Gilteritinib Pregnancy and Breastfeeding Warnings

Brand names: Xospata

Medically reviewed by Drugs.com. Last updated on Aug 10, 2023.

Gilteritinib Pregnancy Warnings

Use should be avoided.

US FDA pregnancy category: Not assigned.

Risk Summary: Administration of this drug to pregnant animals during organogenesis caused adverse developmental outcomes including embryofetal lethality, suppressed fetal growth, and teratogenicity at maternal exposures approximately 0.4 times the recommended human dose. There are no controlled data in human pregnancy.

Comments:
-Females of reproductive potential should use effective contraception during therapy and for at least 6 months after.
-Males with female partners of reproductive potential should use effective contraception during therapy and for at least 4 months after.
-Male and female patients should be apprised of the potential risk to the fetus.
-Verify negative pregnancy status in females of reproductive potential prior to initiating therapy.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.

Animal studies at exposures approximately 0.4 times the recommended human dose included decreased body weight and food consumption in the mother and embryofetal death (postimplantation loss), decreased fetal body and placental weight, and decreased numbers of ossified sternebrae and sacral and caudal vertebrae, and increased incidence of fetal gross external (anasarca, local edema, exencephaly, cleft lip, cleft palate, short tail, umbilical hernia), visceral (microphthalmia; atrial and/or ventricular defects; and malformed/absent kidney, and malpositioned adrenal, and ovary), and skeletal (sternoschisis, absent rib, fused rib, fused cervical arch, misaligned cervical vertebra, and absent thoracic vertebra). There are no controlled data in human pregnancy. It is not known whether this drug can cause fetal harm or adversely affect reproductive capacity in humans.

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

Gilteritinib Breastfeeding Warnings

Use should be avoided.

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

Comments:
-Following administration of this drug to lactating animals, milk concentrations of radioactivity were higher than radioactivity in maternal plasma at 4 and 24 hours post-dose.
-Because of the potential for serious adverse reactions in a breastfed child, women should not breastfeed during therapy and for 2 months after.

See references

Further information

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