Consists of emtricitabine, tenofovir disoproxil fumarate
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Emtricitabine and Tenofovir Tablets Pregnancy |
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Consists of emtricitabine, tenofovir disoproxil fumarate
Emtricitabine (Emtricitabine and Tenofovir Tablets) has a high level of transfer across the human placenta.
No increased risk of overall birth defects 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 delivery, stillbirth, 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 without HIV but who were exposed to ART in utero and develop significant organ system abnormalities of unknown etiology (particularly of the CNS or heart) should be evaluated for potential mitochondrial dysfunction. Cases of lactic acidosis and hepatic steatosis have been reported in pregnant women with use of nucleoside reverse transcriptase inhibitors (NRTIs).
The Health and Human Services (HHS) perinatal HIV guidelines consider Emtricitabine (Emtricitabine and Tenofovir Tablets) a preferred NRTI for pregnant females living 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, females who become pregnant while taking Emtricitabine (Emtricitabine and Tenofovir Tablets) may continue if viral suppression is effective and the regimen is well tolerated. The pharmacokinetics of Emtricitabine (Emtricitabine and Tenofovir Tablets) are not significantly altered during pregnancy and dosing adjustments are not needed.
The HHS perinatal HIV guidelines consider Emtricitabine (Emtricitabine and Tenofovir Tablets) with tenofovir disoproxil fumarate to be a preferred NRTI backbone for initial therapy in antiretroviral-naive pregnant females. The guidelines also consider Emtricitabine (Emtricitabine and Tenofovir Tablets) plus tenofovir disoproxil fumarate a recommended dual NRTI backbone in regimens for HIV/hepatitis B virus-coinfected pregnant females. Use caution with hepatitis B coinfection; hepatitis B flare may occur if Emtricitabine (Emtricitabine and Tenofovir Tablets) is discontinued. Emtricitabine (Emtricitabine and Tenofovir Tablets) is also a preferred component of an initial regimen when acute HIV infection is detected during pregnancy.
In general, ART is recommended for all pregnant females living with HIV to keep the viral load below the limit of detection and reduce the risk of perinatal transmission. Therapy should be individualized following a discussion of the potential risks and benefits of treatment during pregnancy. Monitoring of pregnant females is more frequent than in nonpregnant adults. ART should be continued postpartum for all females living with HIV and can be modified after delivery.
Health care providers are encouraged to enroll pregnant females exposed to antiretroviral medications as early in pregnancy as possible in the Antiretroviral Pregnancy Registry (1-800-258-4263 or http://www. APRegistry.com). Health care providers caring for pregnant females living with HIV and their infants may contact the National Perinatal HIV Hotline (888-448-8765) for clinical consultation (HHS [perinatal] 2019).
Samples of breast milk obtained from 5 HIV-1 infected women showed that Emtricitabine (Emtricitabine and Tenofovir Tablets) is secreted in human milk. Breastfeeding infants whose mothers are being treated with Emtricitabine (Emtricitabine and Tenofovir Tablets) may be at risk for developing viral resistance to Emtricitabine (Emtricitabine and Tenofovir Tablets). Other Emtricitabine (Emtricitabine and Tenofovir Tablets)-associated risks in such infants are unknown.
Emtricitabine (Emtricitabine and Tenofovir Tablets) is excreted into human milk. The effects in the nursing infant are unknown. The U.S. Public Health Service Centers for Disease Control and Prevention advise HIV-1 infected women not to breast-feed to avoid postnatal transmission of HIV-1 to a child who may not yet be infected. The manufacturer recommends that due to the potential for HIV-1 transmission and the potential for serious adverse reactions in nursing infants, mothers should not breastfeed while taking Emtricitabine (Emtricitabine and Tenofovir Tablets).
See references
Category B: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
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