Can pregnant women use sotorasibu?

Pregnant women are not advised to use sotoracib, a KRAS G12C-mutant targeted drug for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) who have received at least one systemic therapy.

Can pregnant women use sotorasibu?

In the instruction manual of , there is special mention about the use of pregnant women and lactating women. The instructions state that the safety of sotorasiib in pregnant and lactating women has not been established and therefore its use during pregnancy or lactation is not recommended. If you discover that you are pregnant while taking sotoraxib, you should stop taking it immediately and contact your doctor.

Basic principles for medication use during pregnancy

First of all, it needs to be clear that medication during pregnancy always follows the principle of "no absolute safety". During pregnancy, the use of any drug needs to be treated with caution as fetal development is highly sensitive to maternally ingested substances. Drugs may not only directly affect the growth and development of the fetus, but may also pass through the placental barrier and cause irreversible damage. Therefore, the principle generally followed by the international medical community is that the use of drugs whose safety has not been proven during pregnancy should be avoided unless absolutely necessary. If pregnant women need to use sotoraxib, careful evaluation and decision-making should be made under the guidance of a physician. Pregnant women need to consider two factors when using drugs: the mother's own health and the effect of the drug on the fetus.

Risk Assessment

Given the mechanism of action of sotoraxib, which targets and inhibits specific oncogenic mutant proteins, this highly targeted treatment strategy could theoretically have unknown effects on embryonic development. Especially for rapidly dividing cells (such as those during fetal development), the potential cytotoxicity cannot be ignored. Therefore, a thorough risk and benefit assessment must be performed before initiating treatment with sotorasiib in women with known or suspected pregnancy.

Therefore, given the current lack of safety data on the use of sotoraxib in pregnant women and the potential risk the drug may pose to the fetus, pregnant women should not be treated with sotoraxib. Under special circumstances, any treatment decision should be made after a comprehensive assessment of the patient's individual situation, a full discussion of the pros and cons of treatment, and under the guidance of a multidisciplinary team to ensure the safety of mother and baby as the highest principle. At the same time, exploring and developing more safe treatment options is critical to meeting the needs of specific patient groups.