtricitabine/rilpivirine/tenofovir DF (Complera(R)), elvitegravir/cobicistat/emtricitabine/tenofovir DF (Stribild(R)), elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya(R)), emtricitabine/rilpivirine/tenofovir alafenamide (Odefsey(R)), emtricitabine/tenofovir alafenamide (Descovy(R)), and bictegravir/emtricitabine/tenofovir alafenamide (Biktarvy(R)).
See the full prescribing information for administration of each of these combination products. Emtricitabine is used in conjunction with other antiretrovirals. Single-entity emtricitabine should not be used concomitantly with any other emtricitabine-containing preparations.
Store capsules at 25degreesC (excursions permitted to 15-30degreesC). Store oral solution at 2-8degreesC. For patient use, store at 25degreesC (excursions permitted to 15-30degreesC); use within 3 months.
See the full prescribing information for administration of each of these combination products. Emtricitabine is used in conjunction with other antiretrovirals. Single-entity emtricitabine should not be used concomitantly with any other emtricitabine-containing preparations.
Store capsules at 25degreesC (excursions permitted to 15-30degreesC). Store oral solution at 2-8degreesC. For patient use, store at 25degreesC (excursions permitted to 15-30degreesC); use within 3 months.
No dosing information available.
No generic dosing information available.
The following drug interaction information is available for EMTRICITABINE (emtricitabine):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for EMTRICITABINE (emtricitabine):
Drug contraindication overview.
*Known hypersensitivity to the drug or any ingredient in the formulation.
*Known hypersensitivity to the drug or any ingredient in the formulation.
There are 2 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Lactation |
| Lactic acidosis |
There are 4 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Chronic kidney disease stage 3A (moderate) GFR 45-59 ml/min |
| Chronic kidney disease stage 3B (moderate) GFR 30-44 ml/min |
| Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min |
| Chronic kidney disease stage 5 (failure) GFr<15 ml/min |
There are 1 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Chronic hepatitis B |
The following adverse reaction information is available for EMTRICITABINE (emtricitabine):
Adverse reaction overview.
The most common adverse reactions experienced in at least 10% of adult patients with HIV-1 treated with emtricitabine include headache, GI effects (diarrhea, nausea), fatigue, dizziness, depression, insomnia, abnormal dreams, rash, abdominal pain, asthenia, increased cough, and rhinitis. Adverse effects reported in pediatric patients 3 months of age or older receiving emtricitabine in clinical studies have been similar to those in adults, with the exception of a higher frequency of hyperpigmentation.
The most common adverse reactions experienced in at least 10% of adult patients with HIV-1 treated with emtricitabine include headache, GI effects (diarrhea, nausea), fatigue, dizziness, depression, insomnia, abnormal dreams, rash, abdominal pain, asthenia, increased cough, and rhinitis. Adverse effects reported in pediatric patients 3 months of age or older receiving emtricitabine in clinical studies have been similar to those in adults, with the exception of a higher frequency of hyperpigmentation.
There are 15 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Depression Gastroenteritis Vomiting |
Anemia Bullous dermatitis Maculopapular rash Peripheral neuropathy Urticaria |
| Rare/Very Rare |
|---|
|
Autoimmune hepatitis Graves' disease Guillain-barre syndrome Lactic acidosis Pneumonia Polymyositis Steatosis of liver |
There are 19 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Acute abdominal pain Cough Diarrhea Dizziness Dream disorder Fatigue General weakness Headache disorder Nausea Pruritus of skin Rhinitis Skin rash |
Acute bacterial otitis media Arthralgia Dyspepsia Insomnia Myalgia Paresthesia |
| Rare/Very Rare |
|---|
|
Dyschromia |
The following precautions are available for EMTRICITABINE (emtricitabine):
Safety and efficacy of emtricitabine have been established for treatment of HIV-1 infection in children 3 months of age and older. The pharmacokinetics and safety of emtricitabine were evaluated in a dose-finding study in 20 neonates born to HIV-infected mothers. These neonates received zidovudine prophylaxis for 6 weeks.
In addition, these neonates received 2 short courses of emtricitabine (3 mg/kg daily for 4 days per course) during the first 12 weeks of life. This dosage was not associated with any safety issues. Systemic exposure (AUC) in infants 0-3 months of age receiving emtricitabine 3 mg/kg daily was similar to that reported in children 3 months to 17 years of age receiving emtricitabine 6 mg/kg daily. All neonates were HIV-1 negative at the end of the study (6 months postpartum); the efficacy of emtricitabine for the prevention or treatment of HIV was not determined.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
In addition, these neonates received 2 short courses of emtricitabine (3 mg/kg daily for 4 days per course) during the first 12 weeks of life. This dosage was not associated with any safety issues. Systemic exposure (AUC) in infants 0-3 months of age receiving emtricitabine 3 mg/kg daily was similar to that reported in children 3 months to 17 years of age receiving emtricitabine 6 mg/kg daily. All neonates were HIV-1 negative at the end of the study (6 months postpartum); the efficacy of emtricitabine for the prevention or treatment of HIV was not determined.
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
The Antiretroviral Pregnancy Registry (APR) monitors pregnancy outcomes in women exposed to emtricitabine during pregnancy. Clinicians are encouraged to register patients in the APR by calling 800-258-4263 or visiting https://www.APRegistry.com.
Based on prospective reports to the APR, the overall risk of birth defects among live births with first-trimester exposure to emtricitabine was 2.4%, and 2.3% with second/third trimester exposure, compared to the background rate for major birth defects of 2.7%
in the United States reference population of the Metropolitan Atlanta Congenital Defects Program (MACDP). Limitations of using an external comparator (i.e., MACDP) include differences in populations and methodology, and confounding due to the underlying disease. The rate of miscarriage for individual drugs is not reported in the APR. Additional observational data have not shown an increase in major malformations with emtricitabine exposure in pregnancy.
