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Naxitamab Pregnancy and Breastfeeding Warnings

Naxitamab is also known as: Danyelza

Naxitamab Pregnancy Warnings

There are no available data on the use of this drug in animal reproduction studies. There are no controlled data in human pregnancy.

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: Based on its mechanism of action, this drug may cause fetal harm when administered to pregnant women. IgG1 monoclonal antibodies are transported across the placenta in a linear fashion as pregnancy progresses, with the largest amount transferred during the third trimester.

Comments:
-Adequate methods of contraception should be encouraged.
-Verify negative pregnancy status in females of reproductive potential prior to initiating therapy.
-Advise females of reproductive potential to use effective contraception during therapy and for 2 months after.
-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.

See references

Naxitamab Breastfeeding Warnings

Use is not recommended.

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

Comments:
-There are no data on the presence of this drug in human milk or its effects on the breastfed child, or on milk production; however, human IgG is present in human milk.
-Because of the potential for serious adverse reactions in a breastfed, women should not breastfeed during therapy and for 2 months after.

See references

References for pregnancy information

  1. "Product Information. Danyelza (naxitamab)." Y-mAbs Therapeutics, New York, NY.

References for breastfeeding information

  1. "Product Information. Danyelza (naxitamab)." Y-mAbs Therapeutics, New York, NY.

Further information

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