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Dolutegravir Pregnancy and Breastfeeding Warnings

Dolutegravir is also known as: Tivicay

Dolutegravir Pregnancy Warnings

Animal studies have failed to reveal evidence of adverse developmental outcomes at up to the highest dose tested in rats and rabbits; systemic exposures to this drug were less than (rabbits) and about 27 times (rats) the exposure in humans at the maximum recommended human dose. This drug was shown to cross the placenta in animal studies. There are no controlled data in human pregnancy. 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: Due to limited number of pregnancies exposed to dolutegravir-containing regimens reported to the APR, no final decisions regarding safety of this drug in pregnancy can be made. AU TGA pregnancy category B1: 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 not shown evidence of an increased occurrence of fetal damage. 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.

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus. AU TGA pregnancy category: B1 US FDA pregnancy category: Not assigned. Risk summary: Insufficient data available on use of this drug in pregnant women to inform a drug-related risk. Comments: -A pregnancy exposure registry is available.

See references

Dolutegravir Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug; if replacement feeding is not an option, a different drug may be preferred, particularly while breastfeeding newborn or preterm infants. 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.

Limited published data available regarding use during breastfeeding. An HIV-infected mother took a combination tablet (abacavir 600 mg/dolutegravir 50 mg/lamivudine 300 mg) once a day. Her breast milk dolutegravir levels over 10 months averaged about 10 mg/L at 11 hours after dosing; authors estimated an infant dose of 15 mcg/kg/day. During the period of exclusive nursing (up to about 30 weeks postpartum), her infant had a plasma dolutegravir level of 10 mg/L; as supplemental food was introduced, plasma levels declined to about 0.3 mg/L at 35 weeks and to zero with no nursing after about 50 weeks postpartum. With exclusive nursing for about 30 weeks and partial nursing for about 20 weeks, the infant showed no obvious side effects.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Tivicay (dolutegravir)." ViiV Healthcare, Research Triangle Park, NC.

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. HHS Panel on Treatment of HIV-Infected Pregnant Women and Prevention of Perinatal Transmission — A Working Group of the Office of AIDS Research Advisory Council (OARAC) "Recommendations for Use of Antiretroviral Drugs in Pregnant HIV-1-Infected Women for Maternal Health and Interventions to Reduce Perinatal HIV Transmission. Available from: URL:" ([2017, Oct 05]):
  4. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL:" ([cited 2013 -]):
  5. "Product Information. Tivicay (dolutegravir)." ViiV Healthcare, Research Triangle Park, NC.
  6. "Infant feeding and transmission of human immunodeficiency virus in the United States." Pediatrics 131 (2013): 391-6

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