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Daratumumab Pregnancy and Breastfeeding Warnings

Daratumumab is also known as: Darzalex

Medically reviewed on June 22, 2017

Daratumumab Pregnancy Warnings

No animal or human studies have been conducted with this drug. Immunoglobulin G1 (IgG1) monoclonal antibodies are transferred across the placenta. Based on its mechanism of action, this drug may cause fetal myeloid or lymphoid-cell depletion and decreased bone density.

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.

Safety has not been established during pregnancy.

US FDA pregnancy category: Not assigned

Comments:
-IgG1 monoclonal antibodies cross the placenta after the first trimester of pregnancy; therefore, this drug should not be used during pregnancy unless the benefit of treatment to the woman is considered to outweigh the potential risks to the fetus.
-If the patient becomes pregnant while taking this medicine, the patient should be informed of the potential risk to the fetus.
-Women of reproductive potential should use effective contraception during treatment and for 3 months after cessation of treatment.
-Administration of live vaccines to neonates and infants exposed to this drug in utero should be deferred until a hematology evaluation is completed.

See references

Daratumumab Breastfeeding Warnings

Safety has not been established.

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

There is no information regarding the presence of this drug in human milk, the effects on the breastfed infant, or the effects on milk production. Human IgG is known to be present in human milk. Data suggest antibodies in breast milk do not enter the neonatal and infant circulations in substantial amounts.

See references

References for pregnancy information

  1. "Product Information. Darzalex (daratumumab)." Janssen Biotech, Inc., Horsham, PA, PA.

References for breastfeeding information

  1. "Product Information. Darzalex (daratumumab)." Janssen Biotech, Inc., Horsham, PA, PA.

Further information

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

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