Can lurbinectedin cause miscarriage or stillbirth?

Can lurbinectedin cause miscarriage or stillbirth?

Lurbinectedin is not approved for use in pregnant women. Animal studies show that the drug harms fetal development at doses lower than those given to patients, so pregnancy is considered a contraindication.

Why would lurbinectedin affect a pregnancy?
Lurbinectedin interferes with DNA repair in rapidly dividing cells. In a developing fetus those same cells are essential for organ formation, which explains the observed embryo-fetal toxicity in laboratory animals.

What happens if a woman becomes pregnant while taking it?
Any exposure during the first trimester is likely to result in miscarriage or major birth defects. Exposure later in pregnancy raises the risk of stillbirth, low birth weight, and neonatal complications.

How long should pregnancy be avoided after stopping treatment?
Women of childbearing potential are advised to use effective contraception during therapy and for at least six months after the last dose. Men receiving lurbinectedin should use contraception for four months after treatment ends.

Are there recorded human cases?
No controlled human studies exist. All safety warnings rest on animal data and the drug’s mechanism of action. Regulators therefore treat any pregnancy during or soon after lurbinectedin as high risk and recommend immediate consultation with a specialist.

What alternatives exist for women who wish to conceive?
Patients who need systemic therapy for small-cell lung cancer or other approved indications should discuss fertility preservation or alternative regimens with their oncologist before starting lurbinectedin.