Based on prospective reports to the APR, the overall risk of birth defects among live births with first-trimester exposure to emtricitabine was 2.4%, and 2.3% with second/third trimester exposure, compared to the background rate for major birth defects of 2.7%
in the United States reference population of the Metropolitan Atlanta Congenital Defects Program (MACDP). Limitations of using an external comparator (i.e., MACDP) include differences in populations and methodology, and confounding due to the underlying disease. The rate of miscarriage for individual drugs is not reported in the APR. Additional observational data have not shown an increase in major malformations with emtricitabine exposure in pregnancy.
Based on published data, emtricitabine is distributed into human milk. It is not known whether emtricitabine affects milk production or has effects on the breast-fed infant. The HHS perinatal HIV transmission guideline provides updated recommendations on infant feeding.
The guideline states that patients with HIV should receive evidence-based, patient-centered counseling to support shared decision making about infant feeding. During counseling, patients should be informed that feeding with appropriate formula or pasteurized donor human milk from a milk bank eliminates the risk of postnatal HIV transmission to the infant. Additionally, achieving and maintaining viral suppression with antiretroviral therapy during pregnancy and postpartum reduces the risk of breastfeeding HIV transmission to <1%, but does not completely eliminate the risk. Replacement feeding with formula or banked pasteurized donor milk is recommended when patients with HIV are not on antiretroviral therapy and/or do not have a suppressed viral load during pregnancy (at a minimum throughout the third trimester), as well as at delivery.
Contraindicated
Absolute contraindication. (Human data usually available to support recommendations.) This drug should not be given to breast feeding mothers.
The guideline states that patients with HIV should receive evidence-based, patient-centered counseling to support shared decision making about infant feeding. During counseling, patients should be informed that feeding with appropriate formula or pasteurized donor human milk from a milk bank eliminates the risk of postnatal HIV transmission to the infant. Additionally, achieving and maintaining viral suppression with antiretroviral therapy during pregnancy and postpartum reduces the risk of breastfeeding HIV transmission to <1%, but does not completely eliminate the risk. Replacement feeding with formula or banked pasteurized donor milk is recommended when patients with HIV are not on antiretroviral therapy and/or do not have a suppressed viral load during pregnancy (at a minimum throughout the third trimester), as well as at delivery.
Contraindicated
Absolute contraindication. (Human data usually available to support recommendations.) This drug should not be given to breast feeding mothers.
| Drug Name | Excretion Potential | Effect on Infant | Notes |
|---|---|---|---|
| Emtricitabine | Excreted.This drug is known to be excreted in human breast milk. | It is not known whether this drug has an adverse effect on the nursing infant. (No data or inconclusive human data) | Mfg does not recommend breastfeeding in hiv-positive women |
Experience in those 65 years of age or older is insufficient to determine whether they respond differently to emtricitabine than younger adults. Dosage should be selected with caution because of age-related decreases in hepatic, renal, and/or cardiac function and potential for concomitant disease and drug therapy.
Precaution Exists
Geriatric management or monitoring precaution exists.
Precaution Exists
Geriatric management or monitoring precaution exists.
| Drug Name | Narrative | REN | HEP | CARDIO | NEURO | PULM | ENDO |
|---|---|---|---|---|---|---|---|
| Emtricitabine | Renal- Adhere to manufacturer guidelines for renal impairment and lower CrCL. | Y | Y | N | N | N | N |
The following prioritized warning is available for EMTRICITABINE (emtricitabine):
WARNING: This medication is not approved for the treatment of hepatitis B virus infection. If you have hepatitis B infection in addition to HIV, your hepatitis symptoms may get worse or become very serious if you stop taking emtricitabine. Talk with your doctor before stopping this medication.
Your doctor will perform liver function tests for several months after you stop emtricitabine. Tell your doctor right away if you develop symptoms of worsening liver problems.
WARNING: This medication is not approved for the treatment of hepatitis B virus infection. If you have hepatitis B infection in addition to HIV, your hepatitis symptoms may get worse or become very serious if you stop taking emtricitabine. Talk with your doctor before stopping this medication.
Your doctor will perform liver function tests for several months after you stop emtricitabine. Tell your doctor right away if you develop symptoms of worsening liver problems.
The following icd codes are available for EMTRICITABINE (emtricitabine)'s list of indications:
| HIV infection | |
| B20 | Human immunodeficiency virus [HIv] disease |
| B97.35 | Human immunodeficiency virus, type 2 [HIV 2] as the cause of diseases classified elsewhere |
| O98.7 | Human immunodeficiency virus [HIv] disease complicating pregnancy, childbirth and the puerperium |
| O98.71 | Human immunodeficiency virus [HIv] disease complicating pregnancy |
| O98.711 | Human immunodeficiency virus [HIv] disease complicating pregnancy, first trimester |
| O98.712 | Human immunodeficiency virus [HIv] disease complicating pregnancy, second trimester |
| O98.713 | Human immunodeficiency virus [HIv] disease complicating pregnancy, third trimester |
| O98.719 | Human immunodeficiency virus [HIv] disease complicating pregnancy, unspecified trimester |
| O98.72 | Human immunodeficiency virus [HIv] disease complicating childbirth |
| O98.73 | Human immunodeficiency virus [HIv] disease complicating the puerperium |
| Z21 | Asymptomatic human immunodeficiency virus [HIv] infection status |
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