Epcoritamab Pregnancy and Breastfeeding Warnings

Brand names: Epkinly

Epcoritamab Pregnancy Warnings

Use is not recommended in pregnant patients or patients of childbearing potential not using contraception.

AU TGA pregnancy category: C
US FDA pregnancy category: Not assigned

Risk summary: Based on mechanism of action, this drug may cause fetal harm (including B-cell lymphocytopenia and alterations in normal immune responses) when used during pregnancy; no data are available on the use of this drug in pregnant women to inform a drug-related risk.

Comments:
-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.
-Pregnancy status of patients of childbearing potential should be verified before starting this drug; these patients should be advised to use effective contraception during therapy and for at least 4 months after the last dose.
-Human immunoglobulin G crosses the placenta; therefore, this drug may be transmitted from the mother to the developing fetus.
-This drug causes T-cell activation and cytokine release; immune activation may compromise pregnancy maintenance.
---Drug-induced cytokine release may present a risk for embryofetal loss.
-Based on expression of CD20 on B-cells and the finding of B-cell depletion in nonpregnant animals, B-cell lymphocytopenia can occur in infants exposed to this drug in utero.
---Fetal B-cell depletion creates a risk of opportunistic infections in neonates.
-According to some authorities: Vaccination with live or live-attenuated vaccines should be postponed for neonates and infants exposed to this drug in utero until recovery of B-cell levels.

Animal studies have not been reported. There are no controlled data in human pregnancy.

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.

See references

Epcoritamab Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug and for at least 4 months after the last dose.

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

Comments:
-No information is available on the use of this drug during breastfeeding.
-The effects in the nursing infant are unknown; there is the potential for serious adverse reactions.
-Because maternal immunoglobulin G is present in human milk, absorption of this drug may occur in a breastfed child.

Because this drug is a large protein molecule (molecular weight about 149 kilodaltons), the amount in milk is likely to be very low. It is also likely to be partially destroyed in the infant's gastrointestinal tract; absorption by the infant is probably minimal.

See references

Further information

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

Medical Disclaimer