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.
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.
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.
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 also
References for pregnancy information
- Cerner Multum, Inc. "UK Summary of Product Characteristics."
- Cerner Multum, Inc. "Australian Product Information."
- (2009) "Product Information. Ilaris (canakinumab)." Novartis Pharmaceuticals
References for breastfeeding information
- Cerner Multum, Inc. "UK Summary of Product Characteristics."
- Cerner Multum, Inc. "Australian Product Information."
- (2009) "Product Information. Ilaris (canakinumab)." Novartis Pharmaceuticals
- United States National Library of Medicine (2013) Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Further information
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