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Tisagenlecleucel Pregnancy and Breastfeeding Warnings

Tisagenlecleucel is also known as: Kymriah

Medically reviewed on November 1, 2017

Tisagenlecleucel Pregnancy Warnings

Use is not recommended during pregnancy.

US FDA pregnancy category: Not Assigned

Comments:
-This drug may cause fetal toxicity, including B-cell lymphocytopenia, if the transduced cells cross the placenta; however, it is not known if this drug has the potential to be transferred to the fetus.
-Verify the pregnancy status of females with reproductive potential prior to treatment initiation, and encourage them to use effective contraception.
-Advise patients who are considering pregnancy after treatment to consult their healthcare providers.

No animal reproductive and developmental toxicity studies have been conducted. There are no controlled data on the effect of this drug in human pregnancy and fertility. Pregnancies that occur during treatment should be reported to Novartis Pharmaceuticals Corporation at 1-888-669-6682.

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

Tisagenlecleucel Breastfeeding Warnings

Safety has not been established.

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

Comments: The effects in the nursing infant and on milk production are unknown.

See references

References for pregnancy information

  1. "Product Information. Kymriah (tisagenlecleucel)." Novartis Pharmaceuticals, East Hanover, NJ.

References for breastfeeding information

  1. "Product Information. Kymriah (tisagenlecleucel)." Novartis Pharmaceuticals, East Hanover, NJ.

Further information

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

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