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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, reproductive toxicity, or teratogenicity. There are no controlled data in human pregnancy; however, emtricitabine-tenofovir DF has been evaluated in a limited number of women during pregnancy and postpartum. Available human data suggest emtricitabine-tenofovir DF does not increase risk of major birth defects overall compared to background rate; data in pregnant women (between 300 to 1000 outcomes) showed no malformations, fetotoxicity, or neonatal toxicity with emtricitabine and tenofovir DF. 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: apregistry.com The APR has received prospective reports of over 2900 exposures to emtricitabine-containing regimens (over 1900 exposed in the first trimester; over 900 exposed in the second/third trimester) and over 3800 exposures to tenofovir DF-containing regimens (over 2600 exposed in the first trimester; over 1200 exposed in the second/third trimester) resulting in live births; there was no difference between emtricitabine or tenofovir DF and overall birth defects compared with the background birth defect rate of 2.7% in the reference population. The prevalence of defects in the first trimester was 2.4% for emtricitabine and 2.3% for tenofovir DF. The prevalence of defects in the second/third trimester was 2.1% for emtricitabine and 2.1% for tenofovir DF. 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 Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out. 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.

Treatment of HIV Infection: This drug should be used during pregnancy only if clearly needed. Preexposure Prophylaxis: If an uninfected individual becomes pregnant while using emtricitabine-tenofovir disoproxil fumarate (DF), continued use should be carefully considered, taking into account the potential increased risk of HIV-1 infection during pregnancy. AU TGA pregnancy category: B3 US FDA pregnancy category: -Emtricitabine-tenofovir alafenamide: Not assigned. -Emtricitabine-tenofovir DF: B Risk summary (emtricitabine-tenofovir alafenamide): Insufficient data available on use of this drug in pregnant women to inform a drug-related risk of birth defects and miscarriage. Comments: -A pregnancy exposure registry is available.

See references

Emtricitabine / tenofovir Breastfeeding Warnings

EMTRICITABINE: 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. TENOFOVIR DF: 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. In a multicenter study, a single 600 or 900 mg tenofovir dose was administered to mothers during labor; samples of breast milk were collected at various times postpartum. In 75% of samples obtained from 25 mothers during the first 2 days postpartum, tenofovir was detected (greater than 2.5 mcg/L); levels ranged from 6.3 to 17.8 mcg/L. Only 1 of 21 milk samples had detectable tenofovir level (15.7 mcg/L) at 4 to 6 days postpartum. Tenofovir (dose not provided; presumed 300 mg/day), lamivudine, and efavirenz were administered daily (between 6 and 8 PM) for prevention of mother-to-child HIV transmission. At 1 month postpartum, milk samples were collected in the morning from 33 women; tenofovir level was 5 mcg/L (interquartile range [IQR]: 0 to 6.1 mcg/L). At 12 months postpartum, milk samples were collected in the morning from 47 women; tenofovir level was 2.5 mcg/L (IQR: 0 to 5.5 mcg/L). Blood samples were obtained from 25 of their breastfed infants; the morning infant plasma level of tenofovir at 6 and 12 months of age was 24 mcg/L (IQR: 0 to 51.6 mcg/L) and 0 mcg/L, respectively. Serum tenofovir levels were measured in 5 infants exclusively breastfed by 4 mothers using tenofovir 245 mg daily; infant age averaged 1.8 months. In 4 infants, serum tenofovir was undetectable (less than 0.005 mg/L); in 1 infant, the serum tenofovir was 0.0055 mg/L. At 4 months of age, no adverse outcomes (on standard developmental parameters) were observed in 2 of the infants 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; emtricitabine and tenofovir disoproxil fumarate (DF) are included in the first-choice regimen. Emtricitabine-tenofovir alafenamide: -Excreted into human milk: Yes (emtricitabine); Unknown (tenofovir alafenamide) -Excreted into animal milk: Unknown (tenofovir alafenamide) Emtricitabine-tenofovir DF: -Excreted into human milk: Yes (emtricitabine, tenofovir) Comments: -The effects in the nursing infant are unknown; potential for HIV-infected infants developing viral resistance and breastfed infants developing side effects similar to those in adults -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.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Interim Guidance for Clinicians Considering the Use of Preexposure Prophylaxis for the Prevention of HIV Infection in Heterosexually Active Adults." MMWR Morb Mortal Wkly Rep 61 (2012): 586-9
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. HHS Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission "Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States. Available from: URL: https://aidsinfo.nih.gov/contentfiles/lvguidelines/pe" ([2015 Aug 6]):
  5. "Product Information. Descovy (emtricitabine-tenofovir)." Gilead Sciences, Foster City, CA.
  6. Melbourne: Therapeutic Guidelines Limited "eTG complete [Online] Available from: URL: http://online.tg.org.au/complete/desktop/tgc.htm." ([2014, Nov -]):
  7. "Product Information. Truvada (emtricitabine-tenofovir)." Gilead Sciences, Foster City, CA.
  8. TGA. Therapeutic Goods Administration. Australian Drug Evaluation Committee "Prescribing medicines in pregnancy: an Australian categorisation of risk of drug use in pregancy. Available from: URL: http://www.tga.gov.au/docs/pdf/medpreg.pdf." ([1999]):

References for breastfeeding information

  1. "Product Information. Descovy (emtricitabine-tenofovir)." Gilead Sciences, Foster City, CA.
  2. HHS Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission "Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission in the United States. Available from: URL: https://aidsinfo.nih.gov/contentfiles/lvguidelines/pe" ([2015 Aug 6]):
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. Melbourne: Therapeutic Guidelines Limited "eTG complete [Online] Available from: URL: http://online.tg.org.au/complete/desktop/tgc.htm." ([2014, Nov -]):
  5. "Product Information. Truvada (emtricitabine-tenofovir)." Gilead Sciences, Foster City, CA.
  6. Cerner Multum, Inc. "Australian Product Information." O 0
  7. "Infant feeding and transmission of human immunodeficiency virus in the United States." Pediatrics 131 (2013): 391-6

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