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Daratumumab / hyaluronidase Pregnancy and Breastfeeding Warnings

Brand names: Darzalex Faspro

Medically reviewed by Last updated on Oct 3, 2022.

Daratumumab / hyaluronidase Pregnancy Warnings

Safety has not been established during pregnancy.

US FDA pregnancy category: Not assigned

Risk Summary: Based on its mechanism of action, this drug may cause depletion of fetal immune cells and decreased bone density. No data available on use of this drug in pregnant women to inform a drug-related risk.

-Use of this drug in combination with lenalidomide, thalidomide, or pomalidomide is contraindicated in pregnant women as it may cause birth defects and death of the unborn child.
-Immunoglobulin G1 (IgG1) monoclonal antibodies are transferred across the placenta.
-This drug can cause fetal harm when administered to a pregnant woman.
-Advise females of reproductive potential to use effective contraception during treatment and for 3 months after.
-Lenalidomide, thalidomide, and pomalidomide are only available through a Risk Evaluation and Mitigation Strategy (REMS) program.
-If used with lenalidomide, thalidomide, or pomalidomide, refer to the lenalidomide, thalidomide, or pomalidomide labeling for additional recommendations for pregnancy.

Animal studies with hyaluronidase did not detect systemic exposure 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 are no animal studies with daratumumab. 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.

See references

Daratumumab / hyaluronidase Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug.

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

-No information is available on the clinical use of this drug during breastfeeding.
-The effects in the nursing infant or on milk production are unknown.
-Human immunoglobulin G1 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 a breastfed child when this drug is administered with lenalidomide and dexamethasone. Women should not breastfeed during treatment. Refer to lenalidomide, thalidomide, or pomalidomide prescribing information for additional information.

No information is available on the use of daratumumab during breastfeeding. Because it is a large protein molecule (148,000 Da), the amount in milk is likely to be very low, and absorption is unlikely because it is probably destroyed in the infant gastrointestinal tract.

See references

References for pregnancy information

  1. (2020) "Product Information. Darzalex Faspro (daratumumab-hyaluronidase)." Janssen Biotech, Inc.
  2. (2022) "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.
  2. (2020) "Product Information. Darzalex Faspro (daratumumab-hyaluronidase)." Janssen Biotech, Inc.
  3. (2022) "Product Information. Darzalex Faspro (daratumumab-hyaluronidase)." Janssen Biotech, Inc.

Further information

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