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Mogamulizumab Pregnancy and Breastfeeding Warnings

Mogamulizumab is also known as: Poteligeo

Medically reviewed by Drugs.com. Last updated on Nov 15, 2018.

Mogamulizumab Pregnancy Warnings

Animal studies from the start of organogenesis through delivery did not show a potential for adverse developmental outcomes at maternal systemic exposures 27 times the exposure in human patients at the recommended dose.

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.

Use should be avoided.

US FDA pregnancy category: Not assigned.

Comments:
-Adequate methods of contraception should be encouraged during therapy and for at least 6 months after treatment.
-IgG is known known to cross the placental barrier and was detected in fetal plasma in animal studies; therefore, this drug has the potential to be transmitted from the mother to the developing fetus.

See references

Mogamulizumab Breastfeeding Warnings

Safety has not been established.

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

Comments:
-The effects in the nursing infant are unknown.
-Human IgGs are known to be excreted in breast milk during the first few days after birth, which decreases to low concentrations soon afterwards; therefore, a risk to the breast-fed child cannot be excluded during this short period.

See references

References for pregnancy information

  1. "Product Information. Poteligeo (mogamulizumab)." Kyowa Kirin, Inc, Bedminster, NJ.

References for breastfeeding information

  1. "Product Information. Poteligeo (mogamulizumab)." Kyowa Kirin, Inc, Bedminster, NJ.

Further information

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