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Cytarabine liposomal / daunorubicin liposomal Pregnancy and Breastfeeding Warnings

Cytarabine liposomal / daunorubicin liposomal is also known as: Vyxeos

Medically reviewed on September 15, 2017

Cytarabine liposomal / daunorubicin liposomal Pregnancy Warnings

Cytarabine can cause fetal harm if a pregnant woman is exposed to the drug. Major limb malformations have been reported in infants after their mothers received IV cytarabine, alone or in combination with other drugs, during the first trimester.

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.

This drug should be used during pregnancy only if the benefit outweighs the risk.

AU TGA pregnancy category: Not assigned.

Risk Summary: Daunorubicin and cytarabine can cause embryofetal harm when administered to a pregnant woman. These drugs were shown to be reproductive and developmental toxicants in animal studies, starting at a dose that was approximately 0.02 times the exposure in patients at the recommended human dose on mg/m2 basis.

Comments:
-This drug can harm a developing fetus.
-Advise patients not to become pregnant while receiving therapy.
-If this drug combination is used during pregnancy or if the patient becomes pregnant while taking this drug combination, apprise the patient of the potential risk to a fetus.
-Advise females and males of reproductive potential to use effective contraception during therapy and for 6 months following the last dose.

See references

Cytarabine liposomal / daunorubicin liposomal Breastfeeding Warnings

Use should be avoided.

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

Comments:
-Advise women not to breastfeed during therapy and for at least 2 weeks after the last dose.

See references

References for pregnancy information

  1. "Product Information. Vyxeos (cytarabine liposomal-daunorubicin liposomal)." Jazz Pharmaceuticals, Palo Alto, CA.

References for breastfeeding information

  1. "Product Information. Vyxeos (cytarabine liposomal-daunorubicin liposomal)." Jazz Pharmaceuticals, Palo Alto, CA.

Further information

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

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