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Pralsetinib Pregnancy and Breastfeeding Warnings

Pralsetinib is also known as: Gavreto

Medically reviewed by Drugs.com. Last updated on Oct 19, 2020.

Pralsetinib Pregnancy Warnings

Use should be avoided.

US FDA pregnancy category: Not assigned.

Risk Summary: Based on findings from animal studies and its mechanism of action, this drug can cause fetal harm when administered to a pregnant woman. Oral administration to pregnant rats during organogenesis resulted in malformations and embryolethality at maternal exposures below the equivalent recommended human dose.

Comments:
-This drug can harm a developing 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.
-Advise females of reproductive potential to use effective nonhormonal contraception during therapy and for 2 weeks after.
-Advise males with female partners of reproductive potential to use effective contraception during therapy and for 1 week after.
-This drug may render hormonal contraceptives ineffective.
-This drug may impair fertility.

Animal studies have revealed evidence of 100% post-implantation loss at dose levels 1.5 to 2.2 times the human exposure. Post-implantation loss also occurred at approximately 0.5 times the human exposure. At dose levels approximately 0.2 times the equivalent 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.

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

Use should be avoided.

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

Comments:
-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

References for pregnancy information

  1. "Product Information. Gavreto (pralsetinib)." Blueprint Medicines Corporation, Cambridge, MA.

References for breastfeeding information

  1. "Product Information. Gavreto (pralsetinib)." Blueprint Medicines Corporation, Cambridge, MA.

Further information

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