Pemetrexed Pregnancy and Breastfeeding Warnings

Medically reviewed by Drugs.com. Last updated on Dec 16, 2022.

Pemetrexed is also known as: Alimta, Pemfexy

Pemetrexed Pregnancy Warnings

This drug has been shown to be embryotoxic, fetotoxic, and teratogenic in animal studies. This drug can also cause reduced or irreversible male infertility, hypospermia, and testicular atrophy. 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.

Use should be avoided.

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. When administered IV to pregnant animals during organogenesis it was teratogenic, resulting in developmental delays and malformations at doses lower than the recommended human dose.

Comments:
-This drug can cause fetal harm when administered to a pregnant woman due to its genetically damaging effects.
-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 hazard to the fetus.
-Women of childbearing potential should use effective contraception during treatment.
-Sexually mature males are advised not to father a child during the treatment and up to 6 months thereafter. Contraceptive measures or abstinence are recommended.
-Due to the possibility of irreversible infertility, men should be advised to seek counseling on sperm storage before starting therapy.

See references

Pemetrexed Breastfeeding Warnings

Use is contraindicated.

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

Comment: The effects in the nursing infant are unknown.

See references