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Emtricitabine / rilpivirine / tenofovir Pregnancy and Breastfeeding Warnings

Emtricitabine / rilpivirine / tenofovir is also known as: Complera

Emtricitabine / rilpivirine / tenofovir Pregnancy Warnings

Use is recommended only if clearly needed and the benefit outweighs the risk to the fetus. AU TGA pregnancy category: B3 US FDA pregnancy category: B Comments: Effective contraception recommended during therapy; local protocol should be consulted regarding contraception timing.

Animal studies have failed to reveal evidence of embryofetal toxicity, reproductive toxicity, or teratogenicity; placental transfer was observed with rilpivirine. There are no controlled data in human pregnancy. To monitor maternal-fetal outcomes of pregnant women exposed to antiretroviral therapy, an Antiretroviral Pregnancy Registry has been established. Healthcare providers are encouraged to prospectively register patients. For additional information: apregistry.com 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.

Emtricitabine / rilpivirine / 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.

Breastfeeding is not recommended during use of this drug; if replacement feeding is not an option, a different drug may be preferred. Excreted into human milk: Unknown (rilpivirine); Yes (emtricitabine, tenofovir) Excreted into animal milk: Yes (rilpivirine) 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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