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.20 1 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 dose was well tolerated and was not associated with any safety issues. Systemic exposure (area under the plasma concentration-time curve [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); efficacy of
emtricitabine for the prevention or treatment of HIV was not determined.
American Society of Health-System Pharmacists 2013; Drug Information 2013. Bethesda, MD. 2013, p. 703
Lactic acidosis and severe hepatomegaly with steatosis, including fatalities, have been reported in patients receiving nucleoside reverse transcriptase inhibitors (NRTIs), including
emtricitabine, in conjunction with other antiretroviral agents. Most reported cases have involved women; obesity and long-term therapy with a nucleoside analog also may be risk factors.
American Society of Health-System Pharmacists 2013; Drug Information 2013. Bethesda, MD. 2013, p. 702
Caution should be observed when nucleoside reverse transcriptase inhibitors are used in patients with known risk factors for liver disease; however, lactic acidosis and severe hepatomegaly with steatosis have been reported in patients with no known risk factors.
Emtricitabine therapy should be interrupted in any patient with clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity (signs of hepatotoxicity include hepatomegaly and steatosis even in the absence of marked increases in serum aminotransferase concentrations).
American Society of Health-System Pharmacists 2013; Drug Information 2013. Bethesda, MD. 2013, p. 702
Prior to initiation of
emtricitabine therapy for the treatment of HIV-1 infection, patients should be tested for chronic hepatitis B virus (HBV).
Emtricitabine is not indicated for the treatment of chronic HBV infection; safety and efficacy of the drug have not been established in patients with coexisting HBV and HIV infections. Exacerbations of HBV infection have been reported in HIV-infected patients following discontinuance of
emtricitabine. Patients with HBV infection and HIV infection should be closely monitored with clinical and laboratory follow-up for at least several months after stopping
emtricitabine therapy.
American Society of Health-System Pharmacists 2013; Drug Information 2013. Bethesda, MD. 2013, p. 702
Redistribution or accumulation of body fat, including central obesity, dorsocervical fat enlargement ("buffalo hump"), peripheral wasting, breast enlargement, and general cushingoid appearance noted in patients receiving antiretroviral therapy.
American Society of Health-System Pharmacists 2013; Drug Information 2013. Bethesda, MD. 2013, p. 702
Emtricitabine is distributed into human milk in low concentrations. Because of the risk of adverse effects in the infant and the risk of HIV transmission, HIV-infected women should not breast-feed infants.
American Society of Health-System Pharmacists 2013; Drug Information 2013. Bethesda, MD. 2013, p. 703
Experience in those 65 years of age or older insufficient to determine whether they respond differently than younger adults. Use caution in dosage selection; the greater frequency of decreased hepatic, renal, and/or cardiac function and of concomitant disease or drug therapy observed in geriatric individuals should be considered.
American Society of Health-System Pharmacists 2013; Drug Information 2013. Bethesda, MD. 2013, p. 703
The most common adverse effects in adults receiving
emtricitabine in conjunction with other antiretrovirals are mild to moderate headache, diarrhea, nausea, and rash. Adverse effects reported in children 3 months to 21 years of age receiving
emtricitabine in clinical studies have been similar to those in adults, with the exception of a higher frequency of hyperpigmentation.
American Society of Health-System Pharmacists 2013; Drug Information 2013. Bethesda, MD. 2013, p. 703
FDA Pregnancy Risk Category: B /NO EVIDENCE OF RISK IN HUMANS. Adequate, well controlled studies in pregnant women have not shown increased risk of fetal abnormalities despite adverse findings in animals, or, in the absence of adequate human studies, animal studies show no fetal risk. The chance of fetal harm is remote but remains a possibility./
American Society of Health-System Pharmacists 2013; Drug Information 2013. Bethesda, MD. 2013, p. 703
Antiretroviral therapy is not a cure for HIV infection, and oppertunistic infection still may occur. HIV transmission durring sexual contact or sharing needles is not prevented by antiretrovirals.
American Society of Health-System Pharmacists 2013; Drug Information 2013. Bethesda, MD. 2013, p. 704
Obesity or prolonged nucleoside exposure may be risk factors for lactic acidosis/severe hepatomegaly with steatosis. Cases have been reported with the use of nucleoside analogues alone or in combination with other antiretrovirals; a majority of these cases have been in women and cases have been reported with no known risk factors.
Thomson.Micromedex. Drug Information for the Health Care Professional. 25th ed. Volume 1. Plus Updates. Content Reviewed by the United States Pharmacopeial Convention, Inc. Greenwood Village, CO. 2005., p. 1266
/Adverse effects occurring at an /incidence less frequent include: Abdominal pain; abnormal dreams; arthralgia (pain in the joints; muscle pain stiffness; difficulty in moving); depressive disorders; dizziness; dyspepsia (acid or sour stomach; belching; heartburn; indigestion; stomach discomfort, upset or pain); insomnia (sleeplessness; trouble sleeping; unable to sleep); myalgia (joint pain; swollen joints; muscle aching or cramping; muscle pains or stiffness); neuritis (numbness or tingling of hands, feet, or face); paresthesia (burning, crawling, itching, numbness, prickling, pins and needles, or tingling feelings); peripheral neuropathy; rash and vomiting.
Thomson.Micromedex. Drug Information for the Health Care Professional. 25th ed. Volume 1. Plus Updates. Content Reviewed by the United States Pharmacopeial Convention, Inc. Greenwood Village, CO. 2005., p. 1267
FDA approved a REMS for
emtricitabine to ensure that the benefits outweigh the risk. The REMS may apply to one or more preparations of
emtricitabine and consists of the following: medication guide and elements to assure safe use.
American Society of Health-System Pharmacists 2013; Drug Information 2013. Bethesda, MD. 2013, p. 699