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Moxetumomab pasudotox Pregnancy and Breastfeeding Warnings

Moxetumomab pasudotox is also known as: Lumoxiti

Medically reviewed by Drugs.com. Last updated on Oct 22, 2018.

Moxetumomab pasudotox Pregnancy Warnings

Use is not recommended.

US FDA pregnancy category: Not assigned.

Risk Summary: Based on animal studies and the mechanism of action, this drug can cause maternal and fetal harm when administered to a pregnant woman.

Comments:
-Adequate methods of contraception should be encouraged.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.

Animal reproduction or developmental toxicity studies have not been conducted with this drug. 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.

See references

Moxetumomab pasudotox Breastfeeding Warnings

Caution is recommended.

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

Comments:
-The effects in the nursing infant are unknown.

Because this drug is a large protein molecule, the amount in milk is likely to be very low and absorption is unlikely because it is probably destroyed in the infant GI tract. If this drug is required by the mother, it is not a reason to discontinue breastfeeding. Use with caution during breastfeeding, especially while nursing a newborn or preterm infant.

See references

References for pregnancy information

  1. "Product Information. Lumoxiti (moxetumomab pasudotox)." Astra-Zeneca Pharmaceuticals, Wilmington, DE.

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. Lumoxiti (moxetumomab pasudotox)." Astra-Zeneca Pharmaceuticals, Wilmington, DE.

Further information

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

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