Daratumumab Pregnancy and Breastfeeding Warnings

Brand names: Darzalex

Daratumumab Pregnancy Warnings

Safety has not been established during pregnancy.

AU TGA pregnancy category: C
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 therapy and for 3 months after cessation of therapy; however, when this drug is used in combination with lenalidomide and dexamethasone, patients should also
follow advice about use in pregnancy of those products.
-Administration of live vaccines to neonates and infants exposed to this drug in utero should be deferred until a hematology evaluation is completed.

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.

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.

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.

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Daratumumab Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

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

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

No information is available on the use of this drug during breastfeeding. Because it 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. Until more data become available, this drug should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant.

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Further information

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

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