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Ibalizumab Pregnancy and Breastfeeding Warnings

Ibalizumab is also known as: Trogarzo

Medically reviewed by Drugs.com. Last updated on Mar 27, 2018.

Ibalizumab Pregnancy Warnings

Animal studies have not been reported. Monoclonal antibodies (such as this drug), are transported across the placenta as pregnancy progresses; this drug may potentially be transferred from the mother to the developing fetus. 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

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: No adequate 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

Ibalizumab Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-Human IgG is present in human milk; published data indicate antibodies in breast milk do not enter neonatal or infant circulation system in substantial amounts.
-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.

See references

References for pregnancy information

  1. "Product Information. Trogarzo (ibalizumab)." Theratechnologies Inc., Montreal, ON.

References for breastfeeding information

  1. "Infant feeding and transmission of human immunodeficiency virus in the United States." Pediatrics 131 (2013): 391-6
  2. "Product Information. Trogarzo (ibalizumab)." Theratechnologies Inc., Montreal, ON.

Further information

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

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