Lurbinectedin Pregnancy and Breastfeeding Warnings

Brand names: Zepzelca

Medically reviewed by Drugs.com. Last updated on Aug 10, 2023.

Lurbinectedin Pregnancy Warnings

Use is not recommended during pregnancy.

AU TGA pregnancy 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 a pregnant woman.

Comments:
-Adequate methods of contraception should be encouraged.
-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.
-Advise female patients of reproductive potential to use effective contraception during therapy and for 6 months after the last dose.
-Advise male patients with a female sexual partner of reproductive potential to use effective contraception during therapy and for 4 months after the last dose.

Animal studies have revealed evidence of embryolethality at a dose lower than the recommended human dose. In pregnant rats administered this drug at approximately 0.2 times the recommended human dose on gestation day 10, 100% post-implantation loss was reported. Some authorities reported testicular atrophy and hypospermia in rats and dogs when this drug was administered at doses below the recommended clinical dose. 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 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

Lurbinectedin Breastfeeding Warnings

Breastfeeding is not recommended during the use of this drug.

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

Comments:
-There is no data on the presence of this drug in human milk or its effects on the breastfed child or on milk production.
-Women are advised not to breastfeed during treatment and for 2 weeks after the last dose due to the potential for serious adverse effects on 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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