Ripretinib Pregnancy and Breastfeeding Warnings

Brand names: Qinlock

Medically reviewed by Drugs.com. Last updated on Sep 23, 2022.

Ripretinib Pregnancy Warnings

Safety has not been established during pregnancy.
-Some authorities recommend avoidance of this drug during pregnancy unless clearly needed.

AU TGA pregnancy category: Category D
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 pregnant women. There are no available data on the use of this drug during pregnancy to inform a drug-associated risk.

Comments:
-Females and males of reproductive potential should use effective contraception during treatment and for one week after.
-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.
-Infertility can be impaired in males of reproduction potential based on results from animal studies.

Animal studies have revealed evidence of fetal malformations, anatomic variations, and total loss of pregnancy at high doses. In pregnant rats given this drug during organogenesis, malformation of the cardiovascular and skeletal systems and anatomic variations were reported at approximately one-half the recommended human exposure dose. An embryo-fetal study on pregnant rabbits administered this drug during organogenesis resulted in total loss of pregnancy at doses over three times the human exposure. There are no controlled data in human pregnancy.

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 healthcare 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

Ripretinib Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug.

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

Comments: Breastfeeding is not recommended during treatment and at least one week after due to the potential for serious adverse reactions in the breastfed child.

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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