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Rilonacept Pregnancy and Breastfeeding Warnings

Medically reviewed by Last updated on Mar 22, 2023.

Rilonacept is also known as: Arcalyst

Rilonacept Pregnancy Warnings

Animal studies have revealed evidence of an increase in the number of stillbirths, an increased incidence of lumbar ribs, and one case of multiple fusion and absence of the ribs and thoracic vertebral bodies and arches. Increased maternal levels of interleukin (IL)-1Beta, which induces inflammation that occurs in Cryopyrin-Associated Periodic Syndromes may be associated with preterm birth.

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.

Use is not recommended.

US FDA pregnancy category: Not assigned.

-Based on animal studies, this drug can cause fetal harm.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.

See references

Rilonacept Breastfeeding Warnings

Caution is recommended.

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

Comments: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. Product Information. Arcalyst (rilonacept). Regeneron Pharmaceuticals Inc. 2008.

References for breastfeeding information

  1. Product Information. Arcalyst (rilonacept). Regeneron Pharmaceuticals Inc. 2008.

Further information

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