Pralsetinib Pregnancy and Breastfeeding Warnings

Brand names: Gavreto

Medically reviewed by Drugs.com. Last updated on Oct 9, 2023.

Pralsetinib Pregnancy Warnings

Use should be avoided.
-According to some authorities: Use is not recommended unless clearly needed.

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

Risk Summary: No data available on use of this drug in pregnant women to inform a drug-related risk. Based on findings from animal studies and its mechanism of action, this drug may cause fetal harm when administered to a pregnant woman.

Comments:
-Pregnancy status should be verified 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.
-Females of reproductive potential should use effective non-hormonal contraception during therapy and for 2 weeks after. This drug may render hormonal contraceptives ineffective.
-Male patients with female partners of reproductive potential should use effective contraception during therapy and for 1 week after the final dose.
-This drug may impair fertility. Advise patients to seek advice on effective fertility preservation prior to starting therapy.

Animal studies have revealed 100% post-implantation loss at dose levels approximately 1.8 times the human exposure. Post-implantation loss also occurred at dose levels approximately 0.6 times the estimated human exposure. Once daily administration in pregnant rats at dose levels approximately 0.2 times the expected human dose resulted in an increase in visceral malformations and variations (absent or small kidney and ureter, absent uterine horn, malpositioned kidney or testis, retroesophageal aortic arch) and skeletal malformations and variations (vertebral and rib anomalies and reduced ossification). There are no controlled data in human pregnancy.

Based on histopathological findings in the reproductive tissues of male and female rats and reproduction studies with both sexes, this drug may impair fertility.

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.

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

Pralsetinib Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug and for 1 week after the last dose.

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

Comments:
-The effects in the nursing infant or on milk production are unknown.
-A risk to the breast-fed child cannot be excluded.
-As the drug is 97% bound to plasma proteins, its amount in milk is likely to be low.
-This drug may accumulate in the infant, as it has a half-life of about 22 hours.
-Because of the potential for serious adverse reactions in breastfed children, women should not breastfeed while taking this drug and for 1 week after.

See references

Further information

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

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