Based on findings in animals, male fertility may be compromised with the use of this drug. Cytarabine can cause fetal harm if a pregnant woman is exposed to it. 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.

In animals, administration of a liposomal formulation of daunorubicin produced severe maternal toxicity and embryo lethality at doses of 2.0 mg/kg/day and was embryotoxic (increased embryo-fetal deaths, reduced numbers of litters, and reduced litter sizes) and caused fetal malformations (anophthalmia, microphthalmia, incomplete ossification) at doses of 0.3 mg/kg/day.

Cytarabine was teratogenic in mice (cleft palate, phocomelia, deformed appendages, skeletal abnormalities) at doses more than or equal to 2 mg/kg/day when administered intraperitoneally (IP) during the period of organogenesis, and in rats (deformed appendages) at doses of 20 mg/kg when administered as a single IP dose on day 12 of gestation. Reduced prenatal and postnatal brain size and permanent impairment of learning ability occurred at single IP doses of 50 mg/kg on day 14 of gestation. Cytarabine was embryotoxic in mice when administered during the period of organogenesis.

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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.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

This combination drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned.

Risk Summary:
Daunorubicin and cytarabine can cause embryofetal harm when administered to a pregnant woman.

Comments:
-Verify the pregnancy status of females of reproductive potential prior to initiating therapy with this combination drug.
-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.
-Cardiologic examination and a blood count are recommended in fetuses and newborns born to mothers who received treatment with this drug during pregnancy.

See references

Use should be avoided.

Excreted into human milk: Data not available
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