Skip to Content

Tisagenlecleucel Pregnancy and Breastfeeding Warnings

Tisagenlecleucel is also known as: Kymriah

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.

Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective, or appropriate for any given patient. Multum Information Services, Inc. does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. Copyright 2000-2008 Multum Information Services, Inc. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.