Skip to Content

Raltegravir Pregnancy and Breastfeeding Warnings

Raltegravir is also known as: Isentress

Raltegravir Pregnancy Warnings

Animal studies have failed to reveal evidence of teratogenicity; an increased incidence of fetal supernumerary ribs was seen in offspring of rats at dose of 600 mg/kg/day (exposures about 3-fold the human value), but not at dose of 300 mg/kg/day in rats (exposures about 2-fold the human value) or at dose of 1000 mg/kg/day in rabbits (exposures about 4-fold the human value). Placental transfer to the fetus has been reported as high (cord blood/maternal delivery plasma drug ratio greater than 0.6); in 3 studies, cord blood/maternal plasma ratios were 1.5, 1.48 (range: 0.32 to 4.33), and 1.21. 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 The APR has received prospective reports of about 400 exposures to raltegravir-containing regimens. Too few first-trimester exposures to this drug (about 200) have been monitored to accurately calculate prevalence of birth defects in exposed cases. 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 C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

AU, UK: Use is not recommended. US: This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus. AU TGA pregnancy category: B3 US FDA pregnancy category: C Comments: -A pregnancy exposure registry is available.

See references

Raltegravir Breastfeeding Warnings

In rats administered 600 mg/kg/day, drug levels in milk were about 3-fold greater than maternal plasma drug levels.

Breastfeeding is not recommended during use of this drug. Excreted into human milk: Unknown Excreted into animal 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.

See references

References for pregnancy information

  1. 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/guidelines/html/3/perinatal-gui" ([2016, Jun 7]):
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Isentress (raltegravir)." Merck & Company Inc, West Point, PA.
  4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Isentress (raltegravir)." Merck & Company Inc, West Point, PA.
  4. "Infant feeding and transmission of human immunodeficiency virus in the United States." Pediatrics 131 (2013): 391-6
  5. 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/guidelines/html/3/perinatal-gui" ([2016, Jun 7]):

See Also...

Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and Drugs.com is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective, or appropriate for any given patient. Multum Information Services, Inc. does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. Copyright 2000-2008 Multum Information Services, Inc. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.

Hide