Sodium zirconium cyclosilicate Pregnancy and Breastfeeding Warnings

Brand names: Lokelma

Medically reviewed by Drugs.com. Last updated on Sep 21, 2023.

Sodium zirconium cyclosilicate Pregnancy Warnings

Use caution

US FDA pregnancy category: Not assigned

Risk Summary: This drug is not systemically absorbed following oral administration and therefore maternal use is not expected to result in fetal exposure.

Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. There are no controlled data in human pregnancy.

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

Sodium zirconium cyclosilicate Breastfeeding Warnings

Use is considered acceptable

Excreted into human milk: Not expected (not systemically absorbed)
Excreted into animal milk: Data not available

Comments: This drug is not absorbed systemically following oral administration and therefore breastfeeding is not expected to result in infant exposure.

See references

Further information

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