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Cisplatin Pregnancy and Breastfeeding Warnings

Medically reviewed by Last updated on Aug 14, 2023.

Cisplatin is also known as: Platinol, Platinol-AQ

Cisplatin Pregnancy Warnings

Use is contraindicated.

AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned.

`Risk Summary: Based on human data, this drug can cause fetal harm when administered to pregnant women. This drug crosses the placenta. Exposure of pregnant women to this drug has been associated with oligohydramnios, intrauterine growth restriction, and preterm birth. Cases of neonatal acute respiratory distress syndrome, cytopenias, and hearing loss have been reported.

-This drug can harm a developing fetus.
-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.
-This drug has been associated with cumulative dose-dependent ovarian failure, premature menopause, and reduced fertility.
-Genetic consultation is recommended if the patient wishes to have children after ending therapy.
-Since this drug may cause irreversible infertility, it is recommended that men who wish to become fathers in the future ask for advice regarding cryoconservation of their sperm prior to treatment.
-Advise females of reproductive potential to use effective contraception during therapy and for 14 months after.
-Advise male patients with female partners of reproductive potential to use effective contraception during therapy and for 11 months after.

Animal studies have revealed evidence of embryotoxicity and teratogenicity.

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

Cisplatin Breastfeeding Warnings

Most sources consider breastfeeding to be contraindicated during maternal antineoplastic drug therapy, especially alkylating agents such as this drug. Excretion of platinum into milk occurs, but results are inconsistent. The exact form and toxicity of platinum excreted into breastmilk are also not known. The nursing infant would receive any platinum compounds orally rather than IV and oral absorption of oral platinum compounds by infants is not known.

Use is contraindicated.

Excreted into human milk: Yes

-This drug can harm a nursing infant.
-Chemotherapy may adversely affect the normal microbiome and chemical makeup of breastmilk.
-Women who receive chemotherapy during pregnancy are more likely to have difficulty nursing their infant.

See references

References for pregnancy information

  1. Product Information. Cisplatin (cisplatin). Teva SICOR Pharmaceuticals Inc. 2018.

References for breastfeeding information

  1. United States National Library of Medicine. Toxnet. Toxicology Data Network. 2013.
  2. Product Information. Cisplatin (cisplatin). Teva SICOR Pharmaceuticals Inc. 2018.

Further information

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