Bimekizumab Pregnancy and Breastfeeding Warnings

Brand names: Bimzelx

Bimekizumab Pregnancy Warnings

Safety has not been established during pregnancy
-According to some authorities: this drug should be avoided during pregnancy as a precautionary measure.

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

Risk summary: Inconclusive data available on the use of this drug in pregnant women to inform a drug-related risk.

Comments:
-Human IgG antibody crosses the placenta as pregnancy progresses and peaks during the third trimester; therefore, it can be transmitted from the mother to the developing fetus.
-The use of this drug during pregnancy may affect neonatal immunity due to its mechanism of action and this drug should be used if the benefits outweigh the potential risks.
-Women of childbearing potential should use an effective method of contraception during treatment and for at least 17 weeks after.
-A pregnancy exposure registry is available.

Animal studies have failed to reveal evidence of teratogenicity and maternal toxicity. When administered to cynomolgus monkeys throughout organogenesis until parturition at maternal doses up to 38 times the human exposure, there were no adverse developmental effects observed. There were effects on fertility parameters observed in sexually mature cynomolgus monkeys when administered this drug. There are no controlled data in human pregnancy.

This drug may interfere with an infant's immune response to infections; therefore, risks and benefits should be considered prior to administering live vaccines to infants exposed to this drug in utero. A minimum of 4 months after birth should be considered because of the half-life of the product.

To monitor the outcomes of pregnant women exposed to this drug, a pregnancy registry has been established. Health care providers or patients can contact the Organization of Teratology Information Specialists (OTIS) Autoimmune Disease Study at http://mothertobaby.org/pregnancy-studies/.

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

Bimekizumab Breastfeeding Warnings

Safety has not been established.

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

Comments:
-There are no data on the presence of this drug, its effects on the breastfed infant, or the effects on milk production.
-Caution is recommended when administering this drug to breastfeeding women as immunoglobulins can be excreted in human milk.
-Some authorities report that a risk to the infant cannot be excluded.
-The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this drug and potential adverse effects on the infant.

See references

Further information

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

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