Olaratumab Pregnancy and Breastfeeding Warnings

Olaratumab is also known as: Lartruvo

Olaratumab Pregnancy Warnings

No animal studies have been conducted with this drug to evaluate its effect on female reproduction and embryofetal development. Animal knockout models link disruption of platelet-derived growth factor receptor alpha (PDGFR-alpha) signaling to adverse effects on embryofetal development. Administration of an anti-murine PDGFR-alpha antibody to pregnant mice during organogenesis at exposures less than at the maximum recommended human dose caused malformations and skeletal variations. 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.

This drug should be used during pregnancy only if the benefit outweighs the risk.

US FDA pregnancy category: Not Assigned

Risk Summary: Based on animal data and its mechanism of action, this drug can cause fetal harm.

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Olaratumab Breastfeeding Warnings

Use is not recommended.

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

Comments: Because of the potential risk for serious adverse reactions in breastfeeding infants from this drug, the manufacturer recommends that women should not breastfeed during therapy and for 3 months following the last dose.

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Further information

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

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