Lomustine Pregnancy and Breastfeeding Warnings

Brand names: CCNSB Capsules, CeeNU, Gleostine

Medically reviewed by Drugs.com. Last updated on Sep 4, 2024.

Lomustine Pregnancy Warnings

Use should be avoided during pregnancy unless the expected benefit outweighs any potential risk.

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

Risk summary: This drug can cause fetal harm when administered to pregnant patients; it has been shown to be embryotoxic and teratogenic in animal studies.

Comments:
-Some experts state that use of this drug is contraindicated in pregnant patients.
-Female patients of childbearing potential should be advised to avoid becoming pregnant while taking this drug and should be apprised of the potential hazard to the fetus if pregnancy occurs during treatment.
-Some experts state that female patients should be instructed to use effective contraception during therapy and for at least 2 weeks after the last dose; local protocol should be consulted regarding contraception timing.
-Male patients should be informed about the possibility of irreversible infertility caused by this drug; advised not to father children during treatment and for 3.5 to 6 months after treatment cessation; and to seek advice regarding sperm conservation prior to treatment initiation.

Animal studies have revealed evidence of embryotoxicity and teratogenicity at dose levels equivalent to the human dose; and fertility impairment in males at doses somewhat higher than the human dose. This drug should be regarded as a potential mutagen. 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

Lomustine Breastfeeding Warnings

UK: Use of this drug is contraindicated in breastfeeding mothers.
AU, US: This drug should not be given to nursing mothers.

Excreted into human milk: Yes

Comments: Some metabolites are excreted in breast milk and may be harmful in young children.

See references

Further information

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

Medical Disclaimer