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Daratumumab / hyaluronidase Pregnancy and Breastfeeding Warnings

Brand names: Darzalex Faspro

Medically reviewed by Drugs.com. Last updated on Oct 3, 2022.

Daratumumab / hyaluronidase Pregnancy Warnings

Use is not recommended.

US FDA pregnancy category: Not assigned.

Risk Summary: This drug can cause fetal harm when administered to a pregnant woman. It may cause depletion of fetal immune cells and decreased bone density.

Comments:
-Advise females of reproductive potential to use effective contraception during treatment and for 3 months after.
-If used with lenalidomide, refer to the lenalidomide labeling for additional recommendations for pregnancy.

No systemic exposure of hyaluronidase was detected in monkeys given 22,000 U/kg subcutaneously (12 times higher than the human dose) and there were no effects on embryofetal development in pregnant mice given 330,000 U/kg hyaluronidase subcutaneously daily during organogenesis, which is 45 times higher than the human dose.
There were no effects on pre- and post-natal development through sexual maturity in offspring of mice treated daily from implantation through lactation with 990,000 U/kg hyaluronidase subcutaneously, which is 134 times higher than the human doses.

See references

Daratumumab / hyaluronidase Breastfeeding Warnings

Caution is recommended.
-According to some authorities use is contraindicated.

Excreted into human milk: Unknown (daratumumab, hyaluronidase)
Excreted into animal milk: No

Comments:
-Human IgG is present in human milk but does not enter the neonatal and infant circulations in substantial amounts.
-There is potential for serious adverse reactions in the breastfed child when this drug is administered with lenalidomide and dexamethasone. Women should not breastfeed during treatment. Refer to lenalidomide prescribing information for additional information.

No information is available on the use of daratumumab 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.

See references

See also

References for pregnancy information

  1. (2020) "Product Information. Darzalex Faspro (daratumumab-hyaluronidase)." Janssen Biotech, Inc.

References for breastfeeding information

  1. United States National Library of Medicine (2013) Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
  2. (2020) "Product Information. Darzalex Faspro (daratumumab-hyaluronidase)." Janssen Biotech, Inc.

Further information

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