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Sipuleucel-T Pregnancy and Breastfeeding Warnings

Sipuleucel-T is also known as: Provenge

Sipuleucel-T Pregnancy Warnings

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.

The manufacturer makes no recommendation regarding use during pregnancy; this drug is not indicated for use in female patients. US FDA pregnancy category: Not Assigned Comments: The manufacturer product information indicates studies on the effects of fertility have not been conducted.

See references

Sipuleucel-T Breastfeeding Warnings

The manufacturer makes no recommendation regarding use during lactation; this drug is not indicated for use in female patients. Excreted into human milk: Unknown Excreted into animal milk: Unknown

See references

References for pregnancy information

  1. "Product Information. Provenge (sipuleucel-T)." Dendreon Corporation, Seattle, WA.

References for breastfeeding information

  1. "Product Information. Provenge (sipuleucel-T)." Dendreon Corporation, Seattle, WA.

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