Avapritinib Pregnancy and Breastfeeding Warnings

Brand names: Ayvakit

Medically reviewed by Drugs.com. Last updated on Feb 21, 2024.

Avapritinib Pregnancy Warnings

Safety has not been established during pregnancy.

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.

Comments:
-Verify the pregnancy status of females of reproductive potential prior to initiating treatment.
-Apprise pregnant patients of the potential risk to a fetus.
-Advise females of reproductive potential, and males with female partners of reproductive potential, to use effective contraception during therapy and for 6 weeks after the last dose.
-Male and female fertility may be impaired by this drug, especially at higher doses.

Animal studies have revealed evidence of teratogenicity and embryofetal toxicity when this drug was administered to pregnant animals during the period of organogenesis. Adverse effects included decreased fetal body weights, post-implantation loss, and increases in visceral/skeletal malformations at doses approximately 2.7 to 31.4 times the human exposure based on AUC. There are no controlled data in human pregnancy.

Compromised fertility was observed in animal studies and findings were not reversible within a two month recovery period. Adverse effects on fertility included impaired spermatogenesis and negative impacts on early embryogenesis.

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

Avapritinib Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug and for 2 weeks after the last dose.

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

Comments:
-There are no data on the presence of this drug or its metabolites in human milk.
-The effects of this drug on the nursing infant or on milk production are unknown.
-Advise women of the potential for serious adverse reactions in the breastfed child.
-According to some experts: As this drug is highly protein bound, the amounts potentially present in human milk are expected to be low.

See references

Further information

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