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Dolutegravir / rilpivirine Pregnancy and Breastfeeding Warnings

Dolutegravir / rilpivirine is also known as: Juluca

Medically reviewed on February 12, 2018

Dolutegravir / rilpivirine Pregnancy Warnings

Animal studies have failed to reveal evidence of adverse developmental outcomes with the components of this drug. Animal studies with dolutegravir showed no adverse effects on embryofetal development at up to the highest dose tested in rats and rabbits; systemic exposures to this component were less than (rabbits) and 38 times (rats) the exposure at the recommended human dose. Animal studies with rilpivirine showed no evidence of significant embryofetal toxicity at exposures 15 (rats) and 70 (rabbits) times higher than the exposure in humans at the recommended dose (25 mg/day). 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: apregistry.com

Insufficient prospective pregnancy data from APR to adequately assess risk of birth defects and miscarriage. Due to limited number of pregnancies exposed to dolutegravir-containing regimens, no final decisions regarding safety of dolutegravir in pregnancy can be made. The APR has received prospective reports of over 300 exposures to rilpivirine-containing regimens (over 200 exposed in the first trimester; over 100 exposed in the second/third trimester) resulting in live births; there was no difference between overall risk of birth defects for rilpivirine compared with the background birth defect rate of 2.7% in the reference population. The prevalence of birth defects in live births with first trimester and second/third trimester exposures to rilpivirine-containing regimens was 1.2% and 1.4%, respectively.

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.

The manufacturer makes no recommendation regarding use during pregnancy.

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 / rilpivirine Breastfeeding Warnings

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: Yes (dolutegravir); Unknown (rilpivirine)
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.

DOLUTEGRAVIR:
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.

RILPIVIRINE:
No published data available regarding use during breastfeeding.

See references

References for pregnancy information

  1. "Product Information. Juluca (dolutegravir-rilpivirine)." ViiV Healthcare, Research Triangle Park, NC.

References for breastfeeding information

  1. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  2. "Product Information. Juluca (dolutegravir-rilpivirine)." ViiV Healthcare, Research Triangle Park, NC.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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