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Emtricitabine / tenofovir Pregnancy and Breastfeeding Warnings

Emtricitabine / tenofovir is also known as: AccessPak for HIV PEP Basic, Truvada

Emtricitabine / tenofovir Pregnancy Warnings

Animal studies have failed to reveal evidence of embryofetal toxicity or teratogenicity. There are no controlled data in human pregnancy. However, this drug has been evaluated in a limited number of women during pregnancy and postpartum. Available human data suggest this drug does not increase risk of major birth defects overall compared to background rate. To monitor maternal-fetal outcomes of pregnant women exposed to antiretroviral therapy, an Antiretroviral Pregnancy Registry (APR) has been established. Healthcare providers are encouraged to prospectively register patients. For additional information: As of July 2011, the APR has received prospective reports of 764 and 1219 exposures to emtricitabine- and tenofovir-containing regimens, respectively, in the first trimester, 321 and 455 exposures, respectively, in second trimester, and 140 and 257 exposures, respectively, in the third trimester. Birth defects occurred in 18 of 764 (2.4%) live births for emtricitabine-containing regimens and 27 of 1219 (2.2%) live births for tenofovir-containing regimens with first trimester exposure and 10 of 461 (2.2%) live births for emtricitabine-containing regimens and 15 of 712 (2.1%) live births for tenofovir-containing regimens with second or third trimester exposure. Among pregnant women in the US reference population, the background rate of birth defects is 2.7%. There was no association between emtricitabine or tenofovir and overall birth defects observed in the APR. AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans. US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

HIV: This drug should be used during pregnancy only if clearly needed. Preexposure Prophylaxis: If an uninfected individual becomes pregnant while using this drug, continued use should be carefully considered, taking into account the potential increased risk of HIV-1 infection during pregnancy. AU TGA pregnancy category: B3 FDA pregnancy category: B

Emtricitabine / tenofovir Breastfeeding Warnings

Samples of breast milk obtained from 5 HIV-1-infected women show that emtricitabine is secreted in human milk. Average peak and trough drug levels in breast milk were 679 and 177 mcg/L, respectively. An exclusively breastfed infant would receive about 2% of the proposed emtricitabine dose for infants (estimated). Breastfeeding infants whose mothers are treated with emtricitabine may be at risk for developing viral resistance to emtricitabine. Other emtricitabine-associated risks in such infants are unknown. Samples of breast milk obtained from 5 HIV-1-infected mothers show that tenofovir is secreted in human milk. Average peak and trough drug levels in breast milk were 14.1 and 6.8 mcg/L, respectively. An exclusively breastfed infant would receive about 0.03% of the proposed tenofovir dose for infants (estimated) and attain trivial infant serum levels. The impact of this exposure in infants breastfed by mothers treated with tenofovir is unknown. Breast milk samples were obtained at various times postpartum from mothers who received a single 600 or 900 mg tenofovir dose during labor. Tenofovir was detected (greater than 2.5 mcg/L) in 75% of samples collected from 25 mothers during the first 2 days postpartum; levels ranged from 6.3 to 17.8 mcg/L. At 4 to 6 days postpartum, only 1 of 21 milk samples had detectable drug level (15.7 mcg/L). Serum tenofovir levels were measured in 5 exclusively breastfed infants whose mothers were treated with tenofovir 245 mg daily; infant age averaged 1.8 months. The drug was undetectable (less than 0.005 mg/L) in the serum of 4 infants; serum level was 0.0055 mg/L in 1 infant. No adverse outcomes on standard developmental parameters were observed in two 4-month-old infants whose mothers were treated with tenofovir 245 mg daily; the infants were exclusively breastfed for 3 months.

Breastfeeding is not recommended during use of this drug. If replacement feeding is not an option, the WHO recommends a triple-drug regimen for HIV-infected women who are nursing; both drugs are included in the first-choice regimen. Excreted into human milk: Yes Comments: -The effects in the nursing infant are unknown. -The US CDC, American Academy of Pediatrics, and manufacturer advise HIV-infected women not to breastfeed to avoid postnatal transmission of HIV to a child who may not yet be infected. -Local guidelines should be consulted if replacement feeding is not an option.

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