Efgartigimod alfa Pregnancy and Breastfeeding Warnings

Brand names: Vyvgart

Efgartigimod alfa Pregnancy Warnings

Benefit should outweigh risk.

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

Risk summary: There are no data on the use of this drug during pregnancy; animal data has not shown evidence of adverse developmental outcomes.

Comments:
-A pregnancy exposure registry is available.
-This drug may be transmitted from the mother to the developing fetus. Monoclonal antibodies are increasingly transported across the placenta as pregnancy progresses, with the largest amount transferred during the third trimester.
-Because this drug is expected to reduce maternal immunoglobulin G (IgG) antibody levels, a reduction in passive protection to the newborn is anticipated; risk and benefits should be considered prior to administering live or live attenuated vaccines to infants exposed to this drug in utero.

Animal studies have failed to reveal evidence of adverse effects on embryofetal development in either rat or rabbits with doses up to 10 times the recommended human dose administered during organogenesis. Administration to rats throughout gestation and lactation did not show adverse effects on pre- or postnatal development. There are no controlled data in human pregnancy.

To monitor the outcomes of pregnant women exposed to this drug, a pregnancy registry has been established. Health care providers and patients are encouraged to enroll in or obtain further information by visiting www.vyvgartpregnancy.com.

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

Efgartigimod alfa Breastfeeding Warnings

Caution is recommended; benefit should outweigh risk.

Excreted into human milk: Unknown
Excreted into animal milk: Unknown

Comments:
-There is no information available on the presence in human milk, the effects on the breastfed infant, or the effects on milk production; maternal immunoglobulin G (IgG) is known to be present in human milk.
-Being a large protein molecule (54,000 Da), the amount in milk is likely to be very low and is likely to be partially destroyed in the infant's gastrointestinal tract with minimal absorption.
-Use with caution during breastfeeding, especially while nursing a newborn or preterm infant. Waiting for at least 2 weeks postpartum to resume therapy may minimize the risk of transfer to the infant.
-Developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this drug and any potential adverse effects on the breastfed infant from this drug or from the underlying maternal condition.

See references

Further information

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

Medical Disclaimer