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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 did not show a potential for adverse developmental outcomes at maternal systemic exposures 27 times the exposure in patients at the recommended dose. There are no controlled data in human pregnancy. It is not known whether this drug can cause fetal harm or adversely affect reproductive capacity in humans.

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 is not recommended.

US FDA pregnancy category: Not assigned.

Risk Summary: 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. 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.

Comments: Adequate methods of contraception should be encouraged.

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.

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.

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