Canakinumab Pregnancy and Breastfeeding Warnings

Brand names: Ilaris

Medically reviewed by Drugs.com. Last updated on Aug 16, 2023.

Canakinumab Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk.

AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned.

Risk Summary: Available human data the use of this drug in pregnancy are insufficient to identify a drug-associated risk of major birth defects, miscarriage, and adverse maternal or fetal outcomes. Like other monoclonal antibodies, it is actively transported across the placenta mainly during the third trimester of pregnancy and may cause immunosuppression in the in utero exposed infant.

This drug did not cause maternal toxicity, embryotoxicity, or teratogenicity in animal studies when administered throughout organogenesis. There are no controlled data in human pregnancy. It is not known whether this drug can cause fetal harm or adversely affect reproductive capacity in humans.

AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

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.

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Canakinumab Breastfeeding Warnings

Benefit should outweigh risk.

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

Comment:
-The effects in the nursing infant are unknown.

No information is available on the clinical use of this drug 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

Further information

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