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: Insufficient data is available on the use of this drug in pregnant women to inform a drug-related risk.

Comments:
-This drug is transferred across the placenta in humans, especially in the third trimester, and it may cause immunosuppression in in-utero exposed infants.
-It is not known whether this drug can cause fetal harm or adversely affect reproductive capacity in humans.
-Advise female patients of the potential risk to a fetus.
-Women should use effective contraception during therapy and for 3 months after the last dose.
-Live vaccines should be avoided in newborns exposed to this drug in-utero for 16 weeks after the mother's last dose before childbirth.
-Advice women who took this drug during pregnancy to inform about it to their baby's healthcare provider before newborn's vaccinations.

Animal studies have failed to reveal evidence of embryotoxicity or teratogenicity when administered throughout organogenesis. However, some delays in fetal skeletal development were observed in marmoset monkeys and mice following prenatal
exposure to this drug at concentrations approximately 11 times the MRHD and greater. These delays were changes from the expected ossification state in an otherwise normal bone and were generally reversible or transitory and not detrimental to postnatal survival. There are insufficient controlled data in human pregnancy.

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.

See references

Canakinumab Breastfeeding Warnings

Caution is recommended.
-According to some authorities: Benefit should outweigh risk.
-According to some authorities: Breastfeeding is not recommended during use of this drug.

Excreted into human milk: Yes

Comments:
-No information is available on the clinical use of this drug during breastfeeding.
-Maternal immunoglobulin G is known to be present in human milk.
-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 gastrointestinal tract.
-Developmental and health benefits of breastfeeding should be considered, as well as the mother's clinical need for this drug.
-The effects in the breastfed infant are unknown; potential adverse effects in the breastfed infant due to this drug or the mother's underlying condition should be considered.

See references

Further information

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